A Pilot Randomized Controlled Trial of a Decision Support Tool to Improve the Quality of Communication and Decision-Making in Individuals with Atrial Fibrillation

Objectives To design a tool for nonvalvular atrial fibrillation (NVAF) to inform individuals of their individual stroke and bleeding risks, assist in clarifying priorities, and promote communication. Design Clustered randomized controlled trial. Setting Primary care clinics. Participants Individuals with NVAF (N = 135). Intervention Completion of tool before regularly scheduled visit. Measurements Primary outcomes included the 100-point informed and values clarity subscales of the decisional conflict scale (lower scores indicate individual is more informed and has greater clarity). Secondary outcomes included knowledge, patientclinician communication, and change in treatment. Results Sixty-nine individuals were enrolled in the intervention group and 66 in the control group. After their visit, intervention participants had lower scores on the informed (mean difference = -11.9, 95% confidence interval (CI) = -21.1 to -2.7) and values clarity subscales (mean difference = -14.6, 95% CI = -22.6 to -6.6). Greater proportions of intervention participants knew medications for reducing stroke risk (61% vs 31%, P < .001) and side effects (49% vs 37%, P = .07). Stroke (71% vs 12%) and bleeding risk (69% vs 20%) were discussed more frequently in the intervention than control group (P < .001). Five intervention participants expressed a preference for medication that was not concordant with their current treatment plan. There was no change in treatment plan in either group. Conclusion The tool was effective in improving perceived and actual knowledge and values clarity and in increasing physicianpatient communication but did not change treatment.