Special features of health services and register based trials - experiences from a randomized trial of childbirth classes. A randomized trial of assertive community treatment for homeless persons with severe mental illness. Heavy users of acute psychiatric beds: randomized controlled trial of enhanced community management in an outer London borough. A randomized control trial of nursing-based case management for patients with chronic obstructive pulmonary disease. Telehomecare: quality, perception, satisfaction. Cluster randomized controlled trial of the effectiveness of audit and feedback and educational outreach on improving nursing practice and patient outcomes. Effects of a multidisciplinary, post-discharge continuance of care intervention on quality of life, discharge satisfaction, and hospital length of stay: a randomized controlled trial. An experimental evaluation of residential and nonresidential treatment for dually diagnosed homeless adults. Controlled evaluation of a hospital-originated community transitional system. Randomised trial of in-hospital geriatric intervention: impact on function and morale. Hepatitis C and human immunodeficiency virus risk behaviors in polydrug users on methadone maintenance. Multiphasic Health Checkup Evaluation: a 16-year follow-up. Educational workshop improved information-seeking skills, knowledge, attitudes and the search outcome of hospital clinicians: a randomised controlled trial. A randomized controlled trial of a community nurse-supported hospital discharge programme in older patients with chronic heart failure. User fees plus quality equals improved access to health care: results of a field experiment in Cameroon. A brief intervention for hazardous drinkers in a needle exchange program. Effect of a collaborative approach on the quality of prescribing for geriatric inpatients: a randomized, controlled trial. Five years of lifestyle intervention improved self-reported mental and physical health in a general population: the Inter99 study. A randomized control trial of right-heart catheterization in critically ill patients. Ontario Intensive Care Study Group. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Task-shifting of antiretroviral delivery from health care workers to persons living with HIV/AIDS: clinical outcomes of a community-based program in Kenya. Patient participation in the patient-provider interaction: the effects of patient question asking on the quality of interaction, satisfaction and compliance.
Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services.
                The example intervention was education to public health nurses (PHN) (childbirth classes) to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC) were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers). The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR). Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence.
                It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial.
                Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health service providers is a challenging intervention.
                not registered (see Results). This experiment evaluated the effectiveness of an innovative program of assertive community treatment (ACT) for homeless persons with severe and persistent mental illnesses.
                One hundred fifty-two homeless persons with severe and persistent mental illness were randomized to either the experimental ACT program or to usual community services. Baseline assessments included the Structured Clinical Interview for DSM-III-R, Quality-of-Life Interview, Colorado Symptom Index, and the Medical Outcomes Study 36-Item Short Form Health Survey. All assessments (except the Structured Clinical Interview) were repeated at the 2-, 6-, and 12-month follow-up evaluations.
                Subjects in the ACT program used significantly fewer psychiatric inpatient days, fewer emergency department visits, and more psychiatric outpatient visits than the comparison subjects. The ACT subjects also spent significantly more days in stable community housing, and they experienced significantly greater improvements in symptoms, life satisfaction, and perceived health status.
                Relative to usual community care, the ACT program for homeless persons with severe and persistent mental illness shifts the locus of care from crisis-oriented services to ongoing outpatient care and produces better housing, clinical, and life satisfaction outcomes. Heavy users of psychiatric services, often defined as the population that uses the most beds, consume a large part of the resources used by the whole service, despite being relatively small in number. Any intervention that reduces heavy use is therefore likely to lead to significant savings, and enhancement of standard care using a form of intensive case management akin to assertive community treatment was thought to be a pragmatic strategy for testing in this group.
                The effectiveness of enhanced community management (ECM) was compared with standard care alone in heavy users, who represented the 10% of patients with the highest number of hospital admissions and occupied bed days over the previous 6.5 years in an outer London borough. One hundred and ninety-three patients were randomly assigned to ECM or standard care and their use of services was determined after 1 and 2 years, with assessments of costs, clinical symptoms, needs, and social function made before entry into the study and after 1 and 2 years.
                Despite a 24 fold increase in community contacts in the study group, there were no significant differences between the two groups in any of the main outcome measures. Small savings on in-patient and day-hospital service costs were counterbalanced by the increased costs of outpatient and community care for the subjects assigned to ECM. Clinical outcome data derived from interviews in two-thirds of the subjects were similar in both groups.
                Providing additional intensive community focused care to a group of heavy users of psychiatric in-patient services in an outer London borough does not lead to any important clinical gains or reduced costs of psychiatric care. This study assessed the impact of a randomized trial of nursing-based case management for patients with chronic obstructive pulmonary disease, their caregivers, and nursing and medical staff. Sixty-six patients were matched by FEV on admission to hospital, and randomized into an intervention or control group. Intervention group patients reported significantly less anxiety at 1 month postdischarge; however, this effect was not sustained. There was little difference between groups in terms of unplanned readmissions, depression, symptoms, support, and subjective well being. Interviews with patients and caregivers found that the case management improved access to resources and staff-patient communication. Interviews with nursing and medical staff found that case management improved communication between staff and enhanced patient care.(1) The aim of this study was to demonstrate that telehomecare linking homebound patients with their home health-care nurses over the plain old telephone system (POTS) provides high-quality, clinically useful, and patient satisfactory interactions. Congestive heart failure, chronic obstructive pulmonary disease, and chronic wound-care patients receiving skilled home nursing care were randomized into control (standard home health care, HHC) and two intervention (standard care plus video conferencing/Internet access; the above plus physiological monitoring) groups. Virtual visits (VVs), consisting of two-way audio and video interactions between the central site HHC nurse and the subject at home, were compared for technical quality and clinical usefulness by the HHC nurses who performed the VVs. Subject perception of telehomecare and satisfaction with their HHC were assessed over the course of the project. There were a total of 567 virtual and 1,057 actual visits conducted for the 53 subjects completing the study. The technical quality of VVs were rated at 94.7%. They were considered to be as useful as actual visits in 90.7% of cases. Subject telehomecare perception increased after experiencing the process. All subjects were satisfied with their HHC; satisfaction increased with an increasing level of telehomecare intervention. Subjects receiving physiological monitoring and video conferencing/Internet access in addition to standard care were most satisfied with their care. VVs can be conducted over POTS. Patients can use telehomecare with moderate levels of training. These programs can provide timely and quality home health nursing care with VVs augmenting traditional home visits. Current understanding of implementation methods is limited, and research has focused on changing doctors' behaviors.
                Our aim was to evaluate the impact of audit and feedback and educational outreach in improving nursing practice and patient outcomes.
                Using a factorial design, cluster randomized controlled trial, we evaluated 194 community nurses in 157 family practices and 1078 patients with diagnosis of urinary incontinence (UI) for nurses compliance with evidence-linked review criteria for the assessment and management of UI and impact on psychologic and social well-being and symptoms. In the outreach arms, nurses' self-reported barriers informed development of tailored strategies.
                In comparison with educational materials alone, the implementation methods tested did not improve care at 6 months follow-up. Moderate rates of improvement (10-17% of patients) in performance for the assessment of UI and greater rates of improvement (20-30% of patients) for the management of care were found but effects were similar across arms. Improvement in patient outcomes was more consistently positive for educational outreach than for audit and feedback but differences were not significant. Adjustment for caseload size, severity or duration of UI and patients' age did not alter results.
                Printed educational materials alone may be as effective as audit and feedback and educational outreach in improving nurses' performance and outcomes of care for people with UI. Greater understanding of the underlying processes in improving performance within multidisciplinary teams through further, theory-driven studies with "no intervention" control groups and longer follow-up are needed. To determine the impact of a hospital-coordinated discharge care plan, involving a multidisciplinary team of primary health care providers, on hospital length of stay, quality of life, and both patient and general practitioner inclusion in, and satisfaction with, discharge procedures.
                This investigation comprised a prospective, randomized, controlled, clinical trial.
                This multicentre and cross-jurisdictional study focused on areas of tertiary and primary health care as well as community allied health in Western Australia.
                Patients (n = 189) with chronic cardiorespiratory diagnoses were recruited from respiratory, cardiovascular, and general medical wards at two tertiary hospitals.
                Subjects were randomly assigned to one of two groups. Intervention group patients received a discharge care plan in accordance with that outlined in the Australian Enhanced Primary Care Package, completed before discharge and sent to the patient's general practitioner and other community service providers for review. Control patients were discharged under existing hospital processes. Outcome measures. Patients and general practitioners were surveyed pre-discharge and 7 days post-discharge for quality of life and opinion of discharge procedures. Hospital length of stay was also determined.
                Significant improvements in discharge planning involvement, health service access, confidence with discharge procedures, and opinion of discharge based on previous experience were seen for patients who received the discharge care plan. Further, improved perceptions of mental quality of life were observed within the first week post-discharge for intervention patients. Length of stay showed no difference between groups. Extent and speed of hospital-general practitioner communication were significantly improved via the intervention.
                Our results indicate that a multidisciplinary discharge care plan, initiated before separation, improves quality of life, involvement, and satisfaction with discharge care, and hospital-general practitioner integration. As such, it possesses benefits over current Western Australian hospital discharge procedures for the care of chronically ill populations. Homeless adults with both a serious mental illness and substance dependence (N = 276) were randomly assigned to: (1) a social model residential program providing integrated mental health and substance abuse treatment; (2) a community-based nonresidential program using the same social model approach; or (3) a control group receiving no intervention but free to access other community services. Interventions were designed to provide 3 months of intensive treatment, followed by 3 months of nonresidential maintenance. Subjects completed baseline interviews prior to randomization and reinterviews 3, 6, and 9 months later. Results showed that, while substance use, mental health, and housing outcomes improved from baseline, subjects assigned to treatment conditions differed little from control subjects. Examination of the relationship between length of treatment exposure and outcomes suggested that residential treatment had positive effects on outcomes at 3 months, but that these effects were eroded by 6 months. The effect of a treatment program (E) providing inpatient care, a day hospital, community housing, and sheltered work are compared with a program (C) emphasizing rapid discharge. A group of 94 male general psychiatric patients were randomized to the two units. Outcome data collected at 18 months from admission revealed small but significant differences between the total samples in employment, maintenance of treatment contact, use of medication, and social adjustment. More C than E patients were in the hospital after the 14th month. Program effects varied considerably with patient type. Patients with less social disability had somewhat better employment outcomes with the E program, but no differences in use of services. Patients with a better prognosis by measure of psychopathology (Minnesota Multiphasic Personality Inventory cluster and diagnosis of schizophrenia) spent less inpatient time in the E program, but were not helped to better employment outcomes. Patients with greater social handicap were not differentially affected. More E patients than C with a poorer prognosis stayed in outpatient treatment and used antipsychotic medications. Patients in the E group with better previous employment and more social isolation used the E day hospital and community housing more heavily than other E subgroups. In two previous publications, we have shown that treatment of acutely sick, frail elderly patients in a Geriatric Evaluation and Management Unit (GEMU) compared to treatment in the general Medical Wards (MW) reduced mortality and improved the chances of living at home in contrast to living in nursing homes or being dead.
                The aim of this presentation was to study the impact on function, symptoms of depression and general well-being of treatment in the GEMU as compared to treatment in MW. Methods: Acutely sick, frail patients aged >or=75 years, admitted as emergencies to the Department of Internal Medicine, were randomised either to treatment in the GEMU (n = 127) or the MW (n = 127). In the GEMU the treatment strategy emphasised comprehensive interdisciplinary assessment of all relevant disorders, prevention of complications and iatrogenic conditions, early mobilisation, rehabilitation and discharge planning. The control group received treatment as usual from the Department of Internal Medicine. After discharge neither group received specific follow-up. Activities of daily living (ADL), instrumental ADL, cognitive function, symptoms of depression and general well-being were assessed 3, 6 and 12 months after discharge from hospital.
                There was no difference in function, depression or general well-being in the GEMU as compared to the MW group. If the dead were included in the analysis at the highest ADL dependency level, there was better function in the GEMU group at 3 months (p = 0.03).
                Treatment in the GEMU had no measurable beneficial impact on function, morale or symptoms of depression. Taken the previously shown mortality reduction into consideration an additional effect on function was less likely and the overall treatment effect was considered to be positive. We examined the impact of methadone maintenance treatment (MMT) on risk behaviors for transmission of blood-borne diseases in polydrug users who had tested positive or negative for hepatitis C virus (HCV). At intake, HCV-positive participants (n=362) engaged in more human immunodeficiency virus (HIV) risk behaviors (as measured by the HIV Risk-Taking Behavior Scale) than HCV-negative participants (n=297; p< .001). This difference was specific to injection-related behaviors and decreased significantly within the first few weeks of MMT (p< .0001). Where needles continued to be used, HCV-positive participants became more likely over time to engage in safer injecting practices. Furthermore, HCV-positive participants became more likely to use condoms than HCV-negative participants. These findings demonstrate that both drug- and sex-related risk behaviors decrease during MMT and emphasize the benefits of methadone programs for public health and HIV/HCV prevention. The Multiphasic Health Checkup Evaluation Study, a long-term clinical trial, has been completed. A study group of 5156 men and women age 35-54 at entry was urged to have annual multiphasic health checkups (MHCs) for 16 years. A control group of 5557 comparable subjects was not so urged but was followed up in a comparable fashion. The mean and median number of MHCs per person were 6.8 and 6, respectively, in the study group and 2.8 and 1, respectively, in the control group. During 16 years the study group experienced a 30% reduction (p less than 0.05) in deaths from pre-specified "potentially postponable" causes, largely associated with lower death rates from colorectal cancer and hypertension. This reduction was most pronounced in the early years of the study. The two groups did not differ to a statistically significant degree in mortality from all other causes (84% of total mortality) or in total mortality. There was no difference in self-reported disability in the overall groups. In the setting of our prepaid health care plan where MHCs were already available on a voluntary basis, a program of urging middle-aged persons to undergo regular MHCs brought about a substantial reduction in mortality from preselected diseases. A double-blind randomised controlled trial was conducted on a group of Hong Kong hospital clinicians. The objective was to test if a three-hour educational workshop (with supervised hands-on practice) is more effective (than no training) to improve clinical question formulation, information-seeking skills, knowledge, attitudes, and search outcomes. The design was a post-test-only control group; recruitment by stratified randomization (by profession), blocked at 800. End-user training was more effective than no training in improving clinical question formulation, in raising awareness, knowledge, confidence and use of databases, but had made no impact on preference for secondary databases. It changed the attitude of clinicians to become more positive towards the use of electronic information services (EIS). Participants had higher search performance and outcomes (satisfaction with information obtained (NNT = 3), EIS satisfaction (NNT = 3) and success in problem solving (NNT = 4)). The workshop improved knowledge and skills in evidence-based searching, but this effect gradually eroded with time. Search logs confirmed that follow-up is required if effects are to be sustained. Longer effects on search behaviours appear to be positive. A randomised controlled trial is valuable in identifying cause-and-effect relations and to quantify the magnitude of the effects for management decision-making. To evaluate the effectiveness and cost-effectiveness of a community nurse-supported hospital discharge programme in preventing hospital re-admissions, improving functional status and handicap of older patients with chronic heart failure.
                Randomized controlled trial; 105 hospitalized patients aged 60 years or over with chronic heart failure and history of hospital admission(s) in previous year were randomly assigned into intervention group (n = 49) and control group (n = 56) for six months. Intervention group subjects received community nurse visits before discharge, within seven days of discharge, weekly for four weeks, then monthly. Community nurse liaised closely with a designated specialist in hospital and were accessible to subjects during normal working hours. Control and intervention group subjects were followed up in the same specialist medical clinics. Primary outcome was the rate of unplanned re-admission at six months. Secondary outcomes were number of unplanned re-admissions, six-minute walking distance, London Handicap Scale and public health care and personal care costs.
                At sixth months, the re-admission rates were not significantly different (46 vs. 57% in control subjects, p = 0.233, Chi-square test). But the median number of re-admissions tended to lower in the intervention group (0 vs. 1 in control group, p = 0.057, Mann Whitney test). Intervention group subjects had less handicap in independence (median change 0 vs. 0.5 in control subjects, p = 0.002, Mann Whitney test), but there was no difference in six-minute walking distance. There was no significant group difference in median total public health care and personal care costs.
                Community nurse-supported post-discharge programme was effective in preserving independence and was probably effective in reducing the number of unplanned re-admissions. The cost benefits to public health care were not significant.
                Older chronic heart failure patients are likely to benefit from post-discharge community nurse intervention programmes. More comprehensive health economic evaluation needs to be undertaken. Since the Bamako Initiative was launched in 1988, many African countries have embarked on comprehensive primary health care programs relying, at least partially, on revenues generated through user fees to revitalize health care delivery systems. Although these programs contain two critical components, user fees and improved quality, policy debates have tended to focus on the former and disregarded the latter. The purpose of this study is to provide a net assessment of these two components by testing how user fees and improved quality affect health facility utilization among the overall population and specifically among the poorest people. A "pretest-posttest controlled" experiment was conducted in five public health facilities in the Adamaoua province of Cameroon. Three health centers which were to introduce a user fee and quality improvement (i.e. reliable drug supply) policy were selected as "treatment" centers and two comparable facilities not yet phased into this policy were selected as "controls". Two rounds of household surveys were conducted (each to 800 households in 25 villages surrounding the five study sites) to measure the percentage of ill people seeking care at the health center before and after the implementation of the policy. The experiment was tightly controlled by conducting monthly observations at each study site. Results indicate that the probability of using the health center increased significantly for people in the "treatment" areas compared to those in the "control" areas. Travel and time costs involved in seeking alternative sources of care are high; when good quality drugs became available at the local health center, the fee charged for care and treatment represented an effective reduction in the price of care and thus utilization rose. Moreover, contrary to previous studies which have found that the poorest quintile is most hurt by user fees, this study found that probability of the poorest quintile seeking care increases at a rate proportionately greater than the rest of the population. Since the poor are most responsive to price changes, they appear to be benefitting from local availability of drugs more than others. Active injection drug users (IDUs) who are also hazardous alcohol users are at particularly high risk for HIV transmission due to sharing of injection equipment. We recruited AUDIT-positive injectors from the Providence, RI needle exchange program for a randomized clinical trial testing the effect of a brief motivational intervention (MI) on frequency of injection-related HIV risk behavior (IRRB). HIV drug risk behavior was measured as the number of days on which subjects reported sharing works using the 30-day Timeline Followback Method. Overall, 109 subjects reported a mean reduction of IRRB days of 9.1 days from baseline to 6-month follow-up (p <.001). When compared to controls, there was a trend in reduction of IRRB days to zero at follow-up for MI subject (OR = 2.1; 95% CI = 0.9-4.5), and strongly significant reductions in IRRB days across a range of alternative improvement thresholds. Results from this study demonstrate that MI reduces drug-related HIV risk behaviors among active IDUs. As a brief intervention, MI may be a useful adjunct to existing services intended to reduce harm. To evaluate the effect of pharmaceutical care provided in addition to acute Geriatric Evaluation and Management (GEM) care on the appropriateness of prescribing.
                Randomized, controlled trial, with the patient as unit of randomization.
                Acute GEM unit.
                Two hundred three patients aged 70 and older.
                Pharmaceutical care provided from admission to discharge by a specialist clinical pharmacist who had direct contacts with the GEM team and patients.
                Appropriateness of prescribing on admission, at discharge, and 3 months after discharge, using the Medication Appropriateness Index (MAI), Beers criteria, and Assessing Care of Vulnerable Elders (ACOVE) underuse criteria and mortality, readmission, and emergency visits up to 12 months after discharge.
                Intervention patients were significantly more likely than control patients to have an improvement in the MAI and in the ACOVE underuse criteria from admission to discharge (odds ratio (OR)=9.1, 95% confidence interval (CI)=4.2-21.6 and OR=6.1, 95% CI=2.2-17.0, respectively). The control and intervention groups had comparable improvements in the Beers criteria.
                Pharmaceutical care provided in the context of acute GEM care improved the appropriate use of medicines during the hospital stay and after discharge. This is an important finding, because only limited data exist on the effect of various strategies to improve medication use in elderly inpatients. The present approach has the potential to minimize risk and improve patient outcomes. Self-reported health has been shown to predict mortality. We lack knowledge on whether a lifestyle intervention can improve self-reported mental and physical health in a general population.
                Inter99, Denmark (1999-2006) is a randomised population-based intervention study. We screened for ischemic heart disease and repeatedly offered advice and assistance to obtain a healthier lifestyle. Health related quality of life was measured by Short Form 12 (SF-12); completed by 9322 at baseline and 7719 at five-year follow-up. In linear mixed models we investigated the effect of the intervention on self-reported health over time.
                At baseline men had higher physical health-component scores (PCS) than women. Living with a partner, being employed, and being healthy was associated with high PCS. The mental health-component scores (MCS) showed the same socio-demographic differences, except that MCS increased with age. Significantly fewer participants in the intervention groups had decreased their PCS and MCS compared with the control group. Adjusted multilevel analyses confirmed that the intervention significantly improved physical- (p=0.008) and mental health (p<0.001) over time compared with the control group.
                Screening for ischemic heart disease and offering lifestyle intervention had a significantly beneficial effect on mental and physical self-reported health in the long term in a general population. We investigated the impact of right-heart catheterization (RHC) on physiological status and stay in the intensive care unit. Thirty-three of 148 potentially eligible patients were randomized. Fifty-two otherwise eligible patients were excluded because the attending physician felt that RHC was ethically mandated. Ten of 16 (63%) patients randomized to RHC, and 9 of 17 (53%) to no RHC, died (difference: -10%; 95% confidence interval [CI], -43% to 24%). Mean number of days in the intensive care unit were 10.3 for RHC and 8.1 for no RHC (difference, -2.2; CI, -10.2 to 5.8). The lowest modified APACHE score achieved after randomization was 10.8 for RHC and 8.1 for no RHC (difference, -3.8; CI, -7.0 to -0.6), and the mean modified APACHE score was 14.4 for RHC and 11.1 for no RHC (difference, -3.3; CI, -6.47 to -0.2). Physiological measures in this trial showed statistically significant differences in favor of patients not receiving RHC. Confidence intervals around other outcomes include clinically important differences in favor of both RHC and control groups. Although other controlled trials of RHC are crucial, investigators face major practical difficulties. This study evaluated the effectiveness (changes in health behaviors, health status, and health service utilization) of a self-management program for chronic disease designed for use with a heterogeneous group of chronic disease patients. It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities.
                The study was a six-month randomized, controlled trial at community-based sites comparing treatment subjects with wait-list control subjects. Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease, lung disease, stroke, or arthritis. Health behaviors, health status, and health service utilization, as determined by mailed, self-administered questionnaires, were measured.
                Treatment subjects, when compared with control subjects, demonstrated improvements at 6 months in weekly minutes of exercise, frequency of cognitive symptom management, communication with physicians, self-reported health, health distress, fatigue, disability, and social/role activities limitations. They also had fewer hospitalizations and days in the hospital. No differences were found in pain/physical discomfort, shortness of breath, or psychological well-being.
                An intervention designed specifically to meet the needs of a heterogeneous group of chronic disease patients, including those with comorbid conditions, was feasible and beneficial beyond usual care in terms of improved health behaviors and health status. It also resulted in fewer hospitalizations and days of hospitalization. To assess whether community-based care delivered by people living with HIV/AIDS (PLWAs) could replace clinic-based HIV care.
                Prospective cluster randomized controlled clinical trial.
                Villages surrounding 1 rural clinic in western Kenya.
                HIV-infected adults clinically stable on antiretroviral therapy (ART).
                The intervention group received monthly Personal Digital Assistant supported home assessments by PLWAs with clinic appointments every 3 months. The control group received standard of care monthly clinic visits.
                Viral load, CD4 count, Karnofsky score, stability of ART regimen, opportunistic infections, pregnancies, and number of clinic visits.
                After 1 year, there were no significant intervention-control differences with regard to detectable viral load, mean CD4 count, decline in Karnofsky score, change in ART regimen, new opportunistic infection, or pregnancy rate. Intervention patients made half as many clinic visits as did controls (P < 0.001).
                Community-based care by PLWAs resulted in similar clinical outcomes as usual care but with half the number of clinic visits. This pilot study suggests that task-shifting and mobile technologies can deliver safe and effective community-based care to PLWAs, expediting ART rollout and increasing access to treatment while expanding the capacity of health care institutions in resource-constrained environments. The purpose of this study was to investigate the effectiveness, dynamics, and consequences of a health education intervention designed to increase patient question asking during the patient's medical visit. Data were collected at a Baltimore family and community health center which provides outpatient services to a low income, predominantly black and female population. The majority of the study participants were, in addition, elderly and chronically ill. A total of 294 patients and 3 providers took part in the study. The study design included random assignment of patients to experimental and placebo groups with two non-equivalent (non-randomized) control groups. Findings included: (1) The experimental group patients asked more direct questions and fewer indirect questions than did placebo group patients. (2) The experimental group patient-provider interaction was characterized by negative affect, anxiety, and anger, while the placebo group patient-provider interaction was characterized as mutually sympathetic. (3) The experimental group patients were less satisfied with care received in the clinic on the day of their visit than were placebo patients. (4) The experimental group patients demonstrated higher appointment-keeping ratios (an average number of appointments kept divided by an average number of appointments made) during a four-month prospective monitoring period.
IHCAs appear to have largely positive effects on users, in that users tend to become more knowledgeable, feel better socially supported, and may have improved behavioural and clinical outcomes compared to non-users. There is a need for more high quality studies with large sample sizes to confirm these preliminary findings, to determine the best type and best way to deliver IHCAs, and to establish how IHCAs have their effects for different groups of people with chronic illness.