Implementation of the Individual Danish Emergency Process Triage

Emergencies Clinical Trial

— I-DEPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571021
• Other study ID #: 568
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2023
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250000
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 110 Years

Eligibility

Inclusion Criteria:

• Admission to a participating Emergency Department in the study period

• Full triage assesment in the index admission

Exclusion Criteria:

• Age below 17 years

• Death at arrival or before triage assesment

Related Conditions & MeSH terms

• Acute Disease
• Clinical Syndrome
• Emergencies

Intervention

Other:
• I-DEPT
Implementation of the novel triage algorithm
• DEPT
Existing triage algorithm

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg hospital	Copenhagen
Denmark	Herlev and Gentofte hospital	Herlev	Capital Region
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Holbæk hospital	Holbæk
Denmark	Hvidovre, Amager and Glostrup Hospital	Hvidovre
Denmark	Sjælland University hospital	Køge
Denmark	Nykøbing Falster Hospital	Nykøbing Falster
Denmark	Slagelse Hospital	Slagelse

Sponsors (8)

Lead Sponsor

Collaborator

Herlev Hospital

Bispebjerg and Frederiksberg Hospital, Department of Emergency Medicine, Holbæk Hospital, Department of Emergency Medicine, Hvidovre, Amager and Glostrup Hospital, Department of Emergency Medicine, Køge Hospital, Department of Emergency Medicine, Nordsjællands Hospital, Department of Emergency Medicine, Nykøbing Falster Hospital, Department of Emergency Medicine, Slagelse Hospital, Department of Emergency Medicine

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	All cause mortality within 30 days following triage in the index admission by non-inferiority	30 days
Secondary	2-day mortality	All cause mortality within 2 days following triage in the index admission	2 days
Secondary	Distribution of triage categories	There are four categories in both triage algorithms used in this study: (green (least urgent), yellow, orange, and red (most urgent))	1 day
Secondary	Patients in the orange triage category	Number of patients assigned to the orange category	1 day
Secondary	Doctor assessment	Time from triage to arrival of a doctor	1 day
Secondary	Days in hospital	The number of days admitted to a hospital within 30 days	30 days
Secondary	Time in the Emergency Department	Time spent in the Emergency department from triage to either admission, transfer or discharge	30 days
Secondary	Patients left without being seen	Number of patients leaving the Emergency Department without being assessed by a doctor	30 days