Promoting Shared Decision Making for Severe Aortic Stenosis
NCT06171737 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300
Last updated 2025-06-08
Summary
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.
Conditions
- Aortic Stenosis
Interventions
- BEHAVIORAL
-
Decision Aid
The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery
- BEHAVIORAL
-
Shared Decision Making Skills Training
60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies
Sponsors & Collaborators
-
University of California, San Francisco
collaborator OTHER -
University of Colorado, Denver
collaborator OTHER -
University of North Carolina, Chapel Hill
collaborator OTHER -
Emory University
collaborator OTHER - collaborator OTHER
-
University of Texas Southwestern Medical Center
collaborator OTHER - collaborator OTHER
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Karen Sepucha, PhD · Massachusetts General Hospital
-
Sammy Elmariah, MD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 65 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-27
- Primary Completion
- 2027-05-31
- Completion
- 2027-10-31
Countries
- United States
Study Locations
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