Implementation of the Individual Danish Emergency Process Triage

NCT ID: NCT04571021

Last Updated: 2023-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-05-01

Brief Summary

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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

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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.

Conditions

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Acute Disease Emergencies Clinical Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped-Wedge cluster randomized design
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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I-DEPT

Novel triage. The triage nurse can adjust the triage category one level of urgency down or one or two levels up.

Group Type EXPERIMENTAL

I-DEPT

Intervention Type OTHER

Implementation of the novel triage algorithm

DEPT

Existing triage algorithm

Group Type ACTIVE_COMPARATOR

DEPT

Intervention Type OTHER

Existing triage algorithm

Interventions

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I-DEPT

Implementation of the novel triage algorithm

Intervention Type OTHER

DEPT

Existing triage algorithm

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre, Amager and Glostrup Hospital, Department of Emergency Medicine

UNKNOWN

Sponsor Role collaborator

Bispebjerg and Frederiksberg Hospital, Department of Emergency Medicine

UNKNOWN

Sponsor Role collaborator

Nykøbing Falster Hospital, Department of Emergency Medicine

UNKNOWN

Sponsor Role collaborator

Slagelse Hospital, Department of Emergency Medicine

UNKNOWN

Sponsor Role collaborator

Køge Hospital, Department of Emergency Medicine

UNKNOWN

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role collaborator

Holbæk Hospital, Department of Emergency Medicine

UNKNOWN

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kasper Iversen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kasper K Iversen, Professor

Role: PRINCIPAL_INVESTIGATOR

Herlev and Gentofte Hospital

Locations

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Herlev and Gentofte hospital

Herlev, Capital Region, Denmark

Site Status

Bispebjerg and Frederiksberg hospital

Copenhagen, , Denmark

Site Status

Nordsjællands Hospital

Hillerød, , Denmark

Site Status

Holbæk hospital

Holbæk, , Denmark

Site Status

Hvidovre, Amager and Glostrup Hospital

Hvidovre, , Denmark

Site Status

Sjælland University hospital

Køge, , Denmark

Site Status

Nykøbing Falster Hospital

Nykøbing Falster, , Denmark

Site Status

Slagelse Hospital

Slagelse, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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568

Identifier Type: -

Identifier Source: org_study_id

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