An observational study in Mitral Valve Prolapse, sponsored by Northwell Health. Recruiting at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Northwell Health · Observational
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.
Prior qualitative research in decision-making related to heart valve disease has occurred largely in transcatheter aortic valve replacement (TAVR). Among patients undergoing TAVR, physicians estimate patients' symptoms and functional status poorly both before and after treatment. Prior studies have shown that significant variability exists in outcomes most important to patients versus those most important to providers. Specifically, providers may place greater emphasis on clinical endpoints such as mortality or echocardiographic improvement in valve function whereas patients often place greater emphasis on quality-of-life outcomes such as having greater independence, feeling better, and being able to return to daily activities.
These disparities between patient and provider preference in outcomes in TAVR highlight the importance of prospectively measuring patient and provider preferences in outcomes of transcatheter edge-to-edge repair (TEER) and surgical mitral valve repair (MVR), which share similar tradeoffs in decision-making. The ongoing Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) trial will compare TEER to MVR in patients with primary, degenerative MR. To allow for the creation of a decision aid that can be utilize simultaneously with completion of the parent clinical trial, the investigators seek to conduct a quantitative and quality study of patient and physician factors that influence decision-making in TEER versus MVR for degenerative mitral regurgitation.
This study will consist of prospectively conducted qualitative focus groups among patients and providers (surgeons and cardiologists) to elicit the range of outcomes when considering TEER or MVR. These data will be analyzed to develop a consolidated framework of outcomes patients and providers value. Using these data, the investigators will then create and administer a quantitative survey to characterize how patients with severe MR and their providers prioritize outcomes when making treatment decisions and recommendations. The survey will include an allocation task whereby participants will be presented with a set of alternative treatment outcomes from the qualitative surveys and components of the PRIMARY composite endpoint and asked to allocate a total of 100 points across these outcomes based on their preferences. Lastly, the investigators will identify barriers and facilitators for implementing shared decision making (SDM) in multidisciplinary mitral valve hear teams by conducting qualitative focus groups across health care provider stakeholders (e.g. surgeons, cardiologists, nurses in office). 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. Collectively, these aims lay the foundation for developing and implementing a patient centered decision aid to support SDM in the future, but also model a novel approach for implementing the results of PRIMARY into routine clinical care.
47 studies on the registry are indexed under Mitral Valve Prolapse; 11 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 25 observational studies indexed under Mitral Valve Prolapse.
Browse Mitral Valve Prolapse studies →Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with severe degenerative MR
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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.
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 groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.
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
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
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
Plan to share: Undecided
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