Comparison of Sepsis Prediction Algorithms

Emory University

Status: Begins enrollment in 3 months

Conditions: Sepsis

Treatments: Other: Epic Sepsis Model Version - 2; Other: Emory Sepsis Model; Other: Epic Sepsis Model Version - 1

Study type: Observational

Funder types: Other

Identifiers

NCT05943938

STUDY00005958

2024P008316 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patients admitted through the ED

Exclusion criteria

• None

Trial design

1,200 participants in 1 patient group

ED Patients

Description:

All adult patients presenting to Emergency Departments (ED) in the Emory Healthcare system

Treatment:

Other: Epic Sepsis Model Version - 1

Other: Emory Sepsis Model

Other: Epic Sepsis Model Version - 2