Assessing the impact of a semi-structured intraoperative anaesthesia handoff cognitive aid on surgical patient outcomes: study protocol for a cluster randomised trial

评估半结构化术中麻醉交接认知辅助工具对患者手术结局的影响:一项整群随机试验的研究方案

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Abstract

INTRODUCTION: Intraoperative anaesthesia handoffs represent a risk point in the care of surgical patients. Although often necessary to prevent fatigue, improve vigilance and optimise operational efficiency, critical information can be lost, potentially leading to postoperative complications. Structured handoffs can increase the transfer of knowledge during intraoperative anaesthesia handoffs, improving their quality. We therefore propose to test the primary hypothesis that a semi-structured intraoperative anaesthesia handoff cognitive aid reduces the number of serious 30-day complications in surgical patients. METHODS AND ANALYSIS: We will enrol adults having non-cardiac surgery who are scheduled to have an intraoperative anaesthesia handoff for operational reasons. We plan a cluster randomised trial (enrolling over 18 months, anticipated sample size approximately 4500 patients) that will compare the Epic Electronic Health Record intraoperative anaesthesia handoff cognitive aid to routine handoffs. Our primary outcome will be the number of serious postoperative complications within 30 days. Our secondary outcomes will be: (1) the number of minor complications; and (2) the duration of postoperative hospitalisation. Bayesian analysis with generalised linear multilevel modelling will be used to estimate the effect of structured handoffs on the primary and secondary outcomes. ETHICS AND DISSEMINATION: This study has been approved by the local institutional review board with a waiver of informed consent. Results will be disseminated in the medical literature with de-identified data available on request. TRIAL REGISTRATION NUMBER: NCT06533111.

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