Promoting Shared Decision Making for Severe Aortic Stenosis
- Conditions
- Aortic Stenosis
- Interventions
- Behavioral: Decision AidBehavioral: Shared Decision Making Skills Training
- Registration Number
- NCT06171737
- Lead Sponsor
- Massachusetts General Hospital
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1300
- Between 65-85 years of age
- 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
- Prior aortic valve replacement surgery
- Surgical risk (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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention Decision Aid 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 Intervention Shared Decision Making Skills Training 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
- Primary Outcome Measures
Name Time Method Shared Decision Making About 1 week post visit Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred.
- Secondary Outcome Measures
Name Time Method Reach About 1 week post visit % of eligible patients who receive decision aid
Patient Knowledge About 1 week post visit Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge
Preference-treatment concordance About 1 week post visit % of patients who received preferred treatment within 6 months of visit
Patient experience About 1 week post visit CAHPS MD-patient communication subscale and visit rating score
Clinician satisfaction About 1 week post visit % of clinicians who mark "very" or "extremely" satisfied with visit
Adoption 4 weeks from the start of intervention period for each site % of eligible clinicians who complete the shared decision making skills training
Timeliness (time to decision) About 1 week post visit % of patients who report stage of decision making is "made a decision"
Timeliness (burden) About 1 week post visit % of visits where clinicians report visit length is "longer than normal"
Trial Locations
- Locations (8)
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
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
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States