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Clinical Trials/NCT05335135
NCT05335135
Unknown
N/A

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

Stocastic, LLC2 sites in 1 country300,000 target enrollmentFebruary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Inpatient Hospitalization, Intensive Care Unit Admission, Inpatient Mortality, Sepsis and Septic Shock
Sponsor
Stocastic, LLC
Enrollment
300000
Locations
2
Primary Endpoint
Critical Care
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
January 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients receiving care at a study site ED

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Critical Care

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (2)

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