Statistical Analysis Plan for the Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN): a study protocol for a stepped-wedge cluster randomized controlled trial

Abstract

Abstract Background It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) is to examine the effect of electronic screening for sepsis compared to no screening among hospitalized ward patients on all-cause 90-day hospital mortality. Methods This study is designed as a stepped-wedge cluster randomized controlled trial. A sepsis e-alert was developed in the electronic medical record (EMR), with the feature of being active (visible to treating team) or masked (inactive in EMR frontend for the treating team but active in the backend of the EMR). Forty-five hospital wards in 5 hospitals are randomized to active sepsis e-alert versus masked sepsis e-alert on 2-month sequences, with 5 wards in each sequence totaling 10 sequences. The primary endpoint is in-hospital mortality by 90 days. All data are extracted from EMR. Discussion The SCREEN trial provides an opportunity for a novel trial design and analysis of routinely collected and entered data to evaluate the effectiveness of an intervention (sepsis alert) for a common medical problem (sepsis in ward patients). In this statistical analysis plan, we outline details of the planned analyses in advance of trial completion. Prior specification of the statistical methods and outcomes analysis will facilitate unbiased analyses of these important clinical data. Trial registration ClinicalTrials.gov NCT04078594. Registered on September 6, 2019, https://clinicaltrials.gov/ct2/show/NCT04078594 Keywords Sepsis, Alert, Screening, qSOFA, mortality, electronic medical records