Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

Study Overview
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Brief Summary
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This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR).

Detailed Description
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The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recruit patients at Massachusetts General Hospital or at the University of Colorado Health Heart and Vascular Center, Anschutz Medical in Denver, Colorado and randomly assign them to usual care arm or decision aid arm. The decision aid will be given to the participant in clinic at the time of their appointment. Patient participants in both arms will be asked to complete a short survey after the visit. The survey will assess knowledge, treatment preference, shared decision making (SDM), and decisional conflict. Analyses will compare the two arms on these outcomes to generate preliminary data on impact of the intervention.

Official Title
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Pilot Randomized Trial of a Patient Decision Aid for Treatment of Aortic Stenosis

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Behavioral: Treatment Choices for Aortic Stenosis Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-85 years only English speaking Severe aortic stenosis, defined as an aortic valve area < 1 cm2 Never had AVR or who had previous AVR > 6 months previous Patients perceived by the clinician to be at low or intermediate risk for SAVR Exclusion Criteria: Concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Interventional Model Description: Patients are randomly assigned to receive the decision aid or usual care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants will receive usual care and will not get the decision aid to review. | |
| Experimental: Patient Decision Aid<br>Participants in this arm will receive the patient decision aid, titled Treatment Choices for Aortic Stenosis to review. | Behavioral: Treatment Choices for Aortic Stenosis Decision Aid<br>* A decision aid, titled Treatment Choices for Aortic Stenosis, produced by the American College of Cardiology that contains information for patients deciding between TAVR and surgery to treat their aortic stenosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge score | Patients will complete 6 multiple choice knowledge items and a total knowledge score (0-100%) will be created by summing the number of correct responses and dividing by the number of items. | About 1 week after receiving the decision aid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shared Decision Making Process score | Items from the SDM Process survey will be summed to create a total score (0-4) with higher scores indicating more shared decision making. | About 1 week after receiving the decision aid | 
| Treatment Preference | Patients will indicate their preferred treatment (TAVR, surgery, or unsure) | About 1 week after receiving the decision aid | 
| Treatment received | Chart review will determine type of treatment received (e.g. TAVR, SAVR, other) | 12-21 weeks post visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared Decision Making