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

外周动脉疾病（PAD）影响着大约1200万美国人，占美国总收入的210亿美元。 每年的医疗费用。PAD患者未来发生心血管事件的风险增加， 包括截肢心肌梗死和死亡接受外周血管造影术的PAD患者 跛行症状或下肢溃疡或坏疽的干预（PVI）有基于指南的 适应症是多种循证药物。这些药物包括高强度他汀类药物， 阿司匹林、P2 Y12抑制剂（氯吡格雷）和血管紧张素转换酶（ACE）抑制剂或血管紧张素 受体阻滞剂（ARB）。PVI后坚持使用这些药物可以显著降低未来的风险， 截肢、心肌梗死和/或死亡。然而，肺静脉隔离术后PAD患者的观察数据表明， 对这些循证药物的依从性较差。此外， 没有对这一患者人群中药物依从性的障碍和促进因素进行预先检查。 此外，几乎没有证据表明，在这种脆弱的情况下， 患者人群。该提案旨在确定药物依从性的障碍和促进因素， 接受肺静脉隔离的PAD患者人群，并开发药物依从性工具， 促进讨论和缓解门诊环境中的依从性障碍。目标1： 将对40名接受肺静脉隔离的PAD患者进行半结构化访谈，以检查障碍 和药物依从性的促进者。在目标2中，我们将使用基于证据的质量改进 方法和多样化的研究参与小组，由供应商，患者，护士和专家组成， 信息技术，开发一个在门诊诊所使用的药物依从性工具。该工具将 整合到电子健康记录中，并将促进对依从性和潜在障碍的讨论 提高依从性的策略。在目标3中，我们将对200名患者进行初步可行性随机对照试验， 杜克卫生系统内两个研究中心的患者，以检查依从性的可行性和可接受性 工具，以及干预对药物依从率的影响。本试验随机对照 这项试验将为未来的多中心随机对照试验奠定基础， 提高依从率和临床结局的工具。这项研究将在一个 全面的职业发展计划，旨在提供博士Rymer，介入心脏病学家和 一名血管手术医生，经过培训，经验丰富，领导力发展，成为一名 独立的临床研究者。在颁奖期间，Rymer博士的杰出导师团队 将指导她发展定性研究，实施科学和临床试验设计方面的专业知识。博士 Rymer的长期目标是通过以下方式改善接受干预的PAD患者的健康状况： 实现对指南指导的医学治疗的最佳依从性。

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.