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

Overview

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.

Interventions

• Device SEPSys
  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.
• Device RESCUE
  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.

Primary outcome measures

• Time To Vital Sign Measurement [Time frame: 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 outcome measures (4)

• Sepsis diagnosis [Time frame: Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).]
• Time to sepsis-specific treatment [Time frame: 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).]
• Deterioration Events [Time frame: Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).]
• Frequency of laboratory orders [Time frame: 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).]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 8 centers

• University of Maryland Medical Center - Midtown — Baltimore
• University of Maryland Medical Center — Baltimore
• University of Maryland Upper Chesapeake Medical Center — Bel Air
• University of Maryland Shore Medical Center — Easton
• University of Maryland Baltimore Washington Medical Center — Glen Burnie
• University of Maryland Charles Regional Medical Center — La Plata
• University of Maryland Capital Region Medical Center — Largo
• University of Maryland St. Joseph Medical Center — Towson

Identifiers

NCT: NCT06779617 · HP-00109072

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗