Identifying Modifiable Practices Related to Outcome Variation and Enhancement in Transcatheter Aortic Valve Replacement (IMPROVE TAVR)

确定与经导管主动脉瓣置换术结果变化和增强相关的可修改实践（IMPROVE TAVR）

• 批准号: 10370068
• 负责人: Dhaval Sanjeev Kolte
• 金额: $ 19.23万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-21 至 2026-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10370068
• 关键词: Acute Renal Failure with Renal Papillary Necrosis; Adopted; Adverse event; Advisory Committees; Age-Years; American College of Surgeons; Aortic Valve Stenosis; Award; Biometry; Cardiology; Cardiovascular system; Caring; Characteristics; Clinical; Data; Death Rate; Development Plans; Evaluation; Financial Hardship; Funding; Goals; Guidelines; Heart Valve Diseases; Heart Valves; Hemorrhage; Hospitals; Intervention; Interview; Learning; Length of Stay; Life; Logistic Regressions; Mentored Patient-Oriented Research Career Development Award; Mentors; Methods; Modeling; Morbidity - disease rate; Outcome; Outcomes Research; Patient Selection; Patient-Focused Outcomes; Patients; Performance; Policies; Procedures; Process; Process Measure; Qualitative Research; Registries; Research; Research Methodology; Research Personnel; Risk; Sampling; Selection Criteria; Self Management; Societies; Standardization; Stroke; Structure; Techniques; Thoracic Surgeon; Training; United States; United States Food and Drug Administration; Variant; adverse event risk; aortic valve replacement; base; career; career development; comorbidity; comparative; demographics; design; deviant; evidence base; hospital readmission; improved; improved outcome; intervention program; mortality; programs; readmission rates; skills; surgical risk; theories; therapeutically effective

Project Summary/Abstract Approximately 12.4% of patients >75 years of age have aortic stenosis (AS) and 3.4% have severe AS. Transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option for patients with symptomatic severe AS. More than 50,000 TAVRs are now performed annually across >500 hospitals in the United States (US). Despite stringent patient selection criteria and standardized procedural techniques, there remains significant hospital variation in outcomes, including mortality, morbidity, and readmissions, following TAVR in the US. However, the reasons underlying hospital variation in TAVR outcomes remain poorly understood. Identifying organizational practices and processes of care associated with better outcomes is critical to improve the overall outcomes of patients undergoing TAVR. The overarching objective of this proposal is to perform a mixed methods study using a positive deviance approach to understand determinants of hospital variation in TAVR outcomes and to identify modifiable practices associated with improved outcomes. In Aim 1, we will use data from the Transcatheter Valve Therapy Registry to identify high- and low-performing TAVR hospitals based on variation in two key patient-centered outcomes after TAVR – 30-day major adverse events (MAE, defined as a global ranked composite of mortality, stroke, major/life-threatening bleeding, acute kidney injury stage 3, and moderate/severe paravalvular leak) and 30- day readmissions. In Aim 2, we will conduct in-depth, semi-structured interviews of key clinical and administrative staff involved in the care of TAVR patients in a representative sample of high- and low- performing hospitals. The qualitative data will be analyzed to identify specific themes associated with high performance, and to develop two distinct conceptual models of factors influencing MAE and readmissions, respectively, after TAVR. This study will identify ‘best practices’ that can be adopted by low-performing and new TAVR programs to improve their patient outcomes. Further, this research has the potential to identify clear evidence-based structure and process measures that can inform guidelines and policies on evaluation of the quality of TAVR and other transcatheter valve intervention programs. This research will be accomplished in the setting of a comprehensive career development plan designed to provide Dr. Kolte, an early career investigator, with the training and skills necessary to achieve his long-term career goal of becoming an independent clinician-investigator with expertise in cardiovascular outcomes and mixed methods research in the field of transcatheter heart valve interventions. An outstanding mentoring team and scientific advisory committee of established investigators in the fields of valvular heart disease, outcomes research, quantitative methods, and qualitative/mixed methods research will guide Dr. Kolte in his transition to independence over the course of the award period.

项目摘要/摘要 大约12.4%的75岁患者患有主动脉狭窄(AS)，3.4%的患者患有严重的AS。 经导管主动脉瓣置换术(TAVR)已成为一种安全有效的治疗方法 有症状的重症AS患者。现在，500家企业每年执行的TAVR超过50,000台 美国的医院。尽管有严格的患者选择标准和标准化的程序 技术方面，在医院结果方面仍然存在显著差异，包括死亡率、发病率和 再次入院，跟随美国的TAVR。然而，TAVR中医院差异的原因 人们对结果仍然知之甚少。确定与以下项目相关的组织实践和护理流程 更好的结果对于改善接受TAVR的患者的整体结果至关重要。最重要的是 这项建议的目标是使用正偏差方法进行混合方法研究 了解TAVR结果中医院差异的决定因素，并确定可修改的做法 与改善结果相关。在目标1中，我们将使用来自经导管瓣膜治疗注册中心的数据 根据两个以患者为中心的关键结果的差异来确定高绩效和低绩效的TAVR医院 在TAVR-30天的主要不良事件(MAE)之后，MAE被定义为死亡率、中风、 严重/危及生命的出血、急性肾损伤3级和中度/重度瓣膜旁渗漏)和30- 重新入院一天。在目标2中，我们将进行深入的、半结构化的访谈，对关键的临床和 参与TAVR患者护理的行政人员在具有代表性的高-低- 表演医院。将分析定性数据，以确定与High相关的特定主题 性能，并开发影响MAE和再入院因素的两个截然不同的概念模型， 分别在TAVR后。这项研究将确定可供业绩不佳和 新的TAVR计划，以改善患者的预后。此外，这项研究有可能找出明确的 以证据为基础的结构和程序措施，可为评价的指导方针和政策提供信息 TAVR和其他经导管瓣膜介入计划的质量。这项研究将在 制定全面的职业发展计划，旨在为科尔特博士提供早期职业生涯 调查员，拥有必要的培训和技能，以实现他成为一名 独立的临床医生-调查员，在心血管结果和混合方法研究方面具有专业知识 经导管心脏瓣膜介入治疗领域。一支优秀的指导团队和科学顾问 瓣膜心脏病、结果研究、定量研究领域的知名调查人员委员会 方法，以及定性/混合方法研究将指导科尔特博士向独立的过渡 获奖期的进程。