A Multicenter, Mixed Methods Study of United States Heart Teams and Health Policy: The EVOLVE Study Design and Protocol.

BACKGROUND: The management of patients with aortic stenosis is rapidly evolving, along with the "heart team," a multidisciplinary group collaborating in program management. There is scant research providing rigorous data on the variability in heart teams' approach to optimal patient care delivery. This investigation aimed to describe the current health care delivery strategies and attitudes of contemporary heart teams at diverse hospitals across the United States and provide key insight into future health policy and guideline directions. METHODS: We will conduct a convergent parallel design mixed methods study integrating quantitative (survey) and qualitative (semistructured interviews, coded using qualitative research software) data to develop a deeper understanding of heart valve team roles, functions, health care delivery strategies, and clinician perceptions of the impacts of health policy mandates on team and patient experience. Guided by a grounded theory approach, we will generate themes inductively from perspectives expressed by the participants. Heart valve teams will be recruited until saturation of themes and to maximize variation in practice settings (academic status, geographical location, transcatheter aortic valve replacement program volume, program tenure). We anticipate 8 to 20 programs and 40 to 100 participants. This study is approved by the Western Copernicus Group Institutional Review Board and adheres to Good Reporting of a Mixed Methods Study guidelines for mixed methods research. CONCLUSIONS: This study is designed to be the largest investigation to date of United States heart teams focused on aortic stenosis, aimed to inform health policy and guideline efforts to streamline care, address continued inequities and undertreatment, and optimize patient outcomes.