Leah L Zullig1, Joshua Pathman2, S Dee Melnyk2, Jamie N Brown3, Linda L Sanders4, Celine Koropchak4, Teresa Howard2, Susanne Danus2, Felicia McCant2, Hayden B Bosworth5. 1. Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States; Department of Medicine, Duke University, United States. 2. Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States. 3. Investigational Drug Service, Durham Veterans Affairs Medical Center, United States. 4. Department of Medicine, Duke University, United States. 5. Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States; Department of Medicine, Duke University, United States; Departments of Psychiatry and School of Nursing, Duke University, United States. Electronic address: boswo001@mc.duke.edu.
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. Published by Elsevier Inc.
RCT Entities:
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. Published by Elsevier Inc.
Authors: Leah L Zullig; Linda L Sanders; Steven Thomas; Jamie N Brown; Susanne Danus; Felicia McCant; Hayden B Bosworth Journal: Patient Educ Couns Date: 2015-11-27