PROJECT SUMMARY/ABSTRACT Peripheral artery disease (PAD) affects up to 12 million Americans and accounts for healthcare expenditures totaling $21 billion annually. Invasive procedures, one of multiple therapies available to improve PAD symptoms, are increasingly being used, but are costly, may cause complications, and do not benefit all patients equally. Furthermore, selecting a PAD treatment strategy requires aligning patient preferences with the risks and benefits of therapies available to them. However, PAD care is fragmented across clinical settings and specialties, resulting in variable approaches in eliciting patient preferences and presenting treatment choices. These combined factors make implementation of shared decision-making in PAD care an urgent yet challenging endeavor. This proposal seeks to address this issue using a multi-faceted approach. In Aim 1, we will use prospective patient-level data to build and rigorously validate models that prognosticate 1- year health status and estimate responses to different therapeutic strategies (medical therapy, supervised exercise and vascular intervention). These tools will be used to individualize treatment with a focus on outcomes that are meaningful to the patient. In Aim 2, we will conduct semi-structured interviews and use a formative diagnostic tool to evaluate vascular stakeholders' beliefs, concerns, and challenges related to shared decision-making. These interviews will then be used to design practical implementation strategies. In Aim 3, we will perform a pilot study of 50 patients with claudication to evaluate the impact of an established PAD decision aid on measures of decision quality and knowledge. This study will provide preliminary data for a larger, multicenter trial evaluating how the aid can be applied to improve decision-making, health status, and long-term outcomes for patients with claudication. The overarching goal of this proposal is to promote informed, evidence-based treatment decisions among patients with claudication in order to improve quality of care and outcomes, and reduce healthcare utilization and costs. The first two aims of the proposal will provide the necessary evidence and resources to introduce shared decision-making into the vascular clinic. The third aim will evaluate the direct influence of a decision aid specific to PAD on the quality of treatment decisions. This research will be accomplished in the setting of a comprehensive career development program designed to provide Dr. Secemsky, an early career investigator and interventional cardiologist, with the skills needed to become an independent physician-scientist. His long-term career goal is to ensure that cardiovascular patients who face important medical decisions are meaningfully engaged, well informed, and receive treatments that match their preferences and goals. Over the course of the award period, Dr. Secemsky will be guided in his transition to independence by an outstanding mentoring team and advisory committee of established clinical investigators with expertise in cardiovascular medicine, outcomes research, advanced biostatistical and qualitative methods, shared decision-making, and implementation science.

PROJECT NARRATIVE Invasive procedures to open arteries supplying the legs for patients with pain and peripheral artery disease (PAD) include risks of complications and uncertainty around individual benefits. Aligning goals and values between patients with PAD and available treatment options requires better evidence of patient-centered outcomes and a deeper understanding of the decision-making process. The proposed work leverages complementary methods in advanced statistics and decision science to address these gaps, enabling clinicians and patients to make more informed, personalized, and goal-concordant decisions about PAD care.