Clinical trial NCT06738537: Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse
Official title: Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse (PRIMARY SDM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Prolapse
Keywords: transcatheter edge-to-edge repair
surgical mitral valve repair
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: West Virginia University
name: Cedars-Sinai Medical Center
name: The Cleveland Clinic
name: University of Kansas Medical Center
name: Saint Luke's Mid America Heart Institute
First posted: 2024-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe degenerative MR

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR
timeFrame: 1 year
measure: Identify outcomes most important to healthcare providers (HCPs) in recommendingTEER or MVR
timeFrame: 1 year
measure: Identify barriers and facilitators to implementing shared decision making (SDM) in multidisciplinary mitral valve Heart Teams
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: New York
country: United States
facility: Northwell Health
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Morgantown
country: United States
facility: West Virginia University Medicine
state: West Virginia
Study officials:
affiliation: Northwell Health
name: Alexander Iribarne, MD, MS, FACC
role: PRINCIPAL_INVESTIGATOR
References: