Patients with atrial fibrillation (AF) are often ill-equipped for shared decision-making. This study investigated the effects of a patient empowerment care model on patient-reported health outcomes and treatment decision-making in patients with AF. This randomized controlled trial prospectively randomized patients with AF to receive standard care (n=194) or a 13-week nurse-led multicomponent behavioral activation intervention (n=198). The intervention consisted of risk profile assessments, empowered shared decision-making regarding the use of oral anticoagulants (OACs), empowered AF self-management, and increased access to professional advice. The primary outcome was health-related quality of life measured after the completion of the intervention (T1), while the secondary outcomes were patient-physician decision concordance regarding OAC use, actual OAC use, AF knowledge, medication adherence, anxiety, and depression. The intervention group showed significantly greater improvements in health-related quality of life (β, -6.702 [95% CI, -9.556 to -3.847]; P<0.001), AF knowledge (β, -1.989 [95% CI, -2.342 to -1.635]; P<0.001), and medication adherence (β, 0.340 [95% CI, 0.148-0.532]; P<0.001) at immediate post-intervention compared with the control group, and the improvements were sustained at 6 months for all outcomes. A higher proportion of patients in the intervention group were prescribed an OAC compared with the control group at 6 months (odds ratio, 5.870 [95% CI, 1.957-12.331]; P=0.012). No significant between-group differences were detected for patient-physician decision concordance regarding OAC use, anxiety, or depression at both time points. The nurse-led multicomponent behavioral activation intervention improved patient-reported outcomes and increased OAC prescription among patients with AF.
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