CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,117 enrolled
Drug / intervention
Patient Decision Aid +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04357288
NCT04357288N/ACompleted
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Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

University of Utah·interventional·Posted Apr 22, 2020·Updated Jan 8, 2025

In Brief

A clinical study evaluating Patient Decision Aid and Encounter Decision Aid for Atrial Fibrillation. Completed, enrolled 1,117 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
CollaboratorsAmerican Heart Association, Patient-Centered Outcomes Research Institute, Mayo Clinic, Northwestern University, Vanderbilt University, University of Michigan, University of Alabama at Birmingham

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 22, 2020
Enrollment StartDec 16, 2020
Primary CompletionSep 20, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.2 years ago

Interventions

Patient Decision Aidother

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.

Encounter Decision Aidother

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.