Evaluation of patient and encounter decision aid interventions for atrial fibrillation: Baseline characteristics of the RED-AF study - A Randomized Controlled Trial

the STEP-UP AF Writing Group

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation (RED-AF) trial is a multi-site, randomized controlled clinical trial examining the effectiveness of a patient decision aid and an encounter decision aid in promoting shared decision-making (SDM) during a clinical encounter for patients with atrial fibrillation (AF). We sought to describe baseline characteristics of patients and clinicians in the trial and compare them to the demographics of the larger AF population. We also conducted an analysis of possible predictors of attrition rates at baseline, 6 and 12 months. Methods: This study was a multi-center randomized controlled trial conducted at six academic centers across the U.S. Patients with non-valvular AF who qualify for anticoagulation therapy were eligible for enrollment. Patient demographics and characteristics were evaluated via questionnaires after their baseline clinical encounter. Participating clinicians completed demographic surveys, reporting educational background, specialty, and years of experience. Patient characteristics were analyzed via univariate logistic regression to identify potential trends among those lost to follow-up at each timepoint. Findings: A total of 1117 patients were enrolled in the RED-AF trial, with an average age of 69 (SD 9.3). Patients were predominantly male (61.7 %) and white (89.1 %), with 33.7 % reporting graduate or professional education. Clinicians (N = 107) were enrolled from specialties including cardiology (68.2 %), internal medicine (13.1 %), and pharmacy (14.0 %). No significant associations were found between any measured patient characteristics with survey completion at baseline, 6 or 12 months. Conclusion: The baseline demographics of the RED-AF trial reflect that patient participants were largely similar to prior studies investigating shared-decision making in patients with AF. The lack of association between patient demographics and attrition rates may highlight equity across the tested subgroups for survey completion for the study as a whole.

Original languageEnglish (US)
Article number107773
JournalContemporary Clinical Trials
Volume148
DOIs
StatePublished - Jan 2025

Funding

We would like to acknowledge and thank the following individuals who supported this project: Marie Bonebrake, Glenda Booker, Sherry Bowman, Jess Burns, Amanda Carroll, Emily Chen, Sherron Crook, Monika Do, Rachel Donegan, Morris Fabbri, Joanna Gupta Med, Adriana Guzman, Shiza Jeewa, Carly Martin, Carol Meisch, Spencer Moseley, Hadassah Pegues, Jamie Rich, Monica Schmidt, Kevin V. Shaw, Angela Sivly, Michele Straub, Terry Weyand, Shalonda Williams, Victoria Yusiric Northwestern University Feinberg School of Medicine study staff is supported by an AHA SFRN Grant Number: 18SFRN34250013 to Dr Rod S. Passman Vanderbilt University Medical Center study staff is supported by an AHA SFRN Grant Number: 18SFRN34110369/201 to Dr Dan Roden.

Keywords

  • Atrial fibrillation
  • Clinical trial
  • Decision aids
  • Randomized controlled trial
  • Shared decision-making

ASJC Scopus subject areas

  • Pharmacology (medical)

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