Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

Massachusetts General Hospital67 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

"Treatment Choices for Aortic Stenosis" Decision AidBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Colorado Denver I Anschutz Medical Campus

Aurora, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: About 1 week after receiving the decision aid

Secondary Outcomes

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.

Time frame: About 1 week after receiving the decision aid

Treatment Preference

Patients will indicate their preferred treatment (TAVR, surgery, or unsure)

Time frame: About 1 week after receiving the decision aid

Treatment received

Chart review will determine type of treatment received (e.g. TAVR, SAVR, other)

Time frame: 12-21 weeks post visit

Data from ClinicalTrials.gov

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