Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103931
• Other study ID #: 2017P001883
• Status: Completed
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Denver I Anschutz Medical Campus	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SURE scale	The 4 item SURE scale will measure decisional conflict and the percent with the top score (4 out of 4) will be reported	About 1 week after receiving the decision aid
Other	CollaboRATE scale	The 3 item Collaborate scale will be scored and the percent receiving the top score (27 out of 27) will be reported	About 1 week after the visit
Primary	Knowledge score	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.	About 1 week after receiving the decision aid
Secondary	Shared Decision Making Process score	Items from the SDM Process survey will be summed to create a total score (0-4) with higher scores indicating more shared decision making.	About 1 week after receiving the decision aid
Secondary	Treatment Preference	Patients will indicate their preferred treatment (TAVR, surgery, or unsure)	About 1 week after receiving the decision aid
Secondary	Treatment received	Chart review will determine type of treatment received (e.g. TAVR, SAVR, other)	12-21 weeks post visit