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

在周围血管介入治疗后有症状的周围动脉疾病患者中实施药物依从性工具

• 批准号: 10739335
• 负责人: Jennifer Rymer
• 金额: $ 16.58万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-27 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10739335
• 关键词: Address; Adherence; Affect; Ambulatory Care Facilities; American; Amputation; Angiotensin Receptor; Angiotensin-Converting Enzyme Inhibitors; Antiplatelet Drugs; Aspirin; Award; Blood Vessels; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Characteristics; Chronic Disease; Clinic; Clinical; Clinical Research; Clinical Trials Design; Communication; Competence; Complex; Data; Development; Electronic Health Record; Ensure; Environment; Ethnic Origin; Event; Feedback; Foundations; Future; Gangrene; Goals; Guidelines; Health; Health Care Costs; Health system; Information Technology; Intervention; Interview; K-Series Research Career Programs; Leg Ulcer; Limb structure; Lower Extremity; Measurement; Medical; Mentors; Methodology; Methods; Myocardial Infarction; Needs Assessment; Nurses; Outcome; Outpatients; Patient Selection; Patients; Performance; Peripheral; Peripheral arterial disease; Persons; Pharmaceutical Preparations; Pharmacy facility; Process; Program Development; Provider; Qualitative Research; Quality of life; Race; Randomized; Randomized, Controlled Trials; Regimen; Reporting; Research; Research Personnel; Risk; Risk Reduction; Site; Structure; Symptoms; Testing; Training; Visit; Vulnerable Populations; Work; acceptability and feasibility; adherence rate; cardiovascular risk factor; career development; claudication; clopidogrel; cohort; comorbidity; compliance behavior; cost; design; effectiveness testing; efficacy outcomes; evidence base; experience; health care service utilization; health literacy; high risk; implementation science; implementation strategy; implementation tool; improved; inhibitor; instrument; intervention effect; leadership development; limb loss; low health literacy; medication compliance; meetings; mortality; patient oriented; patient population; prevent; primary outcome; secondary outcome; sex; skills; socioeconomics; therapy design; tool; treatment as usual

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.

周围动脉疾病 (PAD) 影响着大约 1200 万美国人，造成的经济损失超过 210 亿美元 PAD 患者未来发生心血管事件的风险增加， 包括截肢、心肌梗塞和接受周围血管手术的 PAD 患者。 针对跛行症状或下肢溃疡或坏疽的干预（PVI）有基于指南的 多种基于证据的药物的适应症这些药物包括高强度他汀类药物， 阿司匹林、P2Y12 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 PVI 后坚持使用这些药物可以显着降低未来的风险。 然而，PVI 后 PAD 患者的观察数据显示，截肢、心肌梗塞和/或死亡。 另外还表明，对这些循证药物的服药依从性较差。 事先没有检查该患者群体中药物依从性的障碍和促进因素。 此外，几乎没有证据表明可以采取策略来提高这一弱势群体的药物依从性。 该提案旨在确定药物依从性的障碍和促进因素。 接受 PVI 的 PAD 患者群体，并开发药物依从性工具 促进对门诊环境中依从性障碍的讨论和减轻。在目标 1 中，我们。 将对 40 名接受 PVI 的 PAD 患者进行半结构化访谈，以检查障碍 在目标 2 中，我们将使用基于证据的质量改进。 方法和多元化的研究参与小组，由提供者、患者、护士和专家组成 信息技术，开发一种用于门诊的药物依从性工具。 纳入电子健康记录并将促进对依从性障碍和潜力的讨论 在目标 3 中，我们将进行一项 200 人的试点可行性随机对照试验。 杜克大学医疗系统内两个地点的患者，以检查依从性的可行性和可接受性 工具，以及干预措施对药物依从率的影响。 试验将为未来的多中心随机对照试验奠定基础，该试验检查该药物的使用 这项研究将在以下环境中进行： 全面的职业发展计划旨在为介入心脏病专家 Rymer 博士提供 血管程序学家，拥有成为血管程序学家所需的培训、经验和领导力发展 在获奖期间，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。 Rymer 的长期目标是改善接受过干预的 PAD 患者的健康 实现对指南指导的医疗治疗的最佳依从性。