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Real-time surveillance system for patient deterioration: a pragmatic cluster-randomized controlled trial

Sarah Collins Rossetti, Patricia C. Dykes, Chris Knaplund, Sandy Cho, Jennifer Withall, Graham Lowenthal, David J. Albers, Rachel Lee, Haomiao Jia, Suzanne Bakken, Min‐Jeoung Kang, Frank Chang, Li Zhou, David W. Bates, Temiloluwa Daramola, Fang Liu, Jessica Schwartz-Dillard, Mai Tran, Syed Mohtashim Abbas Bokhari, Jennifer Thate, Kenrick Cato

2025Nature Medicine39 citationsDOIOpen Access PDF

Abstract

The COmmunicating Narrative Concerns Entered by RNs (CONCERN) early warning system (EWS) uses real-time nursing surveillance documentation patterns in its machine learning algorithm to identify deterioration risk. We conducted a 1-year, multisite, pragmatic trial with cluster-randomization of 74 clinical units (37 intervention; 37 usual care) across 2 health systems. Eligible adult hospital encounters were included. We tested if outcomes differed between patients whose care teams were and patients whose care teams were not informed by the CONCERN EWS. Coprimary outcomes were in-hospital mortality (examined as instantaneous risk) and length of stay. Secondary outcomes were cardiopulmonary arrest, sepsis, unanticipated intensive care unit transfers and 30-day hospital readmission. Among 60,893 hospital encounters (33,024 intervention; 27,869 usual care), intervention group encounters had 35.6% decreased instantaneous risk of death (adjusted hazard ratio (HR), 0.64; 95% confidence interval (CI), 0.53-0.78; P < 0.0001), 11.2% decreased length of stay (adjusted incidence rate ratio, 0.91; 95% CI, 0.90-0.93; P < 0.0001), 7.5% decreased instantaneous risk of sepsis (adjusted HR, 0.93; 95% CI, 0.86-0.99; P = 0.0317) and 24.9% increased instantaneous risk of unanticipated intensive care unit transfer (adjusted HR, 1.25; 95% CI, 1.09-1.43; P = 0.0011) compared with usual-care group encounters. No adverse events were reported. A machine learning-based EWS, modeled on nursing surveillance patterns, decreased inpatient deterioration risk with statistical significance. ClinicalTrials.gov registration: NCT03911687 .

Topics & Concepts

MedicineHazard ratioConfidence intervalEmergency medicineEarly warning scoreCluster randomised controlled trialRandomized controlled trialRelative riskIntensive care unitAdverse effectSepsisCluster (spacecraft)Emergency departmentPatient safetyRandomizationHealth careInternal medicineNursingComputer scienceProgramming languageEconomic growthEconomicsSepsis Diagnosis and TreatmentMachine Learning in HealthcareHealthcare Technology and Patient Monitoring