Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse (PRIMARY SDM)

Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse (PRIMARY SDM)

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Prolapse
• Intervention / Treatment: Other: Focus Groups/Quantitative Survey for Patients; Other: Focus Group/Quantitative Survey for HCPs; Other: Qualitative Focus Group

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Nancy Stone, MEd, NBC-HWC; Phone Number: 816-932-5367; Email: nanstone@saint-lukes.org
• Study Contact Backup: Name: Shangyi Liu, MS; Phone Number: 516-757-5949; Email: sliu11@northwell.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Achille Peiris; Phone Number: 310-423-3277; Email: achille.peiris@cshs.org
      • Contact: Maria Thottam; Phone Number: 310-423-3277; Email: maria.thottam@cshs.org
      • Principal Investigator: Joanna Chickwe, MD
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Saint Luke's Hospital
      • Contact: Nancy Stone, MEd, NBC-HWC; Phone Number: 816-932-5367; Email: nanstone@saint-lukes.org
      • Principal Investigator: Stacy Farr, PhD
      • Contact: Christine Fuss, RN; Phone Number: 816-932-5363; Email: cfuss@saint-lukes.org
      • Sub-Investigator: Danielle Olds, PhD, RN
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Northwell Health
      • Contact: Shangyi Liu, MS; Phone Number: 516-757-5949; Email: sliu11@northwell.edu
      • Contact: Efstathia Mihelis, PA-C, MBA; Phone Number: 516-474-3745; Email: emihelis@northwell.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Principal Investigator: Marc Gillinov, MD
      • Contact: Mary Alice Bowman; Phone Number: 216-444-2200; Email: BOWMANM3@ccf.org
      • Contact: Laurie Ann Moennich; Phone Number: 216-444-2200
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University Medicine
      • Principal Investigator: Vinay Badhwar, MD
      • Contact: Josh Bombard; Phone Number: 304-598-4000; Email: josh.bombard@wvumedicine.org
      • Contact: Kimberly Quedado; Phone Number: 3045984000; Email: kq10006@wvumedicine.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe degenerative MR

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.
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; Qualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: The Cleveland Clinic; University of Kansas Medical Center; Cedars-Sinai Medical Center; West Virginia University; Saint Luke's Mid America Heart Institute
• Investigators: Principal Investigator: Alexander Iribarne, MD, MS, FACC, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): January 28, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: surgical mitral valve repair; transcatheter edge-to-edge repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Heart Valve Prolapse; Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: 23-0905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No