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A Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. Journal of the American Heart Association Wang, P. J., Lu, Y., Mahaffey, K. W., Lin, A., Morin, D. P., Sears, S. F., Chung, M. K., Russo, A. M., Lin, B., Piccini, J., Hills, M. T., Berube, C., Pundi, K., Baykaner, T., Garay, G., Lhamo, K., Rice, E., Pourshams, I. A., Shah, R., Newswanger, P., DeSutter, K., Nunes, J. C., Albert, M. A., Schulman, K. A., Heidenreich, P. A., Bunch, T. J., Sanders, L. M., Turakhia, M., Verghese, A., Stafford, R. S. 2022: e8009

Abstract

Background Oral anticoagulation (OAC) reduces stroke and disability in atrial fibrillation (AF) but is underutilized. We evaluated the effects of a novel patient-clinician shared decision-making (SDM) tool in reducing OAC patient's decisional conflict as compared to 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 SDM Toolkit was developed using patient-centered design with clear health communication principles (e.g. 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 non-valvular AF and a CHA2DS2-VASc stroke score =1 for men or =2 for women. Participants were randomized in a 1:1 ratio to either Usual Care (UC) or the SDM Toolkit. The primary endpoint was the validated 16-item Decisional Conflict Scale (DCS) at 1 month. Secondary outcomes included DCS at 6 months and the 10-item Decision Regret Scale (DRS) at 1 and 6 months as well as a weighted average of Mann-Whitney U-statistics for both DCS and DRS. A total of 1001 participants were enrolled and followed at 5 different sites in the United States between 12/18/19 and 8/17/22. The mean patient age was 69 ±10years (40% females, 16.9% Black, 4.5% Hispanic, 3.6% Asian), and 50% of participants had CHA2DS2-VASc scores =3 (M) or =4 (F). The primary endpoint at 1 month showed a clinically meaningful reduction in decisional conflict: a 7-point difference in median scores between the two arms (16.4 v 9.4; Mann-Whitney U-statistics=0.550; p-value=0.007). For the secondary endpoint of 1-month DRS, the difference in median scores between arms was 5 points in the direction of less decisional regret (p-value of 0.078). The treatment effects lessened over time: at 6 months the difference in medians was 4.7 points for DCS (p-value=0.060) and 0 points for DRS (p-value=0.35). Conclusions Implementation of a novel, Shared Decision-Making Toolkit (afibguide.com; afibguide.com/clinician) achieved significantly lower decisional conflict compared to usual care in patients with AF.

View details for DOI 10.1161/JAHA.122.028562

View details for PubMedID 36342828