title: The @RISK Study: Risk communication for patients with type 2 diabetes: design of a randomised controlled trial Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol) Effect of a Computer-Guided, Quality Improvement Program for Cardiovascular Disease Risk Management in Primary Health Care: The Treatment of Cardiovascular Risk Using Electronic Decision Support Cluster-Randomized Trial Shared decision making for patients with type 2 diabetes: a randomized trial in primary care The impact of individualised cardiovascular disease (CVD) risk estimates and lifestyle advice on physical activity in individuals at high risk of CVD: a pilot 2 × 2 factorial understanding risk trial Web-Based Risk Communication and Planning in an Obese Population: Exploratory Study A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol Intensified preventive care to reduce cardiovascular risk in healthcare centres located in deprived neighbourhoods: a randomized controlled trial NHS health checks through general practice: randomised trial of population cardiovascular risk reduction Communicating risk using absolute risk reduction or prolongation of life formats: cluster-randomised trial in general practice. Derivation and validation of QRISK, a new cardiovascular disease risk score for the United Kingdom: prospective open cohort study Cardiovascular risk management and its impact on hypertension control in primary care in low-resource settings: a cluster-randomized trial. Discussing Coronary Risk with Patients to Improve Blood Pressure Treatment: Secondary Results from the CHECK-UP Study Protocol for the 'e-Nudge trial': a randomised controlled trial of electronic feedback to reduce the cardiovascular risk of individuals in general practice [ISRCTN64828380] Improving lifestyle and risk perception through patient involvement in nurse-led cardiovascular risk management: a cluster-randomized controlled trial in primary care. The impact of a population-based multi-factorial lifestyle intervention on changes in long-term dietary habits: the Inter99 study. Individualized Risk Communication and Outreach for Primary Cardiovascular Disease Prevention in Community Health Centers: Randomized Trial A self-determination multiple risk intervention trial to improve smokers’ health Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2 Effects Of Internet-Based Tailored Advice on the Use of Cholesterol-Lowering Interventions: A Randomized Controlled Trial Effect of the statin choice encounter decision aid in Spanish patients with type 2 diabetes: A randomized trial. The impact of a decision aid about heart disease prevention on patients' discussions with their doctor and their plans for prevention: a pilot randomized trial Prediction of coronary heart disease using risk factor categories. The long-term effect of screening and lifestyle counseling on changes in physical activity and diet: the Inter99 Study – a randomized controlled trial Pilot study to validate a computer-based clinical decision support system for dyslipidemia treatment (HTE-DLP). The effect of a patient-oriented treatment decision aid for risk factor management in patients with diabetes (PORTDA-diab): study protocol for a randomised controlled trial Controlled trial of effect of documented cardiovascular risk scores on prescribing General health screenings to improve cardiovascular risk profiles: a randomized controlled trial in general practice with 5-year follow-up. Can computerized risk profiles help patients improve their coronary risk? The results of the Coronary Health Assessment Study (CHAS). Screening for risk of cardiovascular disease is not associated with mental distress: the Inter99 study. The effect of different cardiovascular risk presentation formats on intentions, understanding and emotional affect: a randomised controlled trial using a web-based risk formatter (protocol) Individualised multifactorial lifestyle intervention trial for high-risk cardiovascular patients in primary care. A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial Evaluation of computer based clinical decision support system and risk chart for management of hypertension in primary care: randomised controlled trial Shared electronic vascular risk decision support in primary care: Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III) randomized trial. Combined Task Delegation, Computerized Decision Support, and Feedback Improve Cardiovascular Risk for Type 2 Diabetic Patients A real-world stepped wedge cluster randomized trial of practice facilitation to improve cardiovascular care Improving cardiovascular risk management: a randomized, controlled trial on the effect of a decision support tool for patients and physicians Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial Changes in CVD risk factors in the activity counseling trial Improved delivery of cardiovascular care (IDOCC) through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care: study protocol for a randomised controlled trial Rational Prescribing in Primary Care (RaPP-trial). A randomised trial of a tailored intervention to improve prescribing of antihypertensive and cholesterol-lowering drugs in general practice [ISRCTN48751230] A randomized multifactorial intervention study for prevention of ischaemic heart disease (Inter99): The long-term effect on physical activity The PreCardio-study protocol – a randomized clinical trial of a multidisciplinary electronic cardiovascular prevention programme Evaluation of a community intervention program in Japan using Framingham risk score and estimated 10-year coronary heart disease risk as outcome variables: a non-randomized controlled trial The effect of a decision aid intervention on decision making about coronary heart disease risk reduction: secondary analyses of a randomized trial Implementing clinical guidelines in the treatment of hypertension in general practice. Evaluation of patient outcome related to implementation of a computer-based clinical decision support system. The Treatment of cardiovascular Risk in Primary care using Electronic Decision suppOrt (TORPEDO) study: intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare Should Clinicians Deliver Decision Aids? Further Exploration of the Statin Choice Randomized Trial Results The effectiveness of personalized coronary heart disease and stroke risk communication. The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial Cardiovascular Risk Reduction: A Randomized Trial of Two Health Promotion Strategies for Lowering Risk in a Community with Low Socioeconomic Status Cost-Effectiveness of the Diabetes Care Protocol, a Multifaceted Computerized Decision Support Diabetes Management Intervention That Reduces Cardiovascular Risk Effect of Nurse Case Management Compared With Usual Care on Controlling Cardiovascular Risk Factors in Patients With Diabetes Impact of a multifaceted intervention on cholesterol management in primary care practices: guideline adherence for heart health randomized trial. Cardiovascular Risk Assessment and Effects on Behavior in Switzerland The Swiss Heart Foundation HerzCheck®/Cardio-Test® A novel risk score to predict cardiovascular disease risk in national populations (Globorisk): a pooled analysis of prospective cohorts and health examination surveys. EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting Improving cardiovascular health at population level: 39 community cluster randomised trial of Cardiovascular Health Awareness Program (CHAP) Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial A novel programme to evaluate and communicate 10-year risk of CHD reduces predicted risk and improves patients' modifiable risk factor profile Randomized trial evaluating the framing of cardiovascular risk and its impact on blood pressure control [ISRCTN87597585] Effects of Cardiovascular Disease Risk Communication for Patients With Type 2 Diabetes on Risk Perception in a Randomized Controlled Trial Design of a randomized controlled trial of disclosing genomic risk of coronary heart disease: the Myocardial Infarction Genes (MI-GENES) study Impact of effectiveness information format on patient choice of therapy and satisfaction with decisions about chronic disease medication: the "Influence of intervention Methodologies on Patient Choice of Therapy (IMPACT)" cluster-randomised trial in general practice A randomized trial of an intervention to improve use and adherence to effective coronary heart disease prevention strategies A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial Rational Prescribing in Primary Care (RaPP): A Cluster Randomized Trial of a Tailored Intervention A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale Effect of screening and lifestyle counselling on incidence of ischaemic heart disease in general population: Inter99 randomised trial Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour Does early intensive multifactorial therapy reduce modelled cardiovascular risk in individuals with screen-detected diabetes? Results from the ADDITION-Europe cluster randomized trial Willingness to pay for a cardiovascular prevention program in highly educated adults: a randomized controlled trial. A multidimensional integrative medicine intervention to improve cardiovascular risk Rationale and design of the Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a factorial, cluster-randomized trial of 2 practical cardiovascular disease prevention strategies developed for rural Andhra Pradesh, India. Effect of intensive structured care on individual blood pressure targets in primary care: multicentre randomised controlled trial Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. The Statin Choice decision aid in primary care: a randomized trial. A Cluster-Randomized Trial of a Centralized Clinical Pharmacy Cardiovascular Risk Service to Improve Guideline Adherence. Chronic care model and shared care in diabetes: randomized trial of an electronic decision support system. Ebeltoft project: baseline data from a five-year randomized, controlled, prospective health promotion study in a Danish population. Translating Cholesterol Guidelines Into Primary Care Practice: A Multimodal Cluster Randomized Trial The Fremantle Primary Prevention Study: a multicentre randomised trial of absolute cardiovascular risk reduction. One-year follow-up of a therapeutic lifestyle intervention targeting cardiovascular disease risk [Can systematic general health screening and patient-physician health discussions improve the cardiovascular profile of the population? A randomized controlled trial in general practice with a 5-year follow-up]. Influence of cardiovascular absolute risk assessment on prescribing of antihypertensive and lipid-lowering medications: a cluster randomized controlled trial. Automated electronic reminders to facilitate primary cardiovascular disease prevention: randomised controlled trial. Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT). Arriba: effects of an educational intervention on prescribing behaviour in prevention of CVD in general practice Sustaining cardiovascular absolute risk management in Australian general practice. Involving patients in cardiovascular risk management with nurse-led clinics: a cluster randomized controlled trial Evaluation of a cardiovascular disease risk assessment tool for the promotion of healthier lifestyles A primary care cardiovascular risk reduction clinic in Canada was more effective and no more expensive than usual on-demand primary care--a randomised controlled trial. Care manager to control cardiovascular risk factors in primary care: the Raffaello cluster randomized trial. Effect of Adding Systematic Family History Enquiry to Cardiovascular Disease Risk Assessment in Primary Care Effects of a global risk educational tool on primary coronary prevention: the Atherosclerosis Assessment Via Total Risk (AVIATOR) study Increasing knowledge of cardiovascular risk factors among African Americans by use of community health workers: the ABCD community intervention pilot project. Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study. Study protocol for a randomized controlled trial: the feasibility and impact of cardiovascular absolute risk assessment in Australian general practice. Community Outreach and Cardiovascular Health (COACH) Trial: A Randomized, Controlled Trial of Nurse Practitioner/Community Health Worker Cardiovascular Disease Risk Reduction in Urban Community Health Centers A Randomized Trial of Peer Coach and Office Staff Support to Reduce Coronary Heart Disease Risk in African-Americans with Uncontrolled Hypertension Effect of an Educational Program (PEGASE) on Cardiovascular Risk in Hypercholesterolaemic Patients [The estimation of cardiovascular risk in hypertensive patients is not modified by management of the hypertension]. Developing optimal search strategies for detecting clinically sound treatment studies in EMBASE. Patient knowledge of coronary risk profile improves the effectiveness of dyslipidemia therapy: the CHECK-UP study: a randomized controlled trial. Health checks and coronary risk: further evidence from a randomised controlled trial Presenting risk information to people with diabetes: evaluating effects and preferences for different formats by a web-based randomised controlled trial. Disclosing genetic risk for coronary heart disease: effects on perceived personal control and genetic counseling satisfaction Effectiveness of the Heart Age tool for improving modifiable cardiovascular risk factors in a Southern European population: a randomized trial Accuracy of perceptions of heart attack risk: what influences perceptions and can they be changed? Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial A randomised controlled trial of providing personalised cardiovascular risk information to modify health behaviour A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial. Implementing cardiac risk-factor case management: lessons learned in a county health system. A factorial randomised controlled trial of decision analysis and an information video plus leaflet for newly diagnosed hypertensive patients. Randomized trial of a computerized coronary heart disease risk assessment tool in HIV-infected patients receiving combination antiretroviral therapy. No long-term psychological reaction to information about increased risk of coronary heart disease in general practice Effects of a brief cardiovascular prevention program by a health advisor in primary care; the 'Hartslag Limburg' project, a cluster randomized trial. e-Care for heart wellness: a feasibility trial to decrease blood pressure and cardiovascular risk. The Collaborative Cardiovascular Risk Reduction in Primary Care (CCARP) study. Three-year follow-up of a factorial randomised controlled trial of two decision aids for newly diagnosed hypertensive patients. Absolute Cardiovascular Disease Risk and Shared Decision Making in Primary Care: A Randomized Controlled Trial Assessment of coronary heart disease risk, I. A postal inquiry among primary care physicians. Impact of decision support in electronic medical records on lipid management in primary care. Incorporating a Genetic Risk Score Into Coronary Heart Disease Risk Estimates: Effect on Low-Density Lipoprotein Cholesterol Levels (the MI-GENES Clinical Trial) Electronic Health Record-Based Patient Identification and Individualized Mailed Outreach for Primary Cardiovascular Disease Prevention: A Cluster Randomized Trial Impact of personalized cardiovascular disease risk estimates on physical activity-a randomized controlled trial. Cardiovascular Health Awareness Program (CHAP): a community cluster-randomised trial among elderly Canadians.
abstract: Background Patients with type 2 diabetes mellitus ( T2DM ) have an increased risk to develop severe diabetes related complications , especially cardiovascular disease ( CVD ) . The risk to develop CVD can be estimated by means of risk formulas . However , patients have difficulties to underst and the outcomes of these formulas . As a result , they may not recognize the importance of changing lifestyle and taking medication in time . Therefore , it is important to develop risk communication methods , that will improve the patients ' underst and ing of risks associated with having diabetes , which enables them to make informed choices about their diabetes care . The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop CVD on risk perception , attitude and intention to change lifestyle behaviour in patients with T2DM . The conceptual framework of the intervention is based on the Theory of Planned Behaviour and the Self-regulation Theory . Methods A r and omised controlled trial will be performed in the Diabetes Care System West-Friesl and ( DCS ) , a managed care system . Newly referred T2DM patients of the DCS , younger than 75 years will be eligible for the study . The intervention group will be exposed to risk communication on CVD , on top of st and ard managed care of the DCS . This intervention consists of a simple explanation on the causes and consequences of CVD , and possibilities for prevention . The probabilities of CVD in 10 year will be explained in natural frequencies and visualised by a population diagram . The control group will receive st and ard managed care . The primary outcome is appropriateness of risk perception . Secondary outcomes are attitude and intention to change lifestyle behaviour and illness perception . Differences between baseline and follow-up ( 2 and 12 weeks ) between groups will be analysed according to the intention-to-treat principle . The study was powered on 120 patients in each group . Discussion This innovative risk communication method based on two behavioural theories might improve patient 's appropriateness of risk perception and attitude concerning lifestyle change . With a better underst and ing of their CVD risk , patients will be able to make informed choices concerning diabetes care . Trail registration The trial is registered as NTR1556 in the Dutch Trial Register Background Many patients at high risk of cardiovascular diseases are managed and monitored in general practice . Recommendations for cardiovascular risk management , including lifestyle change , are clearly described in the Dutch national guideline . Although lifestyle interventions , such as advice on diet , physical exercise , smoking and alcohol , have moderate , but potentially relevant effects in these patients , adherence to lifestyle advice in general practice is not optimal . The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics . The aim of this paper is to describe the design and methods of a study to evaluate an intervention aim ed at involving patients in cardiovascular risk management . Methods A cluster-r and omised controlled trial in 20 general practice s , 10 practice s in the intervention arm and 10 in the control arm , starting on October 2005 . A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited . In both arms , the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management . Nurses in the intervention arm will receive an extended training in risk assessment , risk communication , the use of a decision aid and adapted motivational interviewing . This communication technique will be used to support the shared decision-making process about risk reduction . The intervention comprises 2 consultations and 1 follow-up telephone call . The nurses in the control arm will give usual care after the risk estimation , according to the national guideline . Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment . Secondary outcome measures are the patients ' perception of risk and their motivation to change their behaviour . The measurements will take place at baseline and after 12 and 52 weeks . Clinical endpoints will not be measured , but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year . Discussion The combined use of risk communication , a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention . Trial registration Current Controlled Trials IS RCT Background — Despite effective treatments to reduce cardiovascular disease risk , their translation into practice is limited . Methods and Results — Using a parallel arm cluster-r and omized controlled trial in 60 Australian primary healthcare centers , we tested whether a multifaceted quality improvement intervention comprising computerized decision support , audit/feedback tools , and staff training improved ( 1 ) guideline -indicated risk factor measurements and ( 2 ) guideline -indicated medications for those at high cardiovascular disease risk . Centers had to use a compatible software system , and eligible patients were regular attendees ( Aboriginal and Torres Strait Isl and er people aged ≥35 years and others aged ≥45 years ) . Patient-level analyses were conducted using generalized estimating equations to account for clustering . Median follow-up for 38 725 patients ( mean age , 61.0 years ; 42 % men ) was 17.5 months . Mean monthly staff support was < 1 hour/site . For the co primary outcomes , the intervention was associated with improved overall risk factor measurements ( 62.8 % versus 53.4 % risk ratio ; 1.25 ; 95 % confidence interval , 1.04–1.50 ; P=0.02 ) , but there was no significant differences in recommended prescriptions for the high-risk cohort ( n=10 308 ; 56.8 % versus 51.2 % ; P=0.12 ) . There were significant treatment escalations ( new prescriptions or increased numbers of medicines ) for antiplatelet ( 4.3 % versus 2.7 % ; P=0.01 ) , and BP lowering ( 18.2 % versus 11.0 % ; P=0.02 ) but not lipid-lowering medications . Conclusions — In Australian primary healthcare setting s , a computer-guided quality improvement intervention , requiring minimal support , improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group . Computerized quality improvement tools offer an important , albeit partial , solution to improving primary healthcare system capacity for cardiovascular disease risk management . Clinical Trial Registration — URL : https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=336630 . Australian New Zeal and Clinical Trials Registry No. 12611000478910 Background Patient-centered diabetes care requires shared decision making ( SDM ) . Decision aids promote SDM , but their efficacy in nonacademic and rural primary care clinics is unclear . Methods We cluster-r and omized 10 practice s in a concealed fashion to implement either a decision aid ( DA ) about starting statins or one about choosing antihyperglycemic agents . Each practice served as a control group for another practice implementing the other type of DA .  From April 2011 to July 2012 , 103 ( DA=53 ) patients with type 2 diabetes participated in the trial . We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes ( patient knowledge and comfort with decision making , patient and clinician satisfaction ) . Medical records provided data on metabolic control . Pharmacy fill profiles provided data for estimating adherence to therapy . Results Compared to usual care , patients receiving the DA were more likely to report discussing medications ( 77 % vs. 45 % , p<.001 ) , were more likely to answer knowledge questions correctly ( risk reduction with statins 61 % vs. 33 % , p=.07 ; knowledge about options 57 % vs. 33 % , p=.002 ) and were more engaged by their clinicians in decision making ( 50 . vs. 28 , difference 21.4 ( 95 % CI 6.4 , 36.3 ) , p=.01 ) . We found no significant impact on patient satisfaction , medication starts , adherence or clinical outcomes , in part due to limited statistical power . Conclusion DAs improved decisional outcomes without significant effect on clinical outcomes . DAs design ed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practice s . Trial Registration Background There is currently much interest in encouraging individuals to increase physical activity in order to reduce CVD risk . This study has been design ed to determine if personalised CVD risk appreciation can increase physical activity in adults at high risk of CVD . Methods / Design In a 2 × 2 factorial design participants are allocated at r and om to a personalised 10-year CVD risk estimate or numerical CVD risk factor values ( systolic blood pressure , LDL cholesterol and fasting glucose ) and , simultaneously , to receive a brief lifestyle advice intervention targeting physical activity , diet and smoking cessation or not . We aim to recruit 200 participants from Oxfordshire primary care practice s. Eligibility criteria include adults age 40–70 years , estimated 10-year CVD risk ≥20 % , ability to read and write English , no known CVD and no physical disability or other condition reducing the ability to walk . Primary outcome is physical activity measured by ActiGraph accelerometer with biochemical , anthropometrical and psychological measures as additional outcomes . Primary analysis is between group physical activity differences at one month powered to detect a difference of 30,000 total counts per day of physical activity between the groups . Additional analyses will seek to further eluci date the relationship between the provision of risk information , and intention to change behaviour and to determine the impact of both interventions on clinical and anthropometrical measures including fasting and 2 hour plasma glucose , fructosamine , serum cotinine , plasma vitamin C , body fat percentage and blood pressure . Discussion This is a pilot trial seeking to demonstrate in a real world setting , proof of principal that provision of personalised risk information can contribute to behaviour changes aim ed at reducing CVD risk . This study will increase our underst and ing of the links between the provision of risk information and behaviour change and if successful , could be used in clinical practice with little or no modification Background A healthy diet , low in saturated fat and high in fiber , is a popular medical recommendation in preventing cardiovascular disease ( CVD ) . One approach to motivating healthier eating is to raise individuals ’ awareness of their CVD risk and then help them form specific plans to change . Objectives The aim was to explore the combined impact of a Web-based CVD risk message and a fully automated planning tool on risk perceptions , intentions , and saturated fat intake changes over 4 weeks . Methods Of the 1187 men and women recruited online , 781 were r and omly allocated to one of four conditions : a CVD risk message , the same CVD risk message paired with planning , planning on its own , and a control group . All outcome measures were assessed by online self-reports . Generalized linear modeling was used to analyze the data . Results Self-perceived consumption of low saturated fat foods ( odds ratio 11.40 , 95 % CI 1.86–69.68 ) and intentions to change diet ( odds ratio 21.20 , 95 % CI 2.6–172.4 ) increased more in participants allocated to the planning than the control group . No difference was observed between the four conditions with regard to percentage saturated fat intake changes . Contrary to our expectations , there was no difference in perceived and percentage saturated fat intake change between the CVD risk message plus planning group and the control group . Risk perceptions among those receiving the CVD risk message changed to be more in line with their age ( change in slopeindividual = 0.075 , P = .01 ; change in slopecomparative = 0.100 , P = .001 ) , whereas there was no change among those who did not receive the CVD risk message . Conclusion There was no evidence that combining a CVD risk message with a planning tool reduces saturated fat intake more than either alone . Further research is required to identify ways in which matching motivational and volitional strategies can lead to greater behavior changes . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 91154001 ; http://www.controlled-trials.com/IS RCT N91154001 ( Archived by WebCite at http://www.webcitation.org/62sBoGeOO Background Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension . Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs . Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce . Given such limited re sources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA . Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy . This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction . Methods Using a cluster r and omized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be r and omized to either the  intervention  group ( 16 CHCs ) or the control group ( 16 CHCs ) . A total of 640 patients with uncomplicated hypertension ( BP 140–179/90–99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) . The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months . The primary outcome is the mean change in systolic BP from baseline to 12 months . The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months . All outcomes will be assessed at baseline , six months and 12 months . Trained community health nurses will deliver the intervention as part of Ghana ’s community-based health planning and services ( CHPS ) program . Discussion Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in re source -poor setting s . Trial registration NCT01802372 Background We examined the effectiveness of a structured collaboration in general practice between a practice nurse , a peer health educator , the general practitioner ( GP ) and a GP assistant in providing intensified preventive care for patients at high risk of developing cardiovascular diseases . Design A r and omized controlled trial in three healthcare centres ( 18 GPs ) in deprived neighbourhoods of two major Dutch cities . Methods Two hundred seventy-five high-risk patients ( 30 - 70 years ) from various ethnic groups were r and omized to intervention ( n = 137 ) or usual care group ( n = 138 ) . We determined group differences in outcomes [ 10-year absolute risk ( Framingham risk equation ) , blood pressure , lipids and body mass index ] at 12-month follow-up . Results The 10-year absolute risk was reduced by 1.76 % ( st and ard error : 0.81 ) in intervention and by 2.27 % ( st and ard error : 0.69 ) in usual care group ; the difference in mean change was 0.88 % [ 95 % confidence interval : −1.16 to 2.93 ] . In both groups significant reductions were observed in the following individual risk factors : total cholesterol , total cholesterol/high-density lipoprotein cholesterol , and low-density lipoprotein cholesterol , with no relevance between group differences . Conclusion The cardiovascular risk profile of intervention and control patients improved after 1-year follow-up . However , no extra effect of the structured preventive care on the risk for cardiovascular diseases was achieved . Eur J Cardiovasc Prev Rehabil 15:488 - 493 © 2008 The European Society of Background The global burden of the major vascular diseases is projected to rise and to remain the dominant non-communicable disease cluster well into the twenty first century . The Department of Health in Engl and has developed the NHS Health Check service as a policy initiative to reduce population vascular disease risk . The aims of this study were to monitor population changes in cardiovascular disease ( CVD ) risk factors over the first year of the new service and to assess the value of tailored lifestyle support , including motivational interview with ongoing support and referral to other services . Methods R and omised trial comparing NHS Health Check service only with NHS Health Check service plus additional lifestyle support in Stoke on Trent , Engl and . Thirty eight general practice s and 601 ( 365 usual care , 236 additional lifestyle support ) patients were recruited and r and omised independently between September 2009 and February 2010 . Changes in population CVD risk between baseline and one year follow-up were compared , using intention-to-treat analysis . The primary outcome was the Framingham 10 year CVD risk score . Secondary outcomes included individual modifiable risk measures and prevalence of individual risk categories . Additional lifestyle support included referral to a lifestyle coach and free sessions as needed for : weight management , physical activity , cook and eat and positive thinking . Results Average population CVD risk decreased from 32.9 % to 29.4 % ( p < 0.001 ) in the NHS Health Check only group and from 31.9 % to 29.2 % ( p < 0.001 ) in the NHS Health Check plus additional lifestyle support group . There was no significant difference between the two groups at either measurement point . Prevalence of high blood pressure , high cholesterol and smoking were reduced significantly ( p < 0.01 ) in both groups . Prevalence of central obesity was reduced significantly ( p < 0.01 ) in the group receiving additional lifestyle support but not in the NHS Health Check only group . Conclusions The NHS Health Check service in Stoke on Trent result ed in significant reduction in estimated population CVD risk . There was no evidence of further benefit of the additional lifestyle support services in terms of absolute CVD risk reduction BACKGROUND It is important that patients are well-informed about risks and benefits of therapies to help them decide whether to accept medical therapy . Different numerical formats can be used in risk communication but It remains unclear how the different formats affect decisions made by real-life patients . AIM To compare the impact of using Prolongation Of Life ( POL ) and Absolute Risk Reduction ( ARR ) information formats to express effectiveness of cholesterol-lowering therapy on patients ' redemptions of statin prescriptions , and on patients ' confidence in their decision and satisfaction with the risk communication . DESIGN AND SETTING Cluster-r and omised clinical trial in general practice s. Thirty-four Danish GPs from 23 practice s participated in a primary care-based clinical trial concerning use of quantitative effectiveness formats for risk communication in health prevention consultations . METHOD GPs were cluster-r and omised ( treating practice s as clusters ) to inform patients about cardiovascular mortality risk and the effectiveness of statin treatment using either POL or ARR formats . Patients ' redemptions of statin prescriptions were obtained from a regional prescription data base . The COMRADE question naire was used to measure patients ' confidence in their decision and satisfaction with the risk communication . RESULTS Of the 240 patients included for analyses , 112 were allocated to POL information and 128 to ARR . Patients redeeming a statin prescription totalled six ( 5.4 % ) when informed using POL , and 32 ( 25.0 % ) when using ARR . The level of confidence in decision and satisfaction with risk communication did not differ between the risk formats . CONCLUSION Patients redeemed statin prescriptions less often when their GP communicated treatment effectiveness using POL compared with ARR Objective To derive a new cardiovascular disease risk score ( QRISK ) for the United Kingdom and to vali date its performance against the established Framingham cardiovascular disease algorithm and a newly developed Scottish score ( ASSIGN ) . Design Prospect i ve open cohort study using routinely collected data from general practice . Setting UK practice s contributing to the Q RESEARCH data base . Participants The derivation cohort consisted of 1.28 million patients , aged 35 - 74 years , registered at 318 practice s between 1 January 1995 and 1 April 2007 and who were free of diabetes and existing cardiovascular disease . The validation cohort consisted of 0.61 million patients from 160 practice s. Main outcome measures First recorded diagnosis of cardiovascular disease ( incident diagnosis between 1 January 1995 and 1 April 2007 ) : myocardial infa rct ion , coronary heart disease , stroke , and transient ischaemic attacks . Risk factors were age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol to high density lipoprotein , body mass index , family history of coronary heart disease in first degree relative aged less than 60 , area measure of deprivation , and existing treatment with antihypertensive agent . Results A cardiovascular disease risk algorithm ( QRISK ) was developed in the derivation cohort . In the validation cohort the observed 10 year risk of a cardiovascular event was 6.60 % ( 95 % confidence interval 6.48 % to 6.72 % ) in women and 9.28 % ( 9.14 % to 9.43 % ) in men . Overall the Framingham algorithm over-predicted cardiovascular disease risk at 10 years by 35 % , ASSIGN by 36 % , and QRISK by 0.4 % . Measures of discrimination tended to be higher for QRISK than for the Framingham algorithm and it was better calibrated to the UK population than either the Framingham or ASSIGN models . Using QRISK 8.5 % of patients aged 35 - 74 are at high risk ( 20 % risk or higher over 10 years ) compared with 13 % when using the Framingham algorithm and 14 % when using ASSIGN . Using QRISK 34 % of women and 73 % of men aged 64 - 75 would be at high risk compared with 24 % and 86 % according to the Framingham algorithm . UK estimates for 2005 based on QRISK give 3.2 million patients aged 35 - 74 at high risk , with the Framingham algorithm predicting 4.7 million and ASSIGN 5.1 million . Overall , 53 668 patients in the validation data set ( 9 % of the total ) would be reclassified from high to low risk or vice versa using QRISK compared with the Framingham algorithm . Conclusion QRISK performed at least as well as the Framingham model for discrimination and was better calibrated to the UK population than either the Framingham model or ASSIGN . QRISK is likely to provide more appropriate risk estimates to help identify high risk patients on the basis of age , sex , and social deprivation . It is therefore likely to be a more equitable tool to inform management decisions and help ensure treatments are directed towards those most likely to benefit . It includes additional variables which improve risk estimates for patients with a positive family history or those on antihypertensive treatment . However , since the validation was performed in a similar population to the population from which the algorithm was derived , it potentially has a “ home advantage . ” Further validation in other population s is therefore required OBJECTIVE To evaluate a simple cardiovascular risk management package for assessing and managing cardiovascular risk using hypertension as an entry point in primary care facilities in low-re source setting s. METHODS Two geographically distant regions in two countries ( China and Nigeria ) were selected and 10 pairs of primary care facilities in each region were r and omly selected and matched . Regions were then r and omly assigned to a control group , which received usual care , or to an intervention group , which applied the cardiovascular risk management package . Each facility enrolled 60 consecutive patients with hypertension . Intervention sites educated patients about risk factors at baseline and initiated treatment with hydrochlorothiazide at 4 months in patients at medium risk of a cardiovascular event , according to a st and ardized treatment algorithm . Systolic blood pressure change from baseline to 12 months was the primary outcome measure . FINDINGS The study included 2397 patients with baseline hypertension : 1191 in 20 intervention facilities and 1206 in 20 control facilities .  Systolic and diastolic blood pressure decreased more in intervention patients than in controls . However , at 12 months more than half of patients still had uncontrolled hypertension ( systolic blood pressure > 140 mmHg and /or diastolic blood pressure > 90 mmHg ) . Behavioural risk factors had improved among intervention patients in Nigeria but not in China . Only about 2 % of hypertensive patients required referral to the next level of care . CONCLUSION Even in low-re source setting s , hypertensive patients can be effectively assessed and managed in primary care facilities Objectives Hypertension is common among patients with dyslipidemia but is often poorly treated . The objective of this analysis was to evaluate how a decision aid , used by primary care physicians to improve lipid therapy , impacted on the treatment of hypertension . Study Design Data were analyzed from patients enrolled in a r and omized trial focusing primarily on the treatment of dyslipidemia . Patients received usual care or a coronary risk profile every three months to monitor the risk reduction following lifestyle changes and /or pharmacotherapy to treat dyslipidemia . Hypertension management was assessed based on a post hoc analysis of individuals whose blood pressure exceeded current national hypertension guidelines . Results There were 2,631 subjects who completed the study . Among 1,352 patients without diagnosed hypertension , 30 % were above target on at least three consecutive visits . Among 1,279 individuals with known hypertension , 69 % were above target on at least two consecutive visits . Overall , patients receiving risk profiles were more likely to receive appropriate antihypertensive therapy  ( OR = 1.40 , 95 % CI 1.11 – 1.78 ) compared to those receiving usual care . After adjustment for inter-physician variability and potential confounders , the use of the risk profile was associated with an increased likelihood of starting therapy ( OR = 1.78 , 95 % CI 1.06 – 3.00 ) or modifying therapy ( OR = 1.40 , 95 % CI 1.03 – 1.91 ) . Conclusions In this clinical trial of dyslipidemia management , inadequately controlled hypertension was common , occurring in nearly 50 % of individuals . Ongoing coronary risk assessment was associated with more appropriate blood pressure management . Cardiovascular risk assessment decision aids should be further evaluated in a r and omized trial of hypertension therapy Background Cardiovascular disease ( including coronary heart disease and stroke ) is a major cause of death and disability in the United Kingdom , and is to a large extent preventable , by lifestyle modification and drug therapy . The recent st and ardisation of electronic codes for cardiovascular risk variables through the United Kingdom 's new General Practice contract provides an opportunity for the application of risk algorithms to identify high risk individuals . This r and omised controlled trial will test the benefits of an automated system of alert messages and practice search es to identify those at highest risk of cardiovascular disease in primary care data bases . Design Patients over 50 years old in practice data bases will be r and omised to the intervention group that will receive the alert messages and search es , and a control group who will continue to receive usual care . In addition to those at high estimated risk , potentially high risk patients will be identified who have insufficient data to allow a risk estimate to be made . Further groups identified will be those with possible undiagnosed diabetes , based either on elevated past recorded blood glucose measurements , or an absence of recent blood glucose measurement in those with established cardiovascular disease . Outcome measures The intervention will be applied for two years , and outcome data will be collected for a further year . The primary outcome measure will be the annual rate of cardiovascular events in the intervention and control arms of the study . Secondary measures include the proportion of patients at high estimated cardiovascular risk , the proportion of patients with missing data for a risk estimate , and the proportion with undefined diabetes status at the end of the trial OBJECTIVE To determine if lifestyle improved at a short term through an intervention to involve patients in cardiovascular risk management by the practice nurse . METHODS The IMPALA study ( 2006 , the Netherl and s ) was a cluster-r and omised controlled trial involving 25 general practice s and 615 patients who were eligible for cardiovascular risk management . The intervention consisted of ( 1 ) individual 10-year cardiovascular risk assessment , ( 2 ) risk communication , ( 3 ) use of a decision aid and ( 4 ) adapted motivational interviewing , applied by practice nurses in two consultations . Outcomes were smoking , alcohol , diet , physical activity and the secondary outcomes risk perception , anxiety , confidence about the decision and satisfaction with the communication , measured at baseline and after 12 weeks . RESULTS Patients of both groups improved their lifestyle , but no relevant significant differences between the groups were found . Intervention group patients improved in terms of the appropriateness of risk perception , although not significantly . Intervention group patients improved significantly in terms of appropriateness of anxiety and were more satisfied with the communication compared to control group patients . CONCLUSION The intervention seems to have improved the patients ' risk perception , anxiety and satisfaction with the communication , which are important conditions for shared decision making . However , we found no additional effect of the intervention on lifestyle OBJECTIVE To evaluate the effectiveness of a  population -based multi-factorial lifestyle intervention on long-term changes in dietary habits compared to a non-intervention control group . METHODS The study was a r and omized controlled lifestyle intervention study , Inter99 ( 1999 - 2006 ) , Copenhagen , Denmark , using a high-risk strategy . Participants in the intervention group ( n=6 091 ) had at baseline a medical health-examination and a face-to-face lifestyle counselling . Individuals at high risk of ischemic heart disease were repeatedly offered both individual and group-based counselling . The control group ( n=3 324 ) was followed by question naires .  Dietary habits were measured by a vali date d 48-item food frequency question naire and changes were analyzed by multilevel analyses . RESULTS At the 5-year follow-up the intervention group compared to the control group had significantly increased their intake of vegetables ( men : net-change : 23 g/week ; p=0.04 ; women : net-change : 27 g/week ; p=0.005 ) and decreased the intake of highly saturated fats used on bread and for cooking ( men : OR=0.59 ( 0.41 - 0.86 ) ; women : OR=0.42 ( 0.30 - 0.59 ) ) . Significant effects on fruit and fish intake were found at the 3-year follow-up but the effect attenuated at the 5-year follow-up . CONCLUSION A population -based multi-factorial lifestyle intervention promoted significant greater beneficial long-term dietary changes compared to the control group , especially the intake of vegetables and saturated fat was improved Background —Many eligible primary cardiovascular disease prevention c and i date s are not treated with statins . Electronic health record data can identify patients with increased cardiovascular disease risk . Methods and Results —We performed a pragmatic r and omized controlled trial at community health centers in 2 states . Participants were men aged ≥35 years and women ≥45 years , without cardiovascular disease or diabetes mellitus , and with a 10-year risk of coronary heart disease of at least 10 % . The intervention group received telephone and mailed outreach , individualized based on patients ’ cardiovascular disease risk and uncontrolled risk factors , provided by lay health workers . Main outcomes included : documented discussion of medication treatment for cholesterol with a primary care clinician , receipt of statin prescription within 6 months , and low-density lipoprotein (LDL)-cholesterol repeated and at least 30 mg/dL lower than baseline within 1 year . Six hundred forty-six participants ( 328 and 318 in the intervention and control groups , respectively ) were included . At 6 months , 26.8 % of intervention and 11.6 % of control patients had discussed cholesterol treatment with a primary care clinician ( odds ratio , 2.79 ; [ 95 % confidence interval , 2.25–3.46 ] ) . Statin prescribing occurred for 10.1 % in the intervention group and 6.0 % in the control group ( odds ratio , 1.76 ; [ 95 % confidence interval , 0.90–3.45 ] ) . The cholesterol outcome did not differ , and the majority of patients did not repeat lipid levels during follow-up . Conclusions —Risk communication and lay outreach increased cholesterol treatment discussion s with primary care clinicians . However , most discussion s did not result in statin prescribing . For outreach to be successful , it should be combined with interventions to encourage clinicians to follow contemporary risk-based cholesterol treatment guidelines . Clinical Trial Registration —URL : http://www.clincialtrials.gov . Unique identifier : NCT01610609 Abstract BACKGROUND : Little is known about how interventions motivate individuals to change multiple health risk behaviors . Self-determination theory ( SDT ) proposes that patient autonomy is an essential factor for motivating change . OBJECTIVE : An SDT-based intervention to enhance autonomous motivation for tobacco abstinence and improving cholesterol was tested . DESIGN : The Smokers ’ Health Study is a r and omized multiple risk behavior change intervention trial . SETTING : Smokers were recruited to a tobacco treatment center . PATIENTS : A total of 1,006 adult smokers were recruited between 1999 and 2002 from physician offices and by newspaper advertisements . INTERVENTIONS : A 6-month clinical intervention ( 4 contacts ) to facilitate internalization of autonomy and perceived competence for tobacco abstinence and reduced percent calories from fat was compared with community care . Clinicians elicited patient perspectives and life strivings , provided absolute coronary artery disease risk estimates , enumerated effective treatment options , supported patient initiatives , minimized clinician control , assessed motivation for change , and developed a plan for change . MAIN OUTCOME MEASURES : Twelve-month prolonged tobacco abstinence , and change in percent calories from fat and low-density lipoprotein-cholesterol ( LDL-C ) from baseline to 18 months . RESULTS : Intention to treat analyses revealed that the intervention significantly increased 12-month prolonged tobacco abstinence ( 6.2 % vs 2.4 % ; odds ratio [OR]=2.7,P=.01 , number needed to treat [NNT]=26 ) , and reduced LDL-C ( −8.9 vs −4.1 mg/dL;P=.05 ) . There was no effect on percent calories from fat . CONCLUSIONS : An intervention focused on supporting smokers ’ autonomy was effective in increasing prolonged tobacco abstinence and lowering LDL-C. Clinical interventions for behavior change may be improved by increasing patient autonomy and perceived competence BACKGROUND Poor quality of information transfer about the benefits and risks of statin drug use may result in patients not making informed decisions that they can act on in a timely fashion . METHODS The effect of a decision aid about statin drugs on treatment decision making in 98 patients with diabetes was determined in a cluster r and omized trial of decision aid vs control pamphlet , with concealed allocation , blinding of participants to study goals , and adherence to the intention-to-treat principle . Twenty-one endocrinologists conducted specialty outpatient metabolic consultations . Patients in the intervention group received Statin Choice , a tailored decision aid that presents the estimated 10-year cardiovascular risk , the absolute risk reduction with use of statin drugs , and the disadvantages of using statin drugs . Patients in the control group received the institution 's pamphlet about cholesterol management . We measured acceptability , knowledge about options and cardiovascular risk , and decisional conflict immediately after the visit , and adherence to pill taking was measured 3 months later . RESULTS Patients favored using the decision aid ( odds ratio [ OR ] , 2.8 ; 95 % confidence interval [ CI ] , 1.2 - 6.9 ) ; patients who received the decision aid ( n = 52 ) knew more ( difference , 2.4 of 9 points ; 95 % CI , 1.5 - 3.3 ) , had better estimated cardiovascular risk ( OR , 22.4 ; 95 % CI , 5.9 - 85.6 ) and potential absolute risk reduction with statin drugs ( OR , 6.7 ; 95 % CI , 2.2 - 19.7 ) , and had less decisional conflict ( difference , -10.6 ; 95 % CI , -15.4 to -5.9 on a 100-point scale ) than did patients in the control group ( n = 46 ) . Of 33 patients in the intervention group taking statin drugs at 3 months , 2 reported missing 1 dose or more in the last week compared with 6 of 29 patients in the control group taking statin drugs ( OR , 3.4 ; 95 % CI , 1.5 - 7.5 ) . CONCLUSIONS A decision aid enhanced decision making about statin drugs and may have favorably affected drug adherence Objective To develop and vali date version two of the QRISK cardiovascular disease risk algorithm ( QRISK2 ) to provide accurate estimates of cardiovascular risk in patients from different ethnic groups in Engl and and Wales and to compare its performance with the modified version of Framingham score recommended by the National Institute for Health and Clinical Excellence ( NICE ) . Design Prospect i ve open cohort study with routinely collected data from general practice , 1 January 1993 to 31 March 2008 . Setting 531 practice s in Engl and and Wales contributing to the national Q RESEARCH data base . Participants 2.3 million patients aged 35 - 74 ( over 16 million person years ) with 140 000 cardiovascular events . Overall population ( derivation and validation cohorts ) comprised 2.22 million people who were white or whose ethnic group was not recorded , 22 013 south Asian , 11 595 black African , 10 402 black Caribbean , and 19 792 from Chinese or other Asian or other ethnic groups . Main outcome measures First ( incident ) diagnosis of cardiovascular disease ( coronary heart disease , stroke , and transient ischaemic attack ) recorded in general practice records or linked Office for National Statistics death certificates . Risk factors included self assigned ethnicity , age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol : high density lipoprotein cholesterol , body mass index , family history of coronary heart disease in first degree relative under 60 years , Townsend deprivation score , treated hypertension , type 2 diabetes , renal disease , atrial fibrillation , and rheumatoid arthritis . Results The validation statistics indicated that QRISK2 had improved discrimination and calibration compared with the modified Framingham score . The QRISK2 algorithm explained 43 % of the variation in women and 38 % in men compared with 39 % and 35 % , respectively , by the modified Framingham score . Of the 112 156 patients classified as high risk ( that is , ≥20 % risk over 10 years ) by the modified Framingham score , 46 094 ( 41.1 % ) would be reclassified at low risk with QRISK2 . The 10 year observed risk among these reclassified patients was 16.6 % ( 95 % confidence interval 16.1 % to 17.0%)—that is , below the 20 % treatment threshold . Of the 78 024 patients classified at high risk on QRISK2 , 11 962 ( 15.3 % ) would be reclassified at low risk by the modified Framingham score . The 10 year observed risk among these patients was 23.3 % ( 22.2 % to 24.4%)—that is , above the 20 % threshold . In the validation cohort , the annual incidence rate of cardiovascular events among those with a QRISK2 score of ≥20 % was 30.6 per 1000 person years ( 29.8 to 31.5 ) for women and 32.5 per 1000 person years ( 31.9 to 33.1 ) for men . The corresponding figures for the modified Framingham equation were 25.7 per 1000 person years ( 25.0 to 26.3 ) for women and 26.4 ( 26.0 to 26.8 ) for men ) . At the 20 % threshold , the population identified by QRISK2 was at higher risk of a CV event than the population identified by the Framingham score . Conclusions Incorporating ethnicity , deprivation , and other clinical conditions into the QRISK2 algorithm for risk of cardiovascular disease improves the accuracy of identification of those at high risk in a nationally representative population . At the 20 % threshold , QRISK2 is likely to be a more efficient and equitable tool for treatment decisions for the primary prevention of cardiovascular disease . As the validation was performed in a similar population to the population from which the algorithm was derived , it potentially has a “ home advantage . ” Further validation in other population s is therefore advised Background Elevated low-density lipoprotein ( LDL ) cholesterol is a leading risk factor for cardiovascular disease . Despite the availability of proven interventions to lower LDL cholesterol , their use remains subobtimal . Many websites provide interactive , tailored advice on cardiovascular risk in an attempt to help bridge this evidence - practice gap , yet there is little evidence that provision of such a tool is effective in changing practice . Objectives The objective was to define the effects on use of  cholesterol-lowering interventions of a consumer-targeted tailored advice website . Methods This was a prospect i ve , double-blind , r and omized controlled trial open to any adult Australian with access to the Internet . A total of 2099 participants were r and omized . Of these , 45 % were male , the mean age of all participants was 56 , and 1385 ( 66 % ) self-reported hypercholesterolemia . Follow-up information was obtained for 1945 ( 93 % ) . Participants completed a brief online question naire . Individuals assigned to intervention received immediate , fully automated , personally tailored advice ( based on current guidelines ) regarding the need for commencement of statin therapy , increased statin therapy in those already on treatment , and nondrug intervention strategies . Control group participants were directed to static Web pages providing general information about cholesterol management . Results The primary outcome was the proportion of participants that commenced or increased use of prescribed cholesterol-lowering therapy . Of the total 2099 r and omized participants , 304 ( 14 % ) met eligibility criteria for cholesterol-lowering therapy but were not prescribed treatment , and 254 ( 12 % ) were prescribed treatment but were not achieving the recommended target level . Treatment was commenced or increased in 64 ( 6.0 % ) of the 1062 intervention group participants and 79 ( 7.6 % ) of the 1037 control group participants ( % difference = -1.6 % , 95 % confidence interval [ CI ] -3.75 to 0.57 , P = .15 ) . No differences were found between the r and omized groups for the secondary outcomes of “ discussed treatment with a health professional ” ( % difference = -3.8 % , 95 % confidence interval [ CI ] -8.16 to 0.19 , P = .08 ) , “ had their cholesterol checked ” ( % difference = -1.5 % , 95 % CI -5.79 to 2.71 , P = .48 ) , “ had their blood pressure checked ” ( % difference = 1.4 % , 95 % CI -2.55 to 5.34 , P = .49 ) or made a lifestyle change ( P values between .49 and .96 ) . Conclusions Despite providing specific carefully tailored advice , this website had no detectable effect on cholesterol management strategies . This finding raises considerable uncertainty about the value of Internet-based tools providing tailored advice directly to consumers . Trial Registration NCT00220974 ; http:// clinical trials.gov/ct2/show/NCT00220974 ( Archived by WebCite at http://www.webcitation.org/5sdq63rrY OBJECTIVE Statin choice , an encounter decision aid ( DA ) , was developed in the USA to facilitate shared decision making between patients and clinicians about the use of statins to reduce cardiovascular risk . We aim ed to assess the efficacy of this DA , compared to usual primary care , in Spanish patients with type 2 diabetes . METHODS Cluster r and omized trial with 29 clinicians and 168 patients .  Knowledge of statins , cardiovascular risk perception , decisional conflict , anxiety and satisfaction with the decision making process were assessed immediately after intervention , and self-reported adherence at three months . RESULTS Intervention significantly improved knowledge ( p=0.01 ) , perception of the 10-year risk of myocardial infa rct ion without ( p=0.01 ) and with statins ( p=0.08 ) , and satisfaction ( p=0.01 ) . There were no significant differences in decisional conflict , anxiety , consultation time or adherence , although more intervention patients reported taking all pills during the last week ( 92.7 % vs. 81 % ; p=0.19 ) . CONCLUSION The statin choice DA improved the quality of decision making about statins . PRACTICE IMPLICATION S This trial contributes to the body of evidence substantiating the efficacy of statin choice and extending it to Spanish clinicians and their patients with type 2 diabetes . TRIAL REGISTRATION This trial is registered with the European Union Clinical Trials Register ( EudraCT : 2010 - 023912 - 14 ) Abstract Background Low utilization of effective coronary heart disease ( CHD ) prevention strategies may be due to many factors , but chief among them is the lack of patient involvement in prevention decisions . We undertook this study to test the effectiveness of an individually-tailored , computerized decision aid about CHD on patients ' discussion s with their doctor and their plans for CHD prevention . Methods We conducted a pilot r and omized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored , computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor . Results We enrolled 75 adults . Mean age was 53 . 59 % were female , 73 % white , and 23 % African-American . 66 % had some college education . 43 % had a 10-year CHD risk of 0–5 % , 25 % a risk of 6–10 % , 24 % a risk of 11–20 % , and 5 % a risk of > 20 % . 78 % had at least one option to reduce their CHD risk , but only 45 % accurately identified the strategies best supported by evidence . 41 patients received the decision aid  , 34 received  usual care . In unadjusted analysis , the decision aid increased the proportion of patients who discussed CHD risk reduction with their doctor from 24 % to 40 % ( absolute difference 16 % ; 95 % CI -4 % to + 37 % ) and increased the proportion who had a specific plan to reduce their risk from 24 % to 37 % ( absolute difference 13 % ; 95 % CI -7 % to + 34 % ) . In pre-post testing , the decision aid also appeared to increase the proportion of patients with plans to intervene on their CHD risk ( absolute increase ranging from 21 % to 47 % for planned medication use and 5 % to 16 % for planned behavioral interventions ) . Conclusion Our study confirms patients ' limited knowledge about their CHD risk and effective risk reduction options and provides preliminary evidence that an individually-tailored decision aid about CHD prevention might be expected to increase patients ' discussion s about CHD prevention with their doctor and their plans for CHD risk reduction . These findings should be replicated in studies with a larger sample size and patients at overall higher risk of CHD . Trial Registration : Clinical Trials.gov BACKGROUND The objective of this study was to examine the association of Joint National Committee ( JNC-V ) blood pressure and National Cholesterol Education Program ( NCEP ) cholesterol categories with coronary heart disease ( CHD ) risk , to incorporate them into coronary prediction algorithms , and to compare the discrimination properties of this approach with other noncategorical prediction functions . METHODS AND RESULTS This work was design ed as a prospect i ve , single-center study in the setting of a community-based cohort . The patients were 2489 men and 2856 women 30 to 74 years old at baseline with 12 years of follow-up . During the 12 years of follow-up , a total of 383 men and 227 women developed  CHD , which was significantly associated with categories of blood pressure , total cholesterol , LDL cholesterol , and HDL cholesterol ( all P<.001 ) . Sex-specific prediction equations were formulated to predict CHD risk according to age , diabetes , smoking , JNC-V blood pressure categories , and NCEP total cholesterol and LDL cholesterol categories . The accuracy of this categorical approach was found to be comparable to CHD prediction when the continuous variables themselves were used . After adjustment for other factors , approximately 28 % of CHD events in men and 29 % in women were attributable to blood pressure levels that exceeded high normal ( > or = 130/85 ) . The corresponding multivariable-adjusted attributable risk percent associated with elevated total cholesterol ( > or = 200 mg/dL ) was 27 % in men and 34 % in women . CONCLUSIONS Recommended guidelines of blood pressure , total cholesterol , and LDL cholesterol effectively predict CHD risk in a middle-aged white population sample . A simple coronary disease prediction algorithm was developed using categorical variables , which allows physicians to predict multivariate CHD risk in patients without overt CHD Background Multi-factorial intervention studies have been found to be successful in the initiation of lifestyle changes . However , little is known about the longer-term maintenance of health behavior improvements . The purpose of this study was to investigate whether improvements in physical activity and dietary habits achieved in a population -based multi-factorial lifestyle intervention of five years duration were maintained five years after intervention activities have ended . Methods The study was a population -based r and omized controlled trial , Inter99 ( 1999–2006 ) , Copenhagen , Denmark . Over five years , all participants in the intervention group ( n = 6,091 ) received individual lifestyle counseling ;  participants at high risk of ischemic heart disease – according to pre-specified criteria – were also offered group-based counseling . The  control group ( n = 3,324 ) was followed by question naires . Both groups were followed one , three , five , and ten years after baseline . Changes in physical activity and dietary habits ( intake of vegetables , fruit , fish , and saturated fat ) during and after the intervention were investigated using r and om-coefficient models . Results Five years after the intervention , women in the intervention group reported greater improvements in the intake of fruit ( MΔ = 90.2 g/week , p = 0.041 ) and less intake of saturated fat ( OR = 0.30 , 95 % CI : 0.17–0.54 ) than the control group . Men in the intervention group reported greater improvements in physical activity ( MΔ = 19.6 min/week , p = 0.003 ) and less intake of saturated fat ( OR = 0.31 , 95 % CI : 0.17–0.56 ) than the control group . Improvements in the intake of vegetables and fish achieved during the intervention were not maintained in the longer-term . Conclusions Screening and lifestyle counseling had sustained effects on physical activity and dietary habits five years after its discontinuation . The patterns of long-term changes in lifestyle differed across behaviors and between men and women . Trial registration Clinical Trials.gov ( NCT00289237 UNLABELLED Pilot study to vali date a Computerized Decision Support Systems ( CDS ) ( HTE-DLP ) for improving treatment of hyperlipidemia . METHODS HTE-DLP was programmed to offer automatic specific reminders for lipid treatment .  Seventy-seven patients with high cardiovascular risk were r and omized . 10 expert physicians in cardiovascular-risk management were recruited . We assessed number of patients at LDL < 70 mg/dl after 12 weeks of treatment . RESULTS A greater proportion of intervention group reached the LDL-C < 70 mg/ml [ 55.0 % vs 12.5 % , p = 0.003 ; OR : 3.26 IC ( 1.16 - 9.15 ) ] .  " High potency statins " and combined therapy  were used more frequently in the intervention group than the control group ( p = 0.001 ) . Seven adverse effects were documented in the intervention group and two in the control group . An acceptable relationship was observed with regard to costeffectiveness in the intervention group . Physicians expressed good agreement with HTE-DLP ( 86.1 % ) and comfortable ease-of-use ( 85 % ) . CONCLUSIONS Use of a CDSS in high-risk cardiovascular patients result ed in a significant reduction in LDL-C levels Background To improve risk factor management in diabetes , we need to support effective interactions between patients and healthcare providers . Our aim is to develop and evaluate a treatment decision aid that offers personalised information on treatment options and outcomes , and is intended to empower patients in taking a proactive role in their disease management . Important features are : ( 1 ) involving patients in setting goals together with their provider ; ( 2 ) encourage them to prioritise on treatments that maximise relevant outcomes ; and ( 3 ) integration of the decision aid in the practice setting and workflow . As secondary aim , we want to evaluate the impact of different presentation formats , and learn more from the experiences of the healthcare providers and patients with the decision aid . Methods and design We will conduct a r and omised trial comparing four formats of the decision aid in a 2 × 2 factorial design with a control group . Patients with type 2 diabetes managed in 18 to 20 primary care practice s in The Netherl and s will be recruited . Excluded are patients with a recent myocardial infa rct ion , stroke , heart failure , angina pectoris , terminal illness , cognitive deficits , > 65 years at diagnosis , or not able to read Dutch . The decision aid is offered to the patients immediately before their quarterly practice consultation . The same decision information will be available to the healthcare provider for use during consultation . In addition , the providers receive a set of treatment cards , which they can use to discuss the benefits and risks of different options . Patients in the  control group will receive care as usual . We will measure the effect of the intervention on patient empowerment , satisfaction with care , beliefs about medication , negative emotions , health status , prescribed medication , and predicted cardiovascular risk . Data will be collected with question naires and automated extraction from medical records in 6 months before and after the intervention . Discussion This decision aid is innovative in supporting patients and their healthcare providers to make shared decisions about multiple treatments , using the patient ’s data from electronic medical records . The results can contribute to the further development and implementation of electronic decision support tools for the management of chronic diseases . Trial registration Dutch Trial register NTR1942 Cardiovascular disease causes the death of around 80 % of patients with type 2 diabetes.1 However , risk factors for cardiovascular disease in such patients are often untreated2 despite the proved benefits of intervention . 3 4 One way to help clinicians identify patients at high risk of cardiovascular disease is to use cardiovascular primary prevention risk tables . These tables integrate the multiple risk factors into a single score . We did a pilot study to test the hypothesis that documentation of a  cardiovascular risk score in the case notes would improve the management of cardiovascular risk factors . We recruited patients with type 2 diabetes who had no history of cardiovascular disease or renal disease . All patients were aged 35–75 years and attending a hospital OBJECTIVES To investigate the impact of general health screenings and discussion s with general practitioners on the cardiovascular risk profile of a r and om population of patients . STUDY DESIGN A population -based , r and omized , controlled , 5-year follow-up trial conducted in a primary care setting . POPULATION The study group consisted of 2000 patients , r and omly selected middle-aged men and women aged 30 to 50 years from family practice s in the district of Ebeltoft , Denmark . Of these patients , 1507 ( 75.4 % ) agreed to participate . Patients were r and omized into ( 1 ) a control group who did not receive health screenings , ( 2 ) an intervention group that received 2 health screenings , ( 3 ) an intervention group that received both the 2 screenings and a 45-minute follow-up consultation annually with their general practitioner . OUTCOMES MEASURED Cardiovascular risk score ( CRS ) , body mass index ( BMI ) , blood pressure , serum cholesterol , carbon monoxide in expiratory air , and tobacco use . RESULTS After 5 years , the CRS , BMI , and serum cholesterol levels were lower in the intervention groups compared with the control group . The improved outcome was greater in the baseline risk groups . The number of patients with elevated CRS in the intervention groups was approximately half the number of patients with elevated CRS in the control group . The difference was not a result of medication use . There was no difference between the group that received consultations after the screenings and the group that had health screenings alone . CONCLUSIONS Health screenings reduced the CRS in the intervention groups . After 5 years of follow-up , the number of persons at elevated cardiovascular risk was about half that expected , based on the prevalence/proportion in a population not receiving the health checks ( the control group ) . The impact of intervention was higher among at-risk individuals . Consultations about health did not appear to improve the cardiovascular profile of the study population BACKGROUND The Coronary Health Assessment Study ( CHAS ) was developed to determine the feasibility of using patient-specific , multifactorial computerized coronary risk profiles as a clinical decision aid to support primary prevention of CHD . METHODS Study participants included 253 community based physicians , r and omized into profile and control groups , and 958 of their patients . The profile group physicians received coronary risk profiles for their patients within 10 working days after the baseline patient assessment providing early feedback . The control group received their profiles only if the patient was clinical ly reevaluated during a 3-month follow-up visit . Patients ' coronary risk factors were evaluated at baseline and at follow-up . RESULTS The profile group had a significantly higher ( P < 0.05 ) ratio of high-risk/low-risk patients who returned for a follow-up visit compared to the control group ( 1.23 vs 0.77 ) . The patients in the profile group also had significantly ( P < 0.05 ) greater mean reductions in total cholesterol ( -0.5 vs -0.1 mmol/L ) , LDL cholesterol ( -0.4 vs 0.0 mmol/L ) , the total cholesterol/ HDL ratio ( -0.6 vs -0.2 ) , and the predicted 8-year coronary risk ( -1.8 vs -0.3 % ) . CONCLUSIONS Computer-generated coronary risk profiles can be effective in assisting physicians to identify high-risk patients . Their use is also associated with significantly greater improvements in the serum lipid profiles and the overall coronary risk of these patients OBJECTIVE To analyze mental distress in relation to participation in lifestyle intervention . METHODS In 2000 - 2001 a total of 1948 consecutive participants , living in the suburbs of Copenhagen , were asked to complete a short version of SCL-90-R ( anxiety , depression , and somatization ) before screening , immediately after screening , and one and 10 months after screening . The screening classified participants into high or low risk individuals . High risk individuals received personal lifestyle counselling and were r and omized to either group-based counselling ( A ) or referred care ( B ) . Multilevel regression models taking into account repeated measurements and missing data at follow-up were performed . RESULTS Before screening , high risk individuals had higher scores on anxiety , depression , and somatization than low risk individuals . All categories of participants decreased in scores after screening . The scores increased after 1 month , but were still significantly lower than before screening . After 10 months , low risk individuals and high risk individuals in group A still had significantly lower scores ( except for depression ) compared with pre-screening levels , whereas high risk individuals in group B reached the pre-screening level ( except for anxiety ) . CONCLUSION Screening for risk of cardiovascular disease followed by health counselling does not give rise to mental distress , but has a temporary beneficial effect Background The future risk of heart disease can be predicted with increasing precision . However , more research is needed into how this risk is conveyed and presented . The aim of this study is to compare the effects of presenting cardiovascular risk in different formats on individuals ' intention to change behaviour to reduce risk , underst and ing of risk information and emotional affect . Methods / design A r and omised controlled trial comprising four arms , with a between subjects design will be performed . There will be two intervention groups and two control groups . The first control comprises a pre-intervention question naire and presents risk in a bar graph format . The second control presents risk in a bar graph format without pre-intervention question naire . These two control groups are to account for the potential Hawthorne effect of thinking about cardiovascular risk before viewing actual risk . The two intervention groups comprise presenting risk in either a pictogram or metonym format ( image depicting seriousness of having a myocardial infa rct ion ) .  800 individuals ' aged between 45 and 64 years , who have not been previously diagnosed with heart disease and have access to a computer with internet , will be given a link to a website comprising a risk calculator and electronic question naires . 10-year risk of having a coronary heart disease event will be assessed and presented in one of the three formats . A post-intervention question naire will be completed after viewing the risk format . Main outcome measures are ( i ) intention to change behaviour , ( ii ) underst and ing of risk information , ( iii ) emotional affect and ( iv ) worry about future heart disease . Secondary outcomes are the sub-components of the theory of planned behaviour : attitudes , perceived behavioural control and subjective norms . Discussion Having review ed the literature , we are not aware of any other studies which have used the assessment of actual risk , in a trial to compare different graphical cardiovascular risk presentation formats . This trial will provide data about which graphical cardiovascular risk presentation format is most effective in encouraging behaviour change to reduce cardiovascular risk . Trial registration Current Controlled Trials IS RCT BACKGROUND The multiprofessional teams in Finnish health centres are well placed to carry out interventions aim ed at the prevention of cardiovascular diseases . AIM To evaluate the effectiveness of an individually tailored multifactorial lifestyle intervention in primary care for individuals at high risk for cardiovascular disease . DESIGN OF STUDY A r and omised controlled trial was conducted over 24 months with interim assessment s at six and 12 months . SETTING A health centre in Finl and with a patient population of 11,000 . METHOD One hundred and fifty adults aged 18 to 65 years old with existing cardiovascular disease or multiple risk factors were r and omised to active multiprofessional risk factor intervention or to st and ard care . The main outcome measure was a change in cardiovascular risk-factor score . Secondary outcomes were changes in blood pressure , weight , body-mass index , serum cholesterol , blood glucose , smoking cessation , and exercise habits . RESULTS The cardiovascular risk score decreased by 28 % in the intervention group ( 23 % in the control group ) , body weight decreased by 3.7 % ( 2 % ) and total cholesterol decreased by 10.8 % ( 6.5 % ) , while time engaged in exercise increased by 39 % ( 43 % ) . Differences were not significant . CONCLUSIONS Cardiovascular risk levels of high-risk individuals decreased in both intervention and control groups . Primary care prevention should be targeted to high-risk persons . Long-term follow-up studies are needed Introduction Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk . In this project , we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice . Consumer Navigation of Electronic Cardiovascular Tools ( CONNECT ) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Isl and er and non-indigenous adults , recruited through primary care , at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care . Methods and analysis R and omised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk . The trial will be augmented by formal economic and process evaluations to assess acceptability , equity and cost-effectiveness of the intervention . The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management . The programme is electronically integrated with the primary care provider 's software and will include interactive smart phone and Internet platforms . The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline -recommended blood pressure ( BP ) and cholesterol targets . Secondary outcomes include change in mean BP and fasting cholesterol levels , proportion meeting BP and cholesterol targets separately , self-efficacy , health literacy , self-reported point prevalence abstinence in smoking , body mass index and waist circumference , self-reported physical activity and self-reported medication adherence . Ethics and dissemination Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences Clinical Trials registration number ACTRN12613000715774 Background Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk ( CVR ) rather than by blood pressure levels alone . However , this paradigm change has not yet arrived in German General Practice . We have evaluated the effect of an educational outreach visit with general practitioners ( GPs ) , encouraging them to consider CVR in treatment decisions for patients with hypertension . Methods Prospect i ve cluster-r and omised trial comprising 3443 patients with known hypertension treated by 87 GPs . Practice s were r and omly assigned to complex ( A ) or simple ( B ) intervention . Both groups received a guideline by mail ; group A also received complex peer intervention promoting the concept of global CVR . Clinical data were collected at baseline and 6 - 9 months after intervention . Main outcome was improvement of calculated CVR in the predefined sub population of patients with a high CVR ( 10-year mortality ≥5 % ) , but no manifest cardiovascular disease . Results Adjusted for baseline the follow-up CVR were 13.1 % ( 95 % CI 12.6%-13.6 % ) ( A ) and 12.6 % ( 95 % CI 12.2%-13.1 % ) ( B ) with a group difference ( A vs. B ) of 0.5 % ( -0.2%-1.1 % ) , p = 0.179 . The group difference was -0.05 % in patients of GPs familiar with global CVR and 1.1 % in patients of GPs not familiar with with global CVR . However , this effect modification was not significant ( p = 0.165 ) . Pooled over groups , the absolute CVR reduction from baseline was 1.0 % , p < 0.001 . The ICC was 0.026 ( p = 0.002 ) . Hypertension control ( BP < 140/90 mmHg ) improved in the same sub population from 38.1 to 45.9 % in the complex intervention group , and from 35.6 to 46.5 % in the simple intervention group , with adjusted follow-up control rates of 46.7 % ( 95 % CI 40.4%-53.1 % ) ( A ) and 46.9 % ( 95 % CI 40.3%-53.5 % ( B ) and an adjusted odds ratio ( A vs B ) of 0.99 ( 95 % CI 0.68 - 1.45 ) , p = 0.966 . Conclusions Our complex educational intervention , including a clinical outreach visit , had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention . Trial registration IS RCT N44478543 Abstract Objectives : To investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk , blood pressure , and prescribing of cardiovascular drugs in hypertensive patients . Design : Cluster r and omised controlled trial . Setting : 27 general practice s in Avon . Participants : 614 patients aged between 60 and 79 years with high blood pressure . Interventions : Patients were r and omised to computer based clinical decision support system plus cardiovascular risk chart ; cardiovascular risk chart alone ; or usual care . Main outcome measures : Percentage of patients in each group with a five year cardiovascular risk≥10 % , systolic blood pressure , diastolic blood pressure , prescribing of cardiovascular drugs . Results : Patients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10 % than patients receiving usual care . Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk≥10 % than chart only patients , odds ratio 2.3 ( 95 % confidence interval 1.1 to 4.8 ) . The chart only group had significantly lower systolic blood pressure compared with the usual care group ( difference in means−4.6 mm Hg ( 95 % confidence interval−8.4 to−0.8 ) . Reduction of diastolic blood pressure did not differ between the three groups . The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups . Conclusions : The computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended . Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure BACKGROUND Computerized decision support systems ( CDSSs ) linked with electronic medical records ( EMRs ) are promoted as an effective means of improving patient care . However , very few high- quality studies are set in routine , community-based clinical care , and no consistent evidence of an effect on patient outcomes has been found . METHODS A r and omized controlled trial among EMR-using primary care practice s in Ontario , Canada . Patients 55 years or older with previous vascular events , diabetes mellitus , hypertension , or hypercholesterolemia were r and omized to the Computerization of Medical Practice s for the Enhancement of Therapeutic Effectiveness ( COMPETE III ) CDSS intervention or to usual care . The intervention included personally tailored electronic vascular risk monitoring and treatment advice shared between the physician and patient , risk calculation , and a clinical re source . The primary outcome was a composite score of 8 recommended process outcomes at 1 year . Data collectors were blinded to group allocation . Analysis used the intention-to-treat principle with multiple imputation for missing data . RESULTS We r and omized and included in the analysis 1102 patients in 49 community-based physician practice s ( 53.4 % female ; mean age , 69.1 years ; 28.0 % with a previous vascular event ) . The intervention group ( 545 [ 49.5 % ] ) had a significantly greater improvement in mean process composite , with a difference of 4.70 ( P < .001 ) on a 27-point scale . Intervention patients had significantly higher odds of rating their continuity of care ( 4.18 ; P < .001 ) and their ability to improve their vascular health ( 3.07 ; P < .001 ) as improved . Despite this improvement , the clinical outcomes -vascular events , clinical variables , and quality of life-were not improved . CONCLUSION Despite favorable review s and important improvements in the complex processes required to reduce vascular risk , clinical outcomes remain unchanged OBJECTIVE —The Diabetes Care Protocol combines task delegation ( a practice nurse ) , computerized decision support , and feedback every 3 months . We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care . RESEARCH DESIGN AND METHODS —In a cluster r and omized trial , mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models . RESULTS —Throughout the Netherl and s , 26 intervention practice s included 1,699 patients and 29 control practice s 1,692 patients . The difference in A1C change was not significant , whereas total cholesterol , LDL cholesterol , and blood pressure improved significantly more in the intervention group . The 10-year coronary heart disease risk estimate of the UK Prospect i ve Diabetes Study improved 1.4 % more in the intervention group . CONCLUSIONS —Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients Background Practice facilitation has been associated with meaningful improvements in disease prevention and quality of patient care . Using practice facilitation , the Improved Delivery of Cardiovascular Care ( IDOCC ) project aim ed to improve the delivery of evidence -based cardiovascular care in primary care practice s across a large health region . Our goal was to evaluate IDOCC ’s impact on adherence to processes of care delivery . Methods A pragmatic stepped wedge cluster r and omized trial recruiting primary care providers in practice s located in Eastern Ontario , Canada ( Clinical Trials.gov : NCT00574808 ) . Participants were r and omly assigned by region to one of three steps . Practice facilitators were intended to visit practice s every 3–4 ( year 1—intensive ) or 6–12 weeks ( year 2—sustainability ) to support changes in practice behavior . The primary outcome was mean adherence to indicators of evidence -based care measured at the patient level . Adherence was assessed by chart review of a r and omly selected cohort of 66 patients per practice in each pre-intervention year , as well as in year 1 and year 2 post-intervention . Results Eighty-four practice s ( 182 physicians ) participated . On average , facilitators had 6.6 ( min : 2 , max : 11 ) face-to-face visits with practice s in year 1 and 2.5 ( min : 0 max : 10 ) visits in year 2 . We collected chart data from 5292 patients . After adjustment for patient and provider characteristics , there was a 1.9 % ( 95 % confidence interval ( CI ) : −2.9 to −0.9 % ) and 4.2 % ( 95 % CI : −5.7 to −2.6 % ) absolute decrease in mean adherence from baseline to intensive and sustainability years , respectively . Conclusions IDOCC did not improve adherence to best- practice guidelines . Our results showed a small statistically significant decrease in mean adherence of question able clinical significance . Potential reasons for this result include implementation challenges , competing priorities in practice s , a broad focus on multiple chronic disease indicators , and use of an overall index of adherence . These results contrast with findings from previously reported facilitation trials and highlight the complexities and challenges of translating research findings into clinical practice .Trial registration Clinical Trials.gov Background There is nonoptimal adherence of general practitioners ( GPs ) and patients to cardiovascular risk reducing interventions . GPs find it difficult to assimilate multiple risk factors into an accurate assessment of cardiovascular risk . In addition , communicating cardiovascular risk to patients has proved to be difficult . Aims Improving primary prevention of cardiovascular disease ( CVD ) in primary care by enhancing patient involvement in the use of a decision support tool . Design Cluster r and omized trial . Methods Thirty-four GPs included patients ( 40 - 75 years old ) without CVD . In an interactive , small group training session lasting 4h , the GPs in the intervention group were trained to use the guidelines on cardiovascular risk and a decision support tool . The control group received educational material s about the guidelines on paper .  GPs ’ clinical performance and patients ’ risk perception and self-reported lifestyles were measured at baseline and after 6 months . Results Thirty-four GPs recorded 490 consultations , 276 in the intervention and 214 in the control group . After 6 months , no significant effect of the intervention on the GPs ’ performance or the patients ’ risk perception was found . There was only an effect on self-reported lifestyle , in that more men in the intervention group than in the control group increased their physical activity ( odds ratio 3.8 , 95 % confidence interval 1.7–8.7 ) . Conclusion The 4-h interactive , small group training did not guarantee correct application of the decision support tool and as such failed to improve GPs ’ performance or correct patients ’ risk perception . The positive effect on physical activity justifies further research on patient involvement . Eur J Cardiovasc Prev Rehabil 14 : 44 - 50 © 2007 The European Society of Background The periodic health check-up has been a fundamental part of routine medical practice for decades , despite a lack of consensus regarding its value in health promotion and disease prevention . A large-scale Danish population -based preventive programme ‘ Check your health ’ was developed based on available evidence of screening and successive accepted treatment , prevention for diseases and health promotion , and is closely aligned with the current health care system . The objective of the ‘ Check your health ’ [ CORE ] trial is to investigate effectiveness on health outcomes of a preventive health check offered at a population -level to all individuals aged 30–49 years , and to establish the cost-effectiveness . Methods / Design The trial will be conducted as a pragmatic household-cluster r and omised controlled trial involving 10,505 individuals . All individuals within a well-defined geographical area in the Central Denmark Region , Denmark ( DK ) were r and omised to be offered a preventive health check ( Intervention group , n = 5250 ) or to maintain routine access to healthcare until a delayed intervention ( Comparison  group , n = 5255 ) . The programme consists of a health examination which yields an individual risk profile , and according to this participants are assigned to one of the following interventions : ( a ) referral to a health promoting consultation in general practice , ( b ) behavioural programmes at the local Health Centre , or ( c ) no need for follow-up . The primary outcomes at 4 years follow-up are : ten-year-risk of fatal cardiovascular event ( Heart-SCORE model ) , physical activity level ( self-report and cardiorespiratory fitness ) , quality of life ( SF12 ) , sick leave and labour market attachment . Cost-effectiveness will be evaluated according to life years gained , direct costs and total health costs . Intention to treat analysis will be performed . Discussion Results from the largest Danish health check programme conducted within the current healthcare system , spanning the sectors which share responsibility for the individual , will provide a scientific basis to be used in the development of systems to optimise population health in the 21st century . Trial registration The trial has registered at Clinical Trials.gov with an ID : NCT02028195 ( 7 . March 2014 ) Primary care facilities may be a natural setting for delivering interventions that focus on behaviors that improve cardiovascular disease ( CVD ) risk factors . The purpose of this study was to examine the 24-month effects of the Activity Counseling Trial ( ACT ) on CVD risk factors , to examine whether changes in CVD risk factors differed according to baseline risk factor status , and to examine whether changes in fitness were associated with changes in CVD risk factors . ACT was a 24-month multicenter r and omized controlled trial to increase physical activity .  Participants were 874 inactive men and women aged 35–74 years . Participants were r and omly assigned to one of three arms that varied by level of counseling , intensity , and re source requirements . Because there were no significant differences in change over time between arms on any of the CVD risk factors examined , all arms were combined , and the effects of time , independent of arm , were examined separately for men and women . Time × Baseline risk factor status interactions examined whether changes in CVD risk factors differed according to baseline risk factor status . Significant improvements in total cholesterol , high-density lipoprotein cholesterol ( HDL-C ) and low-density lipoprotein cholesterol , the ratio of total cholesterol to HDL-C , and triglycerides were seen in both men and women who had high ( or low for HDL-C ) baseline levels of risk factors , whereas significant improvements in diastolic blood pressure were seen only in those men with high baseline levels . There were no improvements in any risk factors among participants with normal baseline levels . Changes in fitness were associated with changes in a number of CVD risk factors . However , most relationships disappeared after controlling for changes in body weight . Improvements in lipids from the ACT interventions could reduce the risk of coronary heart disease in people with already high levels of lipids by 16%–26 % in men and 11%–16 % in women . Interventions that can be implemented in health care setting s nationwide and result in meaningful population -wide changes in CVD risk factors are needed . The ACT physical activity interventions produced substantial improvements among men and women with elevated CVD risk factors Background There is a need to find innovative approaches for translating best practice s for chronic disease care into daily primary care practice routines . Primary care plays a crucial role in the prevention and management of cardiovascular disease . There is , however , a substantive care gap , and many challenges exist in implementing evidence -based care . The Improved Delivery of Cardiovascular Care ( IDOCC ) project is a pragmatic trial design ed to improve the delivery of evidence -based care for the prevention and management of cardiovascular disease in primary care practice s using practice outreach facilitation . Methods The IDOCC project is a stepped-wedge cluster r and omized control trial in which Practice Outreach Facilitators work with primary care practice s to improve cardiovascular disease prevention and management for patients at highest risk . Primary care practice s in a large health region in Eastern Ontario , Canada , were eligible to participate . The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period . Starting with audit and feedback , consensus building , and goal setting , the practice s are supported in changing practice behavior by incorporating chronic care model elements . These elements include ( a ) evidence -based decision support for providers , ( b ) delivery system re design for practice s , ( c ) enhanced self-management support tools provided to practice s to help them engage patients , and ( d ) increased community re source linkages for practice s to enhance referral of patients . The primary outcome is a composite score measured at the level of the patient to represent each practice 's adherence to evidence -based guidelines for cardiovascular care . Qualitative analysis of the Practice Outreach Facilitators ' written narratives of their ongoing practice interactions will be done . These textual analyses will add further insight into underst and ing critical factors impacting project implementation . Discussion This pragmatic , stepped-wedge r and omized controlled trial with both quantitative and process evaluations demonstrates innovative methods of implementing large-scale quality improvement and evidence -based approaches to care delivery . This is the first Canadian study to examine the impact of a large-scale multifaceted cardiovascular quality -improvement program in primary care . It is anticipated that through the evaluation of IDOCC , we will demonstrate an effective , practical , and sustainable means of improving the cardiovascular health of patients across Canada . Trial Registration Clinical Trials.gov : Abstract Background Cardiovascular disease ( CVD ) is an important worldwide cause of mortality . In The Netherl and s , CVD is the leading cause of death for women and the second cause of death for men . Recommendations for diagnosis and treatment of CVD are not well implemented in primary care . In this study , we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with ( high risk for ) CVD . Methods / design A two-arm cluster r and omized trial is planned . We offer practice nurses a tailored program to improve adherence to six specific recommendations related to blood pressure and cholesterol target values , risk profiling and lifestyle advice . Practice nurses are offered training and feedback on their motivational interviewing technique and an e-learning program on cardiovascular risk management ( CVRM ) . They are also advised to screen for the presence and severity of depressive symptoms in patients . We also advise practice nurses to use selected E-health options ( selected websites and Twitter-consult ) in patients without symptoms of depression . Patients with mild depressive symptoms are referred to a physical exercise group . We recommend referring patients with major depressive symptoms for assessment and treatment of depressive symptoms if appropriate before starting CVRM .  Data from 900 patients at high risk of CVD or with established CVD will be collected in 30 general practice s in several geographical areas in The Netherl and s. The primary outcome measure is performance of practice nurses in CVRM and reflects application of recommendations for personalized counselling and education of CVRM patients . Patients ’ health-related lifestyles ( physical exercise , diet and smoking status ) will be measured with vali date d question naires and medical record audit will be performed to document estimated CVD risk . Additionally , we will survey and interview participating healthcare professionals for exploration of processes of change . The control practice s will provide usual care . Discussion Tailored interventions can improve healthcare . An underst and ing of the methods to reach the improved healthcare can be improved . This research contributes a share of it . Identification of the determinants of practice and developing implementation interventions were two steps which were completed . The subsequent step was implementation of the tailored intervention program . Trial registration Name trial register : Nederl and s trial registerWeb address of trial register : http://www.trialregister.nl Data of registration : 11 July 2013Number of registration : Background The underlying reasons for differences between clinical practice and systematic ally developed guidelines vary from one clinical problem to another . It is therefore logical to tailor strategies to support the implementation of guidelines to address identified barriers to change . The objective of this trial is to evaluate the effects of a tailored intervention to support the implementation of systematic ally developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease . Methods / Design Unblinded , cluster-r and omised trial . 150 general practice s will be recruited from two geographical areas in Norway , and r and omised to the intervention or control group ( passive dissemination of guidelines )  . Outcomes will be measured for all eligible patients seen in the participating practice s during one year after the intervention . A multifaceted intervention has been tailored to address identified barriers to change . Key components are an educational outreach visit with audit and feedback , and computerised reminders . Pharmacists will conduct the visits . During the outreach visit the main recommendations will be presented and software will be installed that links to the electronic medical record systems used in the participating practice s. The software will perform an audit that will be fed back during the visit , present pop-up reminders for patients with high blood pressure or cholesterol , and provide a cardiovascular risk calculator and patient education material . The main outcomes are the proportions of 1 ) first time prescriptions for hypertension where thiazides are not prescribed , 2 ) patients not assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs , and 3 ) patients treated for hypertension or high cholesterol for three months or more who have not achieved recommended treatment goals Aim : To examine the effect of a r and omized multiple risk factor intervention study for prevention of ischaemic heart disease ( IHD ) on the development in physical activity over a 36-month period . Methods : Two r and om sample s ( high intensity intervention , group A , n=11,708 ; low intensity intervention , group B , n=1,308 ) were invited for a health examination , an assessment of absolute risk of developing IHD , and an individualized lifestyle intervention . The participation rate was 52.5 % . High-risk persons in group A were also offered diet/physical activity and /or smoking cessation group counselling . High-risk persons in group B were referred to their GP . High-risk persons were re-counselled after 12 and 36 months . The  control group ( group C , n=5,264 , response rate=61.3 % ) answered a mailed question naire . Data were analysed using longitudinal linear regression models with r and om effects . Main outcome : Change in physical activity from baseline to 12- and 36-month follow-up . Results : In men , the high-intensity ( group A ) intervention had a beneficial effect at 12-month follow-up , whereas after 36 months both the high-intensity and the low-intensity ( group B ) intervention had a beneficial effect on the development in physical activity when compared with group C. This was regardless of baseline physical activity level . At 36-month follow-up there was no significant difference between groups A and B. There was no intervention effect among women . Conclusions : Only men seemed to benefit from the intervention Background Cardiovascular diseases ( CVD ) are the leading cause of death and the third cause of disability in Europe . Prevention programmes should include interventions aim ed at a reduction of medical risk factors ( hypertension , hypercholesterol , hyperglycemia , overweight and obesity ) as well as behavioural risk factors ( sedentary lifestyle , high fat intake and low fruit and vegetable intake , smoking ) . The aim of this study is to investigate the effects of a multifaceted , multidisciplinary electronic prevention programme on cardiovascular risk factors . Methods / Design In a r and omized controlled trial , one group will receive a maximal intervention  (= intervention group ) . The intervention group will be compared to the control group receiving a minimal intervention .  An inclusion of 350 patients in total , with a follow-up of 3 years is foreseen . The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas , insuring for guaranteed income in case of illness for self-employed . The maximal intervention group receives several prevention consultations by their general practitioner ( GP ) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors . These patients receive a follow-up with intensive support of health behaviour change via different methods , i.e. a tailored website and personal advice of a multidisciplinary team ( psychologist , physiotherapist and dietician ) . The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines . The primary outcome measures will be cardiovascular risk factors . The secondary outcome measures are cardiovascular events , quality of life , costs and incremental cost effectiveness ratios . The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback . Discussion This trial incorporates interventions by GPs and other health professionals aim ing at a reduction of medical and behavioural cardiovascular risk factors . An assessment of clinical , psychological and economical outcome measures will be performed . Trial registration IS RCT Background Community-based programs are being widely adopted in the struggle to prevent cardiovascular diseases . No study has been conducted in Japan to evaluate the effects of a community-based health promotion program by using the Framingham risk score and 10-year CHD risk as outcome variables . The aim of the present study was to assess the effects of a program involving 6-month intervention and 18-month follow-up using such outcomes . Methods Participants ( n = 1,983 , 39.5 % women , mean age 63.4 years ) were selected for the study in 2008 . Of these 1,983 , 347 ( 42.4 % women ) subjects received the 6-month intervention . The intervention included individual counseling and group sessions , among others . After 18 months , 1,278 participants ( intervention group : 238 , control group : 1,040 ) were followed up . Changes in the Framingham risk score and 10-year coronary heart disease ( CHD ) risk were evaluated . ANCOVA and multiple logistic models adjusted for baseline value , age , sex and intervention times were used . Results The results showed that the differences in the Framingham risk score and mean 10-year CHD risk were significant in the intervention group compared with the control group after 6-month follow-up ( -0.46 and -1.12 , respectively ) and were also significant after 18-month follow-up ( -0.39 and -0.85 , respectively ) . The proportion of those with intermediate 10-year CHD risk ( > = 10 % ) was significantly lower at 6 months ( OR 0.30 , 95 % CI 0.12 - 0.74 ) and at 18 months ( OR 0.41 , 95 % CI 0.19 - 0.92 ) . Conclusions The six-month intervention program effectively decreased estimated 10-year CHD risk and the effects were still present at 18-month follow-up . Trial registration UMIN-CTR : Background Decision aids offer promise as a practical solution to improve patient decision making about coronary heart disease ( CHD ) prevention medications and help patients choose medications to which they are likely to adhere . However , little data is available on decision aids design ed to promote adherence . Methods In this paper , we report on secondary analyses of a r and omized trial of a CHD adherence intervention ( second generation decision aid plus tailored messages ) versus usual care in an effort to underst and how the decision aid facilitates adherence . We focus on data collected from the primary study visit , when  intervention participants presented 45 minutes early to a previously scheduled provider visit ; viewed the decision aid , indicating their intent for CHD risk reduction after each decision aid component ( individualized risk assessment and education , values clarification , and coaching ) ; and filled out a post-decision aid survey assessing their knowledge , perceived risk , decisional conflict , and intent for CHD risk reduction . Control participants  did not present early and received usual care from their provider . Following the provider visit , participants in both groups completed post-visit surveys assessing the number and quality of CHD discussion s with their provider , their intent for CHD risk reduction , and their feelings about the decision aid . Results We enrolled 160 patients into our study ( 81 intervention , 79  control ) . Within the decision aid group , the decision aid significantly increased knowledge of effective CHD prevention strategies ( + 21 percentage points ; adjusted p<.0001 ) and the accuracy of perceived CHD risk ( + 33 percentage points ; adjusted p<.0001 ) , and significantly decreased decisional conflict ( -0.63 ; adjusted p<.0001 ) . Comparing between study groups , the decision aid also significantly increased CHD prevention discussion s with providers ( + 31 percentage points ; adjusted p<.0001 ) and improved perceptions of some features of patient-provider interactions . Further , it increased participants ’ intentions for any effective CHD risk reducing strategies ( + 21 percentage points ; 95 % CI 5 to 37 percentage points ) , with a majority of the effect from the educational component of the decision aid . Ninety-nine percent of participants found the decision aid easy to underst and and 93 % felt it easy to use . Conclusions Decision aids can play an important role in improving decisions about CHD prevention and increasing patient-provider discussion s and intent to reduce CHD risk OBJECTIVE To evaluate the implementation of clinical guidelines for hypertension in general practice by use of a computer-based clinical decision support system ( CDSS ) and a specific implementation strategy . Evaluation of patient outcome . DESIGN R and omised study with health centres as units . The intervention group had the CDSS installed and made ready for use , doctors and assistants were trained and received a user-manual , the doctors were offered telephone repetitions , a seminar in risk intervention and , at the same seminar , further demonstration of the CDSS . The doctors received baseline registration s with information of how they treated their own hypertensive patients , and use of the CDSS was checked repeatedly . SETTING General practice in Sør- and Nord-Trøndelag counties in Norway , 380,000 inhabitants . PARTICIPANTS Seventeen health centres with 24 doctors and 984 patients in the intervention group . Data from 879 patients used in the final analyses . Twelve health centres with 29 doctors and 1255 patients in the control group . Data from 1119 patients used in the final analyses . MAIN OUTCOME MEASURES After an intervention period of 18 months , group differences in level of systolic and diastolic blood pressure , serum cholesterol , body mass index , and risk score for myocardial infa rct ion were calculated , as well as group differences in fractions of smokers . RESULTS Significant group difference in favour of intervention group : diastolic blood pressure 1 mmHg ( 95 % CI -1.89 , -0.17 ) . However , a significant baseline difference in systolic blood pressure in favour of control group of 2.7 mmHg ( 95 % CI 1.0 , 4.5 ) had been reduced to 1.2 mmHg ( 95 % CI -0.6 , 3.0 ) after intervention . CONCLUSION Implementation of clinical guidelines in the treatment of hypertensive patients in general practice by means of a CDSS and several other procedures for implementation did not affect patient outcome in any clinical ly significant way Background Large gaps exist in the implementation of guideline recommendations for cardiovascular disease ( CVD ) risk management .  Electronic decision support ( EDS ) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia . We have developed HealthTracker , a multifaceted EDS and quality improvement intervention to improve the management of CVD risk . Methods / design It is hypothesised that the use of HealthTracker over a 12-month period will result in : ( 1 ) an increased proportion of patients receiving guideline -indicated measurements of CVD risk factors and ( 2 ) an increased proportion of patients at high risk will receive guideline -indicated prescriptions for lowering their CVD risk . Sixty health services ( 40 general practice s and 20 Aboriginal Community Controlled Health Services ( ACCHSs ) will be r and omised in a 1:1 allocation to receive either the intervention package or continue with usual care , stratified by service type , size and participation in existing quality improvement initiatives . The intervention consists of point-of-care decision support ; a risk communication interface ; a clinical audit tool to assess performance on CVD-related indicators ; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance .  The control arm will continue with usual care without access to these intervention components . Quantitative data will be derived from cross-sectional sample s at baseline and end of study via automated data extraction . Detailed process and economic evaluations will also be conducted . Ethics and dissemination The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee ( HREC ) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC . Formal agreements with each of the participating sites have been signed . In addition to the usual scientific forums , results will be disseminated via newsletters , study websites , face-to-face feedback forums and workshops . Trial registration The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910 Background . Statin Choice is a decision aid about taking statins . The optimal mode of delivering Statin Choice ( or any other decision aid ) in clinical practice is unknown . Methods . To investigate the effect of mode of delivery on decision aid efficacy , the authors further explored the results of a concealed 2 × 2 factorial clustered r and omized trial enrolling 21 endocrinologists and 98 diabetes patients and r and omizing them to 1 ) receive either the decision aid or pamphlet about cholesterol , and 2 ) have these delivered either during the office visit ( by the clinician ) or before the visit ( by a research er ) . We estimated between-group differences and their 95 % confidence intervals ( CI ) for acceptability of information delivery ( 1—7 ) , knowledge about statins and coronary risk ( 0—9 ) , and decisional conflict about statin use ( 0—100 ) assessed immediately after the visit . Follow-up was 99 % . Results . The relative efficacy of the decision aid v. pamphlet interacted with the mode of delivery . Compared with the pamphlet , patients whose clinicians delivered the decision aid during the office visit showed significant improvements in knowledge ( difference of 1.6 of 9 questions , CI 0.3 , 2.8 ) and nonsignificant trends toward finding the decision aid more acceptable ( odds ratio 3.1 , CI 0.9 , 11.2 ) and having less decisional conflict ( difference of 7 of 100 points , CI -4 , 18 ) than when a research er delivered the decision aid just before the office visit . Conclusions . Delivery of decision aids by clinicians during the visit improves knowledge and shows a trend toward better acceptability and less decisional conflict BACKGROUND Current guidelines recommend global risk assessment to guide vascular risk factor management ; however , most provider-patient communication focuses on individual risk factors in isolation . We sought to evaluate the impact of personalized coronary heart disease and stroke risk communication on patients ' knowledge , beliefs , and health behavior . METHODS We conducted a r and omized controlled trial testing personalized risk communication based on Framingham stroke and coronary heart disease risk scores compared with a st and ard risk factor education . A total of 89 patients were recruited from primary care clinics and followed up for 3 months . Outcomes included the following : risk perception and worry , risk factor knowledge , risk reduction preferences and decision conflict , medication adherence , health behaviors , and blood pressure . RESULTS Participants had a very low underst and ing of numeric information , high perceived risk for stroke or myocardial infa rct ion , and high proportion of medication nonadherence . Patients ' ability to identify vascular risk factors increased with personalized risk communication ( mean 1.8 additional risk factors , 95 % CI 1.3 - 2.2 ) and st and ard risk factor education ( mean 1.6 additional risk factors , 95 % CI 1.1 - 2.1 ) immediately after the intervention but was not sustained at 3 months . Patients in the personalized group had less decision conflict than the st and ard risk factor education group over intended risk reduction strategies ( 5.9 vs 10.1 , P = .003 ) . There was no appreciable impact of either communication strategy on medication adherence , exercise , smoking cessation , or blood pressure . CONCLUSIONS Personalized risk communication was preferred by patients and had a small impact on risk reduction preferences and decision conflict but had no impact on patient beliefs or behavior compared with st and ard risk factor education Background To evaluate the efficacy of Counselling and Advisory Care for Health ( COACH ) programme in managing dyslipidaemia among primary care practice s in Malaysia . This open-label , parallel , r and omised controlled trial compared the COACH programme delivered by primary care physicians alone ( PCP arm ) and primary care physicians assisted by nurse educators ( PCP-NE arm ) . Methods This was a multi-centre , open label , r and omised trial of a disease management programme ( COACH ) among dyslipidaemic patients in 21 Malaysia primary care practice s. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia ; 149 were r and omised to the COACH programme delivered by primary care physicians assisted by nurse educators ( PCP-NE ) and 148 to care provided by primary care physicians ( PCP ) alone .  The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms . Secondary endpoints included mean percentage change from baseline of lipid profile ( TC , LDL-C , HDL-C , TG , TC : HDL ratio ) , Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24 . The study also assessed the sustainability of programme efficacy at week 36 . Results Both study arms demonstrated improvement in LDL-C from baseline . The least squares ( LS ) mean change from baseline LDL-C were −30.09 % and −27.54 % for PCP-NE and PCP respectively . The difference in mean change between groups was 2.55 % ( p=0.288 ) , with a greater change seen in the PCP-NE arm . Similar observations were made between the study groups in relation to total cholesterol change at week 24 . Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups , 3.01 % , 95 % CI 0.12 - 5.90 , p=0.041 , at week 24 . There was no significant difference in lipid outcomes between 2 study groups at week 36 ( 12 weeks after the programme had ended ) . Conclusion Patients who received coaching and advice from primary care physicians ( with or without the assistance by nurse educators ) showed improvement in LDL-cholesterol . Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone ; however , the improvements were not maintained when the services were withdrawn . Trial registration National Medical Research Registration ( NMRR ) Number : NMRR-08 - 287 - 1442Trial Registration Number ( Clinical Trials.gov Identifier ) : Aim : To compare the effects of information pamphlets with those of group counselling on cardiovascular risk among individuals from a community with low socioeconomic status . Methods : Risk factors for coronary heart disease were assessed in 1131 men and women from a community with low socioeconomic status in suburban Melbourne . Individuals deemed to be at moderate risk , on the basis of an integrated risk score greater than 65 , were asked to participate in a r and omized trial comparing two simple interventions design ed to reduce cardiovascular risk . One hundred and sixty-four individuals were r and omly assigned to group A ( n = 85 ) and participated in a single group counselling session lasting between 1.5 and 2.0 h. Group B ( n = 79 ) received a specially prepared pamphlet that provided brief written information concerning risk-factor modification . Both groups were asked to attend a follow-up assessment of risk factors 3 and 6 months after entry . Results : There was no significant difference in the change in risk-factor levels between those receiving information pamphlets and those attending the group counselling session after 3 or 6 months of follow-up . Small but significant decreases ( P < 0.05 ) were seen in systolic and diastolic blood pressures ( −−5/4 mmHg for group A , −−5/3 mmHg for group B ) , total plasma cholesterol level ( −−0.30 mmol/l for groups A and B ) and overall coronary risk score ( −14.4 and −13.9 for groups A and B , respectively ) . Body weight remained unchanged during the study period in both groups . Conclusion : Screening together with 1.5−2 h group counselling had no more influence on cardiovascular risk factors than screening together with provision of information pamphlets in a population with low socioeconomic status OBJECTIVE The Diabetes Care Protocol ( DCP ) , a multifaceted computerized decision support diabetes management intervention , reduces cardiovascular risk of type 2 diabetic patients . We performed a cost-effectiveness analysis of DCP from a Dutch health care perspective . RESEARCH DESIGN AND METHODS A cluster r and omized trial provided data of DCP versus usual care . The 1-year follow-up patient data were extrapolated using a modified Dutch microsimulation diabetes model , computing individual lifetime health-related costs , and health effects . Incremental costs and effectiveness ( quality -adjusted life-years [ QALYs ] ) were estimated using multivariate generalized estimating equations to correct for practice -level clustering and confounding . Incremental cost-effectiveness ratios ( ICERs ) were calculated and cost-effectiveness acceptability curves were created . Stroke costs were calculated separately . Subgroup analyses examined patients with and without cardiovascular disease ( CVD+ or CVD− patients , respectively ) . RESULTS Excluding stroke  , DCP patients lived longer ( 0.14 life-years , P = NS ) , experienced more QALYs ( 0.037 , P = NS ) , and incurred higher total costs ( € 1,415 , P = NS ) , result ing in an ICER of € 38,243 per QALY gained . The likelihood of cost-effectiveness given a willingness-to-pay threshold of € 20,000 per QALY gained is 30 % . DCP had a more favorable effect on CVD+ patients ( ICER = € 14,814 ) than for CVD− patients ( ICER = € 121,285 ) . Coronary heart disease costs were reduced ( € −587 , P < 0.05 ) . CONCLUSIONS DCP  reduces cardiovascular risk , result ing in only a slight improvement in QALYs , lower CVD costs , but higher total costs , with a high cost-effectiveness ratio . Cost-effective care can be achieved by focusing on cardiovascular risk factors in type 2 diabetic patients with a history of CVD OBJECTIVE To determine whether nurse case management with a therapeutic algorithm could effectively improve rates of control for hypertension , hyperglycemia , and hyperlipidemia compared with usual care among veterans with diabetes . RESEARCH DESIGN AND METHODS A r and omized controlled trial of diabetic patients that had blood pressure ( BP ) > 140/90 mmHg , hemoglobin A1c ( HbA1c ) > 9.0 % , or LDL > 100 mg/dL. Intervention patients received case management ( n = 278 ) versus usual care ( n = 278 ) over a 1-year period . The primary outcome was the percentage of patients achieving simultaneous control of all three parameters ( defined by BP < 130/80 mmHg , HbA1c < 8.0 % , and LDL < 100 mg/dL ) at 1 year . Secondary outcomes included improvements within each individual component of the composite primary outcome . Differences between groups were analyzed using t tests , Pearson χ2 tests , and linear and logistic regression . RESULTS A greater number of individuals assigned to case management achieved the primary study outcome of having all three outcome measures under control ( 61 [ 21.9 % ] compared with 28 [ 10.1 % ] in the usual care group [ P < 0.01 ] ) . In addition , a greater number of individuals assigned to the intervention group achieved the individual treatment goals of HbA1c < 8.0 % ( 73.7 vs. 65.8 % , P = 0.04 ) and BP < 130/80 mmHg ( 45.0 vs. 25.4 % , P < 0.01 ) , but not for LDL < 100 mg/dL ( 57.6 vs. 55.4 % , P = 0.61 ) , compared with those in the usual care group . CONCLUSIONS In patients with diabetes , nurse case managers using a treatment algorithm can effectively improve the number of individuals with control of multiple cardiovascular risk factors at 1 year BACKGROUND Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor . METHODS We recruited 68 primary care family and internal medicine practice s ; 66 were r and omly allocated to a study arm ; 5 practice s withdrew , result ing in 29 receiving the Third Adult Treatment Panel ( ATP III ) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC-7 ) . The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III-recommended treatment . All practice s received copies of each clinical practice guideline , an introductory lecture , 1 performance feedback report , and 4 visits for intervention-specific academic detailing . Data were abstract ed at 61 practice s from r and om sample s of medical records of patients treated from June 1 , 2001 , through May 31 , 2003 ( baseline ) , and from May 1 , 2004 , through April 30 , 2006 ( follow-up ) . The proportion screened with subsequent appropriate decision making ( primary outcome ) was calculated . Generalized estimating equations were used to compare results by arm , accounting for clustering of patients within practice s. RESULTS We examined 5057 baseline and 3821 follow-up medical records . The screening rate for lipid levels increased from 43.6 % to 49.0 % ( ATP III practice s ) and from 40.1 % to 50.8 % ( control practice s ) ( net difference , -5.3 % [ P = .22 ] ) . Appropriate management of lipid levels decreased slightly ( 73.4 % to 72.3 % ) in ATP III practice s and more markedly ( 79.7 % to 68.9 % ) in control practice s. The net change in appropriate management favored the intervention ( + 9.7 % ; 95 % confidence interval [ CI ] , 2.8%-16.6 % [ P < .01 ] ) . Appropriate drug prescription within 4 months decreased in both arms ( 38.8 % to 24.8 % in ATP III practice s and 45.3 % to 24.1 % in control practice s ; net change , + 7.2 % [ P = .37 ] ) Overtreatment declined from 6.6 % to 3.9 % in ATP III and rose from 4.2 % to 6.4 % in control practice s ( net change , -4.9 % [ P = .01 ] ) . CONCLUSIONS A multifactor intervention including personal digital assistant-based decision support may improve primary care physician adherence to the ATP III guidelines . Trial Registration clinical trials.gov Identifier : NCT00224848 Background : “ CardioTest ® ” is a tool for cardiovascular risk assessment . The aim of this study was to evaluate if this test used in Swiss pharmacies provides risk stratification and if it had impact on individual behaviour . Methods : Individuals were evaluated ( blood pressure , body waist circumference , r and om blood sample s and coronary artery disease risk factors ) . The cardiovascular risk was calculated ( AGLA Risk Score ( ARS ) a modified PROCAM Score ) and participants were informed about their result . One year after the initial testing individuals were followed up by question naire with respect to the action they had taken based upon the ARS results . The relation between ARS results and events during follow-up were assessed . Events were defined as cardiovascular events due to chest pain , myocardial infa rct ion or stroke . Result : A total of 1415 individuals were contacted for follow-up , 746 ( 53 % ) with a mean age of 62.7 ( ±12.8 ) years ( 60 % were male ) returned their question naire . The cardiovascular risk throughout the study - population turned out to be low : 73.9 % had a low ARS < 10 % , 21.7 % an intermediate ARS 10 - 20 % and 4.4 % had a high ARS > 20 % . Significantly more participants with ARS > 20 % consulted their family doctor ( 46.2 % ) than those with ARS 10 - 20 % ( 25.2 % ) and ARS < 10 % ( 10.4 % ) , respectively ( p<0,01 for both comparisons ) . Sixty-four individuals ( 9 % ) suffered a cardiovascular event . The event rates increased as a function of ARS . Conclusion : The overall cardiovascular risk of individuals participating in a pharmacy based risk assessment program seems to be low . CardioTest ® provided risk stratification with respect to future cardio-vascular events . CardioTest ® seems to have impact on individual behavior and lifestyle modification . Other setting s and locations for screening might be considered to reach higher risk individuals at an earlier stage BACKGROUND Treatment of cardiovascular risk factors based on disease risk depends on valid risk prediction equations . We aim ed to develop , and apply in example countries , a risk prediction equation for cardiovascular disease ( consisting here of coronary heart disease and stroke ) that can be recalibrated and up date d for application in different countries with routinely available information . METHODS We used data from eight prospect i ve cohort studies to estimate coefficients of the risk equation with proportional hazard regressions . The risk prediction equation included smoking , blood pressure , diabetes , and total cholesterol , and allowed the effects of sex and age on cardiovascular disease to vary between cohorts or countries . We developed risk equations for fatal cardiovascular disease and for fatal plus non-fatal cardiovascular disease . We vali date d the risk equations internally and also using data from three cohorts that were not used to create the equations . We then used the risk prediction equation and data from recent ( 2006 or later ) national health surveys to estimate the proportion of the population at different levels of cardiovascular disease risk in 11 countries from different world regions ( China , Czech Republic , Denmark , Engl and , Iran , Japan , Malawi , Mexico , South Korea , Spain , and USA ) . FINDINGS The risk score discriminated well in internal and external validations , with C statistics generally 70 % or more . At any age and risk factor level , the estimated 10 year fatal cardiovascular disease risk varied substantially between countries . The prevalence of people at high risk of fatal cardiovascular disease was lowest in South Korea , Spain , and Denmark , where only 5 - 10 % of men and women had more than a 10 % risk , and 62 - 77 % of men and 79 - 82 % of women had less than a 3 % risk . Conversely , the proportion of people at high risk of fatal cardiovascular disease was largest in China and Mexico . In China , 33 % of men and 28 % of women had a 10-year risk of fatal cardiovascular disease of 10 % or more , whereas in Mexico , the prevalence of this high risk was 16 % for men and 11 % for women . The prevalence of less than a 3 % risk was 37 % for men and 42 % for women in China , and 55 % for men and 69 % for women in Mexico . INTERPRETATION We developed a cardiovascular disease risk equation that can be recalibrated for application in different countries with routinely available information . The estimated percentage of people at high risk of fatal cardiovascular disease was higher in low-income and middle-income countries than in high-income countries . FUNDING US National Institutes of Health , UK Medical Research Council , Wellcome Trust Background High blood pressure ( HBP ) is a major risk factor for cardiovascular disease ( CVD ) . European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method , the modification of lifestyles to prevent CVD , and achieving good control over risk factors . The EDUCORE ( Education and Coronary Risk Evaluation ) project aims to determine whether the use of a cardiovascular risk visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD ; Methods / Design This work describes a protocol for a clinical trial , r and omised by clusters and involving 22 primary healthcare clinics , to test the effectiveness of the EDUCORE method . The number of patients required was 736 , all between 40 and 65 years of age ( n = 368 in the EDUCORE and control groups ) , all of whom had been diagnosed with HBP at least one year ago , and all of whom had poorly controlled hypertension ( systolic blood pressure ≥ 140 mmHg and /or diastolic ≥ 90 mmHg ) . All personnel taking part were explained the trial and trained in its methodology . The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action , plus the receipt of a pamphlet explaining how to better maintain cardiac health . The main outcome variable was the control of blood pressure ; secondary outcome variables included the SCORE score , therapeutic compliance , quality of life , and total cholesterol level . All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months . Information on sex , age , educational level , physical activity , body mass index , consumption of medications , change of treatment and blood analysis results was also recorded ; Discussion The EDUCORE method could provide a simple , inexpensive means of improving blood pressure control , and perhaps other health problems , in the primary healthcare setting ; Trial registration The trial was registered with Clinical Trials.gov , number NCT01155973 [ http:// Clinical Trials.gov ] Objective To evaluate the effectiveness of the community based Cardiovascular Health Awareness Program ( CHAP ) on morbidity from cardiovascular disease . Design Community cluster r and omised trial . Setting 39 mid-sized communities in Ontario , Canada , stratified by location and population size . Participants Community dwelling residents aged 65 years or over , family physicians , pharmacists , volunteers , community nurses , and local lead organisations . Intervention Communities were r and omised to receive CHAP ( n=20 ) or no intervention ( n=19 ) . In CHAP communities , residents aged 65 or over were invited to attend volunteer run cardiovascular risk assessment and education sessions held in community based pharmacies over a 10 week period ; automated blood pressure readings and self reported risk factor data were collected and shared with participants and their family physicians and pharmacists . Main outcome measure Composite of hospital admissions for acute myocardial infa rct ion , stroke , and congestive heart failure among all community residents aged 65 and over in the year before compared with the year after implementation of CHAP . Results All 20 intervention communities successfully implemented CHAP . A total of 1265 three hour long sessions were held in 129/145 ( 89 % ) pharmacies during the 10 week programme . 15 889 unique participants had a total of 27 358 cardiovascular assessment s with the assistance of 577 peer volunteers . After adjustment for hospital admission rates in the year before the intervention , CHAP was associated with a 9 % relative reduction in the composite end point ( rate ratio 0.91 , 95 % confidence interval 0.86 to 0.97 ; P=0.002 ) or 3.02 fewer annual hospital admissions for cardiovascular disease per 1000 people aged 65 and over . Statistically significant reductions favouring the intervention communities were seen in hospital admissions for acute myocardial infa rct ion ( rate ratio 0.87 , 0.79 to 0.97 ; P=0.008 ) and congestive heart failure ( 0.90 , 0.81 to 0.99 ; P=0.029 ) but not for stroke ( 0.99 , 0.88 to 1.12 ; P=0.89 ) . Conclusions A collaborative , multi-pronged , community based health promotion and prevention programme targeted at older adults can reduce cardiovascular morbidity at the population level . Trial registration Current controlled trials IS RCT N50550004 Background Although hypercholesterolemia is considered a cardiovascular risk factor , in isolation it is not necessarily sufficient cause for a cardiovascular event . To improve event prediction , cardiovascular risk calculators have been developed ; the REGICOR calculator has been vali date d for use in our population . The objective of this project is to develop an intervention with general practitioners ( GPs ) and evaluate its impact on prescription adequacy of cholesterol-lowering drugs in primary prevention of cardiovascular disease and in controlling the costs associated with this disease . Methods This nonblinded , cluster-r and omized clinical trial analyzes data from primary care electronic medical records ( ECAP ) and other data bases . Inclusion criteria are patients aged 35 to 74 years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the 2-year study period . Dependent variables include the following : RETIRA , defined as new cholesterol-lowering drugs initiated during the year preceding the intervention , considered inadequate , and withdrawn during the study period ; EVITA , defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate ; COST , defined as the total cost of inadequate new treatments prescribed ; and REGISTER , defined as the recording of cardiovascular risk factors . Independent variables include the  GP ’s quality -of-care indicators and r and omly assigned study group ( intervention vs control )  , patient demographics , and clinical variables . Aggregated descriptive analysis will be done at the GP level and multilevel analysis will be performed to estimate the intervention effect , adjusted for individual and GP variables . Discussion The study objective is to generate evidence about the effectiveness of implementing feedback information programs directed to GPs in the context of Primary Care . The goal is to improve the prescription adequacy of lipid-lowering therapies for primary prevention . Trial registration Clinical Trials.gov Identifier : NCT01997671 . November 28 , 2013 Aims We assessed whether a novel programme to evaluate/communicate predicted coronary heart disease ( CHD ) risk could lower patients ' predicted Framingham CHD risk vs. usual care . Methods The Risk Evaluation and Communication Health Outcomes and Utilization Trial was a prospect i ve , controlled , cluster-r and omised trial in nine European countries , among patients at moderate cardiovascular risk . Following baseline assessment s , physicians in the intervention group calculated patients ' predicted CHD risk and were instructed to advise patients according to a risk evaluation/communication programme . Usual care physicians did not calculate patients ' risk and provided usual care only . The primary end-point was Framingham 10-year CHD risk at 6 months with intervention vs. usual care . Results Of 1103 patients across 100 sites , 524 patients receiving intervention , and 461 receiving usual care , were analysed for efficacy . After 6 months , mean predicted risks were 12.5 % with intervention , and 13.7 % with usual care [ odds ratio = 0.896 ; p = 0.001 , adjusted for risk at baseline ( 17.2 % intervention ; 16.9 % usual care ) and other covariates ] . The proportion of patients achieving both blood pressure and low-density lipoprotein cholesterol targets was significantly higher with intervention ( 25.4 % ) than usual care ( 14.1 % ; p < 0.001 ) , and 29.3 % of smokers in the intervention group quit smoking vs. 21.4 % of those receiving usual care ( p = 0.04 ) . Conclusions A physician-implemented CHD risk evaluation/communication programme improved patients ' modifiable risk factor profile , and lowered predicted CHD risk compared with usual care . By combining this strategy with more intensive treatment to reduce residual modifiable risk , we believe that substantial improvements in cardiovascular disease prevention could be achieved in clinical practice Background The format or frame in which the results of r and omized trials are presented has been shown to influence health professional 's self-reported practice . We sought to investigate the effect of framing cardiovascular risk as two different formats in a r and omized trial . Methods We recruited 457 patients aged between 60 and 79 years with high blood pressure from 20 family practice s in Avon , UK . Patients were r and omized to cardiovascular risk presented either as 1 ) an absolute risk level ( AR ) or as 2 ) the number needed to treat to prevent an adverse event ( NNT ) . The main outcome measures were : 1 ) percentage of patients in each group with a five-year cardiovascular risk ≥ 10 % , 2 ) systolic and diastolic blood pressure , 3 ) intensity of prescribing of cardiovascular medication . Results Presenting cardiovascular risk as either an AR or NNT had no impact reducing cardiovascular risk at 12 month follow up , adjusted odds ratio 1.53 ( 95%CI 0.76 to 3.08 ) . There was no difference between the two groups in systolic ( adjusted difference 0.97 mmHg , 95%CI -2.34 mmHg to 4.29 mmHg ) or diastolic ( adjusted difference 0.70 mmHg , 95%CI -1.05 mmHg to 2.45 mmHg ) blood pressure . Intensity of prescribing of blood pressure lowering drugs was not significantly different between the two groups at six months follow up . Conclusions Presenting cardiovascular risk in clinical practice guidelines as either an AR or NNT had a similar influence on patient outcome and prescribing intensity . There is no difference in patient outcomes when these alternative formats of risk are used in clinical practice guidelines OBJECTIVE Patients with type 2 diabetes mellitus ( T2DM ) underestimate their risk of developing severe complications , and they do not always underst and the risk communication by their caregivers . The aim of this study was to investigate the effects of an intervention focused on the communication of the absolute 10-year risk of developing cardiovascular disease ( CVD ) in patients with T2DM . RESEARCH DESIGN AND METHODS A r and omized controlled trial was performed in T2DM patients newly referred to the Diabetes Care System ( DCS ) West-Friesl and , a managed-care system in the Netherl and s. The intervention group ( n = 131 ) received a six-step CVD risk communication .  Control subjects ( n = 130 ) received st and ard managed care . The primary outcome measure was appropriateness of risk perception ( difference between actual CVD risk calculated by the UK Prospect i ve Diabetes Study risk engine and risk perception ) . Secondary outcome measures were illness perceptions , attitude and intention to change behavior , satisfaction with the communication , and anxiety and worry about CVD risk . Patients completed question naires at baseline , at 2 weeks ( immediately after the intervention ) , and at 12 weeks . RESULTS Appropriateness of risk perception improved between the intervention and control groups at 2 weeks . This effect disappeared at 12 weeks . No effects were found on illness perceptions , attitude and intention to change behavior , or anxiety and worry about CVD risk . Patients in the intervention group were significantly more satisfied with the communication . CONCLUSIONS This risk communication method improved patients ’ risk perception at 2 weeks but not at 12 weeks . Negative effects were not found , as patients did not become anxious or worried after the CVD risk communication Background Whether disclosure of a genetic risk score ( GRS ) for a common disease influences relevant clinical outcomes is unknown . We describe design of the Myocardial Infa rct ion Genes ( MI-GENES ) Study , a r and omized clinical trial to assess whether disclosing a GRS for coronary heart disease ( CHD ) leads to lowering of low-density lipoprotein cholesterol ( LDL-C ) levels . Methods and design We performed an initial screening genotyping of 28 CHD susceptibility single-nucleotide polymorphisms ( SNPs ) that are not associated with blood pressure or lipid levels , in 1000 individuals from Olmsted County , Minnesota who were participants in the Mayo Clinic BioBank and met eligibility criteria . We calculated GRS based on 28 SNPs and will enroll 110 patients each in two CHD genomic risk categories : high ( GRS ≥1.1 ) , and average/low ( GRS < 1.1 ) . The study coordinator will obtain informed consent for the study that includes placing genetic testing results in the electronic health record . Participants will undergo a blood draw and return 6 - 10 weeks later ( Visit 2 ) once genotyping is completed and a GRS calculated . At this visit , patients will be r and omized ( 1:1 ) to receive CHD risk estimates from a genetic counselor based on a conventional risk score ( CRS ) vs. GRS , followed by shared decision making with a physician regarding statin use . Three and six months following the disclosure of CHD risk , participants will return for measurement of fasting lipid levels and assessment of changes in dietary fat intake and physical activity levels . Psychosocial measures will be assessed at baseline and after disclosure of CHD risk . Discussion The proposed trial will provide insights into the clinical utility of genetic testing for CHD risk assessment . Clinical trial registration Clinical Trials.gov registration number : NCT01936675 Background Risk communication is an integral part of shared decision-making in health care . In the context of interventions for chronic diseases it represents a particular challenge for all health practitioners . By using two different quantitative formats to communicate risk level and effectiveness of a cholesterol-lowering drug , we posed the research question : how does the format of risk information influence patients ’ decisions concerning therapy , patients ’ satisfaction with the communication as well as confidence in the decision . We hypothesise that patients are less prone to accept therapy when the benefits of long-term intervention are presented in terms of prolongation of life ( POL ) in months compared to the absolute risk reduction ( ARR ) . We hypothesise that patients presented with POL will be more satisfied with the communication and confident in their decision , suggesting underst and ing of the time-related term . Methods / Design In 2009 a sample of 328 general practitioners ( GPs ) in the Region of Southern Denmark was invited to participate in a primary care-based clinical trial among patients making real-life clinical decisions together with their GP . Interested GPs were cluster-r and omised to inform patients about cardiovascular disease ( CVD ) risk and the effectiveness of statin therapy using either POL or ARR . The GPs attended a training session before informing their patients . Before training and after the trial period they received a question naire about their attitudes to risk communication and the use of numerical information . Patients ’ redemptions of statin prescriptions will be registered in a regional prescription data base to evaluate a possible association between redemption rates and effectiveness format . The Combined Outcome Measure for Risk Communication And Treatment Decision Making Effectiveness ( COMRADE ) question naire will be used to measure patients ’ confidence and satisfaction with the risk communication immediately after the conversation with their GPs . Discussion This r and omised clinical trial compares the impact of two effectiveness formats on real-life risk communication between patients and GPs , including affective patient outcomes and actual choices about acceptance of therapy . Though we found difficulties in recruiting GPs , according to the study protocol we have succeeded in engaging sufficient GPs for the trial , enabling us to perform the planned analyses . Trial registration Clinical Trials.gov Protocol Registration System http://ww . clinical Background Efficacious strategies for the primary prevention of coronary heart disease ( CHD ) are underused , and , when used , have low adherence . Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice . Methods We conducted a r and omized trial of a CHD prevention intervention ( including a computerized decision aid and automated tailored adherence messages ) at one university general internal medicine practice . After obtaining informed consent and collecting baseline data , we r and omized patients ( men and women age 40 - 79 with no prior history of cardiovascular disease ) to either the intervention or usual care . We then saw them for two additional study visits over 3 months . For intervention participants , we administered the decision aid at the primary study visit ( 1 week after baseline visit ) and then mailed 3 tailored adherence reminders at 2 , 4 , and 6 weeks . We assessed our outcomes ( including the predicted likelihood of angina , myocardial infa rct ion , and CHD death over 10 years ( CHD risk ) and self-reported adherence ) between groups at 3 month follow-up . Data collection occurred from June 2007 through December 2009 . All study procedures were IRB approved . Results We r and omized 160 eligible patients ( 81 intervention ; 79 control ) and followed 96 % to study conclusion . Mean predicted CHD risk at baseline was 11.3 % . The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points ( 95 % CI 8 % to 42 % ) , with the biggest effect for aspirin . It also changed predicted CHD risk by -1.1 % ( 95 % CI -0.16 % to -2 % ) , with a larger effect in a pre-specified subgroup of high risk patients . Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk . Clinical trials registration number Clinical Trials.gov : Background Blood Pressure related disease affected 118 million people in India in the year 2000 ; this figure will double by 2025 . Around one in four adults in rural India have hypertension , and of those , only a minority are accessing appropriate care . Health systems in India face substantial challenges to meet these gaps in care , and innovative solutions are needed . Methods We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare . This intervention will be implemented as a stepped wedge , cluster r and omised controlled trial in 18 primary health centres and 54 villages in rural And hra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk ( approximately 15,000 people ) . Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension ’s region-specific risk charts . Cluster r and omisation will occur at the level of the primary health centres . Outcome analyses will be conducted blinded to intervention allocation . Expected outcomes The primary study outcome is the difference in the proportion of people meeting guideline -recommended blood pressure targets in the intervention period vs. the control period . Secondary outcomes include mean reduction in blood pressure levels ; change in other cardiovascular disease risk factors , including body mass index , current smoking , reported healthy eating habits , and reported physical activity levels ; self-reported use of blood pressure and other cardiovascular medicines ; quality of life ( using the EQ-5D ) ; and cardiovascular disease events ( using hospitalisation data ) . Trial outcomes will be accompanied by detailed process and economic evaluations . Significance The findings are likely to inform policy on a scalable strategy to overcome entrenched inequities in access to effective healthcare for under-served population s in low and middle income country setting s . Trial registration Clinical Trial Registry India CTRI/2013/06/003753 Background A gap exists between evidence and practice regarding the management of cardiovascular risk factors . This gap could be narrowed if systematic ally developed clinical practice guidelines were effectively implemented in clinical practice . We evaluated the effects of a tailored intervention to support the implementation of systematic ally developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease . Methods and Findings We conducted a cluster-r and omized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practice s in two geographical areas in Norway . Each practice was r and omized to either the tailored intervention ( 70 practice s ; 257 physicians ) or control group ( 69 practice s ; 244 physicians ) . Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included . A multifaceted intervention was tailored to address identified barriers to change . Key components were an educational outreach visit with audit and feedback , and computerized reminders linked to the medical record system . Pharmacists conducted the visits . Outcomes were measured for all eligible patients seen in the participating practice s during 1 y before and after the intervention . The main outcomes were the proportions of ( 1 ) first-time prescriptions for hypertension where thiazides were prescribed , ( 2 ) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs , and ( 3 ) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals . The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug . Thiazides were prescribed to 17 % of patients in the intervention group versus 11 % in the control group ( relative risk 1.94 ; 95 % confidence interval 1.49–2.49 , adjusted for baseline differences and clustering effect ) . Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals . Conclusions Our tailored intervention had a significant impact on prescribing of antihypertensive drugs , but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care Background In re source -poor areas of China and India , the cardiovascular disease burden is high , but availability of and access to quality healthcare is limited . Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management . The study aims to develop , implement , and evaluate the feasibility and effectiveness of a simplified , evidence -based cardiovascular management program delivered by community healthcare workers in re source -constrained areas in Tibet , China and Haryana , India . Methods / design This yearlong cluster-r and omized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana . R and omization of villages to usual care or intervention will be stratified by country . High cardiovascular disease risk individuals ( aged 40 years or older , history of heart disease , stroke , diabetes , or measured systolic blood pressure of 160 mmHg or higher ) will be screened at baseline . Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified ‘ 2 + 2 ’ intervention model involving two lifestyle recommendations and the appropriate prescription of two medications . A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management . Baseline and follow-up surveys will be conducted in a st and ardized fashion in all villages . The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention . Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure . Process and economic evaluations will also be conducted . Discussion To our knowledge , this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients . If effective , this intervention strategy can serve as a model that can be implemented , where applicable , in rural China , India , and other re source -constrained areas .Trial registration The trial was registered in the clinical trials.gov data base on 30 December , 2011 and the registration number is NCT01503814 Objective To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level . Design R and omised controlled community based trial . Setting Suburbs of Copenhagen , Denmark Participants 59 616 people aged 30 - 60 years r and omised with different age and sex r and omisation ratios to an intervention group ( n=11 629 ) and a control group ( n=47 987 ) . Intervention The intervention group was invited for screening , risk assessment , and lifestyle counselling up to four times over a five year period . All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits ( at baseline and after one and three years ) ; those at high risk of ischaemic heart disease , according to predefined criteria , were furthermore offered six sessions of group based lifestyle counselling on smoking cessation , diet , and physical activity . After five years all were invited for a final counselling session . Participants were referred to their general practitioner for medical treatment , if relevant . The control group was not invited for screening . Main outcome measures The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group .  Secondary outcome measures were stroke , combined events ( ischaemic heart disease , stroke , or both ) , and mortality . Results 6091 ( 52.4 % ) people in the intervention group participated at baseline . Among 5978 people eligible at five year follow-up ( 59 died and 54 emigrated ) , 4028 ( 67.4 % ) attended . A total of 3163 people died in the 10 year follow-up period . Among 58 308 without a history of ischaemic heart disease at baseline , 2782 developed ischaemic heart disease . Among 58 940 without a history of stroke at baseline , 1726 developed stroke . No significant difference was seen between the intervention and control groups in the primary end point ( hazard ratio for ischaemic heart disease 1.03 , 95 % confidence interval 0.94 to 1.13 ) or in the secondary endpoints ( stroke 0.98 , 0.87 to 1.11 ; combined endpoint 1.01 , 0.93 to 1.09 ; total mortality 1.00 , 0.91 to 1.09 ) . Conclusion A community based , individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease , stroke , or mortality at the population level after 10 years . Trial registration Clinical trials NCT00289237 Background Cardiovascular disease ( CVD ) remains the leading cause of death globally . Primary prevention of CVD requires cost-effective strategies to identify individuals at high risk in order to help target preventive interventions . An integral part of this approach is the use of CVD risk scores . Limitations in previous studies have prevented reliable inference about the potential advantages and the potential harms of using CVD risk scores as part of preventive strategies . We aim to evaluate short-term effects of providing different types of information about coronary heart disease ( CHD ) risk , alongside lifestyle advice , on health-related behaviours . Methods / Design In a parallel-group , open r and omised trial , we are allocating 932 male and female blood donors with no previous history of CVD aged 40–84 years in Engl and to either no intervention ( control group ) or to one of three active intervention groups : i ) lifestyle advice only ; ii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics ; and iii ) lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics . The primary outcome is change in objective ly measured physical activity . Secondary outcomes include : objective ly measured dietary behaviours ; cardiovascular risk factors ; current medication and healthcare usage ; perceived risk ; cognitive evaluation of provision of CHD risk scores ; and psychological outcomes . The follow-up assessment takes place 12 weeks after r and omisation . The experiences , attitudes and concerns of a subset of participants will be also studied using individual interviews and focus groups . Discussion The INFORM study has been design ed to provide robust findings about the short-term effects of providing different types of information on estimated 10-year CHD risk and lifestyle advice on health-related behaviours . Trial registration Current Controlled Trials IS RCT N17721237 . Registered 12 January 2015 Aims Little is known about the long-term effects of intensive multifactorial treatment early in the diabetes disease trajectory . In the absence of long-term data on hard outcomes , we described change in 10-year modelled cardiovascular risk in the 5 years following diagnosis , and quantified the impact of intensive treatment on 10-year modelled cardiovascular risk at 5 years . Methods In a pragmatic , cluster-r and omized , parallel-group trial in Denmark , the Netherl and s and the UK , 3057 people with screen-detected Type 2 diabetes were r and omized by general practice to receive ( 1 ) routine care of diabetes according to national guidelines ( 1379 patients ) or ( 2 ) intensive multifactorial target-driven management ( 1678 patients ) . Ten-year modelled cardiovascular disease risk was calculated at baseline and 5 years using the UK Prospect i ve Diabetes Study Risk Engine ( version 3β ) . Results Among 2101 individuals with complete data at follow up ( 73.4 % ) , 10-year modelled cardiovascular disease risk was 27.3 % ( sd 13.9 ) at baseline and 21.3 % ( sd 13.8 ) at 5-year follow-up ( intensive treatment group difference –6.9 , sd 9.0 ; routine care group difference –5.0 , sd 12.2 ) . Modelled 10-year cardiovascular disease risk was lower in the intensive treatment group compared with the routine care group at 5 years , after adjustment for baseline cardiovascular disease risk and clustering ( –2.0 ; 95 % CI –3.1 to –0.9 ) . Conclusions Despite increasing age and diabetes duration , there was a decline in modelled cardiovascular disease risk in the 5 years following diagnosis . Compared with routine care , 10-year modelled cardiovascular disease risk was lower in the intensive treatment group at 5 years . Our results suggest that patients benefit from intensive treatment early in the diabetes disease trajectory , where the rate of cardiovascular disease risk progression may be slowed OBJECTIVES The aim of this study was to determine  adults '  Willingness To Pay ( WTP ) for CardioVascular Disease ( CVD ) intervention programs of different intensities . METHODS Three hundred fourteen participants were r and omized to two study conditions : ( i ) CVD risk assessment /communication ; ( ii ) CVD risk assessment /communication + a behavior change program . The behavior change program was aim ed at increasing physical activity , reducing saturated fat intake and smoking cessation . It consisted of a tailored Web site and individual coaching with a self-selected dose . At post- assessment , WTP and perceived autonomy support items were included . The intervention dose was registered throughout the trial and post-hoc intervention dose groups were created . Pearson Chi-Square tests , Student 's t-tests , one-way analyses of variance were used to examine WTP-differences between the study conditions and intervention dose groups . RESULTS Twenty-four months after baseline , 61 and 135 participants of the control and intervention condition , respectively , completed the question naires . No WTP difference was found between the study conditions . However , participants that selected a higher intervention dose were willing to pay significantly more for their program ( p < .05 ) . CONCLUSIONS In general , people want to pay the same amount of money for a CVD prevention program , irrespective of the inclusion of a behavior change program . However , there seems to be an association between the self-selected dose of the latter program and the WTP Abstract BACKGROUND : Integrative medicine is an individualized , patient-centered approach to health , combining a whole-person model with evidence -based medicine . Interventions based in integrative medicine theory have not been tested as cardiovascular risk-reduction strategies . Our objective was to determine whether personalized health planning ( PHP ) , an intervention based on the theories and principles underlying integrative medicine , reduces 10-year risk of coronary heart disease ( CHD ) . METHODS : We conducted a r and omized , controlled trial among 154 out patients age 45 or over , with 1 or more known cardiovascular risk factors . Subjects were enrolled from primary care practice s near an academic medical center , and the intervention was delivered at a university Center for Integrative Medicine . Following a health risk assessment , each subject in the intervention arm worked with a health coach and a medical provider to construct a personalized health plan . The plan identified specific health behaviors important for each subject to modify ; the choice of behaviors was driven both by cardiovascular risk reduction and the interests of each individual subject . The coach then assisted each subject in implementing her/his health plan . Techniques used in implementation included mindfulness meditation , relaxation training , stress management , motivational techniques , and health education and coaching .  Subjects r and omized to the comparison group received usual care ( UC ) without access to the intervention  . Our primary outcome measure was 10-year risk of CHD , as measured by a st and ard Framingham risk score , and assessed at baseline , 5 , and 10 months . Differences between arms were assessed by linear mixed effects modeling , with time and study arm as independent variables . RESULTS : Baseline 10-year risk of CHD was 11.1 % for subjects r and omized to UC ( n=77 ) , and 9.3 % for subjects r and omized to PHP ( n=77 ) . Over 10 months of the intervention , CHD risk decreased to 9.8 % for UC subjects and 7.8 % for intervention subjects . Based on a linear mixed-effects model , there was a statistically significant difference in the rate of risk improvement between the 2 arms ( P=.04 ) . In secondary analyses , subjects in the PHP arm were found to have increased days of exercise per week compared with UC ( 3.7 vs 2.4 , P=.002 ) , and subjects who were overweight on entry into the study had greater weight loss in the PHP arm compared with UC ( P=.06 ) . CONCLUSIONS : A multidimensional intervention based on integrative medicine principles reduced risk of CHD , possibly by increasing exercise and improving weight loss BACKGROUND Developing countries are experiencing increasing levels of cardiovascular disease ( CVD ) . Although there is a good underst and ing of how to deliver CVD prevention programs in developed countries , there are few data regarding strategies for CVD prevention in re source -poor setting s. This study aim ed to implement and evaluate a CVD prevention program in a rural area of India . METHODS The 2 strategies of CVD prevention to be investigated are an algorithm-based care approach and a health-promotion campaign . A factorial , cluster-r and omized trial design will be used to evaluate these , in which villages will be exposed to one , both , or neither of the interventions for a period of about 12 months . Surveys of households in every village will be used to assess outcomes in all high-risk individuals and a sample of the general adult population . RESULTS The primary outcome of the algorithm-based component of this study will be the percentage of high-risk individuals that have been " identified"-defined as having received a cardiovascular-risk assessment in the last 12 months . The primary outcome for the health-promotion component will be the percentage of the adult population with correct knowledge about the effects of 6 behavioral determinants of cardiovascular risk ( green-leafy vegetables , fruits , oily foods , salt , smoking , physical activity ) . Secondary outcomes include a range of measures defining uptake of different preventive strategies . CONCLUSIONS This study will provide evidence about the effectiveness of a simple practical mechanism of CVD preventive care specifically design ed for delivery in a re source -poor area in India Objective To determine the effectiveness of intensive structured care to optimise blood pressure control based on individual absolute risk targets in primary care . Design Pragmatic multicentre r and omised controlled trial . Setting General practice s throughout Australia , except Northern Territory , 2009 - 11 . Participants Of 2185 patients from 119 general practice s who were eligible for drug treatment for hypertension according to national guidelines 416 ( 19.0 % ) achieved their individual blood pressure target during a 28 day run-in period of monotherapy . After exclusions , 1562 participants not at target blood pressure ( systolic 150 ( SD 17 ) mm Hg , diastolic 88 ( SD 11 ) mm Hg ) were r and omised ( 1:2 ratio ) to usual care ( n=524 ) or the intervention ( n=1038 ) . Intervention Computer assisted clinical profiling and risk target setting ( all participants ) with intensified follow-up and stepwise drug titration ( initial angiotensin receptor blocker monotherapy or two forms of combination therapy using angiotensin receptor blockers ) for those r and omised to the intervention . The control group received usual care . Main outcome measures The primary outcome was individual blood pressure target achieved at 26 weeks . Secondary outcomes were change in mean sitting systolic and diastolic blood pressure , absolute risk for cardiovascular disease within five years based on the Framingham risk score , and proportion and rate of adverse events . Results On an intention to treat basis , there was an 8.8 % absolute difference in individual blood pressure target achieved at 26 weeks in favour of the intervention group compared with usual care group ( 358/988 ( 36.2 % ) v 138/504 ( 27.4 % ) ) : adjusted relative risk 1.28 ( 95 % confidence interval 1.10 to 1.49 , P=0.0013 ) . There was also a 9.5 % absolute difference in favour of the intervention group for achieving the classic blood pressure target of ≤140/90 mm Hg ( 627/988 ( 63.5 % ) v 272/504 ( 54.0 % ) ) : adjusted relative risk 1.18 ( 1.07 to 1.29 , P<0.001 ) . The intervention group achieved a mean adjusted reduction in systolic blood pressure of 13.2 mm Hg ( 95 % confidence interval −12.3 to −14.2 mm Hg ) and diastolic blood pressure of 7.7 mm Hg ( −7.1 to −8.3 mm Hg ) v 10.1 mm Hg ( −8.8 to 11.3 mm Hg ) and 5.5 mm Hg ( −4.7 to −6.2 mm Hg ) in the usual care group ( P<0.001 ) . Among 1141 participants in whom five year absolute cardiovascular risk scores  were calculated from baseline to the 26 week follow-up , the reduction in risk scores was greater in the intervention group than usual care group ( 14.7 % ( SD 9.3 % ) to 10.9 % ( SD 8.0 % ) ; difference −3.7 % ( SD 4.5 % ) and 15.0 % ( SD 10.1 % ) to 12.4 % ( SD 9.4 % ) ; −2.6 % ( SD 4.5 % ) : adjusted mean difference −1.13 % ( 95 % confidence interval −0.69 % to −1.63 % ; P<0.001 ) . Owing to adverse events 82 ( 7.9 % ) participants in the intervention group and 10 ( 1.9 % ) in the usual care group had their drug treatment modified . Conclusions In a primary care setting intensive structured care result ed in higher levels of blood pressure control , with clinical ly lower blood pressure and absolute risk of future cardiovascular events overall and with more people achieving their target blood pressure . An important gap in treatment remains though and applying intensive management and achieving currently advocated risk based blood pressure targets is challenging AIMS Cardiovascular disease ( CVD ) is the leading cause of morbidity and mortality in people with diabetes in South Asia . The CARRS Translation Trial tests the effectiveness , cost-effectiveness , and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan . METHODS We r and omly assigned 1146 adults with diabetes recruited from 10 urban clinic sites , to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention . The intervention involves electronic health record management , decision-support prompts to the healthcare team , and the support of a care coordinator to actively facilitate patient and provider adherence to evidence -based guidelines . The primary outcome is a composite of multiple CVD risk factor control ( blood glucose and either blood pressure or cholesterol , or all three ) . Other outcomes include control of the individual CVD risk factors , process and patient-centered measures , cost-effectiveness , and acceptability/feasibility . CONCLUSION The CARRS Translation Trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients ( clinical trials.gov number : NCT01212328 ) OBJECTIVE To assess the impact of a decision aid on perceived risk of heart attacks and medication adherence among urban primary care patients with diabetes . METHODS We r and omly allocated 150 patients with diabetes to participate in a usual primary care visit either with or without the Statin Choice tool . Participants completed a question naire at baseline and telephone follow-up at 3 and 6 months . RESULTS Intervention patients were more likely to accurately perceive their underlying risk for a heart attack without taking a statin ( OR : 1.9 , CI : 1.0 - 3.8 ) and with taking a statin ( OR : 1.4 , CI : 0.7 - 2.8 ) ; a decline in risk overestimation among patients receiving the decision aid accounts for this finding . There was no difference in statin adherence at 3 or 6 months . CONCLUSION A decision aid about using statins to reduce coronary risk among patients with diabetes  improved risk communication , beliefs , and decisional conflict , but did not improve adherence to statins . PRACTICE IMPLICATION S Decision aid enhanced communication about the risks and benefits of statins improved patient risk perceptions but did not alter adherence among patients with diabetes BACKGROUND Numerous studies have demonstrated the value of including pharmacists in team-based care to improve adherence to cardiovascular ( CV ) guidelines , medication adherence , and risk factor control . However , there is limited information on whether these models can be successfully implemented more widely in diverse setting s and population s. The purpose of this study is to evaluate whether a central ized , web-based cardiovascular risk service ( CVRS ) managed by clinical pharmacists will improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics . METHODS This study is a prospect i ve trial in 20 primary care offices stratified by the percent of under-represented minorities and then r and omized to either the CVRS intervention or usual care .  The intervention will last for 12 months and all subjects will have research visits at baseline and 12 months . The primary outcome is the difference in guideline adherence between groups . Data will also be abstract ed from the medical record at 24 months to determine if the intervention effect is sustained after it is discontinued . CONCLUSIONS Patient enrollment will continue through 2016 , with results expected in 2019 . This study will provide information on whether a distant , central ized CVRS can be implemented in large numbers of medical offices , if it is effective in diverse population s , and if there is a long-term sustained effect OBJECTIVE To assess the effect of a specialist telemedicine intervention for improving diabetes care using the chronic care model ( CCM ) . PARTICIPANTS AND METHODS As part of the CCM , 97 primary care physicians at 6 primary care practice s in Rochester , MN , referred 639 patients to an on-site diabetes educator between July 1 , 2001 , and December 31 , 2003 . On first referral , physicians were central ly r and omized to receive a telemedicine intervention ( specialty advice and evidence -based messages regarding medication management for cardiovascular risk ) or no intervention , keeping outcome assessors and data analysts blinded to group assignment . After each subsequent clinical encounter , endocrinologists review ed an abstract from the patient 's electronic medical record and provided management recommendations and supporting evidence to intervention physicians via e-mail . Control physicians received e-mail with periodic generic information about cardiovascular risk reduction in diabetes . Outcome measures included diabetes care processes ( diabetes test completion ) , outcomes ( metabolic and cardiovascular risk factors , estimated coronary artery disease risk ) , and patient costs ( payer perspective ) . RESULTS During the intervention , 951 ( 70 % ) of the 1361 endocrinology review s detected performance gaps and result ed in a message ; primary care physicians reported using 49 % of messages in patient care . With a mean of 21 months ' follow-up , the intervention , compared with control , did not significantly enhance metabolic outcomes or reduce estimated risk of coronary artery disease ( adjusted mean difference , -1 % ; 95 % confidence interval , -19 % to 17 % ) . The intervention group incurred lower costs ( P=.02 ) but not in diabetes-related costs . CONCLUSION Specialty telemedicine did not significantly enhance the value of CCM in primary care BACKGROUND There is increasing political pressure on the medical profession to approach welfare diseases , such as coronary heart disease and diabetes , through prevention . General practitioners are required to offer regular health checks to healthy people  , in spite of the lack of scientific evidence for the universal need , usefulness and side effects of such an intervention . R and omized controlled trials are needed . AIM A study was carried out to investigate people 's interest in participating in health checks and in discussion s about health with their own general practitioner , participants ' health status , the proportion who received health advice following health checks , and the lifestyle goals they set following discussion with their general practitioner . This study reports the baseline data from a five-year r and omized , controlled , prospect i ve , population -based study in general practice s in Ebeltoft , Denmark . METHOD All general practitioners from the four practice s in Ebeltoft and a r and om sample of 2000 people aged between 30 and 50 years were invited to participate . Participants were r and omly divided into three groups -- one control group and two intervention groups . One intervention group were given a health check which included being screened for cardiovascular risk factors , lung and liver function , fitness , sight and hearing and an optional test for the human immunodeficiency virus ( HIV ) ; this group received written feedback from the general practitioner . The other intervention group were also given a health check and written feedback ; in addition , they were given the opportunity to attend their general practitioner to discuss preventive health . RESULTS A total of 1370 people participated in the study ( 69 % response rate ) . Health advice was given to 76 % of 905 participants following health checks . Almost all of the 456 participants ( 96 % ) who were offered the opportunity of discussing their health with their general practitioner took up the offer ; 64 % of the 456 participants reported that they had decided to undertake lifestyle changes . Eleven of those who discussed their health with the doctor were referred to a specialist ( 2 % ) . CONCLUSION There was considerable interest in participating in health promotion . Three out of four of those having a health check were given health advice . Two out of three of those offered a health talk with the general practitioner appeared willing to make relevant lifestyle changes . Long-term follow up is needed to determine effects and side effects of health checks and health talks PURPOSE We wanted to determine whether an intervention based on patient activation and a physician decision support tool was more effective than usual care for improving adherence to National Cholesterol Education Program guidelines . METHODS A 1-year cluster r and omized controlled trial was performed using 30 primary care practice s ( 4,105 patients ) in southeastern New Engl and . The main outcome was the percentage of patients screened for hyperlipidemia and treated to their low-density lipoprotein ( LDL ) and non – high-density lipoprotein ( HDL ) cholesterol goals . RESULTS After 1 year of intervention , both r and omized practice groups improved screening ( 89 % screened ) , and 74 % of patients in both groups were at their LDL and non-HDL cholesterol goals ( P < .001 ) . Using intent-to-treat analysis , we found no statistically significant differences between practice groups in screening or percentage of patients who achieved LDL and non-HDL cholesterol goals . Post hoc analysis showed practice s who made high use of the patient activation kiosk were more likely to have patients screened ( odds ratio [ OR ] = 2.54 ; 95 % confidence interval [ CI ] , 1.97–3.27 ) compared with those who made infrequent or no use . Additionally , physicians who made high use of decision support tools were more likely to have their patients at their LDL cholesterol goals ( OR = 1.27 ; 95 % CI , 1.07–1.50 ) and non-HDL goals ( OR = 1.23 ; 95 % CI , 1.04–1.46 ) than low-use or no-use physicians . CONCLUSION This study showed null results with the intent-to-treat analysis regarding the benefits of a patient activation and a decision support tool in improving cholesterol management in primary care practice s. Post hoc analysis showed a potential benefit in practice s that used the e-health tools more frequently in screening and management of dyslipidemia . Further research on how to incorporate and increase adoption of user-friendly , patient-centered e-health tools to improve screening and management of chronic diseases and their risk factors is warranted BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of global mortality . Risk factor management in clinical practice often relies on relative risk modification rather than the more appropriate absolute risk assessment . AIM To determine whether patients receiving more-frequently design ated GP visits had increased benefit in terms of their absolute CVD risk assessment , as compared with patients in receipt of their usual GP care . DESIGN AND SETTING Prospect i ve , open , pragmatic block r and omised study in a 1:1 group allocation ratio in three Western Australian general practice s. METHOD A convenience sample ( n = 1200 ) of patients aged 40 - 80 years were r and omised to 3-monthly GP visits ( five in total for the intensive ) or usual GP care ( two in total for the opportunistic ) , with 12 months ' follow-up . The main outcome was absolute CVD risk scores based on the New Zeal and Cardiovascular Risk Calculator . Others outcome measures were weight , height , waist circumference , blood pressure , and fasting blood lipids and glucose . RESULTS There were 600 patients per group at baseline . At 12 months ' analysis there were 543 in the intensive group and 569 in the opportunistic group . Mean ( st and ard deviation [ SD ] ) absolute CVD risk reduced significantly between baseline and 12 months in the intensive group ( 6.28 % [ 5.11 ] to 6.10 % [ 4.94 ] ) but not in the opportunistic group ( 6.27 % [ 5.10 ] to 6.24 % [ 5.38 ] ) . There was a significant reduction between baseline and 12 months in mean ( SD ) total cholesterol ( 5.28 mmol/l [ 0.94 ] to 5.08 mmol/l [ 0.96 ] ) ; low-density lipoprotein cholesterol ( 3.08 mmol/l [ 0.87 ] to 2.95 mmol/l [ 0.89 ] ) ; triglyceride ( 1.45 mmol/l [ 0.86 ] to 1.36 mmol/l [ 0.84 ] ) ; and in mean ( SD ) waist circumference in men ( 98.74 cm [ 10.70 ] to 97.13 cm [ 10.20 ] ) and females ( 90.64 cm [ 14.62 ] to 88.96 cm [ 14.00 ] ) in the intensive group . CONCLUSION A targeted approach using absolute risk calculators can be used in primary care to modify global CVD risk assessment Background : In this study , we tested the efficacy of a low-intensity lifestyle intervention aim ed at reducing the risk of cardiovascular disease among mid-life individuals . Methods : We conducted a r and omized controlled trial in which participants were r and omly assigned either to receive a health report card with counselling ( from a Telehealth nurse ) on smoking , exercise , nutrition and stress or to receive usual care . The patients were divided into 2 groups on the basis of risk : the primary prevention group , with a Framingham risk score of 10 % or higher ( intervention , n = 157 ; control , n = 158 ) , and the secondary prevention group , who had a diagnosis of coronary artery disease ( intervention , n = 153 ; control , n = 143 ) . The primary outcome was a change in the Framingham global risk score between baseline and 1-year follow-up . Data were analyzed separately for the 2 prevention groups using an intention-to-treat analysis controlling for covariates . Results : Within the primary prevention group , there were statistically significant changes for the treatment group relative to the controls , from baseline to year 1 , in Framingham score ( intervention , –3.10 [ 95 % confidence interval ( CI ) –3.98 to –2.22 ] ; control , –1.30 [ 95 % CI –2.18 to –0.42 ] ; p < 0.01 ) and scores for total cholesterol ( intervention , –0.41 [ 95 % CI –0.59 to –0.23 ] ; control , –0.14 [ 95 % CI –0.32 to 0.04 ] ; p < 0.05 ) , systolic blood pressure ( intervention , –7.49 [ 95 % CI –9.97 to –5.01 ] ; control , –3.58 [ 95 % CI –6.08 to –1.08 ] ; p < 0.05 ) , nutrition level ( intervention , 0.30 [ 95 % CI 0.13 to 0.47 ] ; control , –0.05 [ 95 % CI –0.22 to 0.12 ] ; p < 0.01 ) , and health confidence ( intervention , 0.20 [ 95 % CI 0.09 to 0.31 ] ; control , 0.04 [ 95 % CI –0.07 to 0.15 ] ; p < 0.05 ) , with adjustment for covariates . No significant changes in outcome variables were found for the secondary prevention group . Interpretation : We found evidence for the efficacy of an intervention addressing multiple risk factors for primary prevention at 1 year using Framingham risk score report cards and telephone counselling . ( Requirement for clinical trial registration waived [ enrolment completed before requirement became applicable ] . INTRODUCTION We investigated the impact of general health screenings and discussion s with general practitioners on the  cardiovascular risk profile of the population . MATERIAL AND METHODS A population -based , r and omised , controlled , 5-year follow-up trial conducted in a primary care setting . In total 2000 r and omly selected men and women , aged 30 - 50 years , from family practice s in the district of Ebeltoft , Denmark . Of these persons , 1507 ( 75.4 % ) agreed to participate , and were r and omised into : ( 1 ) a control group who did not receive health screenings ; ( 2 ) an intervention group that received two health screenings ; or ( 3 ) an intervention group that received both the two screenings and a 45-minute follow-up consultation annually with their general practitioner . All were followed up after 5 years by question naires and health screenings . The outcome measures were : cardiovascular risk score ( CRS ) , body mass index ( BMI ) , blood pressure , serum cholesterol , carbon monoxide in expiratory air , and use of tobacco . RESULTS After 5 years , the CRS , BMI , and serum cholesterol levels were lower in the intervention groups , as compared with the control group . The improved outcome was greater in the baseline risk groups . The number of persons with elevated CRS in the intervention groups was about half the number of persons with elevated CRS in the control group . The difference was not a result of medication use . There was no difference between the group that received consultations after the screenings and the group that had health screenings alone . DISCUSSION Systematic health screenings reduce the cardiovascular risk score in a middle-aged population . After 5 years of follow-up , the number of persons at elevated cardiovascular risk was about half the expected . The impact of intervention is higher in at-risk individuals . Planned consultations about health did not appear to improve the cardiovascular profile of the study population BACKGROUND Guidelines for management of hypertension and lipids recommend using cardiovascular absolute risk ( CVAR ) to manage patients . This r and omized controlled trial investigated the impact of CVAR assessment in family practice on management of cardiovascular risk , including prescription of antihypertensive and lipid-lowering medication . METHODS A cluster r and omized controlled trial was conducted from 2008 to 2010 in Sydney , Australia . Family practice s were r and omized , and patients aged 45 to 69 years were invited to participate . Intervention  family physicians ( FP ) were trained in use of CVAR , provided with an electronic CVAR calculator , and assessed their patients ' absolute risk in a dedicated consultation . Control practice patients received a general health check . Primary outcome analyzed was the proportion of patients in each group on antihypertensive and /or lipid-lowering medication  at 12 months . Multilevel logistic regression was performed to explore variables influencing changes in pharmacologic therapy . RESULTS The study recruited 36 FPs from 34 practice s and 1,074 patients , of which 906 ( 84.4 % ) completed 12-month follow-up . At 12 months , there was no significant difference between the intervention and control groups in proportion of patients on antihypertensives ( 31.2 % vs 34.3 % , P = .31 ) , but control group patients were more likely to be on lipid-lowering medications ( 30.2 % vs 22.7 % , P = .01 ) . After multilevel analysis , this difference was not present . Intensification or reduction of pharmacologic therapy was associated with meeting treatment targets for blood pressure and lipids but not with the CVAR or intervention group . CONCLUSIONS Single-risk factor management remains a strong influence on FP prescribing practice s. Shifting to an approach based on CVAR will require more intensive intervention BACKGROUND Primary care data bases contain cardiovascular disease risk factor data , but practical tools are required to improve identification of at-risk patients . AIM To test the effects of a system of electronic reminders ( the ' e-Nudge ' ) on cardiovascular events and the adequacy of data for cardiovascular risk estimation . DESIGN OF STUDY R and omised controlled trial . SETTING Nineteen general practice s in the West Midl and s , UK . METHOD The e-Nudge identifies four groups of patients aged over 50 years on the basis of estimated cardiovascular risk and adequacy of risk factor data in general practice computers . Screen messages highlight individuals at raised risk and prompt users to complete risk profiles where necessary . The proportion of the study population in the four groups was measured , as well as the rate of cardiovascular events in each arm after 2 years . RESULTS Over 38 000 patients ' electronic records were r and omised . The intervention led to an increase in the proportion of patients with sufficient data who were identifiably at risk , with a difference of 1.94 % compared to the control group ( 95 % confidence interval [ CI ] = 1.38 to 2.50 , P<0.001 ) . A corresponding reduction occurred in the proportion potentially at risk but requiring further data for a risk estimation ( difference = -3.68 % , 95 % CI = -4.53 to -2.84 , P<0.001 ) . No significant difference was observed in the incidence of cardiovascular events ( rate ratio = 0.96 , 95 % CI = 0.85 to 1.10 , P = 0.59 ) . CONCLUSION Automated electronic reminders using routinely collected primary care data can improve the adequacy of cardiovascular risk factor information during everyday practice and increase the visibility of the at-risk population OBJECTIVE To test the primary study hypothesis that a physician-delivered coronary heart disease risk evaluation and communication program can lower patients ' predicted 10-year risk of myocardial infa rct ion or death due to coronary heart disease by 10 % within 6 months compared to usual care . DESIGN Prospect i ve , parallel group , open-label , controlled , cluster-r and omized multinational trial ; the study site is the unit of r and omization . SETTING Patients were recruited from 106 general practice s located in nine European countries . PATIENTS Men and women aged 45 to 64 ( N=1500 ) with a documented history of hypertension ( treated or untreated ) , systolic blood pressure > or = 140 mmHg ( or > or = 130 mmHg in the presence of renal or kidney disease ) , no history of cardiovascular disease , and a predicted 10-year risk of myocardial infa rct ion or death due to coronary heart disease > or = 10 % . INTERVENTION Sites were r and omized to deliver a physician-directed coronary heart disease risk communication and education program or usual care . The intervention program included informing patients of their 10-year risk of myocardial infa rct ion or death due to coronary heart disease , educating patients about modifiable risk factors and their control , and three follow-up phone calls by a physician or study nurse . MAIN OUTCOME MEASURE Predicted 10-year risk of myocardial infa rct ion or death due to coronary heart disease at 6 months . CONCLUSIONS REACH OUT will evaluate a novel , patient-focused , physician-implemented application of coronary heart disease risk equations . Results of the study will be of practical relevance to physicians , health care organizations , and those who issue clinical guidelines for the reduction of cardiovascular risk Background : Evidence on the effectiveness of educational interventions on prescribing behaviour modification in prevention of cardiovascular disease is still insufficient . We evaluated the effects of a brief educational intervention on prescription of hydroxymethylglutaryl-CoA reductase inhibitors ( statins ) , inhibitors of platelet aggregation ( IPA ) , and antihypertensive agents ( AH ) . Design : Cluster r and omised controlled trial with continuous medical education ( CME ) groups of general practitioners ( GPs ) . Methods : Prescription of statins , IPA , and AH were verified prior to study start ( BL ) , immediately after index consultation ( IC ) , and at follow-up after 6 months ( FU ) . Prescription in patients at high risk ( > 15 % risk of a cardiovascular event in 10 years , based on the Framingham equation ) and no prescription in low-risk patients ( ≤ 15 % ) were considered appropriate . Results : An intervention effect on prescribing could only be found for IPA . Generally , changes in prescription over time were all directed towards higher prescription rates and persisted to FU , independent of risk status and group allocation . Conclusions : The active implementation of a brief evidence -based educational intervention on global risk in CVD did not lead directly to risk-adjusted changes in prescription . Investigations on an extended time scale would capture whether decision support of this kind would improve prescribing risk-adjusted sustainably This study describes the attitudes and practice s of patients and GPs 12 months after participating in a trial of absolute cardiovascular risk assessment in general practice . It involved a qualitative design using semistructured interviews with 12 Sydney GPs from the intervention arm of a cluster r and omised controlled trial of cardiovascular absolute risk ( CVAR ) assessment and 15 of their moderate to high risk patients who participated in the assessment s. Most GPs had sustained CVAR assessment in their practice , using it primarily to motivate patients to change their behaviour and adhere to management rather than to make decisions about pharmacotherapy or referral . Time was a barrier to its use . Patients who sustained changes to their behaviour had internalised the benefits to their health and received support from family and friends . Those who relapsed attributed this to their own lack of motivation and extrinsic factors . CVAR assessment needs to be incorporated into practice information systems and long-term planned preventive care if it is to be sustained in general practice and have long-term impacts on patient behaviour Background : Preventive guidelines on cardiovascular risk management recommend lifestyle changes . Support for lifestyle changes may be a useful task for practice nurses , but the effect of such interventions in primary prevention is not clear . We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk . Methods : We performed a cluster r and omized controlled trial in 25 practice s that included 615 patients . The intervention consisted of nurse-led cardiovascular risk management , including risk assessment , risk communication , a decision aid and adapted motivational interviewing . The control group received a minimal nurse-led intervention . The self-reported outcome measures at one year were smoking , alcohol use , diet and physical activity . Nurses assessed 10-year cardiovascular mortality risk after one year . Results : There were no significant differences between the intervention groups . The effect of the intervention on the consumption of vegetables and physical activity was small , and some differences were only significant for subgroups . The effects of the intervention on the intake of fat , fruit and alcohol and smoking were not significant . We found no effect between the groups for cardiovascular 10-year risk . Interpretation : Nurse-led risk communication , use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk , despite significant within-group differences Background Although percentage risk formats are commonly used to convey cardiovascular disease ( CVD ) risk , people find it difficult to underst and these representations . Aims To compare the impact of providing a CVD risk message in either a traditional format ( % risk ) or using an analogy of risk ( Heart-Age ) on participants ' risk perceptions and intention to make lifestyle changes . Methods Four hundred and thirteen men and women were r and omly allocated to one of two conditions ;  CVD risk as a percentage or as a Heart-Age score ( a cardiovascular risk adjusted age ) . Results There was a grade d relationship between perceived and actual CVD risk only in those participants receiving a Heart-Age message ( P<0.05 ) . Heart-Age was more emotionally impactful in younger individuals at higher actual CVD risk ( P<0.01 ) . Self-reported emotional reactions further mediated the relationship between risk perception and intention to make lifestyle changes . Conclusion This study found that the Heart-Age message significantly differed from percentage CVD risk score in risk perceptions and was more emotionally impactful in those participants at higher actual CVD risk levels The objective of this r and omised controlled trial was to compare the effects and expense of three approaches to care ( 1 ) proactive cardiovascular risk reduction ( CaRR ) clinic ; ( 2 ) nurse telephone calls ; or ( 3 ) usual care for people with cardiovascular risk factors in a Primary Care , Health Service Organisation ( HSO ) in Ontario , Canada . Subjects included consenting patients with an identified cardiovascular disease ( CVD ) risk factor identified from the HSO computerised patient information system in 2004 . Patients were excluded if they were mentally incompetent , < 18 years of age , in a nursing home , or not English speaking . Of 1570 eligible subjects , 523 ( 33.3 % ) verbally declined , 145 ( 9.2 % ) could not be contacted , and 249 ( 15.9 % ) were not needed . The final sample size was 653 ( 41.6 % ) , 634 completed the follow-up ( 97 % ) . The Cardiovascular Risk Score , Health and Social Service Utilisation , Montgomery-Asberg Depression Rating , Billings and Moos Indices of Coping , Personal Re source and Self-Efficacy Question naires were measured at baseline and 1-year follow-up by clinical examination and telephone interview . Cardiovascular risk scores were reduced in all treatment groups after 1 year . The proportions of subjects showing reduction in risk score greater than or equal to 10 % was greatest in the CaRR group ( 69.2 % ) compared with Nurse Phone intervention ( 57.8 % ) and Usual Care ( 59.0 % ) ( M-Hchi(2 ) = 4.33 , df = 1 , P = 0.037 , CaRR-Usual Care ) . Self-efficacy scores showed the greatest improvements in the CaRR clinic . This effect was achieved with no significant difference in total person per annum costs for direct and indirect health and social service utilisation between all three groups . A CaRR clinic is more effective in reducing CVD risk after 1 year compared with nurse phone intervention and usual care with no additional expense found BACKGROUND AND AIM This cluster r and omized trial evaluated the efficacy of a disease and care management ( D&CM ) model in  cardiovascular ( CVD ) prevention in primary care . METHODS AND RESULTS Eligible subjects had ≥ 1 among : blood pressure ≥ 140/90 mmHg ; glycated hemoglobin ≥ 7 % ; LDL-cholesterol ≥ 160 or ≥ 100 mg/dL ( primary or secondary prevention , respectively ) ; BMI ≥ 30 ; current smoking .  The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans . Control group was allocated to usual-care . The main outcome was the proportion of subjects achieving recommended clinical targets for ≥ 1 of uncontrolled CVD risk factors at 12-month . During 2008 - 2009 we enrolled 920 subjects in the Abruzzo/Marche regions , Italy . Following the exclusion of L'Aquila due to 2009 earthquake , final analyses included 762 subjects . The primary outcome was achieved by 39.1 % ( 95%CI : 34.2 - 44.2 ) and 25.2 % ( 95%CI : 20.9 - 29.9 ) of subjects in the intervention and usual-care group , respectively ( p < 0.001 ) . The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension , with no differences in hypercholesterolemia , smoking status and obesity . CONCLUSIONS The D&CM intervention  was effective in controlling cardiovascular risk factors , in particular hypertension and diabetes . Numbers needed to treat were small . Such intervention may deserve further consideration in clinical practice . REGISTRATION NUMBER ACTRN12611000813987 BACKGROUND Evidence of the value of systematic ally collecting family history in primary care is limited . OBJECTIVE To evaluate the feasibility of systematic ally collecting family history of coronary heart disease in primary care and the effect of incorporating these data into cardiovascular risk assessment . DESIGN Pragmatic , matched-pair , cluster r and omized , controlled trial . ( International St and ardized R and omized Controlled Trial Number Register : IS RCT N 17943542 ) . SETTING 24 family practice s in the United Kingdom . PARTICIPANTS 748 persons aged 30 to 65 years with no previously diagnosed cardiovascular risk , seen between July 2007 and March 2009 . INTERVENTION Participants in control practice s had the usual Framingham-based cardiovascular risk assessment with and without use of existing family history information in their medical records . Participants in intervention practice s also completed a question naire to systematic ally collect their family history . All participants were informed of their risk status . Participants with high cardiovascular risk were invited for a consultation . MEASUREMENTS The primary outcome was the proportion of participants with high cardiovascular risk ( 10-year risk ≥ 20 % ) . Other measures included question naire completion rate and anxiety score . RESULTS 98 % of participants completed the family history question naire . The mean increase in proportion of participants classified as having high cardiovascular risk was 4.8 percentage points in the intervention practice s , compared with 0.3 percentage point in control practice s when family history from patient records was incorporated . The 4.5-percentage point difference between groups ( 95 % CI , 1.7 to 7.2 percentage points ) remained significant after adjustment for participant and practice characteristics ( P = 0.007 ) . Anxiety scores were similar between groups . LIMITATIONS Relatively few participants were from ethnic minority or less-educated groups . The potential to explore behavioral change and clinical outcomes was limited . Many data were missing for anxiety scores . CONCLUSION Systematic ally collecting family history increases the proportion of persons identified as having high cardiovascular risk for further targeted prevention and seems to have little or no effect on anxiety . PRIMARY FUNDING SOURCE Genetics Health Services Research program of the United Kingdom Department of Health ABSTRACT Objective : The use of Framingham equations to determine 10-year absolute coronary risk ( “ global risk ” ) represents an accepted strategy to target coronary prevention measures and enhance clinical outcomes . The aim of this study was to determine the effects of providing global risk scores to physicians on the prescription of lipid-lowering therapy for patients at increased coronary risk . Research design and methods : This prospect i ve , r and omized controlled trial enrolled 368 primary -care patients without a history of coronary heart disease and not on therapy with a hydroxymethylglutaryl coenzyme A reductase inhibitor ( i.e. statin ) .  The study was conducted in the general medical clinics of an academic US teaching hospital . In the intervention group ( n = 186 ) patients ’ charts were review ed , 10‐year absolute coronary risk computed , and this information conveyed via a simple educational tool appended to charts . In the control group ( n = 182 ) , charts were accompanied by a form with general information on coronary prevention goals and strategies . Main outcome measure : The primary endpoint was the proportion of high-risk patients receiving a new statin prescription . Secondary and tertiary endpoints included ( 1 ) the proportion of moderate-risk patients receiving a statin prescription ; and ( 2 ) the proportion of patients in the whole cohort who had other coronary prevention measures recommended . Results : There was no significant difference in statin prescription to high-risk individuals in the intervention group ( 40.0 % ) compared with the control group ( 37.9 % ; p = 0.86 ) . Moderate-risk individuals who were not eligible for treatment according to the National Cholesterol Education Program Adult Treatment Panel II guidelines were more likely to receive a statin prescription in the intervention group versus the control group ( 28.8 % vs. 12.5 % . p = 0.036 ) Conclusions : Although a simple global risk educational tool did not improve the targeting of statin therapy to patients at high absolute coronary risk , it may be of benefit in targeting moderate-risk individuals who do not have markedly elevated low-density lipoprotein cholesterol ( LDL‐C ) levels . Future research should evaluate the effects of physicians performing their own Framingham risk calculations on statin prescribing and on cholesterol goal attainment African Americans have higher rates of cardiovascular disease ( CVD ) and poorer outcomes compared to others . The American Diabetes Association and the National Diabetes Education Program have promoted use of the ABC approach ( glycated hemoglobin A1c , blood pressure , cholesterol ) for identifying and controlling the leading indicators of CVD risk . In the present study , research ers added a D factor , for depression , because this disorder is common and also predictive of CVD risk and of control of diabetes . Particularly among low-income African Americans , depression is frequently not targeted or treated . The current study tests the effectiveness of recruiting African Americans in churches and training community health workers ( CHWs ) to educate their peers about CVD and risk reduction . For the intervention group , CHWs participated in a 16-hour training session and delivered a 6-week tailored educational program with counseling sessions and demonstrations . The control group received a weekly lecture by clinical experts . The CHW active-learning intervention was more effective than lectures by clinical experts in increasing the knowledge of CVD risk . The only significant difference in clinical measures reflected a worsening of HbA1c levels in the control group ; the CHW intervention group showed a slight improvement . Participants also learned self-management skills , such as taking blood pressure , measuring glucose , and reading labels . Nevertheless , more longitudinal research and a larger sample size are needed to confirm the impact of CHWs in community setting s to change factors associated with CVD risk BACKGROUND Although lifestyle and medications are effective for coronary heart disease ( CHD ) risk reduction , few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction . In this paper , we report on the design and baseline characteristics of participants for just such a trial . METHODS We conducted a r and omized trial of the same lifestyle and medication intervention delivered in two alternate formats : counselor-delivered or web-based . The trial was conducted at 5 diverse practice s in a family medicine research network and included men and women age 35 - 79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10 % or a known history of cardiovascular disease . After individual-level r and omization , participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months . The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease . Secondary outcomes , measured among all participants , included changes in CHD risk factors , cost-effectiveness , and acceptability at 4 and 12-month follow-up . RESULTS We r and omized 489 eligible patients : 389 without and 100 with a known history of cardiovascular disease . Mean age was 62.3 . 75 % were white , 25 % African-American . 45 % had a college education . 88 % had health insurance . Mean 10-year predicted CHD risk was 16.9 % . CONCLUSION We have successfully recruited a diverse sample of practice s and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention BACKGROUND Although cardiovascular absolute risk ( CVAR ) assessment has been recommended for use in Australian general practice for a number of years , there is continuing uncertainty about its implementation and impact . Our previous work has developed a multifaceted implementation model . This study aims to investigate both the feasibility of using this model and the impact of CVAR assessment and management on general practice clinical processes and patient care . STUDY DESIGN This cluster r and omized controlled trial will be conducted in general practice s in Sydney , involving general practitioners ( GPs ) , other practice staff , and patients aged 45 to 69 years without existing cardiovascular disease . METHODS A total of 32 practice s ( 40 GPs ) and 1,320 patients will be recruited . R and omization will be conducted at the practice level . The intervention group of GPs will be trained to use a CVAR implementation model , whereas the control group of GPs will continue usual care . Study outcomes include clinical processes , patient risk , use of lifestyle intervention , and prescription of antihypertensive and lipid-lowering medications .  Data will be collected and analyzed using mixed methods . Study outcomes before and after the intervention will be compared , and the 2 groups will also be compared after adjusting for baseline difference and clustering factors . DISCUSSION This trial will be the first study in Australian general practice and one of few international studies to evaluate the impact of implementing CVAR assessment and management . Results of this study will help improve the primary prevention of cardiovascular disease and inform guidelines for clinical practice and the implementation of other health initiatives Background —Despite well-publicized guidelines on the appropriate management of cardiovascular disease and type 2 diabetes , the implementation of risk-reducing practice s remains poor . This report describes the results of a r and omized , controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner /community health worker ( NP/CHW ) teams versus enhanced usual care ( EUC ) to improve lipids , blood pressure , glycated hemoglobin ( HbA1c ) , and patient perceptions of the quality of their chronic illness care in patients in urban community health centers . Methods and Results —A total of 525 patients with documented cardiovascular disease , type 2 diabetes , hypercholesterolemia , or hypertension and levels of LDL cholesterol , blood pressure , or HbA1c that exceeded goals established by national guidelines were r and omly assigned to NP/CHW ( n=261 ) or EUC ( n=264 ) groups . The NP/CHW intervention included aggressive pharmacological management and tailored educational and behavioral counseling for lifestyle modification and problem solving to address barriers to adherence and control . Compared with EUC , patients in the NP/CHW group had significantly greater 12-month improvement in total cholesterol ( difference , 19.7 mg/dL ) , LDL cholesterol ( difference,15.9 mg/dL ) , triglycerides ( difference , 16.3 mg/dL ) , systolic blood pressure ( difference , 6.2 mm Hg ) , diastolic blood pressure ( difference , 3.1 mm Hg ) , HbA1c ( difference , 0.5 % ) , and perceptions of the quality of their chronic illness care ( difference , 1.2 points ) . Conclusions —An intervention delivered by an NP/CHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illness care in high-risk patients . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00241904 OBJECTIVE Adopting features of the Chronic Care Model may reduce coronary heart disease risk and blood pressure in vulnerable population s. We evaluated a peer and practice team intervention on reduction in 4-year coronary heart disease risk and systolic blood pressure . DESIGN AND SUBJECTSA single blind , r and omized , controlled trial in two adjacent urban university-affiliated primary care practice s. Two hundred eighty African-American subjects aged 40 to 75 with uncontrolled hypertension . INTERVENTIONThree monthly calls from trained peer patients with well-controlled hypertension and , on alternate months , two practice staff visits to review a personalized 4-year heart disease risk calculator and slide shows about heart disease risks . All subjects received usual physician care and brochures about healthy cooking and heart disease . MAIN MEASURES Change in 4-year coronary heart disease risk ( primary ) and change in systolic blood pressure , both assessed at 6 months . KEY RESULTS At baseline , the 136 intervention and 144 control subjects ’ mean 4-year coronary heart disease risk did not differ ( intervention = 5.8 % and control = 6.4 % , P = 0.39 ) , and their mean systolic blood pressure was the same ( 140.5 mmHg , p = 0.83 ) . Endpoint data for coronary heart disease were obtained for 69 % of intervention and 82 % of control subjects . After multiple imputation for missing endpoint data , the reduction in risk among all 280 subjects favored the intervention , but was not statistically significant ( difference −0.73 % , 95 % confidence interval : -1.54 % to 0.09 % , p = 0.08 ) . Among the 247 subjects with a systolic blood pressure endpoint ( 85 % of intervention and 91 % of control subjects ) , more intervention than control subjects achieved a > 5 mmHg reduction ( 61 % versus 45 % , respectively , p = 0.01 ) . After multiple imputation , the absolute reduction in systolic blood pressure was also greater for the intervention group ( difference −6.47 mmHg , 95 % confidence interval : −10.69 to −2.25 , P = 0.003 ) . One patient died in each study arm . CONCLUSIONS Peer patient and office-based behavioral support for African-American patients with uncontrolled hypertension did not result in a significantly greater reduction in coronary heart disease risk but did significantly reduce systolic blood pressure Background Many studies have demonstrated a gap between guidelines for the prevention of cardiovascular disease ( CVD ) and their implementation in clinical practice . Aim The PEGASE education program has been devised with an aim to improve the management of patients at high risk of CVD . Methods In a multicentre study carried out from 2001–2004 in France , 96 participating physicians were r and omized into a “ trained ”  group , which included 398 “ educated ” patients , and a  “ non-trained ” group  , which included 242 “ non-educated ” patients . Educated patients received six hospital-based educational sessions , four collective and two individual .  Framingham score , smoking , lipid levels , glycaemia , blood pressure , dietary intake and drug compliance , as well as quality of life , were evaluated at baseline ( M0 ) and 6 months ( M6 ) . The primary endpoint of the study was the efficacy of the PEGASE program in reducing global CVD risk in high-risk patients . Results The Framingham score was calculated for 473 patients .  The Framingham score improved significantly at M6 vs M0 in the educated group ( 13.0 ± 8.21 vs 13.6 ± 8.48 , d = −0.658 , p = 0.016 ) , but not in the non-educated group ( 12.5 ± 8.19 vs 12.4 ± 7.81 , d = + 0.064 , p = 0.836 ) ; the mean change between the two groups did not reach significance . Quality of life , LDL-c level and diet scores improved in the “ educated ” group only . Conclusions The PEGASE education program  improved risk factors for CVD , although global assessment by Framingham score was not significantly different between groups . This program , aim ed at meeting needs and expectations of patients and physicians , was easily implemented in all hospital centres OBJECTIVES To compare antihypertensive therapeutic strategies and efficacy whether the physicians were aware or not of the calculated cardiovascular risk at 10 years obtained from the Framingham equation . It was also possible to evaluate the concordance of the general physicians estimation of the cardiovascular risk with the calculated percentage . METHODS The participation of 953 general physicians to the study allowed to achieve an estimation of the absolute cardiovascular risk for 1,243 hypertensives . Patients were r and omised in 2 groups according to the knowledge or not by the physicians of the calculated risk . The therapeutic strategy included a monotherapy ( Fosinopril 20 mg/days ) for a follow up of 8 weeks , with the possibility to increase the treatment after 4 weeks ( Fosinopril + hydrochlorotiazide ) .  To be included , patients had to be more than 18 and less than 75 years , and a blood pressure above 140/90 mmHg . Estimated and calculated cardiovascular risk at 10 years , were classified according to the 1999 WHO-ISH guidelines : low risk < 15 % , medium risk 15 - 20 % , high risk 20 - 30 % , very high risk > 30 % . RESULTS In this population , aged 60 + /- 10 years , with 54 % of men , the concordance between estimated risk and calculated risk was of 35 % . This concordance was better for the " low risk " and " very high risk " , but remains inferior to 50 % . The determinants of concordance were : gender ( male ) , smoking and a low HDL cholesterol . After 8 weeks of treatment , no difference was observed between the 2 groups concerning final blood pressure level , percentage of normalised patients and number of patients with bi-therapy . CONCLUSIONS General physicians estimation of cardiovascular risk at 10 years of hypertensive subjects has a bad concordance with the calculated risk according to Framingham equation . The results of this study indicate that the estimation of cardiovascular risk of hypertensive subjects does not modify the management of hypertension OBJECTIVE The ability to accurately identify articles about therapy in large bibliographic data bases such as EMBASE is important for research ers and clinicians . Our study aim ed to develop optimal search strategies for detecting sound treatment studies in EMBASE in the year 2000 . METHODS H and search es of journals were compared with retrievals from EMBASE for c and i date search strategies . Six trained research assistants review ed fifty-five journals indexed in EMBASE and rated articles using purpose and quality indicators . C and i date search strategies were developed for identifying treatment articles and then tested , and the retrievals were compared with the h and - search data . The operating characteristics of the strategies were calculated . RESULTS Three thous and eight hundred fifty articles were original studies on treatment , of which 1,256 ( 32.6 % ) were method ologically sound . Combining search terms revealed a top performing strategy ( r and om:.tw . OR clinical trial:.mp . OR exp health care quality ) with sensitivity of 98.9 % and specificity of 72.0 % . Maximizing specificity , a top performing strategy ( double-blind:.mp . OR placebo:.tw . OR blind : .tw . ) achieved a value over 96.0 % , but with compromised sensitivity at 51.7 % . A 3-term strategy achieved the best optimization of sensitivity and specificity ( r and om:.tw . OR placebo:.mp . OR double-blind:.tw . ) , with both these values over 92.0 % . CONCLUSION Search strategies can achieve high performance for retrieving sound treatment studies in EMBASE BACKGROUND Despite increasing evidence that treating dyslipidemia reduces cardiovascular events , many patients do not achieve recommended lipid targets . METHODS To determine whether showing physicians and patients the patient 's calculated coronary risk can improve the effectiveness of treating dyslipidemia in a primary care setting , patients were  r and omized  to receive usual care or ongoing feedback regarding their calculated coronary risk and the change in this risk after lifestyle changes , pharmacotherapy , or both to treat dyslipidemia . Outcomes , based on intention-to-treat analysis , included changes in blood lipid levels , coronary risk , and the frequency of reaching lipid targets . RESULTS Two hundred thirty primary care physicians enrolled 3,053 patients . After 12 months of follow-up , 2,687 patients ( 88.0 % ) remained in the study . After adjustment for baseline lipid values , significantly greater mean reductions in low-density lipoprotein cholesterol levels and the total cholesterol to high-density lipoprotein cholesterol ratio were observed in patients receiving risk profiles ( 51.2 mg/dL [ to convert to millimoles per liter , multiply by 0.0259 ] and 1.5 , respectively ) vs usual care ( 48.0 mg/dL and 1.3 , respectively ) , but the differences were small ( -3.3 mg/dL ; 95 % confidence interval [ CI ] , -5.4 to -1.1 mg/dL ; and -0.1 ; 95 % CI , -0.2 to -0.1 , respectively ) . Patients in the risk profile group were also more likely to reach lipid targets ( odds ratio , 1.26 ; 95 % CI , 1.07 to 1.48 ) . A significant dose-response effect was also noted when the impact of the risk profile was stronger in those with worse profiles . CONCLUSIONS Discussing coronary risk with the patient is associated with a small but measurable improvement in the efficacy of lipid therapy . The value of incorporating risk assessment in preventive care should be further evaluated Abstract Objectives : To determine the effectiveness of a health check and assess any particular benefits result ing from feedback of plasma cholesterol concentration or coronary risk score , or both Design : R and omised controlled trial in two Glasgow work sites Subjects:1632 employees ( 89 % male ) aged 20 to 65 years . Interventions : At the larger work site , ( a ) health education ; ( b ) health education and feedback on cholesterol concentration ; ( c ) health education and feedback on risk score ; ( d ) health education with feedback on cholesterol concentration and risk score ( full health check ) ; ( e ) no health intervention ( internal control ) . At the other work site there was no health intervention ( external control ) . Main outcome measures Changes in Dundee risk score , plasma cholesterol concentration , diastolic blood pressure , body mass index , and self reported behaviours ( smoking , exercise , alcohol intake , and diet ) in comparison with internal and external control groups Results : Comparisons between the full health check and the internal control groups showed a small difference ( 0.13 mmol/l ) in the change in mean cholesterol concentration ( 95 % confidence interval 0.02 to 0.22 , P=0.02 ) but no significant differences for changes in Dundee risk score ( P=0.21 ) , diastolic blood pressure ( P=0.71 ) , body mass index ( P=0.16 ) , smoking ( P=1.00 ) , or exercise ( P=0.41 ) . Significant differences between the two groups were detected for changes in self reported consumption of alcohol ( 41 % in group with full health check v 17 % in internal control group , P=0.001 ) , fruit and vegetables ( 24 % v 12 % , P<0.001 ) , and fat ( 30 % v 9 % , P<0.001 ) . Comparison of all groups showed no advantage from feedback of cholesterol concentration or risk score , or both . Conclusions : The health check only had a small effect on reversible coronary risk . It was effective in influencing self reported alcohol consumption and diet . Feedback on cholesterol concentration and on risk score did not provide additional motivation for a change in behaviour OBJECTIVE Web-based patient information is widespread and information on the benefits and risks of treatments is often difficult to underst and . We therefore evaluated different risk presentation formats - numerical , graphical and others - addressing the pros and cons of tight control versus usual treatment approaches for diabetes . METHOD DESIGN R and omised controlled trial . SETTING Online . Publicity disseminated via Diabetes UK . PARTICIPANTS People with diabetes or their carers . INTERVENTIONS Control group information based on British Medical Journal ' Best Treatments ' . Four intervention groups received enhanced information re sources : ( 1 ) detailed numerical information ( absolute/relative risk , numbers-needed-to-treat ) ; ( 2 ) ' anchoring ' to familiar risks or descriptions ; ( 3 ) graphical ( bar charts , thermometer scales , crowd figure formats ) ; ( 4 ) combination of 1 - 3 .  OUTCOMES Decision conflict scale ( DCS , a measure of uncertainty ) ; satisfaction with information ; further free text responses for qualitative content analysis . RESULTS Seven hundred and ten people visited the website and were r and omised . Five hundred and eight completed the question naire for quantitative data . Mean DCS scores ranged from 2.12 to 2.24 for the five r and omisation groups , indicating neither clear delay or vacillation about decisions ( usually DCS>2.5 ) nor tending to make decisions ( usually DCS<2.0 ) . There were no statistically significant effects of the interventions on DCS , or satisfaction with information .  Two hundred and fifty-six participants provided responses for qualitative analysis : most found graphical representations helpful , specifically bar chart formats ; many found other graphic formats ( thermometer style , crowd figures/smiley faces ) and ' anchoring ' information unhelpful , and indicated information overload . Many negative experiences with healthcare indicate a challenging context for effective information provision and decision support . CONCLUSION Online evaluation of different risk representation formats was feasible . There was a lack of intervention effects on quantitative outcomes , perhaps reflecting already well-informed participants from the Diabetes UK patient organisation . The large qualitative data set included many comments about what participants found helpful as formats for communicating risk information . PRACTICE IMPLICATION S These findings assist the design of online decision aids and the representation of risk information . The challenge is to provide more information , in appropriate and clear formats , but without risking information overload . Interactive web design s hold much promise to achieve this We investigated whether disclosure of coronary heart disease ( CHD ) genetic risk influences perceived personal control ( PPC ) and genetic counseling satisfaction ( GCS ) . Participants ( n = 207 , age : 45–65 years ) were r and omized to receive estimated 10‐year risk of CHD based on a conventional risk score ( CRS ) with or without a genetic risk score ( GRS ) . Risk estimates were disclosed by a genetic counselor who also review ed how GRS altered risk in those r and omized to CRS+GRS . Each participant subsequently met with a physician and then completed surveys to assess PPC and GCS . Participants who received CRS+GRS  had higher PPC than those who received CRS alone although the absolute difference was small ( 25.2 ± 2.7 vs 24.1 ± 3.8 , p = 0.04 ) . A greater proportion of CRS+GRS participants had higher GCS scores ( 17.3 ± 5.3 vs 15.9 ± 6.3 , p = 0.06 ) . In  the CRS+GRS  group , PPC and GCS scores were not correlated with GRS . Within both groups , PPC and GCS scores were similar in patients with or without family history ( p = NS ) . In conclusion , patients who received their genetic risk of CHD had higher PPC and tended to have higher GCS . Our findings suggest that disclosure of genetic risk of CHD together with conventional risk estimates is appreciated by patients . Whether this results in improved outcomes needs additional investigation Aims To test whether communicating cardiovascular diseases ( CVD ) risk using a novel risk assessment tool ( Heart Age ) will be able to motivate a population to adopt healthier lifestyles and improve CVD risk profile over the use of a traditional percentage-based tool . Methods A single-blind r and omized intervention study was carried out in a Caucasian population . A total of 3153 subjects were r and omly allocated to one of three study groups : control ( conventional medical advice was given to the subjects ) , Framingham REGICOR ( 10-year percentage risk score , calibrated to Spanish population was given to the subjects ) , or Heart Age group ( Heart Age tool was administered to the subjects ) . Anthropometrical and metabolic parameters were measured and lifestyle habits were recorded at recruitment and 12-months post intervention . Results Both the Framingham REGICOR and the Heart Age intervention groups demonstrated significant decreases in their risk scores at post intervention compared to the control group , with the improvement being of a greater magnitude in the Heart Age group . No differences per gender were observed in the Heart Age group . Conclusions Informing patients about their CVD risk expressed as the new Heart Age tool results in a reduction in their CVD risk higher than the one observed when the Framingham REGICOR risk score was used Using perceived risk of a heart attack , we examined the relative importance of perceived risk factors and sociodemographic variables on subjects ' perception of heart attack risk , the relationship between perceived and objective ly measured heart attack risk , and the effect of health risk appraisal ( HRA ) feedback on risk perceptions . Data derive from a r and om sample of 732 Greater Boston , Massachusetts area men and women ages 25 - 65 years , who participated in a field trial of health risk appraisal instruments .  At baseline and approximately two months later , all respondents completed a question naire assessing their own health-related behavior , risk factors , and perception of heart attack risk . At baseline , respondents also completed one of four HRA instruments .  Physiologic measures of cholesterol , blood pressure , and weight were taken at either baseline or follow-up visit . Results showed that respondents used established risk factors in estimating overall risk ; that compared to objective measures of risk , a high percentage of respondents displayed an optimistic bias ; and that HRA feedback had some effect on perception of heart attack risk for those at high risk . Implication s of these results for health promotion are discussed Objective To assess the effects of a patient oriented decision aid for prioritising treatment goals in diabetes compared with usual care on patient empowerment and treatment decisions . Design Pragmatic r and omised controlled trial . Setting 18 general practice s in the north of the Netherl and s. Participants 344 patients with type 2 diabetes aged ≤65 years at the time of diagnosis and managed in primary care between April 2011 and August 2012 : 225 were allocated to the intervention group and 119 to the usual care group . Intervention The intervention comprised a decision aid for people with diabetes , with individually tailored risk information and treatment options for multiple risk factors . The aid was intended to empower patients to prioritise between clinical domains and to support treatment decisions . It was offered to participants before a regular diabetes check-up and to their healthcare provider during the consultation . Four different formats of the decision aid were included for additional explorative analyses . Main outcome measures The primary outcome was the effects on patient empowerment for setting and achieving goals . The secondary outcomes were changes in the prescribing of drugs to regulate glucose , blood pressure , lipids , and albuminuria . Data were collected through structured question naires and automated data extraction from electronic health records during six months before and after the intervention . Results Of all intervention participants , 103 ( 46 % ) reported to have received the basic elements of the intervention . For the primary outcome analysis , 199 intervention and 107 control patients with sufficient baseline and follow-up data could be included . The mean empowerment score increased 0.1 on a 5 point scale in the overall intervention group , which was not significantly different from that of the control group ( mean difference after adjusting for baseline 0.039 , 95 % confidence interval −0.056 to 0.134 ) . Lipid regulating drug treatment was intensified in 25 % of intervention and 12 % of control participants with increased cholesterol levels , which did not reach significance when the intervention was compared with the usual care group ( odds ratio 2.54 , 95 % confidence interval 0.89 to 7.23 ) . Prespecified explorative analyses showed that this effect was significant for the printed version of the decision aid in comparison to usual care ( 3.90 , 1.29 to 11.80 ) . No relevant or significant changes were seen for other treatments . Conclusion We found no evidence that the patient oriented treatment decision aid  improves patient empowerment by an important amount . The aid was not used to its full extent in a substantial number of participants . Trial registration Dutch trial register NTR1942 We conducted a feasibility study of a web-based intervention , which provided personalized cardiovascular disease ( CVD ) risk information , behavioural risk reduction strategies and educational re sources . Participants were block-r and omized to the 3-month intervention ( n = 47 ) or to usual care ( n = 49 ) . Participants in the intervention group were presented with their CVD risk based on the Framingham risk score , and in three subsequent online encounters could select two behavioural/lifestyle modules , giving them an opportunity to complete six modules over the course of the study . Because it was self-guided , participants had differing levels of engagement with intervention material s. Most intervention group participants ( 77 % , n = 36 ) completed all modules . After 3 months there were no significant differences between the intervention and usual care groups for systolic blood pressure , body-mass index , CVD risk , smoking cessation or medication non-adherence . The study suggests that modest clinical improvements can be achieved by interventions that are entirely web-administered . However , web-based interventions do not replace the need for human interaction to communicate CVD risk and assist with decision-making IMPORTANCE Most primary care clinicians lack the skills and re sources to offer effective lifestyle and medication ( L&M ) counseling to reduce coronary heart disease ( CHD ) risk . Thus , effective and feasible CHD prevention programs are needed for typical practice setting s. OBJECTIVE To assess the effectiveness , acceptability , and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats . DESIGN , SETTING , AND PARTICIPANTS A comparative effectiveness trial in 5 diverse family medicine practice s in North Carolina . Participants were established patients , aged 35 to 79 years , with no known cardiovascular disease , and at moderate to high risk for CHD ( 10-year Framingham Risk Score [ FRS ] , ≥10 % ) . INTERVENTIONS Participants were r and omized to counselor-delivered or web-based format , each including 4 intensive and 3 maintenance sessions . After r and omization , both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies . Participants chose the risk-reducing strategies they wished to follow . MAIN OUTCOMES AND MEASURES The primary outcome was within-group change in FRS at 4-month follow-up . Other measures included st and ardized assessment s of blood pressure , blood lipid levels , lifestyle behaviors , and medication adherence . Acceptability and cost-effectiveness were also assessed . Outcomes were assessed at 4 and 12 months . RESULTS Of 2274 screened patients , 385 were r and omized ( 192 counselor ; 193 web ) : mean age , 62 years ; 24 % African American ; and mean FRS , 16.9 % . Follow-up at 4 and 12 months included 91 % and 87 % of the r and omized participants , respectively . There was a sustained reduction in FRS at both 4 months ( primary outcome ) and 12 months for both counselor-based ( -2.3 % [ 95 % CI , -3.0 % to -1.6 % ] and -1.9 % [ 95 % CI , -2.8 % to -1.1 % ] , respectively ) and web-based groups ( -1.5 % [ 95 % CI , -2.2 % to -0.9 % ] and -1.7 % [ 95 % CI , -2.6 % to -0.8 % ] respectively ) . At 4 months , the adjusted difference in FRS between groups was -1.0 % ( 95 % CI , -1.8 % to -0.1 % ) ( P = .03 ) , and at 12 months , it was -0.6 % ( 95 % CI , -1.7 % to 0.5 % ) ( P = .30 ) . The 12-month costs from the payer perspective were $ 207 and $ 110 per person for the counselor- and web-based interventions , respectively . CONCLUSIONS AND RELEVANCE Both intervention formats reduced CHD risk through 12-month follow-up . The web format was less expensive . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01245686 METHODS Case-management ( CM ) can positively influence chronic disease care by facilitating guideline -concordant interventions that improve outcomes through intensive , individualized , longitudinal care . Implementation of CM , however , is difficult . We have identified lessons learned from a cardiovascular risk reduction CM program that may aid future CM implementation . INTRODUCTION Heart to Heart is both a clinical trial and program dissemination project implementing CM for persons at elevated risk of coronary heart disease ( CHD ) events in a multiethnic , low-income population in a county health system . Patients were r and omized to CM plus usual primary care ( N = 212 ) or primary care alone ( N = 207 ) . CM  patients received face-to-face nurse and dietitian visits ( mean of 14 hours ) over 17 months . Visits emphasized behavior change , risk-factor monitoring , and guideline -based pharmacotherapy . A total of 341 patients ( 81 % ) were available for follow-up . This CM model is currently transitioning to a County-run program . RESULTS Findings demonstrated statistically significant reductions in mean Framingham Risk for CM versus usual primary care ( 1.56 % absolute decrease in 10-year CHD risk , P = 0.007 ) . Favorable changes were noted across most major CHD risk factors . Lessons learned are the need for the following : ( 1 ) Strategies for implementing CM in low-income , ethnically-diverse population s , ( 2 ) Methods for developing clinical ly more effective CM , and ( 3 ) Approaches to increase the  efficiency of cardiovascular CM . CONCLUSIONS CM for cardiac risk factors faces notable implementation barriers , particularly in County health systems . Specific implementation solutions recommended may help confront these barriers and improve diffusion of this evidence -based and patient centered model of care BACKGROUND There is a lack of evidence regarding the value of tools design ed to aid decision making in patients with newly diagnosed hypertension . AIM To evaluate two interventions for assisting newly diagnosed hypertensive patients in the decision whether to start drug therapy for reducing blood pressure . DESIGN OF STUDY Factorial r and omised controlled trial . SETTING Twenty-one general practice s in south-west Engl and , UK . METHOD Adults aged 32 to 80 years with newly diagnosed hypertension were r and omised to receive either : ( a ) computerised utility assessment interview with individualized risk assessment and decision analysis ; or ( b ) information video and leaflet about high blood pressure ; or ( c ) both interventions ; or ( d ) neither intervention . Outcome measures were decisional conflict , knowledge , state anxiety , intentions regarding starting treatment , and actual treatment decision . RESULTS Of 217 patients r and omised , 212 ( 98 % ) were analysed at the primary follow-up ( mean age = 59 years , 49 % female ) . Decision analysis patients had lower decisional conflict than those who did not receive this intervention ( 27.6 versus 38.9 , 95 % confidence interval [ CI ] for adjusted difference = -13.0 to -5.8 , P < 0.001 ) , greater knowledge about hypertension ( 73 % versus 67 % , adjusted 95 % CI = 2 % to 9 % , P = 0.003 ) and no evidence of increased state anxiety ( 34.8 versus 36.8 , adjusted 95 % CI = -5.6 to 0.1 , P = 0.055 ) . Video/leaflet patients had lower decisional conflict than corresponding controls ( 30.3 versus 36.8 , adjusted 95 % CI = -7.4 to -0.6 , P = 0.021 ) , greater knowledge ( 75 % versus 65 % , adjusted 95 % CI = 6 % to 13 % , P < 0.001 ) and no evidence of increased state anxiety ( 35.7 versus 36.1 , adjusted 95 % CI = -3.9 to 1.7 , P = 0.46 ) . There were no differences between either of the interventions and their respective controls in the proportion of patients prescribed antihypertensive medication ( 67 % ) . CONCLUSIONS This trial demonstrates that , among patients facing a real treatment decision , interventions to inform patients about hypertension and to clarify patients ' values concerning outcomes of treatment are effective in reducing decisional conflict and increasing patient knowledge , while not result ing in any increases in state anxiety BACKGROUND Exposure to combination antiretroviral therapy ( cART ) can lead to important metabolic changes and increased risk of coronary heart disease ( CHD ) . Computerized clinical decision support systems have been advocated to improve the management of patients at risk for CHD but it is unclear whether such systems reduce patients ' risk for CHD . METHODS We conducted a cluster trial within the Swiss HIV Cohort Study ( SHCS ) of HIV-infected patients , aged 18 years or older , not pregnant and receiving cART for > 3 months . We r and omized 165 physicians to either guidelines for CHD risk factor management alone or guidelines plus CHD risk profiles . Risk profiles included the Framingham risk score , CHD drug prescriptions and CHD events based on biannual assessment s , and were continuously up date d by the SHCS data centre and integrated into patient charts by study nurses . Outcome measures were total cholesterol , systolic and diastolic blood pressure and Framingham risk score . RESULTS A total of 3,266 patients ( 80 % of those eligible ) had a final assessment of the primary outcome at least 12 months after the start of the trial . Mean ( 95 % confidence interval ) patient differences where physicians received CHD risk profiles and guidelines , rather than guidelines alone , were total cholesterol -0.02 mmol/l ( -0.09 - 0.06 ) , systolic blood pressure -0.4 mmHg ( -1.6 - 0.8 ) , diastolic blood pressure -0.4 mmHg ( -1.5 - 0.7 ) and Framingham 10-year risk score -0.2 % ( -0.5 - 0.1 ) . CONCLUSIONS Systemic computerized routine provision of CHD risk profiles in addition to guidelines does not significantly improve risk factors for CHD in patients on cART Background R and omised , controlled trials focusing on long-term psychological reactions to information about increased risk of coronary heart disease are scarce . Design A population -based r and omised , controlled , 5-year follow-up trial was conducted in general practice . Methods In 1991 , invitations were sent to 2,000 middle-aged people registered in the general practice s in the district of Ebeltoft , Denmark . A total of 1,507 ( 75.4 % ) agreed to participate and were r and omised into a control group and two intervention groups : one included health screening , a written feedback and an optional follow-up visit with the general practitioner ; the other included health screening , written feedback and a planned 45-min follow-up visit with the general practitioner . The participants were informed at screening about their risk of developing coronary heart disease . Psychological distress was measured by the GHQ-12 before screening and at the 1 and the 5-year follow-up . Results Before the screening ( 0 year ) , 1 and 5 years after there were no significant differences in the GHQ-12 score between the control group and the two intervention groups . Nor were there any differences related to information about increased risk of coronary heart disease between scores obtained at the 1 and the 5-year follow-up . Conclusion Middle-aged persons had no long-term psychological reaction after information about increased risk of developing coronary heart disease following a health screening in general practice evaluated by the GHQ-12,1 year and 5 years after the examinations OBJECTIVE To determine in primary care patients at high risk for a cardiovascular event  , the effects on biomedical risk factors for and incidence of cardiovascular events , of a brief cardiovascular prevention program executed by a health advisor . METHOD DESIGN cluster r and omized controlled trial with 1275 patients ( 24 general practice s ) in and around Maastricht , the Netherl and s ( 1999 - 2004 ) . INTERVENTION health advisors were to complete computerized cardiovascular risk profiles , provide multi-factorial tailored health education and advice , and communicate with GP 's to optimize treatment . OUTCOME differences in changes in risk factors between baseline and follow up at 6 , 18 , and 36 months and incidence of cardiovascular events at 36 months . RESULTS PROCESS Because of logistic reasons risk profiles were put on paper instead of in the computerized patient files . On average patients attended 2.3 counseling sessions . Interaction with GPs was less productive than expected . OUTCOME Effect after six months on BMI ( -0.20 kg/m(2 ) ( 95 % CI -0.38 to -0.01 , p=0.039 ) , Cohen 's d : -0.18 ) , and after 18 months on HDL-cholesterol ( + 0.05 mmol/l ( 95 % CI + 0.01 to + 0.09 , p=0.014 ) , Cohen 's d : 0.14 ) . No other ( subgroup ) effects were found . CONCLUSION Given the lack of clinical ly meaningful effects , implementation of this intervention in its present form is not justified BACKGROUND Pharmacist- or nurse-led team care decreases  patient blood pressure ( BP ) and cardiovascular disease ( CVD ) risk . PURPOSE To evaluate whether a Web-based dietitian-led ( WD ) team care intervention was feasible and result ed in decreased BP , CVD risk , and weight compared to usual care ( UC ) . METHODS Electronic health record ( EHR ) data identified patients aged 30 - 69 years with BMI > 26 , elevated BP , and 10%-25 % 10-year Framingham CVD risk who were registered patient website users . Patients with uncontrolled BP at screening were r and omized to UC or WD , which included a home BP monitor , scale , and dietitian team care . WD participants had a single in-person dietitian visit to obtain baseline information and create a plan to reduce CVD risk . Planned follow-up occurred via secure messaging to report BP , weight , and fruit and vegetable intake and receive ongoing feedback . If needed , dietitians encouraged patients and their physicians to intensify antihypertensive and lipid-lowering medications . Primary outcomes were change in systolic BP and weight loss ≥4 kg at 6 months . Feasibility outcomes included intervention utilization and satisfaction . RESULTS Between 2010 and 2011 , a total of 90 of 101 participants completed 6-month follow-ups . The WD group had higher rates of secure messaging utilization and patient satisfaction . The WD group lost significantly more weight than the UC group ( adjusted net difference=-3.2 kg , 95 % CI=-5.0 , -1.5 , p<0.001 ) and was more likely to lose ≥4 kg ( adjusted relative risk [RRadj]=2.96 , 95 % CI=1.16 , 7.53 ) . BP control and CVD risk reduction were greater in WD than UC , but differences were not statistically significant . CONCLUSIONS WD intervention was feasible and result ed in decreased weight , BP , and CVD risk . A larger trial is justified . TRIAL REGISTRATION NUMBER Trial Registration Number : NCT01077388 STUDY OBJECTIVE To evaluate whether a simple pharmacist protocol , consisting of patient screening and cardiovascular risk stratification , identification and reminders about uncontrolled risk factors , and drug adherence support , can significantly reduce cardiovascular risk . DESIGN Prospect i ve , r and omized , controlled pilot study . SETTING Large primary care medical clinic in Saskatoon , Saskatchewan , Canada . PATIENTS One hundred seventy-six adult patients ( mean age 60 yrs ) who exhibited a 10-year Framingham risk score of 15 % or greater , or a coronary artery disease risk equivalent ( coronary artery disease , peripheral artery disease , cerebrovascular disease , or diabetes mellitus ) . INTERVENTION Eligible patients initially met with the pharmacist to receive general counselling about cardiovascular disease and were then r and omly assigned to receive ongoing follow-up by the pharmacist ( follow-up group [ 88 patients ] ) or to return to usual care ( single-contact group [ 88 patients ] ) for a minimum of 6 months . MEASUREMENTS AND MAIN RESULTS The primary end point was mean reduction in the 10-year Framingham risk score . Secondary end points included individual modifiable risk factors ( systolic and diastolic blood pressures ; total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol [ HDL ] , and triglyceride levels ; total cholesterol : HDL ratio ; and hemoglobin A(1c ) value ) , as well as statin utilization , initiation , and adherence rates . Baseline characteristics were similar across both groups . Neither the mean reduction in 10-year risk ( -2.68 for the follow-up group and -1.25 for the single-contact group , one-tailed p=0.098 ) nor individual risk factors were significantly different between groups . The proportion of patients exhibiting statin adherence of 80 % or greater did not significantly differ between groups at study end ( 73.1 % [ 57/78 ] and 80.0 % [ 52/65 ] , respectively , p=0.333 ) . However , 85.2 % ( 75/88 ) in the follow-up group continued with statin therapy at the end of the study compared with 67.0 % ( 59/88 ) in the single-contact group ( p=0.005 ) . Statin initiations were more frequent in the follow-up group than in the single-contact group ( 75.0 % [ 30/40 ) vs 48.9 % [ 22/45 ] , p=0.013 ) . CONCLUSION This simple cardiovascular care protocol for nonspecialist pharmacists did not result in a clear improvement to cardiovascular risk reduction success among patients in a primary care medical clinic . The intervention did , however , appear to improve statin utilization This study is a 3-year follow-up of a factorial r and omised controlled trial of two decision aids - decision analysis and information video plus leaflet - for newly diagnosed hypertensive patients . We found no evidence of differences for either of the two decision aids compared with controls for the primary outcome of blood pressure control at follow-up . There were also no differences in any of the secondary outcomes measured - the proportion taking blood pressure lowering drugs , self-reported medication adherence , or consulting behaviour . The r and omised controlled trial cohort as a whole , irrespective of r and omised group , demonstrated substantial reductions in blood pressure and 10-year cardiovascular risk over the follow-up period PURPOSE We wanted to determine the effect of promoting the effective communication of absolute cardiovascular disease ( CVD ) risk and shared decision making through disseminating a simple decision aid for use in family practice consultations . METHODS The study was based on a pragmatic , cluster r and omized controlled trial ( phase III ) with  continuing medical education ( CME ) groups of family physicians  as the unit of r and omization . In the intervention arm , 44 physicians ( 7 CME groups ) consecutively recruited 550 patients in whom cholesterol levels were measured . Forty-seven physicians in the control arm ( 7 CME groups ) similarly included 582 patients . Four hundred sixty patients ( 83.6 % ) of the intervention arm and 466 patients ( 80.1 % ) of the control arm were seen at follow-up . Physicians attended 2 interactive CME sessions and received a booklet , a paper-based risk calculator , and individual summary sheets for each patient . Control physicians attended 1 CME-session on an alternative topic . Main outcome measures were patient satisfaction and participation after the index consultation , change in CVD risk status , and decisional regret at 6 months ’ follow-up . RESULTS Intervention patients were significantly more satisfied with process and result ( Patient Participation Scale , difference 0.80 , P<.001 ) . Decisional regret was significantly lower at follow-up ( difference 3.39 , P = .02 ) . CVD risk decreased in both groups without a significant difference between study arms . CONCLUSION A simple transactional decision aid based on calculating absolute individual CVD risk and promoting shared decision making in CVD prevention can be disseminated through CME groups and may lead to higher patient satisfaction and involvement and less decisional regret , without negatively affecting global CVD risk The purpose of the present study was to examine general practitioners ' abilities to make a correct estimation of the risk of coronary heart disease ( CHD ) .  A 10 % r and om sample of Norwegian primary care physicians ( n = 288 ) received a question naire that presented 10 case histories containing information about five CHD risk factors . The respondents ' risk estimation was compared with a composite score computed from epidemiologic data . The observed general tendency was towards underestimating the CHD risk . However , ' high-risk ' histories were recognized as CHD risk persons . Assessment of CHD risk due to multiple marginal abnormalities was only exceptionally correct . Hypercholesterolaemia and hypertension in men were acknowledged as contributing to clinical ly significant CHD risk only by a minority of GPs . Heavy smoking and a positive family history were associated with a more accurate estimation of CHD risk . Forty per cent of the physicians did not recognize the sex dependency of cholesterol as a CHD risk factor . None of the physician characteristics could predict variation in correct risk assessment Electronic decision-support tools may help to improve management of hyperlipidemia and other chronic diseases . This study examined the impact of lipid management tools integrated into an electronic medical record ( EMR ) in primary care practice s. This r and omized controlled trial was conducted in a national network of physicians who use an outpatient EMR . Adult primary care physicians were r and omized by office to receive an electronic form that was embedded in the EMR . The form contained prompts regarding suboptimal care based on Adult Treatment Panel-III ( ATP-III ) guidelines , as well as reporting tools to identify patients outside of office visits whose lipid management was suboptimal . All active patients , ages 20 - 79 years , whose physicians participated in the study , were categorized as high , moderate , or low cardiovascular risk , and the proportion who were tested for hyperlipidemia , at lipid goal , and on lipid-lowering medications if not at goal were measured according to ATP-III guidelines . A total of 105 physicians from 25 offices and 64,150 patients were included in the study . Outcomes improved for most measures from before to 1 year after the intervention ( November 1 , 2005 to October 31 , 2006 ) . However , after controlling for confounding variables and for clustering in multilevel modeling , only up-to- date lipid testing for high-risk patients was statistically better in the intervention group as compared to the control group ( adjusted odds ratio 15.0 , P < 0.05 ) . This study showed few differences in quality of lipid management after implementing an EMR-based disease management intervention in primary care setting s. Future studies may need to examine more comprehensive interventions that include office staff in a team approach to care Background — Whether knowledge of genetic risk for coronary heart disease ( CHD ) affects health-related outcomes is unknown . We investigated whether incorporating a genetic risk score ( GRS ) in CHD risk estimates lowers low-density lipoprotein cholesterol ( LDL-C ) levels . Methods and Results — Participants ( n=203 , 45–65 years of age , at intermediate risk for CHD , and not on statins ) were r and omly assigned to receive their 10-year probability of CHD based either on a conventional risk score ( CRS ) or CRS + GRS ( + GRS ) . Participants in the + GRS group were stratified as having high or average/low GRS . Risk was disclosed by a genetic counselor followed by shared decision making regarding statin therapy with a physician . We compared the primary end point of LDL-C levels at 6 months and assessed whether any differences were attributable to changes in dietary fat intake , physical activity levels , or statin use . Participants ( mean age , 59.4±5 years ; 48 % men ; mean 10-year CHD risk , 8.5±4.1 % ) were allocated to receive either CRS ( n=100 ) or + GRS ( n=103 ) . At the end of the study period , the + GRS group had a lower LDL-C than the CRS group ( 96.5±32.7 versus 105.9±33.3 mg/dL ; P=0.04 ) . Participants with high GRS had lower LDL-C levels ( 92.3±32.9 mg/dL ) than CRS participants ( P=0.02 ) but not participants with low GRS ( 100.9±32.2 mg/dL ; P=0.18 ) . Statins  were initiated more often in the + GRS group than in the CRS group ( 39 % versus 22 % , P<0.01 ) . No significant differences in dietary fat intake and physical activity levels were noted . Conclusions — Disclosure of CHD risk estimates that incorporated genetic risk information led to lower LDL-C levels than disclosure of CHD risk based on conventional risk factors alone . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01936675 ABSTRACT BACKGROUND Many individuals at higher risk for cardiovascular disease ( CVD ) do not receive recommended treatments . Prior interventions using personalized risk information to promote prevention did not test clinic-wide effectiveness . OBJECTIVE AND DESIGN To perform a 9-month cluster-r and omized trial , comparing a strategy of electronic health record-based identification of patients with increased CVD risk and individualized mailed outreach to usual care . PARTICIPANTS Patients of participating physicians with a Framingham Risk Score of at least 5 % , low-density lipoprotein (LDL)-cholesterol level above guideline threshold for drug treatment , and not prescribed a lipid-lowering medication were included in the intention-to-treat analysis .INTERVENTION Patients of physicians r and omized to the intervention group were mailed individualized CVD risk messages that described benefits of using a statin ( and controlling hypertension or quitting smoking when relevant).MAIN MEASURES The primary outcome was occurrence of a LDL-cholesterol level , repeated in routine practice , that was at least 30 mg/dl lower than prior . A secondary outcome was lipid-lowering drug prescribing . Clinical trials.gov identifier : NCT01286311.KEY RESULTS Fourteen physicians with 218 patients were r and omized to intervention , and 15 physicians with 217 patients to control . The mean patient age was 60.7 years and 77 % were male . There was no difference in the primary outcome ( 11.0 % vs. 11.1 % , OR 0.99 , 95 % CI 0.56–1.74 , P = 0.96 ) , but intervention group patients were twice as likely to receive a prescription for lipid-lowering medication ( 11.9 % , vs. 6.0 % , OR 2.13 , 95 % CI 1.05–4.32 , p = 0.038 ) . In post hoc analysis with extended follow-up to 18 months , the primary outcome occurred more often in the intervention group ( 22.5 % vs. 16.1 % , OR 1.59 , 95 % CI 1.05–2.41 , P = 0.029 ) . CONCLUSIONS In this effectiveness trial , individualized mailed CVD risk messages increased the frequency of new lipid-lowering drug prescriptions , but we observed no difference in proportions lowering LDL-cholesterol after 9 months . With longer follow-up , the intervention ’s effect on LDL-cholesterol levels was apparent AIM Informing a person of their individual risk of developing a disease in the future may be sufficient to provide the person with the impetus to adopt risk reducing behaviours . The aim of this study was to determine if a personalised 10-year cardiovascular disease ( CVD ) risk estimate can increase  physical activity  and other risk reduction behaviours in adults at high risk of CVD . METHODS Pilot 2 × 2 factorial r and omised controlled trial conducted in Oxfordshire , UK including 194 adults at increased CVD risk ( 10-year CVD risk ≥ 20 % ) recruited from four general practice s. Main outcome measure at one month was physical activity measured by accelerometer . RESULTS Median ( IQR ) age was 62.3 ( 54.9 , 66.1 ) years , 67 % were men and 19 % had known diabetes . Mean ( SD ) total accelerometer counts per day was 297 × 10(-3 ) ( 110 × 10(-3 ) ) and activity of moderate or greater intensity was undertaken for 53 ( 22 ) minutes per day . In the 185 ( 95 % ) participants attending follow-up an increase in physical activity was not seen . There was a non-significant 0.5 % ( p = 0.56 ) greater increase in accelerometer counts in those receiving personalised CVD risk estimates . No significant within or between group changes were seen at one month in estimated 10-year CVD risk . A net 7 % decrease in mean LDL cholesterol ( p = 0.004 ) was seen in the intervention group despite similar increases in new prescriptions for lipid lowering therapies . CONCLUSION In adults at increased risk of CVD provision of personalised 10-year CVD risk estimates did not appear to increase physical activity or estimated CVD risk over a one-month period OBJECTIVE High blood pressure is an important and modifiable cardiovascular disease risk factor that remains under-detected and under-treated . Community-level interventions that address high blood pressure and other modifiable risk factors are a promising strategy to improve cardiovascular health in population s. The present study is a community cluster-r and omised trial testing the effectiveness of CHAP ( Cardiovascular Health Awareness Program ) on the cardiovascular health of older adults . METHODS Thirty-nine mid-sized communities in Ontario , Canada were stratified by geographic location and size of the population aged > or=65 years and r and omly allocated to receive CHAP or no intervention . In CHAP communities , residents aged > or=65 years were invited to attend cardiovascular risk assessment sessions held in pharmacies over 10 weeks in Fall , 2006 . Sessions included blood pressure measurement and feedback to family physicians . Trained volunteers delivered the program with support from pharmacists , community nurses and local organisations . RESULTS The primary outcome measure is the relative change in the mean annual rate of hospital admission for acute myocardial infa rct ion , congestive heart failure and stroke ( composite end-point ) among residents aged > or=65 years in intervention and control communities , using routinely collected , population -based administrative health data . CONCLUSION This paper highlights considerations in design , implementation and evaluation of a large-scale , community-wide cardiovascular health promotion initiative
target: There is uncertainty whether current strategies for providing CVD risk scores  affect CVD events .
  Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm .
background: BACKGROUND The current paradigm for cardiovascular disease ( CVD ) emphasises absolute risk assessment to guide treatment decisions in primary prevention .
  Although the derivation and validation of multivariable risk assessment tools , or CVD risk scores , have attracted considerable attention , their effect on clinical outcomes is uncertain .
  OBJECTIVES To assess the effects of evaluating and providing CVD risk scores in adults without prevalent CVD on cardiovascular outcomes , risk factor levels , preventive medication prescribing , and health behaviours .