Open-label, single-centre, cluster-randomised controlled trial to Evaluate the Potential Impact of Computerisedantimicrobial stewardship (EPIC) on the antimicrobial use after cardiovascular surgeries: EPIC trial study original protocol

INTRODUCTION: Inappropriate antimicrobial use increases the prevalence of antimicrobial-resistant bacteria. Surgeons are reluctant to implement recommendations of guidelines in clinical practice. Antimicrobial stewardship (AMS) is effective in antimicrobial management, but it remains labour intensive. The computerised decision support system (CDSS) has been identified as an effective way to enable key elements of AMS in clinical settings. However, insufficient evidence is available to evaluate the efficacy of computerised AMS in surgical settings. METHODS AND ANALYSIS: The Evaluate of the Potential Impact of Computerised AMS trial is an open-label, single-centre, two-arm, cluster-randomised, controlled trial, which aims to determine whether a multicomponent CDSS intervention reduces overall antimicrobial use after cardiovascular surgeries compared with usual clinical care in a specialty hospital with a big volume of cardiovascular surgeries. Eighteen cardiovascular surgical teams will be randomised 1:1 to either the intervention or the control arm. The intervention will consist of (1) re-evaluation alerts and decision support for the duration of antimicrobial treatment decision, (2) re-evaluation alerts and decision support for the choice of antimicrobial, (3) quality control audit and feedback. The primary outcome will be the overall systemic antimicrobial use measured in days of therapy (DOT) per admission and DOT per 1000 patient-days over the whole intervention period (6 months). Secondary outcomes include a series of indices to evaluate antimicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption, and user compliance and satisfaction. ETHICS AND DISSEMINATION: The Ethics Committee in Fuwai Hospital approved this study (2020-1329). The results of the trial will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04328090.