Real-time machine learning-assisted sepsis alert enhances the timeliness of antibiotic administration and diagnostic accuracy in emergency department patients with sepsis: a cluster-randomized trial.

Machine learning (ML) has been applied in sepsis recognition across different healthcare settings with outstanding diagnostic accuracy. However, the advantage of ML-assisted sepsis alert in expediting clinical decisions leading to enhanced quality for emergency department (ED) patients remains unclear. A cluster-randomized trial was conducted in a tertiary-care hospital. Adult patient data were subjected to an ML model for sepsis alert. Patient visits were assigned into one of two groups. In the intervention cluster, staff received alerts on a display screen if patients met the ML threshold for sepsis diagnosis, while patients in the control cluster followed the regular alert process. The study compared triage-to-antibiotic (TTA) time, length of stay, and mortality rate between the two groups. Additionally, the diagnostic performance of the ML model was assessed. A total of 256 (intervention) and 318 (control) sepsis patients were analyzed. The proportions of patients who received antibiotics within 1 and 3 h were higher in the intervention group than in the control group (in 1 h; 68.4 vs. 60.1%, respectively; P = 0.04, in 3 h; 94.5 vs. 89.0%, respectively; P = 0.02). The median TTA times were marginally shorter in the intervention group (46 vs. 50 min). The area under the receiver operating characteristic curve (AUROC) of ML in early sepsis identification was significantly higher than qSOFA, SIRS, and MEWS. The ML-assisted sepsis alert system may help sepsis ED patients receive antibiotics more rapidly than with the conventional, human-dedicated alert process. The diagnostic performance of ML in prompt sepsis detection was superior to that of the rule-based system.Trial registration Thai Clinical Trials Registry TCTR20230120001. Registered 16 January 2023-Retrospectively registered, https://www.thaiclinicaltrials.org/show/TCTR20230120001 .