NCT03793972

Brief Summary

Introduction: Patients who might also go to the general practitioner (GP) frequently consult emergency departments (ED). This leads to additional costs for both government and patient and a high workload for emergency physicians in Flanders. The Belgian government wants to address this problem by improved collaboration between EDs and general practice cooperatives (GPCs). Intervention: Patients presenting at the ED during out-of-hours (OOH) will be triaged and allocated to the most appropriate service. For this purpose the Manchester Triage System (MTS) which is commonly used in Flemish hospitals, will be extended (eMTS). By doing so a trained nurse will be able to diverge suitable patients towards the GPC. Methodology: The investigators will conduct a cluster randomised controlled trial in which eligible ED patients will be diverged to the GPC using the eMTS. The investigators will collect data using the iCAREdata database. The investigators will study the use of the eMTS, the effectiveness and effects of triage, work load changes, epidemiology at both departments, patient safety, health insurance (HIS) and patient expenditures. Furthermore, facilitators and barriers will be studied and an incident analysis of problem cases will be performed. Outcome: The primary outcome is the proportion of patients who enter the ED and are handled by the GP after triage. Secondary outcome measurements are related to safety: referral rate to the ED by the GP, proportion of patients not following the triage advice and file review for selected patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 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

January 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 4, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

March 11, 2025

Completed
Last Updated

March 11, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

January 2, 2019

Results QC Date

November 22, 2024

Last Update Submit

February 18, 2025

Conditions

Keywords

TriagePrimary Health CareEmergency Service, Hospital

Outcome Measures

Primary Outcomes (1)

  • The Proportion of Patients Presenting at the ED But Being Treated by the GPC After Referral

    The difference between intervention and control period will be calculated. Treatment at the GPC means having a record at the GPC.

    Patient flow will be followed for 24 hours after presentation at the ED

Study Arms (2)

Triage with referral to primary care

EXPERIMENTAL

Triage and referral according to eMTS.

Other: Triage with referral to primary care

Triage without referral to primary care

ACTIVE COMPARATOR

Weekends with usual care

Other: Usual care

Interventions

During intervention weekends(and holidays) a nurse will triage patients using a newly developped extended Manchester Triage System (eMTS). Patients appropriate for primary care will be referred to the general practitioner on call.We will inform patients about the nature of the intervention using leaflets and broadcasting in the waiting room of the Emergency Department.

Triage with referral to primary care

During a control weekend (and holidays), all data registration and collection will be the same as during intervention weekends but patents will not be informed about their allocation advice. The emergency physician will see all patients deciding to stay at the ED, without influence of the triage advice. As in standard clinical care, patients will have the right to change their mind and go spontaneously to the general practitioner. . During control weekends, we will only inform about triage in general but no about the general practioner or the intervention.

Triage without referral to primary care

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • availability of a Belgian citizen national insurance number

You may not qualify if:

  • Patients arriving at the ED by an ambulance with a doctor or nurse
  • Patients all ready admitted to an other hospital department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AZ Monica

Deurne, 2100, Belgium

Location

HuisartsenWachtpost Antwerpen Oost

Deurne, 2100, Belgium

Location

Related Publications (3)

  • Morreel S, Verhoeven V, Philips H, Meysman J, Homburg I, De Graeve D, Monsieurs KG. Differences in emergency nurse triage between a simulated setting and the real world, post hoc analysis of a cluster randomised trial. BMJ Open. 2022 Jul 1;12(7):e059173. doi: 10.1136/bmjopen-2021-059173.

  • Homburg I, Morreel S, Verhoeven V, Monsieurs KG, Meysman J, Philips H, De Graeve D. Non-compliance with a nurse's advice to visit the primary care provider: an exploratory secondary analysis of the TRIAGE-trial. BMC Health Serv Res. 2022 Apr 8;22(1):463. doi: 10.1186/s12913-022-07904-8.

  • Morreel S, Philips H, De Graeve D, Monsieurs KG, Kampen JK, Meysman J, Lefevre E, Verhoeven V. Triaging and referring in adjacent general and emergency departments (the TRIAGE trial): A cluster randomised controlled trial. PLoS One. 2021 Nov 3;16(11):e0258561. doi: 10.1371/journal.pone.0258561. eCollection 2021.

MeSH Terms

Conditions

Emergencies

Interventions

Triage

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Emergency Medical ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Stefan Morreel
Organization
UAntwerpen

Study Officials

  • Veronique Verhoeven, PhD

    Univeristeit Antwerpen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomised with weekends servings as clusters.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 4, 2019

Study Start

January 4, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 11, 2025

Results First Posted

March 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Even the researchers will only have very limited access to individual data. All collected data will be stored in the "iCAREdata" database (see http://www.icaredata.eu/) and as such will be accessible when necessary.

Locations