Improving medication use by patients with hypertension prevents adverse outcomes. When their blood pressure is carefully controlled, patients with uncomplicated hypertension are spared suffering complications such as myocardial infarction or stroke. Because hypertension is often asymptomatic and antihypertensive drugs have side effects, patients often feel better when they are not taking their medication. Innovative strategies are needed to educate patients and improve their adherence to an often-complex regimen. Doing so can reduce morbidity, mortality, and the costs of care. Minority and low-income patients often do not have access to the resources needed to assist them with their medications and as such they are especially vulnerable. Recent studies suggest that blood pressure control improves when pharmacists provide patients with education and monitoring. This study aims to develop and test, in a randomized controlled trial, a multileveled pharmacy-based program to improve adherence in minority and low-income patients. A study pharmacist will access a computer integrated into an electronic medical database called the Regenstrief Medical Record System. The conceptual framework is built upon two models: (1) a social-cognitive model for medication adherence, and (2) a behavioral model of healthcare utilization. We have designed patient education materials and medication packaging specifically formatted to promote comprehension in persons with low health literacy. Using these materials, a schema for instruction for use by a pharmacist, and an integrated computer system, we will conduct a randomized controlled trial. Patients with hypertension (N about488), stratified as uncomplicated (n about264) or complicated (n=224), will be randomly assigned to usual care or intervention within each stratum. The study duration will be 18 months: 12 months of active intervention and 6 months of post-intervention follow-up. Adherence will be assessed using electronic monitoring of all medications for hypertension. Endpoints will include medication adherence, blood pressure, health-related quality of life, symptoms, incident vascular complications such as myocardial infarction, and patient satisfaction. We hypothesize that patients receiving the intervention will have improved medication adherence, which will be accompanied by improved blood pressure control, improved health-related quality of life, fewer complications, greater satisfaction with care, and reduced health care costs. We further hypothesize that patients in the uncomplicated stratum will initially experience mild drug side effects from improved antihypertensive medication adherence whereas those in the complicated stratum will have fewer symptoms from improved control of blood pressure and the complications associated with poorly controlled hypertension. Finally, we will assess the cost-effectiveness of the intervention.
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