Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF...

Area of Science:

• Cardiology
• Health Services Research
• Patient Engagement

Background:

• Shared decision making (SDM) is crucial for aligning patient care with individual priorities.
• Decision aids (DAs) facilitate SDM, but the comparative effectiveness of patient-focused versus encounter-based DAs is unclear.
• This research addresses the knowledge gap regarding the impact of different DA formats on SDM in atrial fibrillation (AF) stroke prevention.

Purpose of the Study:

• To directly compare the effectiveness of a patient decision aid (PDA) and an encounter decision aid (EDA) on SDM.
• To evaluate the impact of these DAs on patient decision making, knowledge, and clinical outcomes in AF patients.
• To inform the development of future SDM interventions for stroke prevention in AF.

Main Methods:

• A 2x2 cluster randomized multi-center trial involving 1200 adult patients with non-valvular AF and their clinicians.
• Development of two interactive, online DAs: a PDA for pre-encounter use and an EDA for clinician-patient use during encounters.
• Randomization of patients to PDA or usual care, and clinicians to EDA or usual care.

Main Results:

• Primary outcomes include the quality of SDM, patient decision making, and patient knowledge.
• Secondary outcomes assess anticoagulation choice, adherence, and clinical events.
• The study provides the first head-to-head comparison of EDA versus PDA effectiveness on SDM.

Conclusions:

• This trial offers the first direct comparison of encounter-based versus patient-focused decision aids for SDM in AF stroke prevention.
• Findings will guide the optimization of SDM interventions to enhance patient outcomes and experiences in AF management.
• The study contributes valuable evidence for improving the implementation of DAs in clinical practice for chronic disease management.