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.
The goal of this study is to promote 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? 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
1,300
The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery
60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies
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
Shared Decision Making
Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred.
Time frame: About 1 week post visit
Reach
% of eligible patients who receive decision aid
Time frame: About 1 week post visit
Patient Knowledge
Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge
Time frame: About 1 week post visit
Preference-treatment concordance
% of patients who received preferred treatment within 6 months of visit
Time frame: About 1 week post visit
Patient experience
CAHPS MD-patient communication subscale and visit rating score
Time frame: About 1 week post visit
Clinician satisfaction
% of clinicians who mark "very" or "extremely" satisfied with visit
Time frame: About 1 week post visit
Adoption
% of eligible clinicians who complete the shared decision making skills training
Time frame: 4 weeks from the start of intervention period for each site
Timeliness (time to decision)
% of patients who report stage of decision making is "made a decision"
Time frame: About 1 week post visit
Timeliness (burden)
% of visits where clinicians report visit length is "longer than normal"
Time frame: About 1 week post visit
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