Clinical decision support for stroke prevention in atrial fibrillation (CDS-AF): Rationale and design of a cluster randomized trial in the primary care setting

Background Atrial fibrillation (AF) is associated with substantial morbidity, in particular stroke. Despite good evidence for the reduction of stroke risk with anticoagulant therapy, there remains a significant under treatment. The main aim of the current study is to investigate whether a clinical decision support tool for stroke prevention (CDS) integrated in the electronic health record (EHR) can improve adherence to guidelines for stroke prevention in patients with AF. Methods We will conduct a cluster randomized trial where 43 primary care clinics in the county of Östergötland, Sweden (population 444,347), will be randomized to be part of the CDS intervention or serve as controls. The CDS will alert responsible physicians of patients with AF and increased risk for thromboembolism (according to the CHA2 DS2 VASc algorithm) without anticoagulant therapy. The primary endpoint will be adherence to guidelines after one year. Conclusion The present study will investigate whether a clinical decision support system integrated in an EHR can increase adherence to guidelines regarding anticoagulant therapy in patients with AF. Trial registration www.clinicaltrials.gov registration number NCT02635685