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A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication
Leah L Zullig1, Joshua Pathman2, S Dee Melnyk2
1Center of Excellence for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, United States; Department of Medicine, Duke University, United States.
Insights
This study investigates if special medication packaging improves cholesterol control in Veterans. The intervention aims to boost medication adherence and lower LDL-C levels for better cardiovascular health.
Area of Science:
- Cardiovascular disease prevention
- Health services research
- Medication adherence interventions
Background:
- Elevated low-density lipoprotein cholesterol (LDL-C) is a key risk factor for cardiovascular disease (CVD).
- Many Veterans do not achieve recommended LDL-C levels despite clinical guidelines.
- Improving medication adherence is crucial for managing cholesterol and preventing CVD.
Purpose of the Study:
- To evaluate the effectiveness of adherence packaging for improving medication adherence in Veterans with uncontrolled cholesterol.
- To assess the impact of this intervention on LDL-C levels.
- To determine patient and provider reception and cost-effectiveness.
Main Methods:
- A randomized controlled trial enrolling 250 diverse Veterans at risk for CVD.
- Intervention group receives statins in daily-use blister packs with reminders.
- Control group receives standard educational materials.
Main Results:
- The study is designed to provide data on whether adherence packaging improves medication adherence.
- It will also assess the impact on LDL-C levels and patient/provider reception.
- Cost-effectiveness of the intervention will be analyzed.
Conclusions:
- Pre-filled blister packaging presents a potentially inexpensive strategy to enhance medication adherence.
- The findings will inform the utility of this intervention for improving cholesterol management in Veterans.
- This research addresses a critical need for effective adherence solutions in CVD prevention.
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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