Implementation of the Individual Danish Emergency Process Triage (I-DEPT)
Primary Purpose
Acute Disease, Emergencies, Clinical Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
I-DEPT
DEPT
Sponsored by
About this trial
This is an interventional prevention trial for Acute Disease focused on measuring triage, risk stratification, emergency department
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
Sites / Locations
- Herlev and Gentofte hospital
- Bispebjerg and Frederiksberg hospital
- Nordsjællands Hospital
- Holbæk hospital
- Hvidovre, Amager and Glostrup Hospital
- Sjælland University hospital
- Nykøbing Falster Hospital
- Slagelse Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
I-DEPT
DEPT
Arm Description
Novel triage. The triage nurse can adjust the triage category one level of urgency down or one or two levels up.
Existing triage algorithm
Outcomes
Primary Outcome Measures
30-day mortality
All cause mortality within 30 days following triage in the index admission by non-inferiority
Secondary Outcome Measures
2-day mortality
All cause mortality within 2 days following triage in the index admission
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))
Patients in the orange triage category
Number of patients assigned to the orange category
Doctor assessment
Time from triage to arrival of a doctor
Days in hospital
The number of days admitted to a hospital within 30 days
Time in the Emergency Department
Time spent in the Emergency department from triage to either admission, transfer or discharge
Patients left without being seen
Number of patients leaving the Emergency Department without being assessed by a doctor
Full Information
NCT ID
NCT04571021
First Posted
September 24, 2020
Last Updated
March 30, 2023
Sponsor
Herlev Hospital
Collaborators
Hvidovre, Amager and Glostrup Hospital, Department of Emergency Medicine, Bispebjerg and Frederiksberg Hospital, Department of Emergency Medicine, Nykøbing Falster Hospital, Department of Emergency Medicine, Slagelse Hospital, Department of Emergency Medicine, Køge Hospital, Department of Emergency Medicine, Nordsjællands Hospital, Department of Emergency Medicine, Holbæk Hospital, Department of Emergency Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04571021
Brief Title
Implementation of the Individual Danish Emergency Process Triage
Acronym
I-DEPT
Official Title
Implementation of the Individual Danish Emergency Process Triage (I-DEPT)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
Collaborators
Hvidovre, Amager and Glostrup Hospital, Department of Emergency Medicine, Bispebjerg and Frederiksberg Hospital, Department of Emergency Medicine, Nykøbing Falster Hospital, Department of Emergency Medicine, Slagelse Hospital, Department of Emergency Medicine, Køge Hospital, Department of Emergency Medicine, Nordsjællands Hospital, Department of Emergency Medicine, Holbæk Hospital, Department of Emergency Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Disease, Emergencies, Clinical Syndrome
Keywords
triage, risk stratification, emergency department
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-Wedge cluster randomized design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I-DEPT
Arm Type
Experimental
Arm Description
Novel triage. The triage nurse can adjust the triage category one level of urgency down or one or two levels up.
Arm Title
DEPT
Arm Type
Active Comparator
Arm Description
Existing triage algorithm
Intervention Type
Other
Intervention Name(s)
I-DEPT
Intervention Description
Implementation of the novel triage algorithm
Intervention Type
Other
Intervention Name(s)
DEPT
Intervention Description
Existing triage algorithm
Primary Outcome Measure Information:
Title
30-day mortality
Description
All cause mortality within 30 days following triage in the index admission by non-inferiority
Time Frame
30 days
Secondary Outcome Measure Information:
Title
2-day mortality
Description
All cause mortality within 2 days following triage in the index admission
Time Frame
2 days
Title
Distribution of triage categories
Description
There are four categories in both triage algorithms used in this study: (green (least urgent), yellow, orange, and red (most urgent))
Time Frame
1 day
Title
Patients in the orange triage category
Description
Number of patients assigned to the orange category
Time Frame
1 day
Title
Doctor assessment
Description
Time from triage to arrival of a doctor
Time Frame
1 day
Title
Days in hospital
Description
The number of days admitted to a hospital within 30 days
Time Frame
30 days
Title
Time in the Emergency Department
Description
Time spent in the Emergency department from triage to either admission, transfer or discharge
Time Frame
30 days
Title
Patients left without being seen
Description
Number of patients leaving the Emergency Department without being assessed by a doctor
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasper K Iversen, Professor
Organizational Affiliation
Herlev and Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev and Gentofte hospital
City
Herlev
State/Province
Capital Region
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Bispebjerg and Frederiksberg hospital
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Holbæk hospital
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Hvidovre, Amager and Glostrup Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Sjælland University hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Nykøbing Falster Hospital
City
Nykøbing Falster
ZIP/Postal Code
4800
Country
Denmark
Facility Name
Slagelse Hospital
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Implementation of the Individual Danish Emergency Process Triage
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