Clinical trial NCT04103931: Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
Official title: Pilot Randomized Trial of a Patient Decision Aid for Treatment of Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Shared Decision Making
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2019-09-26
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomly assigned to receive the decision aid or usual care.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge score
timeFrame: About 1 week after receiving the decision aid
Secondary outcomes:
measure: Shared Decision Making Process score
timeFrame: About 1 week after receiving the decision aid
measure: Treatment Preference
timeFrame: About 1 week after receiving the decision aid
measure: Treatment received
timeFrame: 12-21 weeks post visit
Other outcomes:
measure: SURE scale
timeFrame: About 1 week after receiving the decision aid
measure: CollaboRATE scale
timeFrame: About 1 week after the visit
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver I Anschutz Medical Campus
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen R Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References: