A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.
Date
2014-09
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Abstract
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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.Type
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Zullig, Leah L, Joshua Pathman, S Dee Melnyk, Jamie N Brown, Linda L Sanders, Celine Koropchak, Teresa Howard, Susanne Danus, et al. (2014). A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence. Contemporary clinical trials, 39(1). pp. 106–112. 10.1016/j.cct.2014.08.003 Retrieved from https://hdl.handle.net/10161/30026.
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Leah L Zullig
Leah L. Zullig, PhD, MPH is a health services researcher and implementation scientist whose work focuses on accelerating the adoption of evidence-based practices to improve healthcare delivery and population health. She is a Professor in the Duke University Department of Population Health Sciences and an investigator with the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham Veterans Affairs Health Care System.
Dr. Zullig is a recognized leader in implementation science. She directs INTERACT, the Implementation Science Research Collaborative, which fosters interdisciplinary collaborations across Duke University and with external partners to accelerate the translation of research into practice. She also leads the Dissemination and Implementation Catalyst within Duke's Clinical and Translational Science Award (CTSA) program and serves as Co-Leader of the Duke Cancer Institute's Cancer Prevention and Control Research Program.
Dr. Zullig's research spans three interconnected areas: improving the quality and delivery of cancer care; advancing cancer survivorship and chronic disease management; and enhancing medication adherence. Across these domains, she applies implementation science methods to develop, evaluate, and scale evidence-based interventions that promote equitable, high-quality care across diverse healthcare settings. Her research is characterized by strong partnerships with healthcare systems, ensuring that findings extend beyond publication to inform clinical practice, health system transformation, and policy.
Dr. Zullig has authored more than 200 peer-reviewed publications and has established a national reputation for leading pragmatic, health system-embedded research that improves patient outcomes and advances the science of implementation.
Dr. Zullig earned her Bachelor of Science in Health Promotion, Master of Public Health in Public Health Administration, and PhD in Health Policy.
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
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