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
Trial ID: NCT06779617
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-02-01
Completion date: 2028-12
Sponsor: University of Maryland, Baltimore
Conditions: Sepsis; Patient Deterioration
Interventions: SEPSys; RESCUE
Locations: University of Maryland Medical Center - Midtown; University of Maryland Medical Center; University of Maryland Upper Chesapeake Medical Center; University of Maryland Shore Medical Center; University of Maryland Baltimore Washington Medical Center; University of Maryland Charles Regional Medical Center; University of Maryland Capital Region Medical Center; University of Maryland St. Joseph Medical Center
Countries: United States; United States; United States; United States; United States; United States; United States; United States
Enrollment: 150000
Age range: 18 Years - None
Sex: ALL

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 criteria:
Hospital Unit Inclusion Criteria:

* 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

General Encounter Inclusion Criteria:

* 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)

Additional SEPSys Encounter Inclusion Criteria:

• Encounter has a SEPSys Score

Additional RESCUE Encounter Inclusion Criteria:

• Encounter has a RESCUE Score

Exclusion Criteria:

Hospital Unit Exclusion Criteria:

* 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

Additional SEPSys Encounter Exclusion Criteria:

* 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.

Additional RESCUE Encounter Exclusion Criteria:

• Encounter is admitted with a high RESCUE Score (RESCUE Score of 4)

Outcomes:
Time To Vital Sign Measurement