- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571021
Implementation of the Individual Danish Emergency Process Triage (I-DEPT)
Implementation of the Individual Danish Emergency Process Triage (I-DEPT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kaper K Iversen, Professor
- Phone Number: 004538686009
- Email: kasper.karmark.iversen@regionh.dk
Study Contact Backup
- Name: Pernille B Nielsen, MD
- Phone Number: 004540416662
- Email: pernille.brok.nielsen@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2200
- Bispebjerg and Frederiksberg Hospital
-
Hillerød, Denmark, 3400
- Nordsjællands Hospital
-
Holbæk, Denmark, 4300
- Holbæk Hospital
-
Hvidovre, Denmark, 2650
- Hvidovre, Amager and Glostrup Hospital
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Køge, Denmark, 4600
- Sjælland University hospital
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Nykøbing Falster, Denmark, 4800
- Nykøbing Falster Hospital
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Slagelse, Denmark, 4200
- Slagelse Hospital
-
-
Capital Region
-
Herlev, Capital Region, Denmark, 2730
- Herlev and Gentofte Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I-DEPT
Novel triage.
The triage nurse can adjust the triage category one level of urgency down or one or two levels up.
|
Implementation of the novel triage algorithm
|
Active Comparator: DEPT
Existing triage algorithm
|
Existing triage algorithm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day mortality
Time Frame: 30 days
|
All cause mortality within 30 days following triage in the index admission by non-inferiority
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-day mortality
Time Frame: 2 days
|
All cause mortality within 2 days following triage in the index admission
|
2 days
|
Distribution of triage categories
Time Frame: 1 day
|
There are four categories in both triage algorithms used in this study: (green (least urgent), yellow, orange, and red (most urgent))
|
1 day
|
Patients in the orange triage category
Time Frame: 1 day
|
Number of patients assigned to the orange category
|
1 day
|
Doctor assessment
Time Frame: 1 day
|
Time from triage to arrival of a doctor
|
1 day
|
Days in hospital
Time Frame: 30 days
|
The number of days admitted to a hospital within 30 days
|
30 days
|
Time in the Emergency Department
Time Frame: 30 days
|
Time spent in the Emergency department from triage to either admission, transfer or discharge
|
30 days
|
Patients left without being seen
Time Frame: 30 days
|
Number of patients leaving the Emergency Department without being assessed by a doctor
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kasper K Iversen, Professor, Herlev and Gentofte Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 568
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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