NCT06738537 · Northwell Health
Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse
(PRIMARY SDM)
What this study is about
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).
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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.
OTHER
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.
Primary outcome measures
Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR
Time frame: 1 year
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.
Identify outcomes most important to healthcare providers (HCPs) in recommendingTEER or MVR
Time frame: 1 year
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.
Identify barriers and facilitators to implementing shared decision making (SDM) in multidisciplinary mitral valve Heart Teams
Time frame: 1 year
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 21 years and older
- Diagnosis of degenerative mitral valve regurgitation
Exclusion criteria
- Non-English speaking
- Unable to consent on own behalf
- Previous mitral surgery
Where
- Los Angeles, California
- Kansas City, Missouri
- New York, New York
- Cleveland, Ohio
- Morgantown, West Virginia
Collaborators
West Virginia University, Cedars-Sinai Medical Center, The Cleveland Clinic, University of Kansas Medical Center, Saint Luke's Mid America Heart Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 17, 2024 · Source of record for eligibility and locations