Promoting Shared Decision Making for Severe Aortic Stenosis
NCT ID: NCT06171737
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
1300 participants
INTERVENTIONAL
2024-03-27
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
NCT04103931
Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
NCT03590730
Electronic Real-Time Heart Team Decision-making vs. Usual Care in Patients With Triple-Vessel Coronary Artery Disease and Diabetes Mellitus
NCT07326514
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
NCT01605669
Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis
NCT06706635
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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?
This study is a batched stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1300 patients. All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. The interventions include a patient decision aid that was created by the American College of Cardiology CardioSmart program and a online shared decision making skills training course for clinicians. The coordinating center will provide implementation support to sites when they transition to the intervention arm. Data collection is similar across usual care and intervention groups. Patient participants will complete surveys before and after their specialist visit. Clinician participants will be randomly selected to complete a survey after the patient visit. Limited clinical data will be collected from the medical record.
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. Researchers will also calculate percentage of patients reached with decision aids and percentage of clinicians who complete training at each site to measure the success of the implementation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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
Decision Aid
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
60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Decision Aid
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
60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Language is English or Spanish
* Diagnosed with severe aortic stenosis defined as (e.g. an aortic valve area \< 1 cm2 or as determined by clinician)
* Attend a scheduled visit with an Interventional Cardiologist and/or Cardiac Surgeon from the Heart Valve Team at a participating site
Exclusion Criteria
* High risk for either SAVR or TAVI (e.g., Society of Thoracic Surgery score \>8% or clinician determined)
* Prior coronary artery bypass surgery (CABG)
* End stage renal disease on dialysis
* Severe lung disease (chronic obstructive pulmonary disease; COPD) requiring home oxygen
* Advanced Cirrhosis
* Unable to consent for self (proxy respondents are not allowed)
65 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
University of Colorado, Denver
OTHER
University of North Carolina, Chapel Hill
OTHER
Emory University
OTHER
University of Pennsylvania
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Washington
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Karen Sepucha
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karen Sepucha, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Sammy Elmariah, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Regents of the University of California, San Francisco
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sepucha K, Elmariah S, Valentine KD, Cavender MA, Chang Y, Devireddy CM, Dickert NW, Gama KD, Knoepke CE, Korngold E, Kumbhani DJ, Matlock DD, Messenger JC, Strong S, Thourani VH, Nathan A, Quader N, Brescia AA. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) Study: study protocol for a cluster randomized stepped wedge trial. Trials. 2024 Dec 18;25(1):820. doi: 10.1186/s13063-024-08640-6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023P001413
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.