Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse

以患者为中心的二尖瓣脱垂治疗决策方法

• 批准号: 10854221
• 负责人: Alexander Iribarne
• 金额: $ 55.67万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-22 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10854221
• 关键词: Administrator; American; American Heart Association; Cardiac; Cardiology; Cardiovascular system; Clinic; Clinical; Clinical Research; Clinical effectiveness; Data; Decision Aid; Decision Making; Development; Enrollment; Focus Groups; Foundations; Future; Goals; Health Personnel; Heart; Heart Valve Diseases; Heart Valves; Heterogeneity; Intervention; Interview; Level of Evidence; Link; Maps; Methods; Mitral Valve; Mitral Valve Insufficiency; Mitral Valve Prolapse; Modeling; Nurses; Operative Surgical Procedures; Outcome; Outcome Study; Participant; Patient Care; Patient-Focused Outcomes; Patients; Positioning Attribute; Process; Professional Organizations; Provider; Ptosis; Publications; Publishing; Recommendation; Risk; Site; Surgeon; Surveys; Technology; Testing; Therapeutic; Translating; Treatment outcome; United States Centers for Medicare and Medicaid Services; Validation; alternative treatment; clinical care; clinical practice; college; comparative effectiveness; comparative effectiveness study; future implementation; human old age (65+); implementation barriers; implementation facilitators; implementation science; implementation strategy; improved; interest; multidisciplinary; novel strategies; patient oriented; personalized decision; preference; rapid growth; repaired; routine care; shared decision making; treatment effect

Project Summary/Abstract Transcatheter edge-to-edge repair (TEER) has transformed the management of patients with degenerative mitral regurgitation (MR). The Cardiothoracic Surgical Trials Network (CTSN) developed the Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY) trial to study the comparative effectiveness of mitral valve repair (MVR) versus TEER. However, decision aids (DAs) are needed to integrate clinical evidence with patients’ values and preferences to allow them to make informed treatment decisions. Currently, no established DAs exist for patients with degenerative MR even though the Centers for Medicare and Medicaid Services and many cardiovascular professional organizations highlight the importance of shared decision-making (SDM). Several obstacles exist toward implementing SDM in clinical practice including the fact that DAs are often developed long after a trial is published, making it challenging to immediately integrate pivotal trial results into clinical workflows. In this proposal, we will conduct a mixed methods study to elicit from patients and providers what outcomes are most important to them so that in the future we can model the heterogeneity in treatment effect using data from PRIMARY to create patient-centered DAs. This proposal will also study the barriers and facilitators toward the use of SDM among key stakeholders in local Heart Teams. Specific Aim 1: Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR. We will conduct qualitative focus groups among patients with severe degenerative MR to elicit the range of outcomes patients consider important when selecting treatment options. Using these data and the components of the PRIMARY composite endpoint, we will then create and administer a quantitative allocation task survey to characterize how patients with severe MR prioritize outcomes when making treatment decisions. Specific Aim 2: Identify outcomes most important to healthcare providers (HCPs) in recommending TEER or MVR. We will conduct qualitative focus groups among cardiac surgeons, referring cardiologists, interventional cardiologists, and nurses involved in the care of patients with degenerative MR to characterize outcomes important to HCPs. We will then use these data to create and administer a quantitative point allocation survey to characterize how HCPs prioritize outcomes. Specific Aim 3: Identify barriers and facilitators to implementing SDM in mitral valve Heart Teams. We will evaluate the process of introducing SDM into local Heart Teams by conducting qualitative interviews with HCP stakeholders. These data will be used to map workflows and identify the optimal timing and process as well as barriers and facilitators to integrating SDM in clinical practice.

项目摘要/摘要 经导管边缘到边缘维修（TEER）已改变了退化患者的管理 二尖瓣反流（MR）。心胸外科手术试验网络（CTSN）开发了经皮或 ≥65岁（初级）试验的二尖瓣脱垂和反流的手术修复，以研究 二尖瓣修复（MVR）与TEER的比较有效性。但是，决策艾滋病（DAS）是 需要将临床证据与患者的价值观和偏好相结合，以使他们能够获得知情 治疗决定。 目前，即使Medicare中心，退化性MR的患者尚无既定的DAS 以及医疗补助服务以及许多心血管专业组织，强调了共享的重要性 决策（SDM）。在临床实践中实施SDM的几个障碍，包括事实 该DA通常是在审判发布后很长时间开发的，这使得立即整合起来挑战 关键试验结果进入临床工作流程。 在此提案中，我们将进行一项混合方法研究，以引起患者和提供者的结果 对他们来说最重要的是，将来我们可以使用数据对治疗效果的异质性进行建模 从主要到创建以患者为中心的DA。该建议还将研究障碍和促进者 在当地心脏团队的主要利益相关者中使用SDM。 特定目标1：确定对严重退化MR考虑患者最重要的结果 TEER或MVR。我们将在患有严重退化性MR的患者中进行定性焦点小组以引起 在选择治疗方案时，患者认为重要的结果范围很重要。使用这些数据和 然后，我们将创建和管理定量分配的组件，然后 任务调查以表征患有严重MR的患者在做出治疗决策时如何优先级的结果。 特定目标2：确定对医疗保健提供者（HCP）最重要的结果 TEER或MVR。我们将在心脏外科医生，参考心脏病学家， 介入的心脏病专家以及参与退化性MR患者护理的护士以表征 结果对HCP很重要。然后，我们将使用这些数据创建和管理定量点 分配调查以表征HCP如何确定结果的优先级。 特定目标3：确定在二尖瓣心脏团队中实施SDM的障碍和促进者。我们 将通过与 HCP利益相关者。这些数据将用于映射工作流程，并确定最佳时机和过程为 以及将SDM集成在临床实践中的障碍和促进者。