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A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.

Zullig LL, Pathman J, Melnyk SD, Brown JN, Sanders LL, Koropchak C, Howard T, Danus S, McCant F, Bosworth HB. A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence. Contemporary clinical trials. 2014 Sep 1; 39(1):106-12.

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PURPOSE: Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease (CVD), a leading cause of death in the United States. Despite clinical practice guidelines aimed at facilitating LDL-C control, many Veterans do not achieve guideline-recommended LDL-C levels. METHODS: We describe a study focused on VA healthcare system users at risk for CVD (i.e., LDL-C level > 130 mg/dl and/or < 80% cholesterol pill refill adherence in the last 12 months). We are conducting a two and a half year randomized controlled trial (i.e., intervention administered over 12 months) among Veterans with uncontrolled cholesterol receiving care at select VA-affiliated primary care clinics in North Carolina. We anticipate enrolling 250 diverse patients (10% women; 40% African American). Patients are randomized to an educational control group or intervention group. Intervention group participants' medication is provided in special blister packaging labeled for daily use that includes reminders; MeadWestvaco Corporation's pre-filled DosePak contains standard doses of statins in accordance with the existing prescriptions. CONCLUSIONS: Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence. Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can: 1) improve medication adherence; 2) improve patients' LDL-C levels; 3) be well received by patients and providers; and 4) provide a cost effective solution to improve medication adherence.

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