Implementation of the Individual Danish Emergency Process... | NCT04571021

Studies
Implementation of the Individual Danish Emergency Process Triage

NCT04571021

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Apr 3, 2023Actual

Enrollment

250,000Actual

Phase

Not Applicable

Conditions

Acute Disease
Emergencies
Clinical Syndrome

Interventions

I-DEPT
DEPT

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Sep 24, 2020

First Submission Date that Met QC Criteria

Sep 29, 2020

First Posted Date

Sep 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2023

Last Update Posted Date

Apr 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kasper Iversen, Professor, Herlev and Gentofte HospitalPrincipal Investigator

Lead Sponsor

Herlev HospitalOTHER

Collaborators

Name	Class
Amager Hospital	OTHER
University Hospital Bispebjerg and Frederiksberg	OTHER
Nykøbing Falster Hospital, Department of Emergency Medicine	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
I-DEPT	Other	Implementation of the novel triage algorithm	I-DEPT
DEPT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30-day mortality	All cause mortality within 30 days following triage in the index admission by non-inferiority	30 days

Secondary Outcomes

Measure	Description	Time Frame
2-day mortality	All cause mortality within 2 days following triage in the index admission	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))

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

110 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kasper K Iversen, Professor	Herlev and Gentofte Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev and Gentofte hospital		Herlev	Capital Region	2730	Denmark
Bispebjerg and Frederiksberg hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Mar 30, 2023	Mar 30, 2023	SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000208	Acute Disease
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided