Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorNorthwell Health

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Focus Groups/Quantitative Survey for Patients

    Other intervention

    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

    Other intervention

    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

    Other intervention

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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Patients with MR1 intervention
Group B: Health Care Providers1 intervention
Group C: Multidisciplinary Mitral Valve Heart Team1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year
3

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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