Promoting Shared Decision Making for Severe Aortic Stenosis

Study Overview
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Brief Summary
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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
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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 stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1400 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.

Official Title
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PCORI-CDR-2022C1-26333 Promoting Shared Decision Making for Decisions About Treatment of Severe Aortic Stenosis (IMPACT SDM Study)

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Behavioral: Decision Aid
* Behavioral: Shared Decision Making Skills Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 65-85 years of age Language is English or Spanish Diagnosed with severe aortic stenosis (aortic valve area <1cm2) Attend Visit with Heart Valve Team physician(s) Exclusion Criteria: Prior aortic valve replacement surgery High surgical risk (determined by clinician or defined as Society of Thoracic Surgery score >8%) 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)

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (usual care)<br>This group will receive usual care without any support for using the decision aid and without any access to the clinician training. | |
| Active Comparator: Intervention<br>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 | Behavioral: Decision Aid<br>* The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery<br>Behavioral: Shared Decision Making Skills Training<br>* 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shared Decision Making | Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred. | About 1 week post visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach | % of eligible patients who receive decision aid | About 1 week post visit | 
| Patient Knowledge | Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge | About 1 week post visit | 
| Preference-treatment concordance | % of patients who received preferred treatment within 6 months of visit | About 1 week post visit | 
| Patient experience | CAHPS MD-patient communication subscale and visit rating score | About 1 week post visit | 
| Clinician satisfaction | % of clinicians who mark very or extremely satisfied with visit | About 1 week post visit | 
| Adoption | % of eligible clinicians who complete the shared decision making skills training | 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 | About 1 week post visit | 
| Timeliness (burden) | % of visits where clinicians report visit length is longer than normal | About 1 week post visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve stenosis, Decision Making, Shared, decision aid, continuing medical education, cardiology, Transcatheter Aortic Valve Replacement