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

• 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

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)

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

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