Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

Mass General Brigham

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Behavioral: "Treatment Choices for Aortic Stenosis" Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04103931

2017P001883

Details and patient eligibility

About

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).

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Participants will receive usual care and will not get the decision aid to review.

Patient Decision Aid

Experimental group

Description:

Participants in this arm will receive the patient decision aid, titled "Treatment Choices for Aortic Stenosis" to review.

Treatment:

Behavioral: "Treatment Choices for Aortic Stenosis" Decision Aid