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

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