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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05335135
Enrollment
300000
Registered
2022-04-19
Start date
2022-02-01
Completion date
2024-01-31
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERTriageGO-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

OTHERUsual Care

Clinical care without decision support provided by TriageGo-MDW

Sponsors

University of Kansas
CollaboratorOTHER
Beckman Coulter, Inc.
CollaboratorINDUSTRY
Truman Medical Center
CollaboratorOTHER
Stocastic, LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Adult patients receiving care at a study site ED

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Viral Infectionbaseline (pre-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
In-Hospital Mortalitybaseline (pre-intervention)Death during index hospital encounter; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured
Emergent Surgerybaseline (pre-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
Sepsisbaseline (pre-intervention)Prediction performance of machine learning algorithms that underlie TriageGO-MDW for this outcome will be measured
Septic Shockbaseline (pre-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
Critical Carebaseline (pre-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

Other

MeasureTime frameDescription
Hospital admission triage capture ratebaseline (pre-intervention)Proportion of patients requiring hospital admission identified as moderate or high acuity at ED triage
ED patient flow metricsbaseline (pre-intervention)Intervals between major ED care events, including arrival to disposition, arrival to treatment space, arrival to treatment provider, arrival to intensive care unit transfer, arrival to ED departure will be measured
Sepsis care quality metricsbaseline (pre-intervention)Standard sepsis care quality metrics including time to diagnosis and treatment and rates of compliance with the Centers for Medicare and Medicaid Services (CMS) Sepsis-1 (SEP-1) Core Measure and its components will be measured
Critical care triage capture ratebaseline (pre-intervention)Proportion of patients with critical care admission, emergency surgery or in-hospital mortality identified as high acuity at ED triage

Countries

United States

Contacts

Primary ContactEric Hamrock
eric.hamrock@stocastic.com4013420373

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026