Effects of a computerised diagnostic decision support tool on diagnostic quality in emergency departments: study protocol of the DDx-BRO multicentre cluster randomised cross-over trial

INTRODUCTION: Computerised diagnostic decision support systems (CDDS) suggesting differential diagnoses to physicians aim to improve clinical reasoning and diagnostic quality. However, controlled clinical trials investigating their effectiveness and safety are absent and the consequences of its use in clinical practice are unknown. We aim to investigate the effect of CDDS use in the emergency department (ED) on diagnostic quality, workflow, resource consumption and patient outcomes. METHODS AND ANALYSIS: This is a multicentre, outcome assessor and patient-blinded, cluster-randomised, multiperiod crossover superiority trial. A validated differential diagnosis generator will be implemented in four EDs and randomly allocated to a sequence of six alternating intervention and control periods. During intervention periods, the treating ED physician will be asked to consult the CDDS at least once during diagnostic workup. During control periods, physicians will not have access to the CDDS and diagnostic workup will follow usual clinical care. Key inclusion criteria will be patients’ presentation to the ED with either fever, abdominal pain, syncope or a non-specific complaint as chief complaint. The primary outcome is a binary diagnostic quality risk score composed of presence of an unscheduled medical care after discharge, change in diagnosis or death during time of follow-up or an unexpected upscale in care within 24 hours after hospital admission. Time of follow-up is 14 days. At least 1184 patients will be included. Secondary outcomes include length of hospital stay, diagnostics and data regarding CDDS usage, physicians’ confidence calibration and diagnostic workflow. Statistical analysis will use general linear mixed modelling methods. ETHICS AND DISSEMINATION: Approved by the cantonal ethics committee of canton Berne (2022-D0002) and Swissmedic, the Swiss national regulatory authority on medical devices. Study results will be disseminated through peer-reviewed journals, open repositories and the network of investigators and the expert and patients advisory board. TRIAL REGISTRATION NUMBER: NCT05346523.