Clinical trial NCT04571021: Implementation of the Individual Danish Emergency Process Triage
Official title: Implementation of the Individual Danish Emergency Process Triage (I-DEPT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Disease
Emergencies
Clinical Syndrome
Keywords: triage
risk stratification
emergency department
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Hvidovre, Amager and Glostrup Hospital, Department of Emergency Medicine
name: Bispebjerg and Frederiksberg Hospital, Department of Emergency Medicine
name: Nykøbing Falster Hospital, Department of Emergency Medicine
name: Slagelse Hospital, Department of Emergency Medicine
name: Køge Hospital, Department of Emergency Medicine
name: Nordsjællands Hospital, Department of Emergency Medicine
name: Holbæk Hospital, Department of Emergency Medicine
First posted: 2020-09-30
Enrollment: 250000
Sex: ALL
Minimum age (years): 17
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-Wedge cluster randomized design
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: 2-day mortality
timeFrame: 2 days
measure: Distribution of triage categories
timeFrame: 1 day
measure: Patients in the orange triage category
timeFrame: 1 day
measure: Doctor assessment
timeFrame: 1 day
measure: Days in hospital
timeFrame: 30 days
measure: Time in the Emergency Department
timeFrame: 30 days
measure: Patients left without being seen
timeFrame: 30 days
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte hospital
state: Capital Region
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg hospital
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Holbæk
country: Denmark
facility: Holbæk hospital
city: Hvidovre
country: Denmark
facility: Hvidovre, Amager and Glostrup Hospital
city: Køge
country: Denmark
facility: Sjælland University hospital
city: Nykøbing Falster
country: Denmark
facility: Nykøbing Falster Hospital
city: Slagelse
country: Denmark
facility: Slagelse Hospital
Study officials:
affiliation: Herlev and Gentofte Hospital
name: Kasper K Iversen, Professor
role: PRINCIPAL_INVESTIGATOR
References: