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Multicenter cluster-randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (the COM99 study).

ABSTRACT: Medication nonadherence is common and results in preventable disease complications. This study assessed the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events.In this multicenter, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ? 50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients' pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end point of all-cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62, 95% confidence interval 0.50 to 0.78) and were more likely to be adherent (odds ratio 1.91, 95% confidence interval 1.19 to 3.05) than control group patients at 6 months. After 5 years, 16% of the patients in the intervention group and 19% in the control group met the composite end point (hazard ratio 0.97, 95% confidence interval 0.67 to 1.39).A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events.

SUBMITTER: Pladevall M

PROVIDER: S-EPMC3001186 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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Multicenter cluster-randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (the COM99 study).

Pladevall Manel M Brotons Carlos C Gabriel Rafael R Arnau Anna A Suarez Carmen C de la Figuera Mariano M Marquez Emilio E Coca Antonio A Sobrino Javier J Divine George G Heisler Michele M Williams L Keoki LK

Circulation 20100907 12

<h4>Background</h4>Medication nonadherence is common and results in preventable disease complications. This study assessed the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events.<h4>Methods and results</h4>In this multicenter, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to th ...[more]

PMID: 20823391

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Project description:Non-adherence to antihypertensive medications is a major cause of uncontrolled hypertension, leading to cardiovascular morbidity and mortality. Ensuring consistent medication possession is crucial in addressing non-adherence. Community-based medication delivery is a strategy that may improve medication possession, adherence, and blood pressure (BP) reduction. Our program in Kenya piloted a community medication delivery program, coupled with blood pressure monitoring and adherence evaluation. Between September 2019 and March 2020, patients who received hypertension care from our chronic disease management program also received community-based delivery of antihypertensive medications. We calculated number of days during which each patient had possession of medications and analyzed the relationship between successful medication delivery and self-reported medication adherence and BP. A total of 128 patient records (80.5% female) were reviewed. At baseline, mean systolic blood pressure (SBP) was 155.7 mmHg and mean self-reported adherence score was 2.7. Sixty-eight (53.1%) patients received at least 1 successful medication delivery. Our pharmacy dispensing records demonstrated that medication possession was greater among patients receiving medication deliveries. Change in self-reported medication adherence from baseline worsened in patients who did not receive any medication delivery (+0.5), but improved in patients receiving 1 delivery (-0.3) and 2 or more deliveries (-0.8). There was an SBP reduction of 1.9, 6.1, and 15.5 mmHg among patients who did not receive any deliveries, those who received 1 delivery, and those who received 2 or more medication deliveries, respectively. Adjusted mixed-effect model estimates revealed that mean SBP reduction and self-reported medication adherence were improved among individuals who successfully received medication deliveries, compared to those who did not. A community medication delivery program in western Kenya was shown to be implementable and enhanced medication possession, reduced SBP, and significantly improved self-reported adherence. This is a promising strategy to improve health outcomes for patients with uncontrolled hypertension that warrants further investigation.

Project description:BackgroundMedications for the prevention and treatment of cardiovascular disease save lives but adherence is often inadequate. The optimal role for physicians in improving adherence remains unclear.ObjectiveUsing existing evidence, we set the goal of evaluating the physician's role in improving medication adherence.DesignWe conducted systematic searches of English-language peer-reviewed publications in MEDLINE and EMBASE from 1966 through 12/31/2008.Subjects and interventionsWe selected randomized controlled trials of interventions to improve adherence to medications used for preventing or treating cardiovascular disease or diabetes.Main measuresArticles were classified as either (1) physician "active"-a physician participated in designing or implementing the intervention; (2) physician "passive"-physicians treating intervention group patients received patient adherence information while physicians treating controls did not; or (3) physicians noninvolved. We also identified studies in which healthcare professionals helped deliver the intervention. We did a meta-analysis of the studies involving healthcare professionals to determine aggregate Cohen's D effect sizes (ES).Key resultsWe identified 6,550 articles; 168 were reviewed in full, 82 met inclusion criteria. The majority of all studies (88.9%) showed improved adherence. Physician noninvolved studies were more likely (35.0% of studies) to show a medium or large effect on adherence compared to physician-involved studies (31.3%). Among interventions requiring a healthcare professional, physician-noninvolved interventions were more effective (ES 0.47; 95% CI 0.38-0.56) than physician-involved interventions (ES 0.25; 95% CI 0.21-0.29; p < 0.001). Among physician-involved interventions, physician-passive interventions were marginally more effective (ES 0.29; 95% CI 0.22-0.36) than physician-active interventions (ES 0.23; 95% CI 0.17-0.28; p = 0.2).ConclusionsAdherence interventions utilizing non-physician healthcare professionals are effective in improving cardiovascular medication adherence, but further study is needed to identify the optimal role for physicians.

Project description:High levels of adherence to medications for HIV infection are essential for optimal clinical outcomes and to reduce viral transmission, but many patients do not achieve required levels. Clinician-delivered interventions can improve patients' adherence, but usually require substantial effort by trained individuals and may not be widely available. Computer-delivered interventions can address this problem by reducing required staff time for delivery and by making the interventions widely available via the Internet. We previously developed a computer-delivered intervention designed to improve patients' level of health literacy as a strategy to improve their HIV medication adherence. The intervention was shown to increase patients' adherence, but it was not clear that the benefits resulting from the increase in adherence could justify the costs of developing and deploying the intervention. The purpose of this study was to evaluate the relation of development and deployment costs to the effectiveness of the intervention.Costs of intervention development were drawn from accounting reports for the grant under which its development was supported, adjusted for costs primarily resulting from the project's research purpose. Effectiveness of the intervention was drawn from results of the parent study. The relation of the intervention's effects to changes in health status, expressed as utilities, was also evaluated in order to assess the net cost of the intervention in terms of quality adjusted life years (QALYs). Sensitivity analyses evaluated ranges of possible intervention effectiveness and durations of its effects, and costs were evaluated over several deployment scenarios.The intervention's cost effectiveness depends largely on the number of persons using it and the duration of its effectiveness. Even with modest effects for a small number of patients the intervention was associated with net cost savings in some scenarios and for durations greater than three months and longer it was usually associated with a favorable cost per QALY. For intermediate and larger assumed effects and longer durations of intervention effectiveness, the intervention was associated with net cost savings.Computer-delivered adherence interventions may be a cost-effective strategy to improve adherence in persons treated for HIV.Clinicaltrials.gov identifier NCT01304186.

Dataset Information

Multicenter cluster-randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (the COM99 study).

Publications

Multicenter cluster-randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (the COM99 study).

Similar Datasets

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