Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-23

Study Completion Date

2021-09-01

Brief Summary

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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).

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Detailed Description

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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

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomly assigned to receive the decision aid or usual care.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Patient Decision Aid

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

Group Type EXPERIMENTAL

"Treatment Choices for Aortic Stenosis" Decision Aid

Intervention Type BEHAVIORAL

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.

Interventions

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"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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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