Viewing Study NCT05335135


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Ignite Modification Date: 2025-12-25 @ 8:15 PM
Study NCT ID: NCT05335135
Status: UNKNOWN
Last Update Posted: 2022-04-19
First Post: 2022-02-22
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Linking Novel Diagnostics With Data-Driven Clinical Decision Support in the Emergency Department
Sponsor: Stocastic, LLC
Organization:

Study Overview

Official Title: Linking Novel Diagnostics With Data-Driven Clinical Decision Support in the Emergency Department
Status: UNKNOWN
Status Verified Date: 2022-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: