Evaluation of an instructional program for improving medication compliance for chronically mentally ill outpatients. Prospective randomized two-Arm controlled study to determine the efficacy of a specific intervention to improve long-term adherence to highly active antiretroviral therapy. Home visits to improve adherence to highly active antiretroviral therapy: a randomized controlled trial. Effects of a treatment adherence enhancement program on health literacy, patient-provider relationships, and adherence to HAART among low-income HIV-positive Spanish-speaking Latinos. Multidisciplinary HIV adherence intervention: a randomized study. Enhancing commitment improves adherence to a medical regimen. A randomized controlled trial to enhance antiretroviral therapy adherence in patients with a history of alcohol problems. A test of interventions to increase adherence to hypertensive medical regimens. Effectiveness of different medication management approaches on elders' medication adherence. A video game improves behavioral outcomes in adolescents and young adults with cancer: a randomized trial. Results of a pilot intervention trial to improve antiretroviral adherence among HIV-positive patients. Effect of individual cognitive behaviour intervention on adherence to antiretroviral therapy: prospective randomized trial. Individualised patient care as an adjunct to standard care for promoting adherence to ocular hypotensive therapy: an exploratory randomised controlled trial. Program to enhance health literacy and treatment adherence in low-income HIV-infected Latino men and women. Use of an on-line pager system to increase adherence to antiretroviral medications. Couple-focused support to improve HIV medication adherence: a randomized controlled trial. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. Influencing adherence among hypertensives. Impact of a health communication intervention to improve glaucoma treatment adherence. Results of the interactive study to increase glaucoma adherence to treatment trial. Electronic monitoring of adherence as a tool to improve blood pressure control. A randomized controlled trial. Enhancing antiepileptic drug adherence: a randomized controlled trial. A cluster randomized trial comparing two interventions to improve treatment of major depression in primary care. Motivational interviewing and cognitive-behavioral intervention to improve HIV medication adherence among hazardous drinkers: a randomized controlled trial. Telephone support to improve antiretroviral medication adherence: a multisite, randomized controlled trial. Effect of patient education on adherence to drug treatment for rheumatoid arthritis: a randomised controlled trial. Impact of a patient education program on adherence to HIV medication: a randomized clinical trial. Can computer-generated evidence-based care suggestions enhance evidence-based management of asthma and chronic obstructive pulmonary disease? A randomized, controlled trial. Using motivational interviewing to promote adherence to antiretroviral medications: a pilot study. Efficacy of an educational and counseling intervention on adherence to highly active antiretroviral therapy: French prospective controlled study. The pilot study of a telephone disease management program for depression. Promoting adherence: effects of theory-based asthma education. Exploratory cluster randomised controlled trial of shared care development for long-term mental illness. Brief behavioral self-regulation counseling for HIV treatment adherence delivered by cell phone: an initial test of concept trial. Evaluation of family health education to build social support for long-term control of high blood pressure. Use of multisystemic therapy to improve regimen adherence among adolescents with type 1 diabetes in chronic poor metabolic control: a randomized controlled trial. Group discussions with parents have long-term positive effects on the management of asthma with good cost-benefit. Effect of intervention through a pharmaceutical care program on patient adherence with prescribed once-daily atorvastatin. Effects of formal education for patients with inflammatory bowel disease: a randomized controlled trial. Adherence feedback to improve asthma outcomes among inner-city children: a randomized trial. Expanding patient involvement in care. Effects on patient outcomes. Patient-initiated prevention discussions. Two interventions to stimulate patients to initiate prevention discussions. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. Impact of the fit and strong intervention on older adults with osteoarthritis. Effects of paying physicians based on their relative performance for quality. Improving primary care in rural Alabama with a pharmacy initiative. Influencing medication adherence among women with AIDS. Randomised controlled trial of compliance therapy. 18-month follow-up. Behavioral contingencies improve counseling attendance in an adaptive treatment model. Empowering older patients to communicate more effectively in the medical encounter. Shared decision making and long-term outcome in schizophrenia treatment. Adherence to antiretroviral therapy in HIV-infected pediatric patients improves with home-based intensive nursing intervention. Effects of computerized guidelines for managing heart disease in primary care. Use of personal trainers and financial incentives to increase exercise in a behavioral weight-loss program. A randomized controlled trial of facilitating information giving to patients with chronic medical conditions: effects on outcomes of care. Reducing long term sickness absence by an activating intervention in adjustment disorders: a cluster randomised controlled design. Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain. A multimethod quality improvement intervention to improve preventive cardiovascular care: a cluster randomized trial. Effects of a physician communication intervention on patient care outcomes. Improving medication use in newly admitted home healthcare patients: a randomized controlled trial. Long-term effects of interventions for weight loss using food provision and monetary incentives. The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial. Impact of presentation of research results on likelihood of prescribing medications to patients with left ventricular dysfunction. One-to-one versus group sessions to improve prescription in primary care: a pragmatic randomized controlled trial. Improving drug use through continuing education: a randomized controlled trial in Zambia. Use of a time series design to test effectiveness of a theory-based intervention targeting adherence of health professionals to a clinical guideline. Providing a web-based online medical record with electronic communication capabilities to patients with congestive heart failure: randomized trial. A medication self-management program to improve adherence to HIV therapy regimens. An endocrinologist-supported intervention aimed at providers improves diabetes management in a primary care site: improving primary care of African Americans with diabetes (IPCAAD) 7. Children's adherence to recommended asthma self-management. A multifaceted intervention to improve treatment of depression in primary care. Collaborative management to achieve treatment guidelines. Impact on depression in primary care. Analysis of the North Carolina long-term care polypharmacy initiative: a multiple-cohort approach using propensity-score matching for both evaluation and targeting. Improving drug-therapy decisions through educational outreach. A randomized controlled trial of academically based "detailing".
Outpatient medication adherence is a major problem, especially for patients repeatedly hospitalized for psychiatric disorders. This study included 39 such patients who were receiving case management services from a community mental health center. Patients were matched and randomly assigned to receive in a single session either (1) information regarding medication and its benefits, (2) guidelines for assuring adherence which encompassed all phases related to pill-taking including filling prescriptions, use of a pill container, transportation, self-reminders, doctor's appointments and so forth, or (3) the same guidelines as (2) above but given in the presence of a family member who was enlisted in support. The results showed that adherence increased to about 94% after the guidelines were given for both the individual and family guideline procedure, whereas adherence remained unchanged at 73% after the medication information procedure. These results suggest a practical means for assuring a high level of medication adherence for patients with psychiatric disorders. Nearly perfect compliance seems to be indispensable to obtain the maximum benefit from highly active antiretroviral therapy (HAART). Interventions to ensure a high level of adherence during a relatively long-term period of therapy are necessary.
                This is a prospective, randomized, two-arm controlled study including patients starting their first-or second-line HAART who were randomized to receive psychoeducative intervention to implement adherence (experimental group [EG]) or a usual medical follow-up (control group [CG]). We aimed to study the efficacy of a psychoeducative intervention to ensure long-term adherence to HAART, its relation with the virologic efficacy of treatment, and to determine the variables related to long-term adherence. Visits were made at weeks 0, 4, 24, and 48 for data collection. Self-reported adherence was registered at each visit and its veracity was tested by randomized blood analyses performed without previous warning to 40% of patients. Appropriate adherence was defined as the consumption of >/=95% of medication prescribed. Statistical analyses were performed both by the as treated (AT) and the intention to treat missing = failure (ITT) methods.
                In all, 116 patients were included. At week 48, 94% of patients in the EG versus 69% controls achieved adherence >/=95% (p =.008); 89% of patients in the EG versus 66% controls had HIV-1 RNA levels <400 copies/ml (p =.026). Overall, 85% of patients with adherence >/=95% but only 45% of those with adherence <95% had viral load (VL) <400 copies/ml (p =. 008). In multivariate analysis, variables significantly related to adherence were having received a psychoeducative intervention (odds ratio [OR], 6.58; p =.04), poor effort to take medication (OR, 5.38; p =.03), and high self-perceived capacity to follow the regimen (OR, 13.76; p =.04). Self-reported adherence and drug plasma levels coincided in 93% of cases. However, differences in adherence did not reach statistical significance in the ITT analysis although a clear tendency toward benefit was observed in EG.
                Specific and maintained psychoeducative interventions based on excellence on clinical practice are useful to keep high levels of adherence as well as high levels of viral suppression. There is a clear relation between high adherence levels and virologic success. Assessment of certain specific variables related to adherence may be helpful to monitor patient's compliance in the clinical setting. Few rigorously designed studies have documented the efficacy of interventions to improve medication adherence among patients prescribed highly active antiretroviral. Data are needed to justify the use of limited resources for these programs.
                A 2-arm, randomized, controlled trial evaluated the efficacy of a community-based, home-visit intervention to improve medication adherence. Participants were 171 HIV-infected adults prescribed a minimum of 3 antiretroviral agents. The majority had a past or current history of substance abuse. Subjects were randomly assigned to receive home visits for 1 year or usual care. Medication adherence was assessed with Medication Event Monitoring stem caps at 3-month intervals from randomization through 3 months after the conclusion of the intervention.
                A larger proportion of subjects in the intervention group demonstrated adherence greater than 90% compared with the control group at each time point after baseline. The difference over time was statistically significant (Extended Mantel-Haenszel test: 5.80, P = 0.02). A statistically significant intervention effect on HIV-RNA level or CD4 cell count was not seen, but there was a statistically significant association between greater than 90% adherence and an undetectable HIV-RNA over time (P < 0.03).
                Home visits from a nurse and a community worker were associated with medication adherence greater than 90% among a cohort of socially vulnerable people living with HIV/AIDS in northeastern United States. The impact of an adherence enhancement program for low income HIV-infected Spanish-speaking Latinos on health literacy, patient-provider relationships, and adherence to HAART was examined. Evaluations were conducted at baseline, 6 weeks, and 6 months for participants (n = 85) randomly assigned to either the intervention group or a comparison group; 69 (81%) remained in the study for the entire 6-month duration. The intervention group scored significantly better than the comparison group on 3 of 5 measures of HIV health literacy at 6 weeks and on 2 of 5 measures, at 6 months. While there was a weak trend for the intervention group to report an increase in self-efficacy of medication adherence management, baseline to 6 weeks, no other changes were significant. Perceptions of the quality of relationship and communications with their HIV-treating physicians improved both at 6 weeks (p = 0.04) and at 6 months (p < 0.001). The comparison group showed little change baseline to 6 weeks and baseline to 6 months. While there was a trend for the pilot group to report better medication adherence, these differences were not statistically significant. Further evaluation of the impact of this adherence enhancement program is needed. Maintaining greater than 95% adherence to antiretroviral medication is necessary in order to have the greatest therapeutic impact on HIV infection. Furthermore, evidence suggests that adherence rates of between 70% and 89% are significantly associated with viral rebound and the development of drug resistance. Adherence rates at and above the 95% level are difficult for patients to achieve and maintain. Our aim was to determine if an adherence intervention could improve adherence among patients attending an ambulatory care clinic at a large public hospital. The intervention was delivered by a multidisciplinary team of health care professionals and consisted of education coupled with the provision of devices designed to assist patient memory and adherence. A crucial component of the intervention consisted of the identification of patient specific barriers to adherence and the development of strategies to circumvent these problems. Adherence was assessed using patient self-report over the past 4, 7, and 28 days and by calculation of the Morisky score. The study was conducted as a randomised controlled trial using the stepped wedge design with a total of 68 subjects randomised to receive the intervention over a 20-week period. Adherence before and after the intervention formed the analysis. There was a significant decrease in the number of missed doses over the past 4 (1.9 to 1.0, p < 0.001), 7 (3.0 to 1.8, p < 0.001) and 28 (7.4 to 4.2, p < 0.001) days and a decrease in the Morisky score, indicating an improvement in medication taking behaviour (1.3 to 0.5 p < 0.001). A commitment-based intervention was evaluated for improvement of adherence to a 10-day antibiotic regimen. Experimental Ss made verbal and written commitments for adherence and completed tasks designed to increase their investment in a medication regimen. Control Ss performed similarly structured tasks unrelated to the medical regimen. Adherence, measured by unannounced pill counts, was significantly higher for experimental subjects than for control Ss. Self-reported adherence was significantly correlated with posttest self-efficacy but not with pretest self-efficacy. Adherence to a medical regimen may be improved by strategies conceptually based on the investment model of commitment, which provides a useful framework for further study of adherence. To assess the effectiveness of an individualized multicomponent intervention to promote adherence to antiretroviral therapy (ART) in a cohort of HIV-infected individuals with a history of alcohol problems.
                We conducted a randomized controlled trial to compare the usual medical follow-up with an adherence intervention.
                The principal enrolment site was Boston Medical Center, a private, not-for-profit, academic medical institution.
                HIV-infected patients with a history of alcohol problems on ART. A total of 151 were enrolled and 141 (93%) were assessed at follow-up. Intervention: A nurse, trained in motivational interviewing, completed the following over 3 months in four encounters: addressed alcohol problems; provided a watch with a programmable timer to facilitate pill taking; enhanced perception of treatment efficacy; and delivered individually tailored assistance to facilitate medication use.
                Prior 30-day adherence > or =95%, prior 3-day adherence of 100%, CD4 cell count, HIV RNA and alcohol consumption, each at both short- and long-term follow-up.
                At follow-up, no significant differences in medication adherence, CD4 cell count, HIV RNA or alcohol consumption were found (all P values >0.25).
                A multicomponent intervention to enhance adherence among HIV-infected individuals with a history of alcohol problems was not associated with changes in medication adherence, alcohol consumption or markers of HIV disease progression. The failure to change adherence in a group at high risk for poor adherence, despite utilizing an intensive individual-focused patient intervention, supports the idea of addressing medication adherence with supervised medication delivery or markedly simplified dosing regimens. Low rates of adherence to hypertensive therapy limit patients' securing the full benefits of treatment. While some factors related to adherence have been identified research on the effectiveness of interventions to increase adherence levels is sparse. The present study was designed to assess the impact of a series of different interventions on a group of some 400 patients, all under the care of private physicians in a small community. A factorial design was employed to deliver four, sequential educational interventions, about four months apart, to randomly selected sub-groups. Interviews before and after each intervention provided information concerning self-reported adherence, health status, health beliefs, and personal characteristics. Pertinent medical records and pharmacy data were also obtained. The first intervention - printed material - did not significantly affect adherence. The second and fourth interventions - nurse telephone calls and social support - each increased medication taking and the third intervention - self-monitoring - led to better weight control. There was no cumulative impact of the interventions and different aspects of regimens were not significantly related to one another. This pilot study investigated the effects of three different medication management approaches on medication adherence and resource utilization. Sixty-one participants living in an independent elder community in South Florida were randomly assigned to one of the three medication management approaches: (1) a pillbox method, (2) a voice-activated method, and (3) self-administration of medications as they had in the past. One outcome was measured by recording the number of doses of medications ingested over a 1-, 3-, and 6-month period. Adherence to medications also was measured by the impact on the medical diagnosis. For example, the hypertensive group was defined adherent by a sustained normotensive pressure. Participants' medical records were examined as to the number of physician office visits, hospitalizations, and home health visits. There were significant differences in the mean number of doses missed, with the fewest in the voice-activated group to the highest in the self-administration (control) group. Additionally, the group that self-administered their own medications had more frequent physician office visits and increased hospitalizations. Because the elder population is prone to medication mismanagement for a variety of reasons, nurses are in a unique position to identify populations at risk and suggest interventions that may improve medication adherence. Suboptimal adherence to self-administered medications is a common problem. The purpose of this study was to determine the effectiveness of a video-game intervention for improving adherence and other behavioral outcomes for adolescents and young adults with malignancies including acute leukemia, lymphoma, and soft-tissue sarcoma.
                A randomized trial with baseline and 1- and 3-month assessments was conducted from 2004 to 2005 at 34 medical centers in the United States, Canada, and Australia. A total of 375 male and female patients who were 13 to 29 years old, had an initial or relapse diagnosis of a malignancy, and currently undergoing treatment and expected to continue treatment for at least 4 months from baseline assessment were randomly assigned to the intervention or control group. The intervention was a video game that addressed issues of cancer treatment and care for teenagers and young adults. Outcome measures included adherence, self-efficacy, knowledge, control, stress, and quality of life. For patients who were prescribed prophylactic antibiotics, adherence to trimethoprim-sulfamethoxazole was tracked by electronic pill-monitoring devices (n = 200). Adherence to 6-mercaptopurine was assessed through serum metabolite assays (n = 54).
                Adherence to trimethoprim-sulfamethoxazole and 6-mercaptopurine was greater in the intervention group. Self-efficacy and knowledge also increased in the intervention group compared with the control group. The intervention did not affect self-report measures of adherence, stress, control, or quality of life.
                The video-game intervention significantly improved treatment adherence and indicators of cancer-related self-efficacy and knowledge in adolescents and young adults who were undergoing cancer therapy. The findings support current efforts to develop effective video-game interventions for education and training in health care. A small pilot trial of a multicomponent (behavioral strategies, simplified patient information, and social support) and multidisciplinary (cognitive-behavioral therapy and nursing) medication adherence intervention was conducted for HIV-infected adults prescribed antiretrovirals. Patients (N = 33) were randomly assigned to the intervention condition or standard care. Compared to the control group, patients in the intervention condition had significantly higher self-efficacy to communicate with clinic staff (p = .04) and to continue treatment (p = .04), were significantly more likely to be using behavioral and cognitive strategies (p = .01 and p = .04), reported significantly higher life satisfaction (p = .03), reported significantly increased feelings of social support (p = .04), and showed a trend toward an increase in taking their medications on schedule (p = .06). The intervention, however, did not appear to affect health-related anxiety or to significantly improve adherence to dose. Implications for future intervention planning are discussed. A high level of adherence to antiretroviral therapy is required for complete suppression of HIV replication, immunological and clinical effectiveness. We investigated whether cognitive behaviour therapy can improve medication adherence.
                Prospective randomized 1-year trial.
                Collaboration of HIV university outpatient clinic and psychotherapists in private practice.
                60 HIV-infected persons on stable antiretroviral combination therapy and viral load below 50 copies/ml.
                Cognitive behaviour intervention in individual patients, in addition to standard of care.
                Feasibility and acceptance of intervention; adherence to therapy assessed using medication event monitoring system (MEMS) and self-report questionnaire; virological failure; psychosocial measures.
                The median number of sessions for cognitive behaviour intervention per patient during the 1-year trial was 11 (range 2-25). At months 10-12, mean adherence to therapy as assessed using MEMS was 92.8% in the intervention and 88.9% in the control group (P=0.2); the proportion of patients with adherence > or = 95% was 70 and 50.0% (P=0.014), respectively. While there was no significant deterioration of adherence during the study in the intervention arm, adherence decreased by 8.7% per year (P=0.006) in the control arm. No differences between the intervention group and standard of care group were found regarding virological outcome. Compared with the control group, participants in the intervention group perceived a significant improvement of their mental health during the study period.
                Cognitive behavioural support in addition to standard of care of HIV-infected persons is feasible in routine practice, and can improve medication adherence and mental health. To evaluate the impact of individualised patient care, as an adjunct to standard care, on adherence to ocular hypotensive therapy.
                A two-arm, single-masked exploratory randomised controlled trial recruited patients newly prescribed ocular hypotensive therapy. The intervention involved an individual assessment of health-care needs and beliefs and a 1-year follow-up period according to need. The primary outcome was refill adherence, measured by collating prescription and dispensing data for 12 months. Secondary outcomes included self-reported adherence, glaucoma knowledge, beliefs about illness and medicines, quality of care, intraocular pressure (IOP) fluctuation, and changes in clinical management assessed at 12 months. The strength of the intervention was measured following withdrawal by reviewing clinical outcomes for a further 12 months.
                In all, 127 patients were recruited (91% response rate). Intervention-arm patients collected significantly more prescriptions than control-arm patients. Self-report adherence was significantly better in the intervention-arm for patients who forgot drops and those who intentionally missed drops. The intervention group demonstrated significantly more glaucoma knowledge, expressed a significantly stronger belief in the necessity of eye drops and believed that they had more personal control over managing their condition. Control-arm patients had more IOP fluctuation and changes in clinical management. However, this finding only reached significance at 24 months.
                Modelling patient care according to health-care needs and beliefs about illness and medicines can have a significant impact on improving adherence to therapy for this patient group, with the potential benefit of improving clinical outcomes. This paper reports the initial results of a pilot study to evaluate the acceptability and effectiveness of a program to enhance health literacy in low-income HIV-infected Latino men and women receiving antiretroviral therapy. Participants rated the program highly on measures of satisfaction, providing evidence of its acceptability. The effectiveness of the program was assessed in comparisons of the intervention (n = 41) and standard care only (n = 40) groups at baseline and 6-week intervals. Program participants showed significant improvement over comparison group participants on measures of HIV/AIDS and treatment-related knowledge and recognition and understanding of HIV terms. Although there were no significant changes in adherence mastery and behaviors during the 6-week follow up period, there were significant changes in program participants' knowledge about medication adherence. Future steps to examine the sustainability of the program in the medical management of patients are planned in addition to determining its long-range relative impact. Adherence to antiretroviral therapy is critical for treatment success. Antiretroviral therapy typically requires multiple pills at multiple dosing times. To address this, we tested the feasibility, utility, and efficacy of a customizable reminder system using pagers, which were programmed using web-based technology, to increase and maintain proper adherence in patients with pre-existing adherence problems. After a two-week monitoring period with an electronic pill-cap, participants with less than 90% adherence were randomized to continue monitoring or to receive a pager. The group who received the pagers had greater improvements in adherence from baseline to Week 2 and Week 12 than those who monitored their medications only. However, adherence in both groups at the outcome assessments points was still poor. While the provision of a reminder system helped improve adherence, it is likely that more intensive interventions are required for patients with pre-existing problems. To assess the efficacy of a couple-based intervention to improve medication-taking behavior in a clinic population with demonstrated adherence problems.
                A randomized controlled trial (SMART Couples Study) conducted between August 2000 and January 2004.
                Two HIV/AIDS outpatient clinics in New York City.
                Heterosexual and homosexual HIV-serodiscordant couples (n = 215) in which the HIV-seropositive partner had < 80% adherence at baseline. The sample was predominantly lower-income racial/ethnic minorities.
                Participants were randomly assigned to a four-session couple-focused adherence intervention or usual care. The intervention consisted of education about treatment and adherence, identifying adherence barriers, developing communication and problem-solving strategies, optimizing partner support, and building confidence for optimal adherence.
                Medication adherence at week 8 (2 weeks after the intervention) compared with baseline, assessed with a Medication Event Monitoring System cap.
                Intervention participants showed higher mean medication adherence at post-intervention when compared with controls whether adherence was defined as proportion of prescribed doses taken (76% versus 60%) or doses taken within specified time parameters (58% versus 35%). Also, participants in the intervention arm were significantly more likely to achieve high levels of adherence (> 80%, > 90%, or > 95%) when compared with controls. However, in most cases, effects diminished with time, as seen at follow-up at 3 and 6 months.
                The SMART Couples program significantly improved medication adherence over usual care, although the level of improved adherence, for many participants, was still suboptimal and the effect was attenuated over time. There is limited evidence on whether growing mobile phone availability in sub-Saharan Africa can be used to promote high adherence to antiretroviral therapy (ART). This study tested the efficacy of short message service (SMS) reminders on adherence to ART among patients attending a rural clinic in Kenya.
                A randomized controlled trial of four SMS reminder interventions with 48 weeks of follow-up.
                Four hundred and thirty-one adult patients who had initiated ART within 3 months were enrolled and randomly assigned to a control group or one of the four intervention groups. Participants in the intervention groups received SMS reminders that were either short or long and sent at a daily or weekly frequency. Adherence was measured using the medication event monitoring system. The primary outcome was whether adherence exceeded 90% during each 12-week period of analysis and the 48-week study period. The secondary outcome was whether there were treatment interruptions lasting at least 48 h.
                In intention-to-treat analysis, 53% of participants receiving weekly SMS reminders achieved adherence of at least 90% during the 48 weeks of the study, compared with 40% of participants in the control group (P = 0.03). Participants in groups receiving weekly reminders were also significantly less likely to experience treatment interruptions exceeding 48 h during the 48-week follow-up period than participants in the control group (81 vs. 90%, P = 0.03).
                These results suggest that SMS reminders may be an important tool to achieve optimal treatment response in resource-limited settings. In the treatment of hypertension, problems of nonadherence and consequent poor blood pressure control are particularly severe. Alternative intervention strategies were compared to explore means of improving adherence and lowering blood pressures. In a 3 x 4 repeated measures analysis of variance design, 115 patients were randomly selected and randomly assigned to one of three treatment modalities (routine clinic care, patient education, and contingency contracting) and were followed over four clinic visits. Subjects' knowledge about hypertension and its management, adherence to requests for regular medical follow-up, and blood pressure levels were measured. Patient education was not effective in lowering blood pressures; it produced an untoward outcome, a dropout rate higher than that for patients receiving only routine clinic care. However, contingency contracting was an effective intervention strategy for improving patient knowledge, F (1,59) = 51.32, p less than .0001; adherence to requests for regular medical care, Max L (2) = 25.9, p less than .0001; and decreasing diastolic blood pressures, F (2,49) = 3.39, p less than .05. To determine the efficacy of an automated, interactive, telephone-based health communication intervention for improving glaucoma treatment adherence among patients in 2 hospital-based eye clinics.
                A total of 312 patients with glaucoma (18-80 years of age) were enrolled in a randomized controlled trial at 2 eye clinics located in hospitals in the southeastern United States. These patients were considered nonadherent because they did not take their medication, refill their medication, and/or keep their appointments. The treatment group received an automated, interactive, tailored, telephone-based health communication intervention and tailored print materials. The control group received usual care.
                Adherence with medication taking, prescription refills, and appointment keeping measured by interviews, medical charts, appointment records, and pharmacy data.
                A statistically significant increase was found for all adherence measures in both the intervention and control groups. Interactive telephone calls and tailored print materials did not significantly improve adherence measures compared with controls.
                During the study period, patient adherence to glaucoma treatment and appointment keeping improved in both study arms. Participation in the study and interviews may have contributed. Strategies that address individuals' barriers and facilitators may increase the impact of telephone calls, especially for appointment keeping and prescription refills.
                Glaucoma patient care should include reminders about consistent use of medication and the importance of keeping appointments. More frequent, and personalized, telephone contact may be helpful to patients who are known to be nonadherent. Trial Registration: clinicaltrials.gov Identifier:NCT00794170. Poor adherence to antihypertensive drug regimens is believed to be a major contributor to treatment failure. Electronic monitoring of adherence may improve adherence and allow differentiation between those who are nonadherent and those who are pharmacologically nonresponsive. This study was designed to evaluate the effectiveness of electronic monitoring of adherence in lowering blood pressure (BP) in comparison with usual care.
                A total of 258 patients with high BP despite use of antihypertensive medication were randomly assigned to either continuation of usual care (with adjustment in antihypertensive medication if necessary) or to the introduction of electronic monitoring. Adherence to antihypertensive medication was monitored for 2 months without medication changes. The primary outcome measure was the proportion of patients who reached target BP levels after a 5-month follow-up period.
                At 5 months, 50.6% of the patients in the usual care group reached adequate BP, v 53.7% in the electronic monitoring group (P = .73). The percentages of patients with drug additions or increases in dosage were higher in the usual care group compared with those in whom adherence was monitored (P < .01).
                These data show that electronic monitoring in comparison to usual care results in similar BP control but leads to fewer drug changes and less drug use. This result is likely to be achieved by improving adherence. Hence a strategy that includes electronic monitoring has the potential to prevent unnecessary treatment escalation in patients with poor adherence. Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (P<0.01). The implementation intention intervention may be an easy-to-administer and effective means of promoting AED adherence. Many patients with major depression are non-adherent to antidepressant medication and do not receive care according to current guidelines. There is increasing evidence that treatment of depression in primary care can be improved. Comparison between effective interventions may help to establish the active ingredients of such interventions.
                In a randomized trial two interventions to improve treatment of major depression in primary care were compared (1) a depression care programme, targeting general practitioners (GPs), patients, and systematic follow-up, and (2) a systematic follow-up programme. Thirty GPs were randomized and 211 primary-care patients with current major depression were included. All patients were prescribed a selective serotonin reuptake inhibitor. Outcome measures included adherence to antidepressant medication, and depression outcome.
                No significant differences in adherence rates and treatment outcome measures were demonstrated between interventions at week 10 or week 26. Adherence rates were high and treatment outcome was favourable.
                The depression care programme was not superior to the systematic follow-up programme. Systematic follow-up in depression treatment in primary care seems to be an intervention per se, having the potential to improve adherence and treatment outcome. To assess the efficacy of a behavioral intervention designed to improve HIV medication adherence and reduce alcohol consumption among HIV-positive men and women.
                A randomized controlled trial conducted between July 2002 and August 2005.
                A behavioral research center in New York City.
                HIV-positive men and women (n = 143) who were on HIV antiretroviral medication and met criteria for hazardous drinking.
                Participants were randomly assigned to an 8-session intervention based on motivational interviewing and cognitive-behavioral skills building or a time- and content-equivalent educational condition.
                Viral load, CD4 cell count, and self-reported adherence and drinking behavior were assessed at baseline and at 3- and 6-month follow-ups.
                Relative to the education condition, participants in the intervention demonstrated significant decreases in viral load and increases in CD4 cell count at the 3-month follow-up and significantly greater improvement in percent dose adherence and percent day adherence. There were no significant intervention effects for alcohol use, however, and effects on viral load, CD4 cell count, and adherence were not sustained at 6 months.
                An 8-session behavioral intervention can result in improvement in self-report and biologic markers of treatment adherence and disease progression. This type of intervention should be considered for dissemination and integration into HIV clinics providing comprehensive care for HIV-positive persons with alcohol problems. Although the effect was attenuated over time, future studies might test the added effectiveness of booster sessions or ongoing adherence counseling. To determine whether proactive telephone support improves adherence to antiretroviral therapy (ART) and clinical outcomes when compared to standard care.
                A multisite, randomized controlled trial (RCT) was conducted with 109 ART-naive subjects coenrolled in AIDS Clinical Trials Group (ACTG) 384. Subjects received standard clinic-based patient education (SC) or SC plus structured proactive telephone calls. The customized calls were conducted from a central site over 16 weeks by trained registered nurses. Outcome measures (collected over 64 weeks) included an ACTG adherence questionnaire and 384 study endpoints.
                For the primary endpoint, self-reported adherence, a significantly better overall treatment effect was observed in the telephone group (P = 0.023). In a post hoc analysis, composite adherence scores, taken as the first 2 factor scores from a principal components analysis, also found significant intervention benefit (P = 0.023 and 0.019 respectively). For the 384 primary study endpoint, time to regimen failure, the Kaplan-Meier survival curve for the telephone group remained above the SC group at weeks 20 to 64; a Cox proportional hazard model that controlled for baseline RNA stratification, CD4, gender, age, race/ethnicity, and randomized ART treatment arm suggested the telephone group tended to have a lower risk for failure (hazard ratio = 0.68; 95% confidence interval: 0.38 to 1.23).
                Findings indicate that customized, proactive telephone calls have good potential to improve long-term adherence behavior and clinical outcomes. To determine whether a patient education programme (PE) would improve rates of adherence to a slow acting antirheumatic drug and to assess any subsequent effect on patient outcome.
                A randomly controlled study comprising 100 patients with rheumatoid arthritis (49 control CG; 51 experimental EG) requiring D-penicillamine (DPA). The same practitioner saw patients on seven occasions, for the same length of time. The EG received 7 x 30 minute one to one sessions of PE, while the CG received standard management. The primary measure of adherence was a pharmacological marker (phenobarbitone) encapsulated with the DPA assayed at monthly intervals for six months. Plasma viscosity (PV), C reactive protein, articular index, morning stiffness, and pain score were used to assess outcome.
                454 blood samples were collected and assayed and the pharmacological marker showed the EG to be significantly more adherent on more occasions than the CG (p<0.05). Patterns of adherence over time showed that at 12 weeks 86% (38/44) of those in the EG compared with 64% (29/45) of the CG remained adherent (p=0.01). These trends continued and by the end of the study 85% (29/34) of the EG compared with 55% (23/42) of the CG were taking their DPA as prescribed. Fifteen patients (12 from the EG) experienced side effects requiring study withdrawal and 14 patients requested study withdrawal (two from the EG). On study entry patients in the CG had significantly higher levels of PV than the EG and this remained so throughout the research. However, on completion, the health status of patients in both groups had improved significantly (p<0.01).
                PE significantly increased adherence to DPA and its effects persisted over a period of six months. No additional clinical benefit was detected in the EG in comparison with the CG. Patients' knowledge of their HIV condition and its treatment, which has been recognized as a factor that influences adherence to antiretroviral therapy, can be improved through educational programs. This prospective, randomized, controlled trial compared an experimental group that participated in an educational program and a control group with standard care. The study evaluated the impact of an educational intervention on adherence to antiretroviral therapy, patients' knowledge, quality of life, and therapeutic response in patients treated with highly active antiretroviral therapy. Three hundred twenty-six patients were analyzed at inclusion. A higher level of adherence was associated with patients who were older, had higher incomes, and did not smoke. CD4 cell count and plasma viral load were correlated with adherence at entry. The educational intervention had an impact on adherence and knowledge in the experimental group at 6 months, which was maintained at 12 and 18 months. A delayed increase in adherence was observed in the control group at 12 months. No significant impact on quality of life was observed over time. The patients' health status improved in 56% of the experimental group subjects and 50% of the control subjects. However, no significant impact was shown on CD4 cell count and plasma viral load. This study shows that an educational intervention improves adherence to antiretroviral regimens and health status and suggests that it should be initiated early in therapy. Translation of evidence-based guidelines into clinical practice has been inconsistent. We performed a randomized, controlled trial of guideline-based care suggestions delivered to physicians when writing orders on computer workstations.
                Inner-city academic general internal medicine practice.
                Randomized, controlled trial of 246 physicians (25 percent faculty general internists, 75 percent internal medicine residents) and 20 outpatient pharmacists. We enrolled 706 of their primary care patients with asthma or chronic obstructive pulmonary disease. Care suggestions concerning drugs and monitoring were delivered to a random half of the physicians and pharmacists when writing orders or filling prescriptions using computer workstations. A 2 x 2 factorial randomization of practice sessions and pharmacists resulted in four groups of patients: physician intervention, pharmacist intervention, both interventions, and controls. DATA EXTRACTION/COLLECTION METHODS: Adherence to the guidelines and clinical activity was assessed using patients' electronic medical records. Health-related quality of life, medication adherence, and satisfaction with care were assessed using telephone questionnaires.
                During their year in the study, patients made an average of five scheduled primary care visits. There were no differences between groups in adherence to the care suggestions, generic or condition-specific quality of life, satisfaction with physicians or pharmacists, medication compliance, emergency department visits, or hospitalizations. Physicians receiving the intervention had significantly higher total health care costs. Physician attitudes toward guidelines were mixed.
                Care suggestions shown to physicians and pharmacists on computer workstations had no effect on the delivery or outcomes of care for patients with reactive airways disease. This report describes a pilot study of a nursing intervention to increase adherence to combination therapy. The intervention was based on motivational interviewing (MI). Participants completed a baseline assessment using the computer-administered self-interview with audio (ACASI) data collection method and then were randomly assigned to the MI intervention or control condition. Nurse counselors met with participants in the MI intervention group for three adherence sessions. Two months following baseline, participants completed a follow-up assessment. Mean scores on ratings of missed medications were lower for participants in the intervention group than those in the control group. Although there were no significant differences in the number of medications missed during the past 4 days, participants in the MI group reported being more likely to follow the medication regimen as prescribed by their health care provider. The pilot study provided useful information about the acceptability of ACASI and the adequacy of intervention procedures. The results of this pilot study show promise for the use of MI as an intervention to promote adherence to antiretroviral medications. The objective was to evaluate the impact of an intervention for improving adherence to antiretroviral therapies (HAART) in HIV-infected patients.
                We designed a prospective, controlled, randomized trial to assess the impact of an educational and counseling intervention in addition to standard of care. At M0, the study enrolled 244 HAART-treated patients who attended a medical consultation between September and December 1999 who were not included in another protocol. Patients in the intervention group (IG) were offered three individual sessions by trained nurses. The proportions of adherent patients at 6 months followup (M6) and the change in HIV RNA between M0 and M6 were measured.
                Between M0 and M6, HIV RNA significantly decreased in the 123 patients of the IG (mean difference = -0.22 log [+/-0.86], p =.013), while it increased (+0.12 log [+/-0.90], p =.14) in the 121 patients of the control group. However, the proportion of patients with HIV RNA <40 copies/mL remained similar in both groups. In an intent-to-treat analysis, the only significant predictor of 100% adherence at M6 was the intervention group (p =.05) after adjustment for baseline adherence (p =.001). Among the 202 patients with available data on adherence, the proportion of adherent patients was similar in both groups at M0 (58% vs. 63%, p =.59) but became higher in the IG at M6 (75% vs. 61%, p =.04).
                The educational and counseling intervention was efficient for increasing adherence to HAART and could be implemented in most clinical settings. Most depressed patients are seen and treated exclusively by primary care clinicians. However, primary care patients with depression are often not adequately treated. The aims of this pilot study were to measure the impact of a telephone disease management program on patient outcome and clinician adherence to practice guidelines, measure the relationship of clinician adherence to patient outcome, and explore the measurement of patient adherence to clinician recommendations and its impact on patient outcomes. Thirty-five primary care practices in the University of Pennsylvania Health System were randomized to telephone disease management (TDM) or "usual care" (UC). All patients received a baseline and a 16-week follow-up clinical evaluation performed over the telephone. Those from TDM practices also received follow-up contact at least every 3 weeks, with formal evaluations at weeks 6 and 12. These interval contacts were designed to facilitate patient and clinician adherence to a treatment algorithm based on the Agency for Health Research and Quality (AHRQ) practice guidelines. Depressive symptoms evaluated with the Community Epidemiologic Survey of Depression (CES-D) scale as well as guideline adherence were the primary outcome measures. Sixty-one patients were enrolled in this pilot project. The overall effect for CES-D scores over time was significant, (P <.001), indicating that those participating in the trial (both TDM and UC groups) showed significant improvement. The interaction between intervention condition and time was also significant (P <.05), indicating that TDM patients improved significantly more over time than did UC patients. A greater proportion of TDM patients had CES-D scores <16 by Week 16 (66.7 versus 33.3%; chi(2), P <.05). The improvement in depression outcome for the TDM group was related to its impact on improving clinician adherence to depression treatment algorithms. The TDM pilot did not show a statistically significant effect on improving patient adherence to clinician recommendations, however. This preliminary data suggests that TDM for depression improves both clinician guideline adherence and patient outcomes in the acute phase of depression. The effect on patient outcome is at least partially explained by the effect of TDM on clinician adherence to depression treatment algorithms. This study compared the effects of a theoretically focused audiotape and a standard educational booklet on asthma preventive medication adherence and other asthma outcomes. Forty-six adult asthmatics were randomly assigned to receive either an experimental audiotape incorporating components of protection motivation theory, a standard asthma management booklet, both, or no educational materials. Outcomes were assessed at baseline, 3 months, and 6 months. Mean pharmacy-verified adherence improved 15% to 19% in the intervention groups and declined 22% in the control group at 6 months. Using analysis of covariance (ANCOVA) to control for baseline adherence, these changes were significant between the control and booklet group (t = 2.47; p = .02) and between control and combined group (t = 2.07; p = .04). Providing a minimal educational intervention can have a beneficial effect on asthma medication adherence that persists at least 6 months. Primary care clinicians have a considerable amount of contact with patients suffering from long-term mental illness. The United Kingdom's National Health Service now requires general practices to contribute more systematically to care for this group of patients.
                To determine the effects of Mental Health Link, a facilitation-based quality improvement programme designed to improve communication between the teams and systems of care within general practice. Design of study: Exploratory cluster randomised controlled trial.
                Twenty-three urban general practices and associated community mental health teams.
                Practices were randomised to service development as usual or to the Mental Health Link programme. Questionnaires and an audit of notes assessed 335 patients' satisfaction, unmet need, mental health status, processes of mental and physical care, and general practitioners' satisfaction with services and beliefs about service development. Service use and intervention costs were also measured.
                There were no significant differences in patients' perception of their unmet need, satisfaction or general health. Intervention patients had fewer psychiatric relapses than control patients (mean = 0.39 versus 0.71, respectively, P = 0.02) but there were no differences in documented processes of care. Intervention practitioners were more satisfied and services improved significantly for intervention practices. There was an additional mean direct cost of pound 63 per patient with long-term mental illness for the intervention compared with the control.
                Significant differences were seen in relapse rates and practitioner satisfaction. Improvements in service development did not translate into documented improvements in care. This could be explained by the intervention working via the improvements in informal shared care developed through better link working. This type of facilitated intervention tailored to context has the potential to improve care and interface working. Affordable and effective antiretroviral therapy (ART) adherence interventions are needed for many patients to promote positive treatment outcomes and prevent viral resistance. We conducted a two-arm randomized trial (n = 40 men and women receiving and less than 95% adherent to ART) to test a single office session followed by four biweekly cell phone counseling sessions that were grounded in behavioral self-management model of medication adherence using data from phone-based unannounced pill counts to provide feedback-guided adherence strategies. The control condition received usual care and matched office and cell phone/pill count contacts. Participants were baseline assessed and followed with biweekly unannounced pill counts and 4-month from baseline computerized interviews (39/40 retained). Results showed that the self-regulation counseling delivered by cell phone demonstrated significant improvements in adherence compared to the control condition; adherence improved from 87% of pills taken at baseline to 94% adherence 4 months after baseline, p < 0.01. The observed effect sizes ranged from moderate (d = 0.45) to large (d = 0.80). Gains in adherence were paralleled with increased self-efficacy (p < 0.05) and use of behavioral strategies for ART adherence (p < 0.05). We conclude that the outcomes from this test of concept trial warrant further research on cell phone-delivered self-regulation counseling in a larger and more rigorous trial. Sustaining patient motivation for long-term adherence to drug therapies remains a substantial problem for physicians, other health care providers, the patients themselves, and their families. Other therapeutic requests such as dietary changes and weight control may be even more difficult to maintain than taking pills. As part of a controlled experimental design implemented in an outpatient teaching hospital, an educational program was implemented to improve family member support for medical compliance among hypertensive patients. Family members were interviewed, counseled, and provided with a booklet for the purpose of educating and involving them in the home management of high blood pressure. The booklet identified ways the family member could assist the patient with medication compliance, appointment keeping, as well as diet and weight control. These items were identified and recorded as behavioral objectives in the booklet. Patients were followed for three years to assess long-term outcomes. Results showed a strong statistically significant difference between the experimental and control groups, with the experimental group demonstrating higher levels of appointment-keeping behavior, weight control, and BP under control (all p values less than .001). Analysis of the main effects of the educational program demonstrated that the family member support intervention accounted for the greatest decrease in diastolic blood pressure variability, R2 = .20, p less than .001. The aim of this study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, could improve adherence and metabolic control and decrease rates of hospital utilization among adolescents with chronically poorly controlled type 1 diabetes.
                A randomized controlled trial was conducted with 127 adolescents with type 1 diabetes and chronically poor metabolic control (HbA(1c) [A1C] > or =8% for the past year) who received their diabetes care in a children's hospital located in a major Midwestern city. Participants randomly assigned to MST received treatment for approximately 6 months. Data were collected at baseline and at 7 months posttest (i.e., treatment termination). Changes in A1C adherence, as measured by semistructured interviews and blood glucose meters and hospital admissions and emergency department visits, were assessed.
                In intent-to-treat analyses, participation in MST was associated with significant improvements in the frequency of blood glucose testing as assessed by blood glucose meter readings (F[1,125] = 16.75, P = 0.001) and 24-h recall interviews (F[1,125] = 6.70, P = 0.011). Participants in MST also had a decreasing number of inpatient admissions, whereas the number of inpatient admissions increased for control subjects (F[1,125] = 6.25, P = 0.014). Per protocol analyses replicated intent-to-treat analyses but also showed a significant improvement in metabolic control for adolescents receiving MST compared with control subjects (F[1,114] = 4.03, P = 0.047).
                Intensive, home-based psychotherapy improves the frequency of blood glucose testing and metabolic control and decreases inpatient admissions among adolescents with chronically poorly controlled type 1 diabetes. To investigate if an intervention with extra information and support in a group setting to parents of preschool children could improve adherence and clinical outcome.
                This is a controlled, prospective study where the parents of 60 newly diagnosed preschool asthmatic children aged 3 mo-6 y were randomized to either a control group or to an intervention that consisted of four group sessions in close connection with the diagnosis. The basic education on asthma and the written treatment plan were the same in both groups. The outcome measures were questionnaires to the parents and classification of the children according to symptoms and medication. The adherence rate and the burden of asthma were calculated with the help of diaries and weighing of the MDIs used between 12 and 18 mo after inclusion.
                The follow-up rate was 85% after 18 mo. The parents' presence in the sessions was around 70%, with no gender difference. The parents' view on adherence issues improved significantly in the intervention group. In the control group, 30% had poor adherence compared to 8% in the intervention group (p=0.015). Both the parents and the paediatricians underestimated the number of children with poor adherence. The children in the intervention group had significantly fewer exacerbation days during the last 6 mo-2.1 compared to 3.9 d/child-although they had lower inhaled steroid doses after 18 mo. An economic calculation showed that the intervention was profitable.
                This intervention resulted in an improvement in the parents' view on adherence, in the measured adherence rates and in the clinical outcome. Correct execution of prescribed dosing regimen(s) is essential for patients to benefit from lipid lowering treatments. The objective of this study was to estimate the effect of a pharmaceutical care program on the adherence of once-daily atorvastatin treatment in patients with elevated cholesterol levels.
                In both linguistic regions of Belgium, two districts were randomized between usual care and a supportive intervention program. Eligible patients included hyperlipemic subjects taking atorvastatin for at least 3 months. 'Adherence' was defined as the proportion of days during which the electronic device record showed that the patient had taken the daily dose. 'Persistence' quantifies how long the treatment is executed.
                A total of 392 patients from 35 pharmacies were included in the intent-to-treat (ITT) analysis of the data (194 patients received intervention and 198 in the control group). The intervention resulted in a 6.5% increase in post-baseline adherence (p < 0.001) mainly driven by a 13% increase in persistence at 1 year (p = 0.002).
                A supportive pharmaceutical care program consisting of review by patient and pharmacist of each patient's electronically compiled dosing history, plus educational reminders, improves patient adherence to the once-daily atorvastatin dosing regimen, mainly by extending persistence.
                Copyright 2005 John Wiley & Sons, Ltd. Patients with inflammatory bowel disease (IBD) suffer physical dysfunction and impaired quality of life (QOL), and need frequent health care. They often lack knowledge about their disease and desire more education. Educational interventions for other chronic diseases have demonstrated reduced health care use and increased knowledge, medication adherence and QOL.
                Sixty-nine participants were randomly assigned to formal IBD education and standard of care (pamphlets and ad hoc physician education) or standard of care alone. Assessment of IBD knowledge and QOL occurred at baseline, immediately posteducation and eight weeks posteducation. Participants documented medication adherence and health care use in diaries. Patient satisfaction was assessed at the end of the study.
                The education group had higher knowledge scores (P=0.000), perceived knowledge ratings (P=0.01) and patient satisfaction (P=0.001). There was a lower rate of medication nonadherence and health care use for the education group, but the differences were not significant. QOL indices did not change. Significant correlations were found for increased health care use in patients with poorer medication adherence (P=0.01) and lower perceived health (P=0.05).
                Formal IBD patient education improves knowledge, perceived knowledge and patient satisfaction. Further study of long-term effects may better demonstrate potential benefits for QOL, medication adherence and health care use. We evaluated the longitudinal effects of home-based asthma education combined with medication adherence feedback (adherence monitoring with feedback [AMF]) and asthma education alone (asthma basic care [ABC]) on asthma outcomes, relative to a usual-care (UC) control group.
                A total of 250 inner-city children with asthma (mean age: 7 years; 62% male; 98% black) were recruited from a pediatric emergency department (ED). Health-outcome measures included caregiver-frequency of asthma symptoms, ED visits, hospitalizations, and courses of oral corticosteroids at baseline and 6-, 12-, and 18-month assessments. Adherence measures included caregiver-reported adherence to inhaled corticosteroid (ICS) therapy and pharmacy records of ICS refills. Multilevel modeling was used to examine the differential effects of AMF and ABC compared with UC.
                ED visits decreased more rapidly for the AMF group than for the UC group, but no difference was found between the ABC and UC groups. The AMF intervention led to short-term improvements in ICS adherence during the active-intervention phase relative to UC, but this improvement decreased over time. Asthma symptoms and courses of corticosteroids decreased more rapidly for the ABC group than for the UC group. Hospitalization rates did not differ between either intervention group and the UC group. No differences were found between the ABC and AMF groups on any outcome.
                Asthma education led to improved adherence and decreased morbidity compared with UC. Home-based educational interventions may lead to modest short-term improvements in asthma outcomes among inner-city children. Adherence feedback did not improve outcomes over education alone. An intervention was developed to increase patient involvement in care. Using a treatment algorithm as a guide, patients were helped to read their medical record and coached to ask questions and negotiate medical decisions with their physicians during a 20-minute session before their regularly scheduled visit. In a randomized controlled trial we compared this intervention with a standard educational session of equal length in a clinic for patients with ulcer disease. Six to eight weeks after the trial, patients in the experimental group reported fewer limitations in physical and role-related activities (p less than 0.05), preferred a more active role in medical decision-making, and were as satisfied with their care as the control group. Analysis of audiotapes of physician-patient interactions showed that patients in the experimental group were twice as effective as control patients in obtaining information from physicians (p less than 0.05). Results of the intervention included increased involvement in the interaction with the physician, fewer limitations imposed by the disease on patients' functional ability, and increased preference for active involvement in medical decision-making. When patients are active participants in discussions, comprehension and compliance are likely to improve. This study examines the use of two interventions to aid patients in initiating such discussions in the area of health maintenance.
                The study was a randomized controlled trial of adult patients. The first intervention used two cards that listed seven core health maintenance concerns. The second intervention used a brief session with a nurse to help patients identify their health risks and develop a plan for seeking any desired information about these risks. An exit questionnaire and a telephone interview 4 to 6 weeks later assessed the extent to which (1) information seeking by patients was stimulated; (2) patients recalled the information obtained; (3) patients used the information to effect lifestyle changes; and (4) patients felt they participated in the decision to discuss health maintenance.
                Both interventions stimulated patients to request health maintenance information (both P < .05); the second intervention significantly increased patient recall (P = .018). Neither intervention, however, had a significant impact on lifestyle change or sense of participation in the decision to initiate discussion. Analysis of the second intervention did show that both increasing patients' recall of information (P = .008) and sense of involvement in the decision to discuss health maintenance (P = .003) significantly increases the likelihood of lifestyle change.
                Two interventions have been developed that are relatively simple and inexpensive methods to stimulate patients to seek health maintenance, and quite probably other health-related information. The blunted impact of these two interventions, however, raises the question of whether such simple and relatively inexpensive interventions are strong enough to stimulate patients to use this information to initiate change when one seeks to address a wide range of risks. Poor medication adherence diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications, placing them at increased risk for nonadherence.
                To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C).
                A multiphase, prospective study with an observational phase and a randomized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications. The study was conducted from June 2004 to August 2006.
                After a 2-month run-in phase (measurement of baseline adherence, BP, and LDL-C), patients entered a 6-month intervention phase (standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific packs). Following the intervention phase, patients were randomized to continued pharmacy care vs usual care for an additional 6 months.
                Primary end point of the observation phase was change in the proportion of pills taken vs baseline; secondary end points were the associated changes in BP and LDL-C. Primary end point of the randomization phase was the between-group comparison of medication persistence.
                A total of 200 elderly patients (77.1% men; mean [SD] age, 78 [8.3] years), taking a mean (SD) of 9 (3) chronic medications were enrolled. Coronary risk factors included drug-treated hypertension in 184 patients (91.5%) and drug-treated hyperlipidemia in 162 (80.6%). Mean (SD) baseline medication adherence was 61.2% (13.5%). After 6 months of intervention, medication adherence increased to 96.9% (5.2%; P<.001) and was associated with significant improvements in systolic BP (133.2 [14.9] to 129.9 [16.0] mm Hg; P = .02) and LDL-C (91.7 [26.1] to 86.8 [23.4] mg/dL; P = .001). Six months after randomization, the persistence of medication adherence decreased to 69.1% (16.4%) among those patients assigned to usual care, whereas it was sustained at 95.5% (7.7%) in pharmacy care (P<.001). This was associated with significant reductions in systolic BP in the pharmacy care group (-6.9 mm Hg; 95% CI, -10.7 to -3.1 mm Hg) vs the usual care group (-1.0 mm Hg; 95% CI, -5.9 to 3.9 mm Hg; P = .04), but no significant between-group differences in LDL-C levels or reductions.
                A pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence.
                clinicaltrials.gov Identifier: NCT00393419 This study assessed the impact of a low cost, multicomponent physical activity intervention for older adults with lower extremity osteoarthritis.
                A randomized controlled trial compared the effects of a facility-based multiple-component training program followed by home-based adherence (n = 80) to a wait list control group (n = 70). Assessments were conducted at baseline and at 2 and 6 months following randomization. The training program consisted of range of motion, resistance training, aerobic walking, and education-group problem solving regarding self-efficacy for exercise and exercise adherence. All training group participants developed individualized plans for posttraining adherence.
                Relative to the persons in the control group, individuals who participated in the exercise program experienced a statistically significant improvement in exercise efficacy, a 48.5% increase in exercise adherence, and a 13.3% increase in 6-min distance walk that were accompanied by significant decreases in lower extremity stiffness at 2 and 6 months. Program participants also experienced a significant decrease in lower extremity pain and a borderline significant improvement in efficacy to adhere to exercise over time at 6 months (p =.052). In contrast, persons in the control group deteriorated over time on the efficacy and adherence measures and showed no change on the other measures. No adverse health effects were encountered.
                These benefits indicate that this low-cost intervention may hold great promise as one of a growing number of public health intervention strategies for older adults in the United States with osteoarthritis. Studies examining the effectiveness of pay-for-performance programs to improve quality of care primarily have been confined to bonus-type arrangements that reward providers for performance above a predetermined threshold. No studies to date have evaluated programs placing providers at financial risk for performance relative to other participants in the program.
                The objective of the study is to evaluate the impact of an incentive program conferring limited financial risk to primary care physicians.
                There were 334 participating primary care physicians in Rochester, New York.
                The design of the study is a retrospective cohort study using pre/post analysis.
                The measurements adhere to 4 diabetes performance measures between 1999 and 2004.
                While absolute performance levels increased across all measures immediately following implementation, there was no difference between the post- and pre-intervention trends indicating that the overall increase in performance was largely a result of secular trends. However, there was evidence of a modest 1-time improvement in physician adherence for eye examination that appeared attributable to the incentive program. For this measure, physicians improved their adherence rate on average by 7 percentage points in the year after implementation of the program.
                This study demonstrates a modest effect in improving provider adherence to quality standards for a single measure of diabetes care during the early phase of a pay-for-performance program that placed physicians under limited financial risk. Further research is needed to determine the most effective incentive structures for achieving substantial gains in quality of care. The effect of pharmaceutical care on the prevention, detection, and resolution of medication-related problems in high-risk patients in a rural community was studied. Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were randomly assigned to a control group or an intervention group. The control group received standard medical care, and the intervention group received pharmaceutical care, including a medical record review, a medication history review, pharmacotherapeutic evaluation, and patient medication education and monitoring over a one-year period. A total of 69 patients completed the study (33 in the intervention group and 36 in the control group). The percentage of patients responding to hypertension, diabetes, dyslipidemia, and anticoagulation therapy increased significantly in the intervention group and declined in the control group. Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group. There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures. Medication compliance scores improved in the intervention group but not in the control group. Medication knowledge increased in the intervention group and decreased in the control group. Pharmaceutical care in a rural, community-based setting appeared to reduce inappropriate prescribing, enhance disease management, and improve medication compliance and knowledge without adversely affecting health-related quality of life. This study examined the effects of a ten-session cognitive-behavioural stress management/expressive supportive therapy (CBSM+) intervention on adherence to antiretroviral medication. Although the intervention was not designed to influence adherence, it was theorized that improved coping and social support could enhance adherence. Women with AIDS (N = 174) in Miami, New York and New Jersey, USA, were randomized to a group CBSM+ intervention or individual control condition. Participants were African American (55%), Latina (18%) and Caribbean (18%) with drug (55%) and/or alcohol (32%) histories. Participants were assessed on self-reported medication adherence over seven days, HIV-related coping strategies and beliefs regarding HIV medication. Baseline overall self-reported adherence rates were moderate and related to coping strategies and HIV medication beliefs. Low adherent (80%) participants in the intervention condition increased their mean self-reported medication adherence (30.4% increase, t44 = 3.1, p < 0.01), whereas low adherent women in the control condition showed a non-significant trend (19.6% increase, t44 = 2.0, p > 0.05). The intervention did not improve adherence in this population; conditions did not differ significantly on self-reported adherence. Low adhering intervention participants significantly decreased levels of denial-based coping (F1,88 = 5.97, p < 0.05). Results suggest that future interventions should utilize group formats and address adherence using coping and medication-knowledge focused strategies. A randomised controlled trial was conducted in an acute treatment setting to examine the effectiveness of compliance therapy, a brief pragmatic intervention targeting treatment adherence in psychotic disorders, based on motivational interviewing and recent cognitive approaches to psychosis.
                Seventy-four patients with psychotic disorders according to DSM-III-R criteria recruited from consecutive admissions to an acute in-patient unit, received 4-6 sessions of either compliance therapy or non-specific counselling, and were followed-up over 18 months. The principal outcome measures were observer-rated compliance, attitudes to treatment, insight and social functioning.
                Significant advantages were found for the compliance therapy group post-treatment on measures of insight, attitudes to treatment and observer-rated compliance which were retained over the follow-up period. Global social functioning improved relatively more over time in the compliance therapy group compared with the control group. Survival in the community prior to readmission was significantly longer in the compliance therapy group.
                The results support the effectiveness of compliance therapy in improving functioning and community tenure after an acute psychotic episode. Poor patient adherence remains a serious obstacle to improving the effectiveness of many drug abuse therapies and the overall quality of care delivered in programs. The present study evaluated the utility and efficacy of incorporating behavioral contingencies in a stepped care treatment approach to motivate patient attendance to the varying amounts of prescribed weekly counseling. Study participants were opioid-dependent patients (n = 127) newly admitted to an ambulatory treatment program that provides methadone. Participants were randomly assigned to a Motivated Stepped Care condition (MSC; n = 65) with behavioral contingencies to specifically motivate counseling attendance vs. a Standard Stepped Care condition (SSC; n = 62) without these contingencies. The MSC vs. SSC condition was associated with a higher rate of counseling attendance (83% vs. 44%, p < .001) and a lower rate of poor treatment response (46% vs. 79%, p < .001). The behavioral contingencies were well tolerated and strongly associated with excellent attendance across both lower and higher doses of weekly counseling. Active involvement of patients in medical encounters has been associated with several desirable outcomes, including greater satisfaction, increased adherence to treatment, and positive treatment outcomes. Older patients, particularly the very old and less well educated, are more likely to place physicians in a dominant role and themselves in a submissive role. Intervention trials to increase patient involvement have shown positive results. Activation interventions with older patients to increase a sense of control and self-efficacy are promising. Most of the attention to improving doctor-patient interaction has been directed toward physicians. The results of these few intervention trials support increased attention to patient behaviors. Compliance with antipsychotic medication is a major issue in schizophrenia treatment, and noncompliance with antipsychotic treatment is closely related to relapse and rehospitalization. An enhanced involvement of patients with schizophrenia in treatment decisions ("shared decision making") is expected to improve long-term compliance and reduce rehospitalizations. The aim of the present analysis was to study whether shared decision making (SDM) in antipsychotic drug choice would influence long-term outcome.
                From February 2003 to January 2004, psychiatric state hospital inpatients with a diagnosis of schizophrenia (ICD-10; N = 107) were recruited for the trial using a cluster-randomized controlled design. An SDM program on antipsychotic drug choice consisting of a decision aid and a planning talk between patient and physician was compared with routine care with respect to long-term compliance and rehospitalizations (6-month and 18-month follow-up).
                On the whole, we found high rates of noncompliance and rehospitalization. There were no differences between intervention and control groups in the univariate analyses. However, when controlling for confounding factors in a multivariate analysis, there was a positive trend (p = .08) that patients in the SDM intervention had fewer rehospitalizations. Additionally, a higher desire of the patient for autonomy and better knowledge at discharge were associated with higher hospitalization rates.
                The intervention studied showed a positive trend but no clear beneficial effect on long-term outcomes. A more thorough implementation of SDM (e.g., iterative administration of decision aid) might yield larger effects. Those patients with higher participation preferences are at higher risk for poor treatment outcomes and therefore require special attention. Strategies to match these patients' needs might improve compliance and long-term outcomes. Adherence to combination antiretroviral therapy (ART) has been shown to be a determining factor in controlling viral replication, maintaining immunologic function and long-term survival in HIV-positive individuals. Little information is available on strategies to improve adherence in pediatric HIV-infected patients. We conducted a randomized, nonblinded, pilot study to determine if a home-based nursing intervention would improve medication adherence. The study was offered to all eligible HIV-positive patients receiving care at Connecticut Children's Medical Center's (CCMC) Pediatric and Youth HIV Program. Sixty-seven percent (37/55) of the patients and their caretakers participated. We randomized participants to either standard of care or the intervention trial. The intervention was designed to improve knowledge and understanding of HIV infection and HIV medications and to resolve or modify barriers to adherence. Both groups completed pre- and post-intervention questionnaires, assessing their knowledge and understanding of HIV, ART, and adherence. Adherence was estimated objectively from medication refill history and subjectively from a self-report score. We also inferred adherence from pre- to post-test plasma viral load and CD4+ T-cell percentages. The knowledge score (p = 0.02) and medication refill history (p = 0.002) improved significantly in the intervention group. The adherence self-report score improved, although not significantly (p = 0.07). We did not observe statistical differences in CD4+ T-cell counts or viral load between groups. We conclude that our home-based nursing intervention helped HIV-positive children and their families in better adhering to prescribed medication regimens. Electronic information systems have been proposed as one means to reduce medical errors of commission (doing the wrong thing) and omission (not providing indicated care).
                To assess the effects of computer-based cardiac care suggestions.
                A randomized, controlled trial targeting primary care physicians and pharmacists.
                A total of 706 outpatients with heart failure and/or ischemic heart disease.
                Evidence-based cardiac care suggestions, approved by a panel of local cardiologists and general internists, were displayed to physicians and pharmacists as they cared for enrolled patients.
                Adherence with the care suggestions, generic and condition-specific quality of life, acute exacerbations of their cardiac disease, medication compliance, health care costs, satisfaction with care, and physicians' attitudes toward guidelines.
                Subjects were followed for 1 year during which they made 3,419 primary care visits and were eligible for 2,609 separate cardiac care suggestions. The intervention had no effect on physicians' adherence to the care suggestions (23% for intervention patients vs 22% for controls). There were no intervention-control differences in quality of life, medication compliance, health care utilization, costs, or satisfaction with care. Physicians viewed guidelines as providing helpful information but constraining their practice and not helpful in making decisions for individual patients.
                Care suggestions generated by a sophisticated electronic medical record system failed to improve adherence to accepted practice guidelines or outcomes for patients with heart disease. Future studies must weigh the benefits and costs of different (and perhaps more Draconian) methods of affecting clinician behavior. Exercise is the best predictor of long-term weight loss. This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese outpatients. Obese men and women (N = 193) were randomized to 1 of 5 treatment groups for 18 months: standard behavior therapy (SBT); SBT with supervised walks (SW) 3 times per week; SBT + SW with personal trainers (PT), who walked with participants, made phone reminders, and did make-up SW; SBT + SW with monetary incentives (I) for completing SW; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs, the combination producing the best adherence. Increased walk attendance did not result in higher overall energy expenditure, however, and long-term weight loss was also not improved. Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs. The purpose of this study was to assess the impact of an intervention to facilitate information giving to patients with chronic medical conditions on outcomes of care.
                A consecutive sample of 276 eligible patients with chronic medical conditions at a family medicine clinic was randomized to control and experimental interventions. A total of 205 completed the study. Experimental group patients received copies of their medical record progress notes, and they completed question lists for physician review, while control group patients received health education sheets and completed suggestion lists for improving clinic care. Self-reported physical functioning, global health, and patient satisfaction and adherence were measured at enrollment and after the interventions. Visit lengths and patient response to medical record sharing after the interventions were also measured.
                After the intervention, experimental group patients reported 3.7% better overall physical functioning than did control patients (mean = 83.6, standard deviation [SD] = 17.6 vs mean = 79.9, SD = 25.3; P = .005 after adjusting for covariates). The experimental group was more satisfied with their physician's care (mean = 31.4, SD = 4.6 vs mean = 31.3, SD = 5.2; P = .045 after adjusting for covariates). They were also more interested in seeing their medical records than were control patients (mean = 12.0, SD = 2.8 vs mean = 11.2, SD = 2.8; P = .002 after adjusting for covariates). Experimental group patients also reported an 8.3% improvement in overall health status (postintervention mean = 3.0, SD = 1.1) compared with their pre-intervention health status (mean = 2.8, SD = 1.0; P =.001). Visit lengths for patients in the experimental group did not differ from those of the control group.
                A simple patient-centered intervention to facilitate information giving in the primary health care of patients with chronic medical conditions can improve self-reported health, physical functioning, and satisfaction with care. To compare an innovative activating intervention with "care as usual" (control group) for the guidance of employees on sickness leave because of an adjustment disorder. It was hypothesised that the intervention would be more effective than care as usual in lowering the intensity of symptoms, increasing psychological resources, and decreasing sickness leave duration.
                A prospective, cluster randomised controlled trial was carried out with 192 patients on first sickness leave for an adjustment disorder. Symptom intensity, sickness duration, and return to work rates were measured at 3 months and 12 months. Analyses were performed on an intention to treat basis.
                At 3 months, significantly more patients in the intervention group had returned to work compared with the control group. At 12 months all patients had returned to work, but sickness leave was shorter in the intervention group than in the control group. The recurrence rate was lower in the intervention group. There were no differences between the two study groups with regard to the decrease of symptoms. At baseline, symptom intensity was higher in the patients than in a normal reference population, but decreased over time in a similar manner in both groups to approximately normal levels.
                The experimental intervention for adjustment disorders was successful in shortening sick leave duration, mainly by decreasing long term absenteeism. A randomized controlled design superimposed on treatment as usual was used to compare the effects of a cognitive-behavior intervention aimed at preventing chronicity with two different forms of information.
                To develop a coping-oriented preventive intervention applicable in primary care, and to compare its impact with educational information.
                Preventing long-term disability resulting from spinal pain has proved difficult. The information provided by health care professions and early interventions aimed at preventing long-term disability may be important, but little scientific evidence exists concerning their use.
                A protocol for a six-session cognitive-behavior group intervention was developed on the basis of earlier research. The main focus was to prevent long-term disability by changing patients' behaviors and beliefs so they can cope better with their problems. Comparison groups received either a pamphlet shown earlier to have an effect, or a more extensive information package consisting of six installments. All the groups continued to receive treatment as usual in primary care. There were 243 patients with acute or subacute spinal pain who perceived that they were at risk for developing a chronic problem. These patients were randomized to the cognitive-behavioral intervention or one of the two information groups. Because the aim was to prevent long-term disability, the key outcome variables at the 1-year follow-up assessment were sick absenteeism and health care use. Other variables were pain, function, fear-avoidance beliefs, and cognitions.
                The comparison groups reported benefits. However, the risk for a long-term sick absence developing was lowered ninefold for the cognitive-behavior intervention group as compared with the risk for the information groups (relative risk, 9.3). Participants in the cognitive-behavior group also reported a significant decrease in perceived risk. In addition, the cognitive-behavior group demonstrated a significant decrease in physician and physical therapy use as compared with two groups receiving information, in which such use increased. All three groups tended to improve on the variables of pain, fear-avoidance, and cognitions.
                This study demonstrates that a cognitive-behavior group intervention can lower the risk of a long-term disability developing. These findings underscore the significance of early interventions that specifically aim to prevent chronic problems. This approach might be applied to primary care settings. Research is needed to validate effective and practical strategies for improving the provision of evidence-based medicine in primary care.
                To determine whether a multimethod quality improvement intervention was more effective than a less intensive intervention for improving adherence to 21 quality indicators for primary and secondary prevention of cardiovascular disease and stroke.
                2-year randomized, controlled clinical trial with the practice as the unit of randomization.
                20 community-based family or general internal medicine practices in 14 states. All used the same electronic medical record.
                44 physicians, 17 midlevel providers, and approximately 200 staff members; data from the electronic medical records of 87,291 patients.
                All practices received copies of practice guidelines and quarterly performance reports. Intervention practices also hosted quarterly site visits to help them adopt quality improvement approaches and participated in 2 network meetings to share "best practice" approaches.
                The percentage of indicators at or above predefined targets and the percentage of patients who had achieved each clinical indicator.
                Intervention practices improved 22.4 percentage points (from 11.3% to 33.7%) in the percentage of indicators at or above the target; control practices improved 16.4 percentage points (from 6.3% to 22.7%). The 6.0-percentage point absolute difference between the intervention and control group was not statistically significant (P > 0.2). Patients in intervention practices had greater improvements than those in control practices for diagnoses of hypertension (improvement difference, 15.7 percentage points [95% CI, 5.2 to 26.3 percentage points]) and blood pressure control in patients with hypertension (improvement difference, 8.0 percentage points [CI, 0.0 to 16.0 percentage points]).
                The study involved a small number of practices and lacked a pure control group.
                Primary care practices that use electronic medical records and receive regular performance reports can improve their adherence to clinical practice guidelines for cardiovascular disease and stroke prevention. To determine whether an intervention designed to improve patient-physician communication increases the frequency with which physicians elicit patients' concerns, changes other communication behaviors, and improves health care outcomes.
                Pretest-posttest design with random assignment of physicians to intervention or control groups.
                General medicine clinics of a university-affiliated Veterans Affairs Hospital.
                Forty-two physicians and 348 continuity care patients taking prescription medications for chronic medical conditions.
                Intervention group physicians received 4.5 hours of training on eliciting and responding to patients' concerns and requests, and their patients filled out the Patient Requests for Services Questionnaire prior to a subsequent clinic visit. Control group physicians received 4.5 hours of training in medical decision-making.
                The frequency with which physicians elicited all of a patient's concerns increased in the intervention group as compared with the control group (p = .032). Patients perceptions of the amount of information received from the physician did increase significantly (p < .05), but the actual magnitude of change was small. A measure of patient satisfaction with the physicians was high at baseline and also showed no significant change after the intervention. Likewise, the intervention was not associated with changes in patient compliance with medications or appointments, nor were there any effects on outpatient utilization.
                A low-intensity intervention changed physician behavior but had no effect on patient outcomes such as satisfaction, compliance, or utilization. Interventions may need to focus on physicians and patients to have the greatest effect. To test the efficacy of a medication use improvement program developed specifically for home health agencies. The program addressed four medication problems identified by an expert panel: unnecessary therapeutic duplication, cardiovascular medication problems, use of psychotropic drugs in patients with possible adverse psychomotor or adrenergic effects, and use of nonsteroidal antiinflammatory drugs (NSAIDs) in patients at high risk of peptic ulcer complications. It used a structured collaboration between a specially trained clinical pharmacist and the patients' home-care nurses to improve medication use.
                Parallel-group, randomized controlled trial.
                Two of the largest home health agencies in the United States.
                Study subjects were consenting Medicare patients aged 65 and older admitted to participating agency offices from October 1996 through September 1998, with a projected home healthcare duration of at least 4 weeks and at least one study medication problem.
                Qualifying patients were randomized to usual care or usual care with the medication improvement program.
                Medication use was measured during an in-home interview, with container inspection at baseline and at follow-up (between 6 and 12 weeks) by interviewers unaware of treatment assignment. The trial endpoint was the proportion of patients with medication use improvement according to predefined criteria at follow-up.
                There were 259 randomized patients with completed follow-up interviews: 130 in the intervention group and 129 with usual care. Medication use improved for 50% of intervention patients and 38% of control patients, an attributable improvement of 12 patients per 100 (95% confidence interval (CI) = 0.0-24.0, P =.051). The intervention effect was greatest for therapeutic duplication, with improvement for 71% of intervention and 24% of control patients, an attributable improvement of 47 patients per 100 (95% CI = 20-74, P =.003). Use of cardiovascular medications also improved more frequently in intervention patients: 55% vs 18%, attributable improvement 37 patients per 100 (95% CI = 9-66, P =.017). There were no significant improvements for the psychotropic medication or NSAID problems. There was no evidence of adverse intervention effects: new medication problems, more agency nurse visits, or increased duration of home health care.
                A program congruent with existing personnel and practices of home health agencies improved medication use in a vulnerable population and was particularly effective in reducing therapeutic duplication. One hundred seventy-seven men and women who had participated in an 18-month trial of behavioral interventions involving food provision and financial incentives were examined 12 months later. Food provision, but not financial incentives, led to better weight loss than standard behavioral treatment during the 18-month trial, but over 12 additional months of no-treatment follow-up, all treated groups gained weight, maintained only slightly better weight losses than a no-treatment control group, and did not differ from each other. Weight loss success during both active treatment and maintenance was associated with increase in exercise, decrease in percentage of energy from fat, increase in nutrition knowledge, and decrease in perceived barriers to adherence. Obesity treatment research should focus on developing better ways to maintain changes in the diet and exercise behaviors needed for sustained weight loss. Patient-centred depression care approaches should better address barriers of insufficient patient information and involvement in the treatment decision process. Additional research is needed to test the effect of increased patient participation on outcomes. The aim of this study was to assess, if patient participation in decision-making via a shared decision-making intervention leads to improved treatment adherence, satisfaction, and clinical outcome without increasing consultation time.
                Cluster-randomized controlled intervention study based on physician training and patient-centered decision aid compared to usual care in primary care settings in Südbaden region of Germany. Twenty-three primary care physicians treating 405 patients with newly diagnosed depression were enrolled. Patient involvement was measured with the patient perceived involvement in care scale (PICS) and a patient participation scale (MSH-scale). Patient satisfaction was measured by the CSQ-8 questionnaire. Treatment adherence was evaluated by patient and provider self-report. Depression severity and remission outcomes were assessed with the Brief PHQ-D.
                Physician facilitation of patient participation improved significantly and to a greater extent in the intervention compared to the control group. There was no intervention effect for depression severity reduction. Doctor facilitation of patient participation, patient-rated involvement, and physician assessment of adherence improved only in the intervention group. Patient satisfaction at post-intervention was higher in the intervention group compared to the control group. The consultation time did not differ between groups.
                A shared decision-making intervention was better than usual care for improving patient participation in treatment decision-making, and patient satisfaction without increasing consultation time. Additional research is needed to model causal linkages in the decision-making process in regard to outcomes.
                The study results encourage the implementation of patient participation in primary care of depression. This study was conducted to evaluate willingness to prescribe medication based on identical data presented in different outcome terms to health professionals of varied discipline, geographic location, and level of training. Cross-sectional survey using a self-administered questionnaire was performed in 400 health professionals (physicians, pharmacists, physicians-in-training, and pharmacy students) in the United States and Europe. Data reflecting a clinical trial were presented in 6 outcome terms: 3 terms describing identical mortality (relative risk reduction, absolute risk reduction, and number of patients needed to be treated to prevent 1 death); and 3 distractors (increased life expectancy, decreased hospitalization rate, and decreased cost). Willingness to prescribe and rank order of medication preference assuming willingness to prescribe were measured. The results of the study showed that willingness to prescribe and first choice preference were significantly greater when study results were presented as relative risk reduction than when identical mortality data were presented as absolute risk reduction or number of patients needed to be treated to avoid 1 death (p <0.001). Increase in life expectancy was the most influential distractor. In conclusion, this study, performed in the era of "evidence-based medicine," demonstrates that the method of reporting research trial results has significant influence on health professionals' willingness to prescribe. The high numerical value of relative risk reduction and the concrete and tangible quality of increased life expectancy exert greater influence on health professionals than other standard outcome terms. The objective of the study was to evaluate the effectiveness of 2 educational strategies aimed at improving prescribing standards in primary care.
                A pragmatic controlled trial was designed; the study population included general and family practitioners in Galicia (northwestern Spain) divided into 3 study groups: a one-to-one education group (n = 98), a by-group education group (n = 92), and a control group (n = 405). The educational intervention included explicit recommendations for selecting nonsteroidal anti-inflammatory drugs (NSAIDs) for inflammation signs. Some of the subjects were given reminders. Mixed-effect linear models were applied to data analysis. Analyses were done by intention-to-treat. The dependent variable is a rate with a numerator that is the number of prescribed units of the NSAIDs recommended during intervention; the denominator is the total number of prescribed units of the NSAID total.
                One-to-one education obtained an average prescribing behavior improvement of 6.5% (P < 0.001) in the 9 months after intervention. In the education group, the average improvement was 2.4% (P < 0.05) for the same period. Statistically significant differences were observed between the group intervention and one-to-one groups. The reminder increased significantly the effectiveness of the one-to-one intervention.
                A single, short educational session to primary care doctors can improve their prescribing standards during long periods of > or = 9 months. Of the 2 strategies followed in the trial, one-to-one education has shown to be the most effective. Results also show that the effectiveness of these interventions increases when presented together with written material. The objective of this study was to evaluate the impact of three continuing education seminars (within a period of 4 months) on the quality of patient management and rational drug use. The study was designed as a randomized controlled trial. Prescribers in 16 general health centers were allocated to an intervention (eight health centers) or a control (eight health centers) group. A total of 5,685 patient cards was analyzed for quality of case management and rational drug use. In the intervention health centers the average number of drugs per patient decreased from 2.3 to 1.9 (p = 0.005) and the proportion of patients managed with nonpharmacological treatment increased from 1 to 13.2%. Recorded history taking, examination, and diagnosis improved in the intervention health centers. More drugs were correctly chosen in the intervention health centers compared to control health centers (p = 0.03). The proportion of patients prescribed antibiotics decreased and the proportion of patients adequately managed increased in the intervention health centers. Our conclusion is that continuing education in the form of repeated seminars is effective in influencing prescribers and in promoting rational drug use in primary care. The aim of this study was to test the effectiveness of a theory of planned behaviour intervention to increase adherence of community mental health professionals to a national suicide prevention guideline.
                Routinely collected audit adherence data from an intervention and control site were collected and analysed using time series analysis to test whether the intervention significantly increased adherence. The effects of a local and national event on adherence were also examined.
                A Theory of Planned Behaviour (TPB) questionnaire, developed from interview findings, was administered to the health professionals. Subjective norms were found to be the most significant predictor of intention to adhere to the guideline, and were targeted with an interactive educational intervention. Time series analysis applied to routinely collected audit adherence data was used to test intervention effectiveness.
                The TPB accounted for 58% of the variance in intention to adhere, with subjective norms the only significant predictor. The intervention did not significantly increase adherence; however, the national and local events were found to have significantly increased adherence.
                The TPB was a useful framework for exploring barriers to adherence; however, this did not translate into an effective intervention. Future research should seek collaboration with local experts, and use this information in combination with the TPB, to develop interventions. Collaborative research with experts in pedagogy may also help to develop more effective interventions, particularly education-based interventions that require adult learning. It is possible to provide patients with secure access to their medical records using the Internet. Such access may assist patients in the self-management of chronic diseases such as heart failure.
                To assess how a patient-accessible online medical record affects patient care and clinic operations. The SPPARO (System Providing Access to Records Online) software consisted of a web-based electronic medical record, an educational guide, and a messaging system enabling electronic communication between the patient and staff.
                A randomized controlled trial was conducted in a specialty practice for patients with heart failure. Surveys assessing doctor-patient communication, adherence, and health status were conducted at baseline, 6 months, and 1 year. Use of the system, message volume, utilization of clinical services, and mortality were monitored.
                One hundred and seven patients were enrolled (54 intervention and 53 controls). At 12 months, the intervention group was not found to be superior in self-efficacy (KCCQ self-efficacy score 91 vs. 85, p=0.08), but was superior in general adherence (MOS compliance score 85 vs. 78, p=0.01). A trend was observed for better satisfaction with doctor-patient communication. The intervention group had more emergency department visits (20 vs. 8, p=0.03), but these visits were not temporally related to use of the online medical record. There were no adverse effects from use of the system.
                Providing patients with congestive heart failure access to an online medical record was feasible and improved adherence. An effect on health status could not be demonstrated in this pilot study. This study examined whether a self-management intervention based on feedback of adherence performance and principles of social cognitive theory improves adherence to antiretroviral dosing schedules. Forty-three individuals with HIV/AIDS who were starting or switching to a new protease inhibitor regimen were randomly assigned to be in a medication self-management program or usual care control group. The self-management program included skills development exercises, three monthly visits for medication consultations, and monthly feedback of adherence performance using electronic monitors on medication bottles. Participants also completed a 40-item questionnaire that measured self-efficacy to take medications, on schedule, in a variety of situations. Logistic regression analysis indicated that individuals in the self-management group were significantly more likely to take 80% or more of their doses each week than individuals in the control group (n=29, OR=7.8, 95% CI=2.2-28.1). Self-management training with feedback of adherence performance is a potentially useful model for improving adherence to complex regimens in HIV/AIDS care. Management of diabetes is frequently suboptimal in primary care settings, where providers often fail to intensify therapy when glucose levels are high, a problem known as clinical inertia. We asked whether interventions targeting clinical inertia can improve outcomes.
                A controlled trial over a 3-year period was conducted in a municipal hospital primary care clinic in a large academic medical center. We studied all patients (4,138) with type 2 diabetes who were seen in continuity clinics by 345 internal medicine residents and were randomized to be control subjects or to receive one of three interventions. Instead of consultative advice, the interventions were hard copy computerized reminders that provided patient-specific recommendations for management at the time of each patient's visit, individual face-to-face feedback on performance for 5 min every 2 weeks, or both.
                Over an average patient follow-up of 15 months within the intervention site, improvements in and final HbA1c (A1C) with feedback + reminders (deltaA1C 0.6%, final A1C 7.46%) were significantly better than control (deltaA1C 0.2%, final A1C 7.84%, P < 0.02); changes were smaller with feedback only and reminders only (P = NS vs. control). Trends were similar but not significant with systolic blood pressure (sBP) and LDL cholesterol. Multivariable analysis showed that the feedback intervention independently facilitated attainment of American Diabetes Association goals for both A1C and sBP. Over a 2-year period, overall glycemic control improved in the intervention site but did not change in other primary care sites (final A1C 7.5 vs. 8.2%, P < 0.001).
                Feedback on performance aimed at overcoming clinical inertia and given to internal medicine resident primary care providers improves glycemic control. Partnering generalists with diabetes specialists may be important to enhance diabetes management in other primary care settings. Adherence to peak expiratory flow rate monitoring by children with asthma was evaluated, and a behavioral strategy to enhance adherence to daily monitoring was tested.
                Forty-two 7- through 11-year-old children with persistent asthma were recruited into a 5-week randomized, controlled clinical trial. Adherence data were collected electronically by PeakLog and the self-report Asthma Diary.
                Adherence declined over time. At week 5, intervention group adherence (Median = 79%) was higher than the usual care group adherence (Median = 64%), but the difference was not statistically significant. The effect size did suggest that differences between groups were present.
                Even small improvements in adherence to asthma treatment may be clinically significant in light of the alarming increases in asthma morbidity and mortality. Contingency management shows promise for improving adherence outcomes. Future research should engage larger sample sizes and increase the number and intensity of sessions to teach behavioral strategies. This research study evaluates the effectiveness of a multifaceted intervention program to improve the management of depression in primary care.
                One hundred fifty-three primary care patients with current depression were entered into a randomized controlled trial. Intervention patients received a structured depression treatment program in the primary care setting that included both behavioral treatment to increase use of adaptive coping strategies and counseling to improve medication adherence. Control patients received "usual" care by their primary care physicians. Outcome measures included adherence to antidepressant medication, satisfaction with care of depression and with antidepressant treatment, and reduction of depressive symptoms over time.
                At 4-month follow-up, significantly more intervention patients with major and minor depression than usual care patients adhered to antidepressant medication and rated the quality of care they received for depression as good to excellent. Intervention patients with major depression demonstrated a significantly greater decrease in depression severity over time compared with usual care patients on all 4 outcome analyses. Intervention patients with minor depression were found to have a significant decrease over time in depression severity on only 1 of 4 study outcome analyses compared with usual care patients.
                A multifaceted primary care intervention improved adherence to antidepressant regimens and satisfaction with care in patients with major and minor depression. The intervention consistently resulted in more favorable depression outcomes among patients with major depression, while outcome effects were ambiguous among patients with minor depression. To compare the effectiveness of a multifaceted intervention in patients with depression in primary care with the effectiveness of "usual care" by the primary care physician.
                A randomized controlled trial among primary care patients with major depression or minor depression.
                Over a 12-month period a total of 217 primary care patients who were recognized as depressed by their primary care physicians and were willing to take antidepressant medication were randomized, with 91 patients meeting criteria for major depression and 126 for minor depression.
                Intervention patients received increased intensity and frequency of visits over the first 4 to 6 weeks of treatment (visits 1 and 3 with a primary care physician, visits 2 and 4 with a psychiatrist) and continued surveillance of adherence to medication regimens during the continuation and maintenance phases of treatment. Patient education in these visits was supplemented by videotaped and written materials.
                Primary outcome measures included short-term (30-day) and long-term (90-day) use of antidepressant medication at guideline dosage levels, satisfaction with overall care for depression and antidepressant medication, and reduction in depressive symptoms.
                In patients with major depression, the intervention group had greater adherence than the usual care controls to adequate dosage of antidepressant medication for 90 days or more (75.5% vs 50.0%; P < .01), were more likely to rate the quality of the care they received for depression as good to excellent (93.0% vs 75.0%; P < .03), and were more likely to rate antidepressant medications as helping somewhat to helping a great deal (88.1% vs 63.3%; P < .01). Seventy-four percent of intervention patients with major depression showed 50% or more improvement on the Symptom Checklist-90 Depressive Symptom Scale compared with 43.8% of controls (P < .01), and the intervention patients also demonstrated a significantly greater decrease in depression severity over time compared with controls (P < .004). In patients with minor depression, the intervention group had significantly greater adherence than controls to adequate dosage of antidepressant medication for 90 days or more (79.7% vs 40.3%; P < .001) and more often rated antidepressant medication as helping somewhat to helping a great deal (81.8% vs 61.4%; P < .02). However, no significant differences were found between the intervention and control groups in the percentage of patients who were satisfied with the care they received for depression (94.4% vs 89.3%), in the percentage who experienced a 50% or more decrease in depressive symptoms, or in the decrease of depressive symptoms over time.
                A multifaceted intervention consisting of collaborative management by the primary care physician and a consulting psychiatrist, intensive patient education, and surveillance of continued refills of antidepressant medication improved adherence to antidepressant regimens in patients with major and with minor depression. It improved satisfaction with care and resulted in more favorable depressive outcomes in patients with major, but not minor, depression. The high cost and undesirable consequences of polypharmacy are well-recognized problems among elderly long-term care (LTC) residents. Despite the implementation of the 1987 Omnibus Budget Reconciliation Act, which requires pharmacist review of drug regimens in this setting, medical and drug costs for LTC residents have continued to increase.
                This study evaluates the North Carolina Long-Term Care Polypharmacy Initiative, a large-scale medication therapy management program (MTMP) that combined drug utilization review activities with drug regimen review techniques.
                This was a prospective records-based study that used a difference-in-difference model with both historical and nonintervention group controls. To ensure equivalence among subjects, propensity scoring was used to match study subjects from participating LTC facilities with comparison subjects from nonparticipating facilities. Residents with interventions were grouped for analysis by intervention type-retrospective only, prospective only, or dual type (residents with both prospective and retrospective interventions)-and by intervention stage-review, recommendation, and drug change-plus an all-inclusive "all types" grouping that aggregated groups by intervention type, for a total of 10 total cohorts.
                In the overall population of 5255 study subjects identified, a US $21.63 per member per month drug-cost savings was observed. Although only 1 of 10 cohorts had a change in the number of drug fills, substantial reductions in 2 of 5 types of drug alerts were observed in all 10 cohorts. A reduction in the relative risk for hospitalization (0.84 [95% CI, 0.71-1.00]) was observed in the cohort of residents receiving a retrospective review.
                This Initiative suggests that an MTMP can be quickly launched in a large number of LTC facility residents to produce monetary drug-cost savings and improved health outcomes. Additionally, the evaluation of this program illustrates the utility of using propensity scoring techniques to target future intervention groups in a cost-effective manner. Improving precision and economy in the prescribing of drugs is a goal whose importance has increased with the proliferation of new and potent agents and with growing economic pressures to contain health-care costs. We implemented an office-based physician education program to reduce the excessive use of three drug groups: cerebral and peripheral vasodilators, an oral cephalosporin, and propoxyphene. A four-state sample of 435 prescribers of these drugs was identified through Medicaid records and randomly assigned to one of three groups. Physicians who were offered personal educational visits by clinical pharmacists along with a series of mailed "unadvertisements" reduced their prescribing of the target drugs by 14 per cent as compared with controls (P = 0.0001). A comparable reduction in the number of dollars reimbursed for these drugs was also seen between the two groups, resulting in substantial cost savings. No such change was seen in physicians who received mailed print materials only. The effect persisted for at least nine months after the start of the intervention, and no significant increase in the use of expensive substitute drugs was found. Academically based "detailing" may represent a useful and cost-effective way to improve the quality of drug-therapy decisions and reduce unnecessary expenditures.
For short-term treatments several quite simple interventions increased adherence and improved patient outcomes, but the effects were inconsistent from study to study with less than half of studies showing benefits. Current methods of improving adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. High priority should be given to fundamental and applied research concerning innovations to assist patients to follow medication prescriptions for long-term medical disorders.