Promoting Shared Decision Making for Severe Aortic Stenosis

Part of paid clinical trials in San Francisco, California.

Sponsor
Massachusetts General Hospital
Study ID
NCT06171737
Status
Enrolling By Invitation

Conditions

  • Aortic Stenosis

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Decision Aid — BEHAVIORAL
    The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery
  • Shared Decision Making Skills Training — BEHAVIORAL
    60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies

Study Details

The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: * Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations? * Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course? All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. Participants will complete surveys before and after their specialist visit. Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions.

Key Dates

Start date
Mar 27, 2024
Status verified
Jun 2025
Primary completion
May 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
1,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Control (usual care)
    This group will receive usual care without any support for using the decision aid and without any access to the clinician training.
  • Active Comparator: Intervention
    The patients in this group will receive a decision aid that covers the main treatment options for aortic stenosis. The clinicians in this group will receive a 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies

Primary Outcome Measure

Shared Decision Making [ Time Frame: About 1 week post visit ]

Locations (8)

FacilityCityStateZIPSite coordinators
The Regents of the University of California, San FranciscoSan FranciscoCalifornia94117-
University of Colorado DenverAuroraColorado80045-7202-
Emory UniversityAtlantaGeorgia30308-0000-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63110-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-1350-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
UT Southwestern Medical CenterDallasTexas75390-9020-

Find similar trials in San Francisco, CA

By research site
The Regents of the University of California, San Francisco· San Francisco, CAUniversity of Colorado Denver· Aurora, COEmory University· Atlanta, GAMassachusetts General Hospital· Boston, MAWashington University School of Medicine· St Louis, MOThe University of North Carolina at Chapel Hill· Chapel Hill, NC

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