Linking Novel Diagnostics With Data-Driven Clinical Decision Support in the Emergency Department

Stocastic

Status: Unknown

Conditions: Inpatient Hospitalization, Intensive Care Unit Admission, Inpatient Mortality, Sepsis and Septic Shock

Treatments: Other: TriageGO-MDW Clinical Decision Support; Other: Usual Care

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05335135

21-STOC-101

Details and patient eligibility

About

The primary objective of this study is to validate the use of an electronic clinical decision support (CDS) tool, TriageGO with Monocyte Distribution Width (TriageGO-MDW), in the emergency department (ED). TriageGO-MDW is non-device CDS designed to support emergency clinicians (nurses, physicians and advanced practice providers) in performing risk-based assessment and prioritization of patients during their ED visit. This study will follow an effectiveness-implementation hybrid design via the following three aims (phases), to be executed sequentially:

(Aim 1) Validate the TriageGO-MDW algorithm locally using retrospective data at ED study sites.

(Aim 2) Deploy TriageGO-MDW integrated with the electronic medical record (EMR) and perform user assessment.

(Aim 3) Evaluate TriageGO-MDW in steady state with respect to clinical, process, and perceived utility outcomes.

Enrollment: 300,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Adult patients receiving care at a study site ED

Exclusion Criteria: None

Trial design

300,000 participants in 2 patient groups

Pre-Implementation

Description:

Usual care will be provided during all ED patient encounters.

Treatment:

Other: Usual Care

Post-Implementation

Description:

TriageGo-MDW CDS will be made available during all ED patient encounters at two points in the ED care continuum: (1) shortly after arrival during initial ED triage (First Triage) and (2) after initial laboratory results have been populated within the EHR. General illness severity estimates will be provided to nurses at ED triage in the form of recommended triage acuity scores (CDS for First Triage). General illness severity estimates along with estimated risk for specific outcomes including sepsis and septic shock will be presented to clinicians after laboratory results have populated (CDS for Early Assessment). TriageGO-MDW risk estimates will be generated by machine learning algorithms using routinely available clinical data as predictor inputs. Nurses and clinicians will receive risk estimates within existing EHR workflows, along with brief and rapidly interpretable explanations of the logic driving each risk estimate.

Treatment:

Other: TriageGO-MDW Clinical Decision Support