Clinical trial NCT05943938: Comparison of Sepsis Prediction Algorithms
Official title: Prospective Evaluation of Sepsis Prediction Algorithms in a Multi-Hospital Healthcare System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Keywords: Infection
Emergency Department
Algorithm
Prediction
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted through the ED from the time they arrive at the hospital until discharge, death, or initiation of intravenous antibiotics.

Brief summary: Sepsis is a severe response to infection resulting in organ dysfunction and often leading to death. More than 1.5 million people get sepsis every year in the U.S., and 270,000 Americans die from sepsis annually. Delays in the diagnosis of sepsis lead to increased mortality. Several clinical decision support algorithms exist for the early identification of sepsis. The research team will compare the performance of three sepsis prediction algorithms to identify the algorithm that is most accurate and clinically actionable. The algorithms will run in the background of the electronic health record (EHR) and the predictions will not be revealed to patients or clinical staff. In this current evaluation study, the algorithms will not affect any part of a patient's care. The algorithms will be deployed across the Emory healthcare system on data from all patients presenting to the emergency department.

Detailed description: The primary goal of this study is to prospectively evaluate three sepsis prediction algorithms that are embedded in the EHR. The models will be deployed in a "shadow" mode, and the results will not be displayed to the treatment team during this study. Two of the algorithms are proprietary algorithms of the EHR provider (Epic). The third algorithm is an internally developed, open-source algorithm.

The algorithms will compute the probability of sepsis at periodic intervals and will continue to run on a patient's data until the patient's discharge, death, or upon initiation of intravenous antibiotics (at which point there is an indirect record of clinical suspicion of an infection).

Eligibility criteria: Inclusion Criteria:

* All adult patients admitted through the ED

Exclusion Criteria:

* None

Primary outcomes:
measure: Patient hospitalization-level area under curve (AUC) for identification of sepsis,
timeFrame: Duration of hospital stay (until discharge or death), an expected average of 30 days
Secondary outcomes:
measure: Sensitivity, specificity, and Positive and Negative Predictive Value of algorithms
timeFrame: Duration of hospital stay (until discharge or death), an expected average of 30 days
measure: Lead time to antibiotic administration
timeFrame: Duration of hospital stay (until discharge or death), an expected average of 30 days
measure: Percent expected increase in unnecessary antibiotics
timeFrame: Duration of hospital stay (until discharge or death), an expected average of 30 days
measure: Number needed to screen
timeFrame: Duration of hospital stay (or death), an expected average of 30 days
measure: Number of Total and false alert burden
timeFrame: Duration of hospital stay (until discharge or death), an expected average of 30 days
measure: Time-horizon based AUCs
timeFrame: 4 hours, 8 hours, and 24 hours
measure: Accuracy and calibration by subgroup
timeFrame: Duration of hospital stay (until discharge or death), an expected average of 30 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Midtown Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare System
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Decatur
country: United States
facility: Emory Decatur Hospital
state: Georgia
city: Johns Creek
country: United States
facility: Emory Johns Creek Hospital
state: Georgia
city: Lithonia
country: United States
facility: Emory Hillandale Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Sivasubramanium Bhavani, MD
role: PRINCIPAL_INVESTIGATOR
References: