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.

项目总结/摘要 大约12.4%的>75岁的患者患有主动脉瓣狭窄（AS），3.4%患有重度AS。 经导管主动脉瓣置换术（TAVR）已成为一种安全有效的治疗选择， 有症状的重度AS患者。现在每年在500多个国家进行50，000多例TAVR 美国的医院（US）。尽管有严格的患者选择标准和标准化的程序， 技术，仍然有显着的医院差异的结果，包括死亡率，发病率， 在美国接受TAVR后再次入院。然而，TAVR中医院差异的根本原因 对结果仍然知之甚少。确定与以下方面有关的组织做法和护理过程： 更好的结局对于改善接受TAVR的患者的总体结局至关重要。总体 本提案的目的是使用正偏差方法进行混合方法研究， 了解医院TAVR结果差异的决定因素并确定可修改的实践 与改善的结果相关。在目标1中，我们将使用来自经导管瓣膜治疗登记研究的数据 根据两个关键的以患者为中心的结局的差异，识别高绩效和低绩效的TAVR医院 TAVR后- 30天主要不良事件（MAE，定义为死亡率、卒中， 严重/危及生命的出血、急性肾损伤3期和中度/重度瓣周漏）和30- 日间再入院在目标2中，我们将对关键的临床和 参与TAVR患者护理的行政人员，在高和低的代表性样本中， 表演医院将对定性数据进行分析，以确定与高风险相关的特定主题。 性能，并制定两个不同的概念模型的因素影响MAE和再入院， TAVR后。这项研究将确定“最佳做法”，可采用低绩效和 新的TAVR项目，以改善患者的预后。此外，这项研究有可能明确 循证结构和程序措施，可为关于评价 TAVR和其他经导管瓣膜介入治疗项目的质量。这项研究将在 制定全面的职业发展计划，旨在为Kolte博士提供早期职业生涯 调查员，具备必要的培训和技能，以实现其长期职业目标， 独立的临床医生-研究者，具有心血管结局和混合方法研究的专业知识， 经导管心脏瓣膜介入领域。优秀的指导团队和科学咨询 瓣膜性心脏病、结局研究、定量研究领域的既定研究者委员会 方法，定性/混合方法研究将指导博士Kolte在他的过渡到独立， 奖励期间的过程。