NCT04571021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

September 24, 2020

Last Update Submit

March 30, 2023

Conditions

Keywords

triagerisk stratificationemergency department

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

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

    30 days

Secondary Outcomes (7)

  • 2-day mortality

    2 days

  • Distribution of triage categories

    1 day

  • Patients in the orange triage category

    1 day

  • Doctor assessment

    1 day

  • Days in hospital

    30 days

  • +2 more secondary outcomes

Study Arms (2)

I-DEPT

EXPERIMENTAL

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

Other: I-DEPT

DEPT

ACTIVE COMPARATOR

Existing triage algorithm

Other: DEPT

Interventions

I-DEPTOTHER

Implementation of the novel triage algorithm

I-DEPT
DEPTOTHER

Existing triage algorithm

DEPT

Eligibility Criteria

Age17 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to a participating Emergency Department in the study period
  • Full triage assesment in the index admission

You may not qualify if:

  • Age below 17 years
  • Death at arrival or before triage assesment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Herlev and Gentofte hospital

Herlev, Capital Region, 2730, Denmark

Location

Bispebjerg and Frederiksberg hospital

Copenhagen, 2200, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Holbæk hospital

Holbæk, 4300, Denmark

Location

Hvidovre, Amager and Glostrup Hospital

Hvidovre, 2650, Denmark

Location

Sjælland University hospital

Køge, 4600, Denmark

Location

Nykøbing Falster Hospital

Nykøbing Falster, 4800, Denmark

Location

Slagelse Hospital

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

Acute DiseaseEmergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kasper K Iversen, Professor

    Herlev and Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Stepped-Wedge cluster randomized design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 30, 2020

Study Start

October 1, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations