Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial

Abstract

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

Electronic medical record implementation in a large healthcare system from a leadership perspective

“…In 2019, the hospital received the Healthcare Information and Management Systems Society (HIMSS) Outpatient-EMRAM Stage 7 accreditation ( https://www.ngha.med.sa/English/MediaCenter/News/Pages/MMXIXIVI.aspx ) , and in 2021 received the HIMSS Adoption Model for Analytics Maturity (AMAM) Stage 7 accreditation ( https://www.healthcareitnews.com/news/emea/two-medical-groups-saudi-arabia-achieve-stage-7-digital-maturity ). The EMR was also used to build an electronic alert system for sepsis that has been implemented throughout the 5 medical campuses, as part of a stepped-wedge randomized trial that included more than 60,000 hospitalized patients [ 19 , 20 ] Furthermore, the EMR has facilitated a quick efficient transformation during the COVID-19 pandemic with the implementation of new screening tools, tracking of patients, and monitoring of their medical care [ 21 – 23 ]. It also allowed rapid implementation of the concepts of virtual clinics and telehealth.…”

Effectiveness of automated alerting system compared to usual care for the management of sepsis

“…Third, there is remarkable heterogeneity among these included studies, which cannot be explained by some prespecified variables. Thus, more homogeneous large RCTs are needed to provide high-quality evidence 63 . Finally, machine-learning algorithms are sensitive to changes in the environment and subject to performance decay 64 .…”

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

“…We present a glossary of terms in line with the CONSORT extension for stepped-wedge cluster randomized trials [ 11 ] in Table 1 . The cluster refers to the unit of randomization, which is the hospital ward, and we will refer to it in the rest of the document as “ward.” A list of ward-level and patient-level eligibility criteria is outlined in the study protocol [ 5 ]. Wards are randomized into 9 sequences of 5 wards each to receive the intervention.…”

“…We will also report vital signs (systolic blood pressure, diastolic blood pressure, heart rate, temperature, and respiratory rate) as well as laboratory parameters (lactate, white blood cells, bilirubin, creatinine) and whether cultures of blood, respiratory, urine, or other body fluids (pleural, ascitic, cerebrospinal, joint) were obtained and whether treatments (intravenous fluids and antibiotics) were received at baseline. Definitions of these variables were outlined in the study protocol [ 5 ].…”

“…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 all-cause 90-day in-hospital mortality [ 5 ]. The electronic screening for sepsis is based on the quick Sequential Organ Failure Assessment qSOFA [ 6 ].…”