Clinical trial NCT06779617: UMMS Sepsis Early Prediction Score (SEPSys) and RESCUE Score Combined Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sepsis
Patient Deterioration
Keywords: Sepsis
Patient Deterioration
AI
Artificial Intelligence
Machine learning
Decision support
Clinical decision support
Early warning systems
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 150000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a 2-intervention + control cluster-randomized factorial stepped wedge design clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: The University of Maryland Medical System is conducting a study 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 (death, cardiac arrest, unplanned ICU transfer, or rapid response call). The goal of this study is to improve provider awareness of a patient's risk of these two negative outcomes, sepsis and deterioration, by providing them with new risk scores. To assess provider awareness of risk, this study will measure time from elevated risk score to measurement of vital signs, such as heart rate or blood pressure with the hope that increased awareness of risk will decrease time to vital sign measurement, indicating closer monitoring.

The first risk score, the RESCUE Score, produces a highly accurate 1-4 color-coded risk score where a 1 indicates that a patient has a low risk of having a deterioration event in the next four hours and a 4 indicates that the patient has a high risk of having a deterioration event in the next four hours. The second risk score, the SEPSys Score, produces a highly accurate 1-4 color coded risk score where 1 indicates that a patient has a low risk of developing sepsis in the next 4 hours and a 4 indicates that the patient has a high risk of developing sepsis in the next 4 hours. Both of these scores are predictive of events that may happen in the future but are not detective or diagnostic of events that are actively occurring.

In this study, hospitals will be randomized for the order in which they cross-over from the control arm (no risk score) to either having the SEPSys or RESCUE Score visible for their inpatients. After a few months with an individual risk score, the second risk score will be added. Thus, at the beginning of the study, no hospitals with have the new risk scores available, for a period in the middle of the study each hospital will have one risk score available, and by the end of the study all hospitals will have both risk scores available. Regardless of which risk scores are available, the clinicians will be free to recommend treatments and implement care plans using their own judgement. No procedures impacting patient care will be specified for this study.

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)

Primary outcomes:
measure: Time To Vital Sign Measurement
timeFrame: From time of elevation of either the Sepsis Early Prediction System (SEPSys) or RESCUE Score to measurement of vital signs, assessed continually during the hospitalization (up to 24 hours after the elevation)).
Secondary outcomes:
measure: Sepsis diagnosis
timeFrame: Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).
measure: Time to sepsis-specific treatment
timeFrame: From time of elevation of the SEPSys Score to initiation of sepsis-specific antibiotics or fluid bolus, assessed continually during the hospitalization (up to 96 hours).
measure: Deterioration Events
timeFrame: Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).
measure: Frequency of laboratory orders
timeFrame: From time of elevation of either the Sepsis Early Prediction System (SEPSys) or RESCUE Score to measurement of laboratory orders, assessed continually during the hospitalization (up to 24 hours).
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center - Midtown
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Bel Air
country: United States
facility: University of Maryland Upper Chesapeake Medical Center
state: Maryland
city: Easton
country: United States
facility: University of Maryland Shore Medical Center
state: Maryland
city: Glen Burnie
country: United States
facility: University of Maryland Baltimore Washington Medical Center
state: Maryland
city: La Plata
country: United States
facility: University of Maryland Charles Regional Medical Center
state: Maryland
city: Largo
country: United States
facility: University of Maryland Capital Region Medical Center
state: Maryland
city: Towson
country: United States
facility: University of Maryland St. Joseph Medical Center
state: Maryland
Study officials:
References: