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Triaging and Referring in Adjacent General and Emergency Departments (TRIAGE)

Primary Purpose

Triage

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Triage with referral to primary care
Usual care
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Triage focused on measuring Triage, Primary Health Care, Emergency Service, Hospital

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • availability of a Belgian citizen national insurance number

Exclusion Criteria:

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

Sites / Locations

  • AZ Monica
  • HuisartsenWachtpost Antwerpen Oost

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Triage with referral to primary care

Triage without referral to primary care

Arm Description

Triage and referral according to eMTS.

Weekends with usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Association between the primary outcome and the patient's presenting complaint expressed as the title of a Manchester Triage System presentation
There are 53 different presentations.
Association between the primary outcome and the urgency of the patient's presentation as expressed by the Manchester Triage System urgency category,
There are five categories of which the least two urgent ones (green and blue) are in general suitable for primary care
Association between the primary outcome and subjective workload at the ED as juged by the emergency nurse
This urgency has four ordinal categories: uncontrollable busy, busy but under control, normal, quiet.
Association between the primary outcome and subjective workload at the GPC.
Workload at the GPC is objectively measured as the number of patients in the waiting room at the time of consultation.
Association between the primary outcome and the age of the patient
Age will be measured in years.
Association between the primary outcome and the sex of the patient
Sex is either male or female
Association between the primary outcome and the ZIP-code of the patient
There are 2825 possible ZIP-codes but only the ten most frequent in the studied population are relevant
Association between the primary outcome and the social status of the patient
Allmost all belgians are subscribed in the national compulsory health insurance. An national database provides information about the social status to allow correct reimbursment of health care costs. This is a dichotomous variable: higher imbursement because of financial situation: yes or no.
Association between the primary outcome and the season
Entire study period of one calendar year will devided in four seasons
Association between the primary outcome and the hour of the day of the patient's presentation
A day has twenty-four hours
Variation of the primary outcome among the triage nurses,
All nurses get an anonymized ID. The primary outcome will be measured for all nures individually.

Full Information

First Posted
January 2, 2019
Last Updated
June 12, 2020
Sponsor
Universiteit Antwerpen
Collaborators
University Hospital, Antwerp, Research Foundation Flanders
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1. Study Identification

Unique Protocol Identification Number
NCT03793972
Brief Title
Triaging and Referring in Adjacent General and Emergency Departments
Acronym
TRIAGE
Official Title
Triaging and Referring in Adjacent General and Emergency Departments (the TRIAGE-trial): a Cluster Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
University Hospital, Antwerp, Research Foundation Flanders

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triage
Keywords
Triage, Primary Health Care, Emergency Service, Hospital

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomised with weekends servings as clusters.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triage with referral to primary care
Arm Type
Experimental
Arm Description
Triage and referral according to eMTS.
Arm Title
Triage without referral to primary care
Arm Type
Active Comparator
Arm Description
Weekends with usual care
Intervention Type
Other
Intervention Name(s)
Triage with referral to primary care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of patients presenting at the ED but being treated by the GPC after referral
Description
The difference between intervention and control period will be calculated. Treatment at the GPC means having a record at the GPC.
Time Frame
Patient flow will be followed for 24 hours after presentation at the ED
Secondary Outcome Measure Information:
Title
Association between the primary outcome and the patient's presenting complaint expressed as the title of a Manchester Triage System presentation
Description
There are 53 different presentations.
Time Frame
Measurement during the triage consultation
Title
Association between the primary outcome and the urgency of the patient's presentation as expressed by the Manchester Triage System urgency category,
Description
There are five categories of which the least two urgent ones (green and blue) are in general suitable for primary care
Time Frame
Measurement during the triage consultation
Title
Association between the primary outcome and subjective workload at the ED as juged by the emergency nurse
Description
This urgency has four ordinal categories: uncontrollable busy, busy but under control, normal, quiet.
Time Frame
Measurement during the triage consultation
Title
Association between the primary outcome and subjective workload at the GPC.
Description
Workload at the GPC is objectively measured as the number of patients in the waiting room at the time of consultation.
Time Frame
Measurement a the start of the GP consultation
Title
Association between the primary outcome and the age of the patient
Description
Age will be measured in years.
Time Frame
Registered at the time of presentation at the ED
Title
Association between the primary outcome and the sex of the patient
Description
Sex is either male or female
Time Frame
Regisetered at the time of presentation at the ED
Title
Association between the primary outcome and the ZIP-code of the patient
Description
There are 2825 possible ZIP-codes but only the ten most frequent in the studied population are relevant
Time Frame
Registered at the time of presentation at the ED
Title
Association between the primary outcome and the social status of the patient
Description
Allmost all belgians are subscribed in the national compulsory health insurance. An national database provides information about the social status to allow correct reimbursment of health care costs. This is a dichotomous variable: higher imbursement because of financial situation: yes or no.
Time Frame
Registered at the time of presentation at the ED
Title
Association between the primary outcome and the season
Description
Entire study period of one calendar year will devided in four seasons
Time Frame
Depends on the time of admission registered at the time of presentation at the ED
Title
Association between the primary outcome and the hour of the day of the patient's presentation
Description
A day has twenty-four hours
Time Frame
Depends on the time of admission registered at the time of presentation at the ED
Title
Variation of the primary outcome among the triage nurses,
Description
All nurses get an anonymized ID. The primary outcome will be measured for all nures individually.
Time Frame
Patient flow will be followed for 24 hours after presentation at the ED
Other Pre-specified Outcome Measures:
Title
Proportion of correct triage decisions: patients compliant to a GPC-advice or non-compliant to an ED-advice.
Description
This is the number of patients treated at the GPC to number of patients referred back to the ED by the GP.
Time Frame
Patient flow will be followed for 24 hours after presentation at the ED
Title
Proportion of correct triage decisions: patients compliant to an ED-advice or non-compliant to a GPC-advice: opinion of the emergency physician.
Description
The emergency physicians will register their opinion about the ideal location of the patient in the routine electronical health records: ED or GPC.
Time Frame
Registred at the time the emergency physicians finishes routine electronical health record
Title
Proportion of correct triage decisions: patients compliant to an ED-advice or non-compliant to a GPC-advice: admissionrate.
Description
Proportion of the number of patients compliant to an ED-advice or non-compliant to a GPC-advice who get admitted tot the hospital to the total number of these patients. Admission is registered by the nursing staff in the routine electronical health records
Time Frame
Registred at the time the emergency physicians finishes routine electronical health record
Title
Proportion of patients compliant to a GPC advice who get admitted
Description
Admission is registered by the nursing staff in the routine electronical health records.
Time Frame
Patient flow will be followed for 24 hours after presentation at the ED
Title
Proportion of patients who are not compliant to the triage a GPC advice
Description
Compliant patients will have a record at the GPC, non-compliant patients will have a consultation report at the ED or will be registred as left without being seen,
Time Frame
Patient flow will be followed for 24 hours after presentation at the ED
Title
Proportion of patients who are not compliant to the triage an ED advice
Description
Compliant patients will have a record at the ED, non-compliant patients will have a consultation report at the GPC or will be registered as left without being seen,
Time Frame
Patient flow will be followed for 24 hours after presentation at the ED
Title
Porportion of patients left without being seen at the ED
Description
Proportion of patients registred as left without being seen in the routine electronical health records to the total number of included patients
Time Frame
Patient flow will be followed for 24 hours after presentation at the ED

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: availability of a Belgian citizen national insurance number Exclusion Criteria: Patients arriving at the ED by an ambulance with a doctor or nurse Patients all ready admitted to an other hospital department
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronique Verhoeven, PhD
Organizational Affiliation
Univeristeit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Monica
City
Deurne
ZIP/Postal Code
2100
Country
Belgium
Facility Name
HuisartsenWachtpost Antwerpen Oost
City
Deurne
ZIP/Postal Code
2100
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
35777880
Citation
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.
Results Reference
derived
PubMed Identifier
35395840
Citation
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.
Results Reference
derived
PubMed Identifier
34731198
Citation
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.
Results Reference
derived

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Triaging and Referring in Adjacent General and Emergency Departments

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