title: A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.
abstract: OBJECTIVE
  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.
authors.affiliation: Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States; Department of Medicine, Duke University, United States.
authors.forename: Leah L
authors.initials: LL
authors.lastname: Zullig
authors.affiliation: Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States.
authors.forename: Joshua
authors.initials: J
authors.lastname: Pathman
authors.affiliation: Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States.
authors.forename: S Dee
authors.initials: SD
authors.lastname: Melnyk
authors.affiliation: Investigational Drug Service, Durham Veterans Affairs Medical Center, United States.
authors.forename: Jamie N
authors.initials: JN
authors.lastname: Brown
authors.affiliation: Department of Medicine, Duke University, United States.
authors.forename: Linda L
authors.initials: LL
authors.lastname: Sanders
authors.affiliation: Department of Medicine, Duke University, United States.
authors.forename: Celine
authors.initials: C
authors.lastname: Koropchak
authors.affiliation: Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States.
authors.forename: Teresa
authors.initials: T
authors.lastname: Howard
authors.affiliation: Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States.
authors.forename: Susanne
authors.initials: S
authors.lastname: Danus
authors.affiliation: Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States.
authors.forename: Felicia
authors.initials: F
authors.lastname: McCant
authors.affiliation: 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.
authors.forename: Hayden B
authors.initials: HB
authors.lastname: Bosworth
mesh_terms: D002318:Cardiovascular Diseases / Q000517:prevention & control; D008078:Cholesterol, LDL / Q000097:blood; D004349:Drug Packaging / Q000379:methods*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D009657:North Carolina; D010353:Patient Education as Topic / Q000379:methods*; D012107:Research Design; D012307:Risk Factors; D014481:United States; D014493:United States Department of Veterans Affairs
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
keywords: Adherence; Cholesterol; Patient education