I-DEPT: Implementation of the Individual Danish Emergency Process Triage

Sponsor
Herlev Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04571021
Collaborator
Hvidovre, Amager and Glostrup Hospital, Department of Emergency Medicine (Other), Bispebjerg and Frederiksberg Hospital, Department of Emergency Medicine (Other), Nykøbing Falster Hospital, Department of Emergency Medicine (Other), Slagelse Hospital, Department of Emergency Medicine (Other), Køge Hospital, Department of Emergency Medicine (Other), Nordsjællands Hospital, Department of Emergency Medicine (Other), Holbæk Hospital, Department of Emergency Medicine (Other)
100,000
8
2
17
12500
737.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: I-DEPT
  • Other: DEPT
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
100000 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stepped-Wedge cluster randomized designStepped-Wedge cluster randomized design
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Implementation of the Individual Danish Emergency Process Triage (I-DEPT)
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

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.

Other: I-DEPT
Implementation of the novel triage algorithm

Active Comparator: DEPT

Existing triage algorithm

Other: DEPT
Existing triage algorithm

Outcome Measures

Primary Outcome Measures

  1. 30-day mortality [30 days]

    All cause mortality within 30 days following triage in the index admission by non-inferiority

Secondary Outcome Measures

  1. 2-day mortality [2 days]

    All cause mortality within 2 days following triage in the index admission

  2. Distribution of triage categories [1 day]

    There are four categories in both triage algorithms used in this study: (green (least urgent), yellow, orange, and red (most urgent))

  3. Patients in the orange triage category [1 day]

    Number of patients assigned to the orange category

  4. Doctor assessment [1 day]

    Time from triage to arrival of a doctor

  5. Days in hospital [30 days]

    The number of days admitted to a hospital within 30 days

  6. Time in the Emergency Department [30 days]

    Time spent in the Emergency department from triage to either admission, transfer or discharge

  7. Patients left without being seen [30 days]

    Number of patients leaving the Emergency Department without being assessed by a doctor

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Herlev and Gentofte hospital Herlev Capital Region Denmark 2730
2 Bispebjerg and Frederiksberg hospital Copenhagen Denmark 2200
3 Nordsjællands Hospital Hillerød Denmark 3400
4 Holbæk hospital Holbæk Denmark 4300
5 Hvidovre, Amager and Glostrup Hospital Hvidovre Denmark 2650
6 Sjælland University hospital Køge Denmark 4600
7 Nykøbing Falster Hospital Nykøbing Falster Denmark 4800
8 Slagelse Hospital Slagelse Denmark 4200

Sponsors and Collaborators

  • Herlev Hospital
  • 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

Investigators

  • Principal Investigator: Kasper K Iversen, Professor, Herlev and Gentofte Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kasper Iversen, Professor, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier:
NCT04571021
Other Study ID Numbers:
  • 568
First Posted:
Sep 30, 2020
Last Update Posted:
Oct 6, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kasper Iversen, Professor, Herlev and Gentofte Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2020