PediAppRREST: effectiveness of an interactive cognitive support tablet app in reducing deviations from guidelines in the management of paediatric cardiac arrest: protocol for a simulation-based randomised controlled trial

INTRODUCTION: Paediatric cardiac arrest (PCA), despite its low incidence, has a high mortality. Its management is complex and deviations from guideline recommendations occur frequently. We developed a new interactive tablet app, named PediAppRREST, to support the management of PCA. The app received a good usability evaluation in a previous pilot trial. The aim of the study is to evaluate the effectiveness of the PediAppRREST app in reducing deviations from guideline recommendations in PCA management. METHODS AND ANALYSIS: This is a multicentre, simulation-based, randomised controlled, three-parallel-arm study. Participants are residents in Paediatric, Emergency Medicine, and Anaesthesiology programmes in Italy. All 105 teams (315 participants) manage the same scenario of in-hospital PCA. Teams are randomised by the study statistician into one of three study arms for the management of the PCA scenario: (1) an intervention group using the PediAppRREST app or (2) a control group Paediatric Advanced Life Support (CtrlPALS+) using the PALS pocket reference card; or (3) a control group (CtrlPALS-) not allowed to use any PALS-related cognitive aid. The primary outcome of the study is the number of deviations (delays and errors) in PCA management from PALS guideline recommendations, according to a novel checklist, named c-DEV15plus. The c-DEV15plus scores will be compared between groups with a one-way analysis of variance model, followed by the Tukey-Kramer multiple comparisons adjustment procedure in case of statistical significance. ETHICS AND DISSEMINATION: The Ethics Committee of the University Hospital of Padova, coordinating centre of the trial, deemed the project to be a negligible risk study and approved it through an expedited review process. The results of the study will be disseminated in peer-reviewed journals, and at national and international scientific conferences. Based on the study results, the PediAppRREST app will be further refined and will be available for download by institutions/healthcare professionals. TRIAL REGISTRATION NUMBER: NCT04619498; Pre-results.