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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: TriageGO-MDW Clinical Decision Support
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients receiving care at a study site ED Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Implementation<br>Usual care will be provided during all ED patient encounters. | Other: Usual Care<br>* Clinical care without decision support provided by TriageGo-MDW<br>|
| Post-Implementation<br>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. | Other: TriageGO-MDW Clinical Decision Support<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical Care | 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 | baseline (pre-intervention) | 
| Critical Care | 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 | during post-implementation steady state (approximately 3 months after intervention) | 
| In-Hospital Mortality | Death during index hospital encounter; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured | baseline (pre-intervention) | 
| In-Hospital Mortality | Death during index hospital encounter; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured | during post-implementation steady state (approximately 3 months after intervention) | 
| Emergent Surgery | 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 | baseline (pre-intervention) | 
| Emergent Surgery | 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 | during post-implementation steady state (approximately 3 months after intervention) | 
| Sepsis | Prediction performance of machine learning algorithms that underlie TriageGO-MDW for this outcome will be measured | baseline (pre-intervention) | 
| Sepsis | Prediction performance of machine learning algorithms that underlie TriageGO-MDW for this outcome will be measured | during post-implementation steady state (approximately 3 months after intervention) | 
| Septic Shock | 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 | baseline (pre-intervention) | 
| Septic Shock | 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 | during post-implementation steady state (approximately 3 months after intervention) | 
| Viral Infection | 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 | baseline (pre-intervention) | 
| Viral Infection | 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 | during post-implementation steady state (approximately 3 months after intervention) |