UMMS SEPSys sepsis prediction and RESCUE deterioration risk scoring for adult inpatients
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
This project will test two four-hour risk scores that alert hospital providers about adult inpatients' near-term risk of developing sepsis or sudden clinical deterioration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 8 sites (Baltimore, Maryland and 7 other locations) |
| Trial ID | NCT06779617 on ClinicalTrials.gov |
What this trial studies
Researchers at the University of Maryland Medical System will deploy two machine-learning risk scores — the SEPSys score for four-hour sepsis risk and the RESCUE score for four-hour deterioration risk — each producing a color-coded 1–4 risk level. The study runs on participating adult inpatient units where the scores are calculated for bedded patients and shown to clinicians during usual care. The primary outcome is the time from when a risk score becomes elevated to when vital signs (for example heart rate or blood pressure) are next measured as a marker of increased provider awareness. These tools are predictive aides meant to prompt closer monitoring and are not diagnostic of an active event.
Who should consider this trial
Good fit: Adult inpatients (age 18 or older) on participating UMMS hospital units who have SEPSys and/or RESCUE scores available are the ideal candidates for this study.
Not a fit: Patients under 18, encounters on nonparticipating units (including units that are outpatient, pediatric-only, psychiatric, or routine OB deliveries without scores) or patients without SEPSys/RESCUE scores are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the scores could help clinicians notice at-risk patients sooner so they monitor and respond earlier, potentially preventing arrests, unplanned ICU transfers, or worsening sepsis.
How similar studies have performed: Prior early-warning and machine-learning approaches for sepsis and deterioration prediction have shown predictive accuracy in research settings but have produced mixed results on changing provider behavior or clinical outcomes in routine practice.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Baltimore, Maryland and 7 other locations
- University of Maryland Medical Center - Midtown — Baltimore, Maryland, United States (Recruiting)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Not_yet_recruiting)
- University of Maryland Upper Chesapeake Medical Center — Bel Air, Maryland, United States (Not_yet_recruiting)
- University of Maryland Shore Medical Center — Easton, Maryland, United States (Not_yet_recruiting)
- University of Maryland Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (Not_yet_recruiting)
- University of Maryland Charles Regional Medical Center — La Plata, Maryland, United States (Not_yet_recruiting)
- University of Maryland Capital Region Medical Center — Largo, Maryland, United States (Recruiting)
- University of Maryland St. Joseph Medical Center — Towson, Maryland, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Samuel A Tisherman, MD
- Email: stisherman@som.umaryland.edu
- Phone: 410-328-9114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.