RED-AF: Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

Project: SFRN

Investigators

  • Elissa M Ozanne (PI)

Description

Chronic nonvalvular atrial fibrillation (AF) is the most common cardiac arrhythmia and an important public health issue affecting up to 3 million U.S. patients annually. AF poses a high risk for morbidity and mortality - namely, an increased risk of thromboembolic stroke. Anticoagulants are effective stroke prevention treatments; however, uptake in patients with AF remains inadequate. Anticoagulation underuse results from challenges patients face in understanding and incorporating these treatments into their daily lives and clinicians face in prescribing these drugs.As a result of these challenges, the AHA and related societies formulated a Class I recommendation to use shared decision making (SDM) for the individualization of anticoagulation therapy in at-risk patients with AF. However, there are no proven methods to improve SDM between patients and their clinicians, and no evidence regarding the impact of SDM on the challenge of initiating and implementing anticoagulation.The positive impact of SDM interventions has been shown in many clinical contexts. They have been found to improve the quality of SDM, patient and provider satisfaction, and treatment outcomes across a wide variety of health conditions and treatment contexts. The most common types of SDM interventions are patient decision aids and encounter decision aids. These two types of tools vary in their depth, their targeted end user (clinician or patient), and the context in which they're used. While both approaches are effective, no studies have directly compared them or a combination of approaches. Informed by our previous research in the development and evaluation of decision aids, including one for AF, we plan to address this evidence gap. We propose a multi-site randomized trial in patients with chronic nonvalvular AF considered to be at high thromboembolic stroke risk (CHA2DS2-VASc score >1, or 2 in women). The study will compare the effectiveness of three approaches - an encounter-based tool alone, a patient-facing decision aid alone, and both tools combined. Trial outcomes include the quality of SDM (primary endpoint, Aim 1), anticoagulation adoption rate, and patient adherence to anticoagulation (Aim 2). The comparative effectiveness of these approaches within patient subgroups will also be explored (Aim 3). If successful, this work will reduce the underuse of anticoagulation therapy and improve the care and outcomes of millions of patients with AF.
Award amount$3,578,569.00
Award date07/01/2018
Program typeStrategically Focused Research Network
Award ID18SFRN34230142
Effective start/end date07/01/201806/30/2022
StatusActive