Shared Decision-Making to Improve the Health Status of Patients with Claudication: Developing and Implementing Strategies to Individualize Treatment Decisions

共同决策以改善跛行患者的健康状况：制定和实施个性化治疗决策的策略

• 批准号: 10685533
• 负责人: Eric Alexander Secemsky
• 金额: $ 17.04万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10685533
• 关键词: Address; Administrator; Advisory Committees; Affect; African American; Aftercare; American; Applications Grants; Arteries; Award; Belief; Benefits and Risks; Biometry; Biostatistical Methods; Blood Vessels; Cardiology; Cardiovascular system; Caring; Classification; Clinic; Clinical; Clinical Investigator; Conflict (Psychology); Consultations; Data; Decision Aid; Decision Making; Development; Elements; Environment; Evaluation; Evidence based treatment; Exercise; Future; Goals; Health Expenditures; Health Status; Hemorrhage; Heterogeneity; Individual; Intervention; Interview; Kidney Failure; Knowledge; Leg; Location; Lower Extremity; Measures; Medical; Medicine; Mental Depression; Mentors; Mentorship; Methods; Modeling; Multicenter Trials; Nurses; Outcome; Outcome Measure; Outcomes Research; Outpatients; Pain; Patient Care; Patient Outcomes Assessments; Patient Preferences; Patient-Focused Outcomes; Patients; Peripheral; Peripheral arterial disease; Physicians; Pilot Projects; Policy Maker; Predictive Factor; Procedures; Process; Program Development; Provider; Qualitative Methods; Qualitative Research; Quality of Care; Quality of life; Questionnaires; Race; Readiness; Research; Research Methodology; Research Personnel; Research Training; Resources; Risk; Science; Scientist; Selection for Treatments; Structure; Symptoms; Therapeutic; Treatment outcome; Uncertainty; Woman; Work; career; career development; claudication; clinical care; clinical practice; clinical training; comparison intervention; cost; design; diagnostic tool; disability; empowerment; experience; health care service utilization; implementation science; implementation strategy; improved; individual patient; individualized medicine; intervention cost; medical specialties; men; novel; pilot test; practice setting; pragmatic implementation; preference; prognostication; prospective; response; shared decision making; skills; statistics; symptomatic improvement; tool; treatment as usual; treatment choice; treatment strategy

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.

项目摘要/摘要 外周动脉疾病(PAD)影响多达1200万美国人，占医疗保健支出的比例 每年总计210亿美元。侵入性手术--改善PAD的多种治疗方法之一 症状，正在越来越多地被使用，但代价高昂，可能导致并发症，并不能使所有人受益 患者是平等的。此外，选择PAD治疗策略需要使患者的偏好与 他们可以使用的治疗方法的风险和好处。然而，PAD护理在临床上是支离破碎的 设置和专业，导致在吸引患者偏好和演示时采用不同的方法 治疗选择。这些综合因素使得在PAD护理中实施共享决策成为一种 紧急但具有挑战性的努力。这项提案试图用多方面的方法解决这一问题。在……里面 目标1，我们将使用预期的患者水平数据来建立并严格验证预测1- 年健康状况和评估对不同治疗策略的反应(药物治疗，监督 运动和血管干预)。这些工具将用于个体化治疗，重点是 对患者有意义的结果。在目标2中，我们将进行半结构化访谈，并使用 形成性诊断工具，用于评估血管利益相关者的信念、担忧和挑战 共享决策。然后，这些访谈将被用来设计实际的执行战略。在……里面 目的3，我们将对50名跛行患者进行初步研究，以评估已建立的 PAD决策辅助工具，用于衡量决策质量和知识。这项研究将为以下项目提供初步数据 一项更大规模的多中心试验，评估如何将援助应用于改善决策、健康状况、 以及跛行患者的长期预后。这项提议的首要目标是促进 在跛行患者中做出知情、循证的治疗决定，以提高患者的治疗质量 护理和结果，并降低医疗保健利用率和成本。该提案的前两个目标将 提供必要的证据和资源，将共享决策引入血管临床。 第三个目标将评估针对PAD的决策辅助对治疗质量的直接影响。 决定。这项研究将在一个全面的职业发展计划的背景下完成 旨在为职业生涯早期的调查员和介入心脏病专家塞肯斯基博士提供技能 需要成为一名独立的内科医生兼科学家。他的长期职业目标是确保 面临重要医疗决策的心血管疾病患者会积极参与，消息灵通， 接受与他们的偏好和目标相匹配的治疗。在整个颁奖过程中，戴维斯博士。 塞肯斯基将在一支杰出的指导团队和顾问的指导下过渡到独立 由在心血管医学、结果研究、 先进的生物统计和定性方法、共享决策和实施科学。

项目成果

Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Artery Disease.

用于治疗外周动脉疾病的紫杉醇装置的真实世界安全性分析。

• DOI: 10.1016/j.jvir.2023.03.014
• 发表时间: 2023
• 期刊: Journal of vascular and interventional radiology : JVIR
• 作者: Dani,SourbhaS;Majithia,Arjun;Ssemaganda,Henry;Robbins,Susan;Bertges,DanielJ;Eldrup-Jorgensen,Jens;Sedrakyan,Art;Levy,Michael;Siami,FloraS;JoyntMaddox,KarenE;Matheny,Michael;Secemsky,Eric;Resnic,Frederic
• 通讯作者: Resnic,Frederic

Acute Kidney Injury Following In-Patient Lower Extremity Vascular Intervention: From the National Cardiovascular Data Registry.

• DOI: 10.1016/j.jcin.2020.10.028
• 发表时间: 2021-02-08
• 期刊: JACC. Cardiovascular interventions
• 作者: Safley DM;Salisbury AC;Tsai TT;Secemsky EA;Kennedy KF;Rogers RK;Latif F;Shammas NW;Garcia L;Cavender MA;Rosenfield K;Prasad A;Spertus JA
• 通讯作者: Spertus JA

The Safety of Paclitaxel-Coated Devices for Patients with Peripheral Artery Disease.

• DOI: 10.1007/s11886-021-01477-4
• 发表时间: 2021-03-18
• 期刊: Current cardiology reports
• 影响因子: 3.7
• 作者: Krawisz AK;Secemsky EA
• 通讯作者: Secemsky EA

Incidence, Treatment, and Outcomes of Symptomatic Device Lead-Related Venous Obstruction.

• DOI: 10.1016/j.jacc.2023.04.017
• 发表时间: 2023-06-20
• 期刊: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
• 影响因子: 24
• 作者: Ferro, Enrico G.;Kramer, Daniel B.;Li, Siling;Locke, Andrew H.;Misra, Shantum;Schmaier, Alec A.;Carroll, Brett J.;Song, Yang;'Avila, Andre A. D.;Yeh, Robert W.;Zimetbaum, Peter J.;Secemsky, Eric A.
• 通讯作者: Secemsky, Eric A.

Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results From the Transcatheter Valve Therapy Registry.

• DOI: 10.1161/circulationaha.120.052874
• 发表时间: 2021-06-08
• 期刊: Circulation
• 影响因子: 37.8
• 作者: Butala NM;Makkar R;Secemsky EA;Gallup D;Marquis-Gravel G;Kosinski AS;Vemulapalli S;Valle JA;Bradley SM;Chakravarty T;Yeh RW;Cohen DJ
• 通讯作者: Cohen DJ