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

• Conditions: Inpatient Hospitalization, Intensive Care Unit Admission, Inpatient Mortality, Sepsis and Septic Shock
• Interventions: Other: Usual Care; Other: TriageGO-MDW Clinical Decision Support

• Registration Number: NCT05335135
• Lead Sponsor: Stocastic, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-02-22
• Status Verified: 2022-03
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2023-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300000

Inclusion Criteria

Adult patients receiving care at a study site ED

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-Implementation	Usual Care	Usual care will be provided during all ED patient encounters.
Post-Implementation	TriageGO-MDW Clinical Decision Support	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.

Primary Outcome Measures

Name	Time	Method
Critical Care	during post-implementation steady state (approximately 3 months after intervention)	Admission to an intensive care unit within 24 hours of ED disposition; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured
In-Hospital Mortality	during post-implementation steady state (approximately 3 months after intervention)	Death during index hospital encounter; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured
Septic Shock	during post-implementation steady state (approximately 3 months after intervention)	Meeting septic shock criteria within 24 hours of ED arrival; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured
Emergent Surgery	during post-implementation steady state (approximately 3 months after intervention)	procedure in the operating room within 12 hours of ED arrival; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured
Sepsis	during post-implementation steady state (approximately 3 months after intervention)	Prediction performance of machine learning algorithms that underlie TriageGO-MDW for this outcome will be measured
Viral Infection	during post-implementation steady state (approximately 3 months after intervention)	Testing positive for influenza or Covid-19 (SARS-CoV-2) infection within 24 hours of ED arrival; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured

Trial Locations

Locations (2)

University Health Truman Medical Center; 🇺🇸 Kansas City, Missouri, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States