RecruitingNot ApplicableNCT06779617

UMMS Sepsis Early Prediction Score (SEPSys) and RESCUE Score Combined Clinical Trial

Full Title: Sepsis Early Prediction System Score (SEPSys Score) and RESCUE Score Multi-Site, Two-Intervention, Cluster-Randomized, Factorial Stepped-Wedge Pragmatic Clinical Trial at the University of Mayland Medical System

Sponsor

University of Maryland, Baltimore

Enrollment

150,000 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Sepsis Patient Deterioration

Summary

This study is designed to test two new risk scores - one designed to predict a patient's four-hour risk of developing sepsis and one designed to predict a patient's four-hour risk of deterioration (cardiac arrest, death, unplanned ICU transfer, or rapid response team call). The goal of this study is to improve provider awareness of a patient's risk of these two negative outcomes by providing them with new risk scores. The primary outcome will be the time from when the risk score becomes elevated to when vital signs such as heart rate or blood pressure are measured, suggesting an increased awareness.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

Units are part of a member hospital of the University of Maryland Medical System (UMMS)
Units treat inpatient patients
Units agree to participate in the study
Encounter is on a participating inpatient unit
Encounter is associated with a bedded patient in the hospital
Encounter is associated with an adult (at least 18 years of age at time of admission)
Encounter has a SEPSys Score
Encounter has a RESCUE Score

Exclusion Criteria8

Unit treats exclusively outpatients or is located in an outpatient setting
Unit treats primarily or exclusively pediatric patients (patients under the age of 18 years old)
Unit treats exclusively psychiatric patients
Encounter is with OB for a normal delivery and the patient has yet to give birth. This encounter can become eligible once the patient has given birth.
Encounter is admitted with a diagnosis of sepsis
Sepsis was already diagnosed during the encounter
This encounter will have been eligible until the patient began showing clinical signs or symptoms of sepsis or received a diagnosis of sepsis. Once they have a diagnosis or clinical signs or symptoms of sepsis, their SEPSys Score will no longer be updated. Data will continue to be collected on time of laboratory orders and treatments.
Encounter is admitted with a high RESCUE Score (RESCUE Score of 4)

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Interventions

DEVICESEPSys

The SEPSys Score is a clinical decision support tool for predicting the risk of developing sepsis in the next 4 hours. The SEPSys Score produces a 1-4, color-coded risk, where 4 (red) is the highest risk and 1 (green) is the lowest risk.

DEVICERESCUE

The RESCUE Score is a clinical decision support tool for predicting the risk of patient experiencing clinical deterioration (cardiac arrest, rapid response team call, death, or unplanned increase in care) in the next 4 hours. The RESCUE Score produces a 1-4, color-coded risk, where 4 (red) is the highest risk and 1 (green) is the lowest risk.