About this trial
This is a qualitative and quantitative study that seeks to obtain information from patients with degenerative mitral valve prolapse and providers regarding factors important in deciding between surgical mitral valve repair (MVR) and transcatheter edge-to-edge repair (TEER). Findings from this study will provide data that can be used to develop decision aids that can assist patients in decision making between these two therapies and assist providers in integrating shared decision making the within the multidisciplinary heart valve team.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 21 years and older
Diagnosis of degenerative mitral valve regurgitation
Disqualifiers
Non-English speaking
Unable to consent on own behalf
Previous mitral surgery
Trial population
Patients with severe degenerative MR
Trial design
Other
Prospective
Treatments tested in this trial
Focus Groups/Quantitative Survey for Patients
Other intervention5 quantitative focus groups will be conducted with 5-10 patients each to elicit the range of outcomes patients consider important when selecting treatment options. 100 quantitative surveys to characterize how patients with severe MR prioritize outcomes when making treatment decisions.
Focus Group/Quantitative Survey for HCPs
Other intervention5 quantitative focus groups will be conducted with 5-10 providers to elicit the range of outcomes providers consider important when recommending treatment options to patients. 100 quantitative surveys to characterize how providers prioritize outcomes for patients with severe MR when making treatment recommendations.
Qualitative Focus Group
Other interventionQualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.
Treatment groups
Trial outcomes
Primary outcomes
Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR
The investigators will conduct qualitative focus groups among patients with severe degenerative MR to elicit the range of outcomes patients consider important when selecting treatment options. These data will be analyzed to develop a consolidated framework of outcomes patients value. Using these data, the investigators will then create and administer a quantitative survey to characterize how patients with severe MR prioritize outcomes when making treatment decisions.
Identify outcomes most important to healthcare providers (HCPs) in recommendingTEER or MVR
The investigators will conduct qualitative focus groups among cardiac surgeons, referring cardiologists, interventional cardiologists who perform TEER, and nurses involved in the care of patients with degenerative MR to characterize outcomes important to HCPs when evaluating MVR versus TEER. Using similar methods as above, the investigators will then use these data to create and administer a quantitative point allocation survey to characterize how HCPs prioritize outcomes when evaluating treatment options for severe degenerative MR patients.
Identify barriers and facilitators to implementing shared decision making (SDM) in multidisciplinary mitral valve Heart Teams
To support the future implementation of SDM, the investigators will evaluate the process of introducing SDM into local Heart Teams by conducting qualitative interviews across HCP stakeholders. Key stakeholders will include multidisciplinary groups of HCPs, ancillary staff, and administrators. These data will be used to map workflows and identify the optimal timing and process of integrating SDM in clinical care. In addition to generating process maps, an understanding of the implementation barriers and facilitators will aid in developing an approach to create and test an implementation strategy for SDM in severe degenerative MR.
Sponsors and contacts
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Northwell Health
Lead sponsor
West Virginia University
Collaborator
Cedars-Sinai Medical Center
Collaborator
The Cleveland Clinic
Collaborator
University of Kansas Medical Center
Collaborator
Saint Luke's Mid America Heart Institute
Collaborator