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

• Published in: Contemporary clinical trials Vol. 39; no. 1; pp. 106 - 112
• Main Authors: Zullig, Leah L, Pathman, Joshua, Melnyk, S. Dee, Brown, Jamie N, Sanders, Linda L, Koropchak, Celine, Howard, Teresa, Danus, Susanne, McCant, Felicia, Bosworth, Hayden B
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2014
• Subjects: Adherence; Cardiovascular; Cardiovascular Diseases - prevention & control; Cholesterol; Cholesterol, LDL - blood; Drug Packaging - methods; Female; Hematology, Oncology and Palliative Medicine; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hypercholesterolemia - drug therapy; Male; Medication Adherence; North Carolina; Patient education; Patient Education as Topic - methods; Research Design; Risk Factors; United States; United States Department of Veterans Affairs; North Carolina; United States; Adherence; Patient education; Cholesterol
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2014.08.003

Abstract 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.