Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial

Abstract

Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision-making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter-level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Keywords: adherence; anticoagulation; atrial fibrillation; communication; conversation aid; decision aid; shared decision‐making.

Figure 1. Flow diagram, demonstrating patient enrollment and available follow‐up data.

Anticoag indicates anticoagulation; and DOAC, direct oral anticoagulant.

Figure 2. Kaplan‐Meier curves, demonstrating the time to start anticoagulation after the initial prescription by arm (A) and the time on anticoagulation (secondary adherence) by arm (B).

Figure 3. Alluvial plot, demonstrating the evolution of anticoagulation fills and adherence before enrollment and after exposure, by trial arm.

Primary adherence reflects a prescription fill after the index visit, whereas secondary adherence reflects the percentage days covered (for patients on a direct oral anticoagulant) and time in therapeutic range (for patients on warfarin). Patients fell in the not applicable (N/A) category for secondary adherence if they did not have ≥30 days of coverage by medication fills or international normalized ratio values. AC indicates Anticoagulation Choice (shared decision‐making tool); Rx, prescription; and UC, usual care.