Recruiting

Observational Study

Sponsor:

Stocastic, LLC

Code:

NCT05335135

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

TriageGO-MDW Clinical Decision Support

Usual Care

Study Details

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.

Conditions

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

Study ID

NCT05335135

Start date

Feb 1, 2022

Status verified date

Mar, 2022

Completion date

Jan, 2024

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria: Adult patients receiving care at a study site ED

Exclusion Criteria: None

Study Design

Enrollment

300000 participants

Anticipated

Interventions and Outcome Measures

Arms

Pre-Implementation

Usual care will be provided during all ED patient encounters.

Post-Implementation

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.

Interventions

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

Usual Care

Clinical care without decision support provided by TriageGo-MDW

Primary outcome measure

  • Critical Care [ Time Frame: baseline (pre-intervention) ]
  • Critical Care [ Time Frame: during post-implementation steady state (approximately 3 months after intervention) ]
  • In-Hospital Mortality [ Time Frame: baseline (pre-intervention) ]
  • In-Hospital Mortality [ Time Frame: during post-implementation steady state (approximately 3 months after intervention) ]
  • Emergent Surgery [ Time Frame: baseline (pre-intervention) ]
  • Emergent Surgery [ Time Frame: during post-implementation steady state (approximately 3 months after intervention) ]
  • Sepsis [ Time Frame: baseline (pre-intervention) ]
  • Sepsis [ Time Frame: during post-implementation steady state (approximately 3 months after intervention) ]
  • Septic Shock [ Time Frame: baseline (pre-intervention) ]
  • Septic Shock [ Time Frame: during post-implementation steady state (approximately 3 months after intervention) ]
  • Viral Infection [ Time Frame: baseline (pre-intervention) ]
  • Viral Infection [ Time Frame: during post-implementation steady state (approximately 3 months after intervention) ]

Central Contacts and Locations

Central contacts

Eric Hamrock

4013420373eric.hamrock@stocastic.com

Locations

Kansas University Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

University Health Truman Medical Center

Recruiting

Kansas City, Missouri, United States, 64108

More Information

Sponsor

Stocastic, LLC

Last update posted

Apr 19, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stocastic, LLC on 2022-04-19.