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, patient-clinician 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 physician-patient communication but did not change treatment.