NCT04103931

Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
BEHAVIORAL	"Treatment 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.

Timeline

• Start date: 2019-09-23
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2019-09-26
• Last updated: 2022-01-05

Locations

2 sites across 1 country: United States