Actively Recruiting

Age: 21Years +
All Genders
ID06738537

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

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years and older
  • Diagnosis of degenerative mitral valve regurgitation
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Qualitative and Quantitative Surveys

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

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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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