Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled...

Area of Science:

• Cardiology
• Health Services Research
• Patient Decision Aids

Background:

• Nonvalvular atrial fibrillation (AF) poses a significant stroke risk.
• Individualized treatment decisions are crucial for managing AF-related stroke risk.
• Shared decision-making (SDM) is recommended to align treatment with patient values.

Purpose of the Study:

• To assess the ANTICOAGULATION CHOICE conversation tool's impact on SDM quality in AF patients.
• To evaluate the tool's influence on anticoagulation uptake and adherence.
• To determine if the tool promotes patient-centered care in AF management.

Main Methods:

• Multicenter, randomized trial comparing the ANTICOAGULATION CHOICE tool to usual care.
• Inclusion of 999 patients with nonvalvular AF and stroke risk (CHA 2DS 2-VASc score 2206 1/2).
• Primary outcome: perceived SDM quality (knowledge transfer, concordance, communication, satisfaction); secondary outcomes: anticoagulant use, adherence, stroke/bleeding events.

Main Results:

• The study is designed to provide a precise measure of the tool's effect.
• Anticoagulant use, choice, and adherence will be analyzed from medical and pharmacy records.
• Clinical outcomes such as strokes and bleeding events will be tracked.

Conclusions:

• The ANTICOAGULATION CHOICE tool is expected to enhance SDM quality in AF patients.
• The study will elucidate the tool's effect on treatment decisions and adherence.
• Findings will inform the use of decision aids for optimizing anticoagulation in AF.