- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03793972
Triaging and Referring in Adjacent General and Emergency Departments (TRIAGE)
Triaging and Referring in Adjacent General and Emergency Departments (the TRIAGE-trial): a Cluster Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Deurne, Belgium, 2100
- AZ Monica
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Deurne, Belgium, 2100
- HuisartsenWachtpost Antwerpen Oost
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Triage with referral to primary care
Triage and referral according to eMTS.
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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.
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Active Comparator: Triage without referral to primary care
Weekends with usual care
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients presenting at the ED but being treated by the GPC after referral
Time Frame: Patient flow will be followed for 24 hours after presentation at the ED
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The difference between intervention and control period will be calculated.
Treatment at the GPC means having a record at the GPC.
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Patient flow will be followed for 24 hours after presentation at the ED
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between the primary outcome and the patient's presenting complaint expressed as the title of a Manchester Triage System presentation
Time Frame: Measurement during the triage consultation
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There are 53 different presentations.
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Measurement during the triage consultation
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Association between the primary outcome and the urgency of the patient's presentation as expressed by the Manchester Triage System urgency category,
Time Frame: Measurement during the triage consultation
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There are five categories of which the least two urgent ones (green and blue) are in general suitable for primary care
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Measurement during the triage consultation
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Association between the primary outcome and subjective workload at the ED as juged by the emergency nurse
Time Frame: Measurement during the triage consultation
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This urgency has four ordinal categories: uncontrollable busy, busy but under control, normal, quiet.
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Measurement during the triage consultation
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Association between the primary outcome and subjective workload at the GPC.
Time Frame: Measurement a the start of the GP consultation
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Workload at the GPC is objectively measured as the number of patients in the waiting room at the time of consultation.
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Measurement a the start of the GP consultation
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Association between the primary outcome and the age of the patient
Time Frame: Registered at the time of presentation at the ED
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Age will be measured in years.
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Registered at the time of presentation at the ED
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Association between the primary outcome and the sex of the patient
Time Frame: Regisetered at the time of presentation at the ED
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Sex is either male or female
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Regisetered at the time of presentation at the ED
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Association between the primary outcome and the ZIP-code of the patient
Time Frame: Registered at the time of presentation at the ED
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There are 2825 possible ZIP-codes but only the ten most frequent in the studied population are relevant
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Registered at the time of presentation at the ED
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Association between the primary outcome and the social status of the patient
Time Frame: Registered at the time of presentation at the ED
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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.
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Registered at the time of presentation at the ED
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Association between the primary outcome and the season
Time Frame: Depends on the time of admission registered at the time of presentation at the ED
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Entire study period of one calendar year will devided in four seasons
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Depends on the time of admission registered at the time of presentation at the ED
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Association between the primary outcome and the hour of the day of the patient's presentation
Time Frame: Depends on the time of admission registered at the time of presentation at the ED
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A day has twenty-four hours
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Depends on the time of admission registered at the time of presentation at the ED
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Variation of the primary outcome among the triage nurses,
Time Frame: Patient flow will be followed for 24 hours after presentation at the ED
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All nurses get an anonymized ID.
The primary outcome will be measured for all nures individually.
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Patient flow will be followed for 24 hours after presentation at the ED
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of correct triage decisions: patients compliant to a GPC-advice or non-compliant to an ED-advice.
Time Frame: Patient flow will be followed for 24 hours after presentation at the ED
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This is the number of patients treated at the GPC to number of patients referred back to the ED by the GP.
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Patient flow will be followed for 24 hours after presentation at the ED
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Proportion of correct triage decisions: patients compliant to an ED-advice or non-compliant to a GPC-advice: opinion of the emergency physician.
Time Frame: Registred at the time the emergency physicians finishes routine electronical health record
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The emergency physicians will register their opinion about the ideal location of the patient in the routine electronical health records: ED or GPC.
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Registred at the time the emergency physicians finishes routine electronical health record
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Proportion of correct triage decisions: patients compliant to an ED-advice or non-compliant to a GPC-advice: admissionrate.
Time Frame: Registred at the time the emergency physicians finishes routine electronical health record
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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
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Registred at the time the emergency physicians finishes routine electronical health record
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Proportion of patients compliant to a GPC advice who get admitted
Time Frame: Patient flow will be followed for 24 hours after presentation at the ED
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Admission is registered by the nursing staff in the routine electronical health records.
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Patient flow will be followed for 24 hours after presentation at the ED
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Proportion of patients who are not compliant to the triage a GPC advice
Time Frame: Patient flow will be followed for 24 hours after presentation at the ED
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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,
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Patient flow will be followed for 24 hours after presentation at the ED
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Proportion of patients who are not compliant to the triage an ED advice
Time Frame: Patient flow will be followed for 24 hours after presentation at the ED
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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,
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Patient flow will be followed for 24 hours after presentation at the ED
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Porportion of patients left without being seen at the ED
Time Frame: Patient flow will be followed for 24 hours after presentation at the ED
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Proportion of patients registred as left without being seen in the routine electronical health records to the total number of included patients
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Patient flow will be followed for 24 hours after presentation at the ED
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Veronique Verhoeven, PhD, Univeristeit Antwerpen
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T000718N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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