Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

Summary

This study will compare the effectiveness of the use of a Patient Decision Aid (PDA) and an Encounter Decision Aid (EDA) on Shared Decision Making (SDM) and health outcomes for at-risk participants with Atrial Fibrillation (AF) at 6 study sites. We hypothesize the combination of the PDA and EDA will be more effective in promoting high-quality SDM and in adoption of and adherence to anticoagulation than either tool alone.

Conditions

• Atrial Fibrillation

Interventions

OTHER

Patient Decision Aid

The Patient Decision Aid (PDA) is an interactive website designed for use by a participant without the need of their clinician present. It provides information about the atrial fibrillation diagnosis, possible treatments, the effect of this diagnosis on daily life, and how to prepare for a discussion about medications with a clinician. Participants may interact with the website by inputting their health information into the stroke risk calculator or answering questions about their values, goals, thoughts, etc. that they would like to discuss with their clinician.

OTHER

Encounter Decision Aid

The Encounter Decision Aid (EDA) is an interactive website designed for use by a participant and their clinician together. Together, the clinician and participant can go through the website together and input the participant's health information into the same stroke risk calculator also in the PDA. The EDA also provides information about the diagnosis of AF, living with this diagnosis, and possible treatments, and prompts discussion of how a participant's values affects these aspects of AF.

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• University of Utah

  lead OTHER

Principal Investigators

• Elissa Ozanne, PhD · University of Utah

• Angela Fagerlin, PhD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-16

Primary Completion

2024-09-20

Completion

2024-09-20

Countries

• United States

Study Locations