Actively Recruiting
Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse (PRIMARY SDM)
Led by Northwell Health · Updated on 2024-12-17
150
Participants Needed
5
Research Sites
56 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
W
West Virginia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a study to understand the decision-making process for patients with degenerative mitral valve prolapse who must choose between surgical mitral valve repair (MVR) and transcatheter edge-to-edge repair (TEER). This study focuses on gathering information from both patients and healthcare providers about the outcomes that matter most to them. The goal is to develop tools that support shared decision making within heart valve care teams, helping patients and providers make informed choices together. The study involves qualitative focus groups and quantitative surveys. Patients with severe mitral regurgitation and healthcare providers such as cardiac surgeons and cardiologists will participate in focus groups to discuss important treatment outcomes. Following this, surveys will assess how patients and providers prioritize these outcomes. Additionally, focus groups with multidisciplinary heart valve teams will explore challenges and supports for shared decision making in clinical care. Participants will engage in discussions and complete surveys that explore their preferences and priorities regarding treatment outcomes. Researchers will analyze these data to identify key factors influencing decision making and to map workflows for integrating shared decision making in practice. The study aims to identify important outcome measures and barriers to shared decision making over a one-year period, providing insights to improve patient-centered care for mitral valve prolapse.
CONDITIONS
Brief Title
Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years and older
- Diagnosis of degenerative mitral valve regurgitation
You will not qualify if you...
- Non-English speaking
- Unable to consent on own behalf
- Previous mitral surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants take part in focus groups and complete surveys to identify outcomes important for treatment decisions in mitral valve prolapse and to understand barriers and facilitators to shared decision making in clinical care.
5 focus group sessions and 1 survey completion
Trial Site Locations
Total: 5 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Actively Recruiting
3
Northwell Health
New York, New York, United States, 10075
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
West Virginia University Medicine
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
N
Nancy Stone, MEd, NBC-HWC
S
Shangyi Liu, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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