The Stop-Stroke Trial Protocol: Supporting treatment decisions to optimise the prevention of stroke

Abstract

Background: Warfarin reduces stroke risk associated with non-valvular atrial fibrillation (NVAF) yet is underutilised. Wider use of warfarin is advocated to reduce the risk of mortality and disability. Aims: We have funding to: 1) develop an innovative intervention (Stop-Stroke) to optimise General Practitioners' (GPs) management of NVAF; 2) evaluate Stop-Stroke using a rigorous, clustered RCT; 3) determine the incremental cost per life year saved due to Stop-Stroke. Methods: Random allocation of 110 GPs from across Australia to control or the Stop-Stroke intervention. Stop-Stroke will comprise patient identification and recall, management plans, peer coaching, specialist support and decision tools. Data will be collected from over 2500 patients. Primary Outcome: The proportion of patients with NVAF over 65 who are on 'appropriate' antithrombotic treatment (judged against standardised criteria) will be compared. 'Appropriate treatment' will be determined using standardised medical record audits and blinded expert review. Results and Analysis: Outcomes will be compared, adjusting for clustered randomisation. Analysis will be by intention to treat. Implications: There is no proven implementation strategy for enhancing the prevention of stroke in patients with NVAF. If effective, Stop-Stroke will bridge evidence-practice gaps in managing NVAF and reduce the risk of stroke and disability in the Australian community.