Promoting Shared Decision Making for Severe Aortic Stenosis

NCT06171737 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2025-06-08

No results posted yet for this study

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
  • University of Pennsylvania

    collaborator OTHER
  • University of Texas Southwestern Medical Center

    collaborator OTHER
  • University of Washington

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06171737 on ClinicalTrials.gov