Aortic Valve Stenosis
Conditions
Keywords
Shared Decision Making
Brief summary
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
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.
Interventions
BEHAVIORALTreatment Choices for Aortic Stenosis Decision Aid
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.
Sponsors
University of Colorado, Denver
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Patients are randomly assigned to receive the decision aid or usual care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge score | About 1 week after receiving the decision aid | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making Process score | About 1 week after receiving the decision aid | Items from the SDM Process survey will be summed to create a total score (0-4) with higher scores indicating more shared decision making. |
| Treatment Preference | About 1 week after receiving the decision aid | Patients will indicate their preferred treatment (TAVR, surgery, or unsure) |
| Treatment received | 12-21 weeks post visit | Chart review will determine type of treatment received (e.g. TAVR, SAVR, other) |
Other
| Measure | Time frame | Description |
|---|---|---|
| SURE scale | About 1 week after receiving the decision aid | The 4 item SURE scale will measure decisional conflict and the percent with the top score (4 out of 4) will be reported |
| CollaboRATE scale | About 1 week after the visit | The 3 item Collaborate scale will be scored and the percent receiving the top score (27 out of 27) will be reported |
Countries
United States
Outcome results
None listed