Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

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

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).

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Behavioral: "Treatment Choices for Aortic Stenosis" Decision Aid

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver I Anschutz Medical Campus
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants will receive usual care and will not get the decision aid to review.
Experimental: Patient Decision Aid; Participants in this arm will receive the patient decision aid, titled "Treatment Choices for Aortic Stenosis" to review.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Shared Decision Making
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2017P001883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study team will create a complete, cleaned, de-identified copy of the final data set.
• IPD Sharing Time Frame: The data will be made available to outside investigators starting 6 months after publication.
• IPD Sharing Access Criteria: Information about the data sets will be on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital (MGH)/ Mass General Brigham policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board (IRB) requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No