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

NCT05335135 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300000

Last updated 2022-04-19

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

TriageGO-MDW Clinical Decision Support

TriageGO-MDW is non-device clinical decision support that provides patient-level clinical risk estimates based on clinical data derived from the electronic health record

OTHER

Usual Care

Clinical care without decision support provided by TriageGo-MDW

Sponsors & Collaborators

  • University of Kansas

    collaborator OTHER

  • Beckman Coulter, Inc.

    collaborator INDUSTRY

  • Truman Medical Center

    collaborator OTHER

  • Stocastic, LLC

    lead INDUSTRY

Principal Investigators

  • Scott Levin, PhD · Stocastic, LLC

  • Jeremiah Hinson, PhD/MD · Stocastic, LLC

  • Nima Sarani, MD · University of Kansas

  • Kevin O'Rourke, MD · Truman Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-01-31
Completion
2024-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335135 on ClinicalTrials.gov