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临床试验/NCT04571021
NCT04571021已完成不适用

Implementation of the Individual Danish Emergency Process Triage (I-DEPT)

Herlev Hospital15 个研究点 分布在 1 个国家目标入组 250,000 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250,000
试验地点
15
主要终点
30-day mortality

研究概览

简要总结

The purpose of the study is to implement and evaluate a novel triage algorithm for risk stratification of acutely admitted patients in the Emergency Department.

详细描述

Triage algorithms are used worldwide to risk assess and prioritize patients in the Emergency Departments. The aim is to identify patient at risk of deterioration or death and/or with a imminent need of treatment. The triage algorithms are also developed to identify patients at low risk, who safely can be assigned to the waiting room.

Currently, several different triage algorithms are used, and they are mostly based on consensus and exper- opinion. Therefore evidence concerning triage is limited.

The investigators has developed a novel evidence-based triage algorithm with integrated individual clinical assesment. The vitals measured at admission assigns the patient to a triage category, and based upon the clinical appearance of the patients, the triage nurse can adjust the assigned triage category to better reflect the patient. The triage algorithm used in Denmark is "DEPT", this algorithm is based purely on vitals and cause of admission and can not be adjusted.

I-DEPT is designed as a cluster randomized stepped-wedge non-inferiority study. The Aim is to implement and compare I-DEPT to the existing triage algorithm. All Emergency Departments in the Capitol Region and the Region og Zealand in Denmark will implement I-DEPT one department at a time (8 centers). The first will start the implementation on october 1, 2020 and after two months the next center will implement I-DEPT. Every two months a new center will start. During 16 months all centers will have implemented I-DEPT the sequence of centers was determined by randomization. The first 30 days of implementation will be censored and not included in the final analyses. The study will conclude with a period of 30 days follow-up. Patients will only be included once.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
17 Years 至 110 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission to a participating Emergency Department in the study period
  • Full triage assesment in the index admission

排除标准

  • Age below 17 years
  • Death at arrival or before triage assesment

结局指标

主要结局

30-day mortality

时间窗: 30 days

All cause mortality within 30 days following triage in the index admission by non-inferiority

次要结局

  • 2-day mortality(2 days)
  • Patients in the orange triage category(1 day)
  • Time in the Emergency Department(30 days)
  • Distribution of triage categories(1 day)
  • Doctor assessment(1 day)
  • Patients left without being seen(30 days)
  • Days in hospital(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kasper Iversen

Professor

Herlev and Gentofte Hospital

研究点 (15)

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