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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04571021
Other study ID # 568
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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