Shared Decision Making for Aortic Stenosis
(IMPACT SDM Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Decision Aid, PrEP Decision Aid, eHealth for Integrated PrEP and MOUD, Shared Decision Making Skills Training for Aortic Stenosis?
Research shows that shared decision-making (a process where doctors and patients make decisions together) can help align treatment with patient goals, especially in severe aortic stenosis where quality of life is a priority. However, shared decision-making is not yet common practice, and more knowledge is needed to effectively implement it in treatment decisions for older patients with this condition.12345
Is shared decision making safe for patients?
How does shared decision making differ from other treatments for aortic stenosis?
Shared decision making (SDM) is unique because it involves patients actively in the decision process about their treatment options, ensuring that their personal goals and preferences are considered. Unlike traditional approaches where decisions are often made solely by healthcare professionals, SDM encourages collaboration and the use of decision aids to align treatment with what matters most to the patient.12359
What is the purpose of this trial?
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.
Research Team
Sammy Elmariah, MD
Principal Investigator
University of California, San Francisco
Karen Sepucha, PhD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for patients with severe aortic stenosis who are considering treatment options. To participate, individuals must be at a stage where they're discussing potential treatments. The study excludes those who have already made their treatment decision or cannot give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Usual Care
Participants receive usual care without decision aids or clinician training
Intervention
Participants receive decision aids and clinicians undergo shared decision making training
Follow-up
Participants are monitored for shared decision making outcomes and other secondary measures
Treatment Details
Interventions
- Decision Aid
- Shared Decision Making Skills Training
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
University of Texas
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Providence Health & Services
Collaborator
University of California, San Francisco
Collaborator
Piedmont Healthcare
Collaborator
University of Colorado, Denver
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Emory University
Collaborator
University of Pennsylvania
Collaborator