UMMS SEPSys sepsis prediction and RESCUE deterioration risk scoring for adult inpatients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Maryland Medical Center - Midtown
  Baltimore, Maryland, United States Recruiting
• University of Maryland Medical Center
  Baltimore, Maryland, United States Recruiting
• University of Maryland Shore Medical Center
  Easton, Maryland, United States Recruiting
• University of Maryland Baltimore Washington Medical Center
  Glen Burnie, Maryland, United States Recruiting
• University of Maryland Charles Regional Medical Center
  La Plata, Maryland, United States Recruiting
• University of Maryland Capital Region Medical Center
  Largo, Maryland, United States Recruiting

Study contacts

• Study coordinator: Samuel A Tisherman, MD
• Email: stisherman@som.umaryland.edu
• Phone: 410-328-9114

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.