Statistical analysis plan for the Stepped-wedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN)

Yaseen M Arabi ,Sheryl Ann Abdukahil ,Eman Al Qasim ,Huda Al Ghamdi ,Hasan M Al‐Dorzi ,Ramesh Vishwakarma ,Fawaz K Al-Rabeah ,Ebtisam Al Ghamdi

doi:10.1186/s13063-021-05788-3

Abstract

BackgroundIt is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) trial is to evaluate whether an electronic screening for sepsis compared to no screening among hospitalized ward patients reduces all-cause 90-day in-hospital mortality.Methods and designThis study is designed as a stepped-wedge cluster randomized trial in which the unit of randomization or cluster is the hospital ward. An electronic alert for sepsis 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 clusters in 5 hospitals are randomized into 9 sequences of 5 clusters each to receive the intervention (active alert) over 10 periods, 2 months each, the first being the baseline period. Data are extracted from EMR and are compared between the intervention (active alert) and control group (masked alert). During the study period, some of the hospital wards were allocated to manage patients with COVID-19. The primary outcome of all-cause hospital mortality by day 90 will be compared using a generalized linear mixed model with a binary distribution and a log-link function to estimate the relative risk as a measure of effect. We will include two levels of random effects to account for nested clustering within wards and periods and two levels of fixed effects: hospitals and COVID-19 ward status in addition to the intervention. Results will be expressed as relative risk with a 95% confidence interval.ConclusionThe 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 (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 outcome analysis will facilitate unbiased analyses of these important clinical data.Trial registrationClinicalTrials.gov NCT04078594. Registered on September 6, 2019

Highlights

It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes
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 for a common medical problem
The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) is to evaluate whether electronic screening for sepsis compared to no screening among hospitalized ward patients reduces allcause 90-day in-hospital mortality [5]

Summary

Introduction

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 Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) trial is to evaluate whether an electronic screening for sepsis compared to no screening among hospitalized ward patients reduces all-cause 90-day in-hospital mortality. Sepsis is a major cause of morbidity and mortality among hospitalized patients. Screening for sepsis using an electronic alert in hospitalized patients may improve outcomes by early sepsis recognition and timely implementation of appropriate care processes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) is to evaluate whether electronic screening for sepsis compared to no screening among hospitalized ward patients reduces allcause 90-day in-hospital mortality [5]. The electronic screening for sepsis is based on the quick Sequential Organ Failure Assessment qSOFA [6]

Methods

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Discussion

Conclusion