Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision‐Making Pathway

Abstract

Background Oral anticoagulation reduces stroke and disability in atrial fibrillation (AF) but is underused. We evaluated the effects of a novel patient‐clinician shared decision‐making (SDM) tool in reducing oral anticoagulation patient's decisional conflict as compared with usual care. Methods and Results We designed and evaluated a new digital decision aid in a multicenter, randomized, comparative effectiveness trial, ENHANCE‐AF (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention). The digital AF shared decision‐making toolkit was developed using patient‐centered design with clear health communication principles (eg, meaningful images, limited text). Available in English and Spanish, the toolkit included the following: (1) a brief animated video; (2) interactive questions with answers; (3) a quiz to check on understanding; (4) a worksheet to be used by the patient during the encounter; and (5) an online guide for clinicians. The study population included English or Spanish speakers with nonvalvular AF and a CHA 2 DS 2 ‐VASc stroke score ≥1 for men or ≥2 for women. Participants were randomized in a 1:1 ratio to either usual care or the shared decision‐making toolkit. The primary end point was the validated 16‐item Decision Conflict Scale at 1 month. Secondary outcomes included Decision Conflict Scale at 6 months and the 10‐item Decision Regret Scale at 1 and 6 months as well as a weighted average of Mann–Whitney U ‐statistics for both the Decision Conflict Scale and the Decision Regret Scale. A total of 1001 participants were enrolled and followed at 5 different sites in the United States between December 18, 2019, and August 17, 2022. The mean patient age was 69±10 years (40% women, 16.9% Black, 4.5% Hispanic, 3.6% Asian), and 50% of participants had CHA 2 DS 2 ‐VASc scores ≥3 (men) or ≥4 (women). The primary end point at 1 month showed a clinically meaningful reduction in decisional conflict: a 7‐point difference in median scores between the 2 arms (16.4 versus 9.4; Mann–Whitney U ‐statistics=0.550; P =0.007). For the secondary end point of 1‐month Decision Regret Scale, the difference in median scores between arms was 5 points in the direction of less decisional regret ( P =0.078). The treatment effects lessened over time: at 6 months the difference in medians was 4.7 points for Decision Conflict Scale ( P =0.060) and 0 points for Decision Regret Scale ( P =0.35). Conclusions Implementation of a novel shared decision‐making toolkit ( afibguide.com ; afibguide.com/clinician ) achieved significantly lower decisional conflict compared with usual care in patients with AF. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04096781.