Implementation of a Medication Adherence Instrument among Patients with Symptomatic Peripheral Artery Disease after Peripheral Vascular Intervention

Peripheral artery disease (PAD) affects roughly 12 million Americans and accounts for over $21 billion in combined annual healthcare costs. Patients with PAD are at an increased risk of future cardiovascular events, including amputation, myocardial infarction, and death. Patients with PAD who undergo a peripheral vascular

intervention (PVI) for claudication symptoms or for lower extremity ulcers or gangrene have a guideline-based indication to be on multiple evidence-based medications. These medications include high intensity statins, aspirin, a P2Y12 inhibitor (clopidogrel), and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin

receptor blocker (ARB). Adherence to these medications after PVI can significantly reduce the future risk of amputation, myocardial infarction, and/or death. However, observational data of patients with PAD after PVI has demonstrated poor medication adherence to these evidence-based medications. Additionally, there has been

no prior examination of the barriers and facilitators of medication adherence in this population of patients. Moreover, there is little evidence regarding strategies to improve medication adherence in this vulnerable population of patients. This proposal seeks to identify the barriers and facilitators of medication adherence in a

population of patients with PAD who have undergone PVI, and to develop a medication adherence tool to promote discussion of and mitigation of barriers to adherence in the outpatient clinic environment. In Aim 1, we will conduct semi-structured interviews of 40 patients with PAD who have undergone PVI to examine barriers

and facilitators of medication adherence. In Aim 2, we will then use evidence-based quality improvement methods and a diverse research engagement panel, consisting of providers, patients, nurses, and experts in information technology, to develop a medication adherence tool for use in the outpatient clinic. This tool will be

integrated into the electronic health record and will facilitate discussion of barriers to adherence and potential strategies for improving adherence. In Aim 3, we will perform a pilot feasibility randomized controlled trial of 200 patients in two sites within the Duke Health System to examine the feasibility and acceptability of the adherence

tool, as well as the effect of the intervention on rates of medication adherence. This pilot randomized controlled trial will establish the foundation for a future, multi-center randomized controlled trial examining the use of the tool to improve rates of adherence and clinical outcomes. This research will occur in the setting of a

comprehensive career development program designed to provide Dr. Rymer, an interventional cardiologist and a vascular proceduralist, with the training, experience, and leadership development needed to become an independent clinical research investigator. During the award period, Dr. Rymer’s team of exceptional mentors

will guide her to develop expertise in qualitative research, implementation science, and clinical trial design. Dr. Rymer’s long-term goal is to improve the health of patients with PAD who have undergone an intervention by achieving optimal adherence to guideline-directed medical therapies.