Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway

Area of Science:

• Cardiology
• Health Communication
• Medical Informatics

Background:

• Oral anticoagulation is vital for stroke prevention in atrial fibrillation (AF) but faces underutilization.
• Patient decisional conflict contributes to the underuse of anticoagulation therapy in AF.
• Shared decision-making (SDM) is a promising approach to improve patient engagement and treatment adherence.

Purpose of the Study:

• To evaluate the effectiveness of a novel digital SDM toolkit in reducing decisional conflict among AF patients.
• To compare the impact of the SDM toolkit versus usual care on patient decision-making regarding oral anticoagulation.
• To assess the influence of the SDM toolkit on decision regret in AF patients.

Main Methods:

• A multicenter, randomized comparative effectiveness trial (ENHANCE-AF) involving 1001 patients with nonvalvular AF.
• Development of a patient-centered digital SDM toolkit with animated videos, interactive questions, and clinician guides.
• Primary endpoint: 16-item Decision Conflict Scale at 1 month; Secondary endpoints: Decision Conflict Scale at 6 months, Decision Regret Scale at 1 and 6 months.

Main Results:

• The SDM toolkit arm showed a significant reduction in decisional conflict at 1 month (7-point difference, P=0.007).
• A trend towards reduced decisional regret was observed at 1 month (P=0.078).
• Treatment effects on decisional conflict diminished by 6 months (4.7-point difference, P=0.060), with no significant difference in decision regret.

Conclusions:

• The novel digital SDM toolkit effectively lowered decisional conflict in AF patients compared to usual care.
• The toolkit facilitates informed decision-making for oral anticoagulation in AF.
• While initial benefits are significant, sustained effects require further investigation.