Acute DiseaseI-DEPTNCT04571021
Implementation of the Individual Danish Emergency Process Triage
A study testing I-DEPT and DEPT in people with Acute Disease and Emergencies, run by Herlev Hospital at 8 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 17 to 110 years
- Conditions the study is for
- Acute Disease, Emergencies, Clinical Syndrome
- What is being tested?
- I-DEPT and DEPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250,000 participants
- Where
- 8 sitesDenmark
- Study dates
- 1 Oct 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admission to a participating Emergency Department in the study period
- Full triage assesment in the index admission
Who cannot join
- Age below 17 years
- Death at arrival or before triage assesment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Bispebjerg and Frederiksberg hospital
Copenhagen, 2200
Herlev and Gentofte hospital
Herlev, Capital Region, 2730
Nordsjællands Hospital
Hillerød, 3400
Holbæk hospital
Holbæk, 4300
Hvidovre, Amager and Glostrup Hospital
Hvidovre, 2650
Sjælland University hospital
Køge, 4600
Nykøbing Falster Hospital
Nykøbing Falster, 4800
Slagelse Hospital
Slagelse, 4200
About this study
Official title: Implementation of the Individual Danish Emergency Process Triage (I-DEPT)
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.
Read the 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.
- Conditions
- Acute Disease, Emergencies, Clinical Syndrome
- Being tested
- I-DEPT, DEPT
- Keywords
- triage, risk stratification, emergency department
- Medical subject headings
- Acute Disease, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-DEPTOther
Implementation of the novel triage algorithm
DEPTOther
Existing triage algorithm
| Study group | Role | What they receive |
|---|---|---|
| I-DEPT | Experimental | Novel triage. The triage nurse can adjust the triage category one level of urgency down or one or two levels up. Receives: Other: I-DEPT |
| DEPT | Active comparator | Existing triage algorithm Receives: Other: DEPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
All cause mortality within 30 days following triage in the index admission by non-inferiority
Measured: 30 days
Secondary outcomes (7)
2-day mortality
All cause mortality within 2 days following triage in the index admission
Measured: 2 days
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))
Measured: 1 day
Patients in the orange triage category
Number of patients assigned to the orange category
Measured: 1 day
Doctor assessment
Time from triage to arrival of a doctor
Measured: 1 day
Days in hospital
The number of days admitted to a hospital within 30 days
Measured: 30 days
Time in the Emergency Department
Time spent in the Emergency department from triage to either admission, transfer or discharge
Measured: 30 days
Patients left without being seen
Number of patients leaving the Emergency Department without being assessed by a doctor
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Oct 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-Wedge cluster randomized design
- Masking
- None (open label)
- Enrolment
- 250,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amager Hospital, University Hospital Bispebjerg and Frederiksberg, Nykøbing Falster Hospital, Department of Emergency Medicine, Slagelse Hospital, Department of Emergency Medicine, Køge Hospital, Department of Emergency Medicine, Nordsjaellands Hospital, Holbæk Hospital, Department of Emergency Medicine
- Responsible party
- Principal investigator, Kasper Iversen, Herlev and Gentofte Hospital
- Investigators
- Kasper K Iversen, Professor, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571021
- Sponsor's protocol ID
- 568
- Acronym
- I-DEPT
- Status last verified
- Mar 2023
- First submitted
- 24 Sep 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Individual Danish Emergency Process Triage (I-DEPT)
- ClinicalTrials.gov ID
- NCT04571021
- Acronym / sponsor ID
- I-DEPT / 568
- Conditions
- Acute Disease, Emergencies, Clinical Syndrome
- Keywords
- triage, risk stratification, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250,000 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Amager Hospital, University Hospital Bispebjerg and Frederiksberg, Nykøbing Falster Hospital, Department of Emergency Medicine, Slagelse Hospital, Department of Emergency Medicine, Køge Hospital, Department of Emergency Medicine, Nordsjaellands Hospital, Holbæk Hospital, Department of Emergency Medicine
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-Wedge cluster randomized design
| Arm | Type | Receives |
|---|---|---|
| I-DEPT | Experimental | Other: I-DEPTNovel triage. The triage nurse can adjust the triage category one level of urgency down or one or two levels up. |
| DEPT | Active comparator | Other: DEPTExisting triage algorithm |
Who may qualify
- Ages
- 17 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Admission to a participating Emergency Department in the study period
- Full triage assesment in the index admission
Key exclusion criteria (2 listed)
- Age below 17 years
- Death at arrival or before triage assesment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-DEPTImplementation of the novel triage algorithm | Other | I-DEPT |
| DEPTExisting triage algorithm | Other | DEPT |
Primary outcome
30-day mortality
Time frame: 30 days
All cause mortality within 30 days following triage in the index admission by non-inferiority
7 secondary outcomes
2-day mortality
Time frame: 2 days
Distribution of triage categories
Time frame: 1 day
Patients in the orange triage category
Time frame: 1 day
Doctor assessment
Time frame: 1 day
Days in hospital
Time frame: 30 days
Time in the Emergency Department
Time frame: 30 days
Patients left without being seen
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasper K Iversen, Professor principal investigator
Herlev and Gentofte Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-DEPT and DEPT in people with Acute Disease and Emergencies, run by Herlev Hospital at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.