Background
To evaluate the effect of screening for sepsis using an electronic sepsis alert vs. no alert in hospitalized ward patients on 90-day in-hospital mortality.
Methods
The SCREEN trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 45 wards, constituting clusters in this design) are randomized to have active alert vs. masked alert, 5 wards at a time, with each 5 wards constituting a sequence. The study consists of ten 2-month periods with a phased introduction of the intervention. In the first period, all wards have a masked alert for 2 months. Afterwards the intervention (alert system) is implemented in a new sequence every 2-month period until the intervention is implemented in all sequences. The intervention includes the implementation of an electronic alert system developed in the hospital electronic medical records based on the quick sequential organ failure assessment (qSOFA). The alert system sends notifications of “possible sepsis alert” to the bedside nurse, charge nurse, and primary medical team and requires an acknowledgment in the health information system from the bedside nurse and physician. The calculated sample size is 65,250. The primary endpoint is in-hospital mortality by 90 days.
Discussion
The trial started on October 1, 2019, and is expected to complete patient follow-up by the end of October 2021.
Trial registration
ClinicalTrials.gov NCT04078594. Registered on September 6, 2019
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 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 design
This 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.
Conclusion
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 (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 registration
ClinicalTrials.gov NCT04078594. Registered on September 6, 2019
Background
To examine the effect of screening for sepsis using an electronic sepsis alert versus no alert in hospitalized patients admitted to wards on hospital mortality.
Methods
This study is conducted in 45 medical-surgical-oncology wards in five hospitals. Based on the quick Sequential Organ Failure Assessment (qSOFA), an electronic alert has been developed in the hospital Electronic Medical Record system. The alert system sends notifications of 'Possible Sepsis Alert' to the bedside nurse, charge nurse, and primary medical team and requires an acknowledgment in the health information system from the bedside nurse and physician. In addition, data on the alert are displayed on management dashboards for each ward. Initially, all wards had a masked alert for 2 months. Hospital wards are then allocated in a randomized fashion to either active or masked alert, such that the alert is activated in five new randomly selected wards every two months until all wards have the active alert. The primary endpoint is in-hospital mortality by 90 days.
Discussion
The trial has started in October 2019 and is expected to continue for 22 months enrolling more than 62550 hospitalized patients.
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
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