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临床试验/NCT05335135
NCT05335135Unknown不适用

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

Stocastic, LLC2 个研究点 分布在 1 个国家目标入组 300,000 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300,000
试验地点
2
主要终点
Critical Care

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients receiving care at a study site ED

排除标准

  • 未提供

结局指标

主要结局

Critical Care

时间窗: during post-implementation steady state (approximately 3 months after 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

In-Hospital Mortality

时间窗: during post-implementation steady state (approximately 3 months after intervention)

Death during index hospital encounter; Prediction performance of machine learning algorithms that underly TriageGO-MDW for this outcome will be measured

Septic Shock

时间窗: during post-implementation steady state (approximately 3 months after 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

Emergent Surgery

时间窗: during post-implementation steady state (approximately 3 months after 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

Sepsis

时间窗: during post-implementation steady state (approximately 3 months after intervention)

Prediction performance of machine learning algorithms that underlie TriageGO-MDW for this outcome will be measured

Viral Infection

时间窗: during post-implementation steady state (approximately 3 months after 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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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