Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse

NCT06738537 | Recruiting

• 1 other identifier: 23-0905
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Mitral Valve Prolapse

Keywords

transcatheter edge-to-edge repair; surgical mitral valve repair

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

Study Arms (3)

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.

Other: Focus Groups/Quantitative Survey for Patients

Health Care Providers

We will recruit Health Care providers (cardiac surgeons and cardiologists) who evaluate and treat patients with mitral regurgitation.

Other: Focus Group/Quantitative Survey for HCPs

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.

Other: Qualitative Focus Group

Interventions

Focus Groups/Quantitative Survey for Patients OTHER

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.

Patients with MR

Focus Group/Quantitative Survey for HCPs OTHER

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.

Health Care Providers

Qualitative Focus Group OTHER

Qualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.

Multidisciplinary Mitral Valve Heart Team

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe degenerative MR

You may qualify if:

• Age 21 years and older
• Diagnosis of degenerative mitral valve regurgitation

You may not qualify if:

• Non-English speaking
• Unable to consent on own behalf
• Previous mitral surgery

Sponsors & Collaborators

• Northwell Health: lead
• 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

Study Sites (5)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

RECRUITING

Northwell Health

New York, New York, 10075, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

West Virginia University Medicine

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Mitral Valve Prolapse

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexander Iribarne, MD, MS, FACC

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Stone, MEd, NBC-HWC

CONTACT

816-932-5367; nanstone@saint-lukes.org

Shangyi Liu, MS

CONTACT

516-757-5949; sliu11@northwell.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: December 17, 2024
• Study Start: September 1, 2023
• Primary Completion: January 28, 2024
• Study Completion: February 28, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

US (5)