Aortic Stenosis
Conditions
Keywords
aortic valve stenosis, Decision Making, Shared, decision aid, continuing medical education, cardiology, Transcatheter Aortic Valve Replacement
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.
Interventions
BEHAVIORALDecision Aid
The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery
BEHAVIORALShared 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
University of California, San Francisco
University of Colorado, Denver
University of North Carolina, Chapel Hill
Emory University
University of Pennsylvania
University of Texas Southwestern Medical Center
University of Washington
Patient-Centered Outcomes Research Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
There is limited blinding in the trial due to the pragmatic focus and batched stepped wedge design. Patients will be told that the study is testing different types of decision support and while they will not be blinded to the materials they receive, they will not know what materials other patients receive. Clinicians and staff will be involved in delivery of the decision aids and will not be blinded to the study arm. Research staff entering survey data and conducting chart review will not be given any explicit information about study assignment; however, it is likely that they will have a sense for the arm due to the timing. The statistician conducting analyses will be blinded to group assignment at each step. For the clinician survey, we will use computer generated random assignment to select one specialist (either interventional cardiologist or cardiac surgeon) to receive the post-visit survey for each patient participant.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Prior aortic valve replacement surgery * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Reach | About 1 week post visit | % of eligible patients who receive decision aid |
| 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 |
| Clinician satisfaction | About 1 week post visit | % of clinicians who mark very or extremely satisfied with visit |
Countries
United States
Outcome results
None listed