Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse
NCT ID: NCT06738537
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2023-09-01
2025-02-28
Brief Summary
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Detailed Description
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These disparities between patient and provider preference in outcomes in TAVR highlight the importance of prospectively measuring patient and provider preferences in outcomes of transcatheter edge-to-edge repair (TEER) and surgical mitral valve repair (MVR), which share similar tradeoffs in decision-making. The ongoing Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) trial will compare TEER to MVR in patients with primary, degenerative MR. To allow for the creation of a decision aid that can be utilize simultaneously with completion of the parent clinical trial, the investigators seek to conduct a quantitative and quality study of patient and physician factors that influence decision-making in TEER versus MVR for degenerative mitral regurgitation.
This study will consist of prospectively conducted qualitative focus groups among patients and providers (surgeons and cardiologists) to elicit the range of outcomes when considering TEER or MVR. These data will be analyzed to develop a consolidated framework of outcomes patients and providers value. Using these data, the investigators will then create and administer a quantitative survey to characterize how patients with severe MR and their providers prioritize outcomes when making treatment decisions and recommendations. The survey will include an allocation task whereby participants will be presented with a set of alternative treatment outcomes from the qualitative surveys and components of the PRIMARY composite endpoint and asked to allocate a total of 100 points across these outcomes based on their preferences. Lastly, the investigators will identify barriers and facilitators for implementing shared decision making (SDM) in multidisciplinary mitral valve hear teams by conducting qualitative focus groups across health care provider stakeholders (e.g. surgeons, cardiologists, nurses in office). 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. Collectively, these aims lay the foundation for developing and implementing a patient centered decision aid to support SDM in the future, but also model a novel approach for implementing the results of PRIMARY into routine clinical care.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients with MR
We will recruit patients with degenerative mitral regurgitation (MR) who are presenting to a surgeon or cardiologist for consultation regarding management of their valve disease.
Focus Groups/Quantitative Survey for Patients
5 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.
Health Care Providers
We will recruit Health Care providers (cardiac surgeons and cardiologists) who evaluate and treat patients with mitral regurgitation.
Focus Group/Quantitative Survey for HCPs
5 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.
Multidisciplinary Mitral Valve Heart Team
We will recruit members of multidisciplinary mitral valve heart teams including cardiac surgeons, cardiologists, nurses, and ancillary staff. These providers will be involved in caring for patients who presents to multidisciplinary heart teams for evaluation of their mitral valve disease.
Qualitative Focus Group
Qualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.
Interventions
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Focus Groups/Quantitative Survey for Patients
5 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
5 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
Qualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of degenerative mitral valve regurgitation
Exclusion Criteria
* Unable to consent on own behalf
* Previous mitral surgery
21 Years
ALL
No
Sponsors
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West Virginia University
OTHER
Cedars-Sinai Medical Center
OTHER
The Cleveland Clinic
OTHER
University of Kansas Medical Center
OTHER
Saint Luke's Mid America Heart Institute
UNKNOWN
Northwell Health
OTHER
Responsible Party
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Principal Investigators
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Alexander Iribarne, MD, MS, FACC
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Northwell Health
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
West Virginia University Medicine
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Achille Peiris
Role: primary
Maria Thottam
Role: backup
Nancy Stone, MEd, NBC-HWC
Role: primary
Christine Fuss, RN
Role: backup
Shangyi Liu, MS
Role: primary
Efstathia Mihelis, PA-C, MBA
Role: backup
Mary Alice Bowman
Role: primary
Laurie Ann Moennich
Role: backup
Josh Bombard
Role: primary
Kimberly Quedado
Role: backup
Other Identifiers
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23-0905
Identifier Type: -
Identifier Source: org_study_id