Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Behavioral: "Treatment Choices for Aortic Stenosis" Decision Aid

• Registration Number: NCT04103931
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2019-09-23
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Decision Aid	"Treatment Choices for Aortic Stenosis" Decision Aid	Participants in this arm will receive the patient decision aid, titled "Treatment Choices for Aortic Stenosis" to review.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Treatment Preference	About 1 week after receiving the decision aid	Patients will indicate their preferred treatment (TAVR, surgery, or unsure)
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 received	12-21 weeks post visit	Chart review will determine type of treatment received (e.g. TAVR, SAVR, other)

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Colorado Denver I Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States