The overall goal of this study is to implement and evaluate the effects of a systems-based and pharmacist-mediated program designed to improve adherence to lipid-lowering pharmacologic therapy for patients with known coronary heart disease (CHD) and of their physicians/nurse practitioners (MD/NPs) to the National Cholesterol Education Program Guidelines. The program to be tested will intervene on three levels: the patient, the provider, and the system. In this two-condition randomized clinical trial the Intervention condition will include: (1) a computer-based tracking system designed to facilitate follow-up of patients who were initially seen for a coronary clinical event at the University hospital of UMass Memorial Health-Care, Inc.; and (2) an initial inpatient contact and a series of coordinated follow-up patient telephone counseling sessions carried out by pharmacists using a patient-centered approach to improve adherence. The pharmacists will utilize pharmacy refill records to obtain medication adherence information, and will provide feedback and recommendations to the patients' MD/NPs. The study population will consist of 800 pts admitted for a clinical CHD event, and recruited from the cardiac catheterization laboratories. Patients will be randomly assigned to a control (usual care) condition (UC) which will consist of patients provided with usual care oniy, or to the adherence-enhancing Special Intervention condition (SI). The patient is the unit of randomization and analysis. SI will be implemented and coordinated by pharmacists, who will utilize the Lotus Notes-based tracking system that we have developed and used successfully in a number of previous projects. The primary outcomes which will be evaluated at one year are the following: 1. Percentage of patients with an LDL level <100 mg per dl; 2. Proportion of prescribed lipid-lowering medication taken by patients as measured by a continuous multiple-interval availability (CMA) measure based on pharmacy records (ratio of days supply obtained to total days in the observation period). Secondary outcomes will include: 1.Percentage of patients on pharmacologic lipid lowering therapy 2. Proportion of selected non-lipid-lowering prescribed medication taken by patients as measured by CMA; and 3. Percentage of patients with an LDL level <130 mg per dl

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project (R01)
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Special Emphasis Panel (ZRG1-RPHB-4 (02))
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Czajkowski, Susan
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University of Massachusetts Medical School Worcester
Internal Medicine/Medicine
Schools of Medicine
United States
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Ma, Yunsheng; Ockene, Ira S; Rosal, Milagros C et al. (2010) Randomized Trial of a Pharmacist-Delivered Intervention for Improving Lipid-Lowering Medication Adherence among Patients with Coronary Heart Disease. Cholesterol 2010:383281
Ma, Yunsheng; Li, Wenjun; Olendzki, Barbara C et al. (2008) Dietary quality 1 year after diagnosis of coronary heart disease. J Am Diet Assoc 108:240-6;discussion 246-7