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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03793972
Other study ID # T000718N
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2019
Est. completion date December 31, 2019

Study information

Verified date June 2020
Source Universiteit Antwerpen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9171
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Triage with referral to primary care
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.
Usual 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.

Locations

Country Name City State
Belgium AZ Monica Deurne
Belgium HuisartsenWachtpost Antwerpen Oost Deurne

Sponsors (3)

Lead Sponsor Collaborator
Universiteit Antwerpen Research Foundation Flanders, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of correct triage decisions: patients compliant to a GPC-advice or non-compliant to an ED-advice. This is the number of patients treated at the GPC to number of patients referred back to the ED by the GP. Patient flow will be followed for 24 hours after presentation at the ED
Other Proportion of correct triage decisions: patients compliant to an ED-advice or non-compliant to a GPC-advice: opinion of the emergency physician. The emergency physicians will register their opinion about the ideal location of the patient in the routine electronical health records: ED or GPC. Registred at the time the emergency physicians finishes routine electronical health record
Other Proportion of correct triage decisions: patients compliant to an ED-advice or non-compliant to a GPC-advice: admissionrate. 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 Registred at the time the emergency physicians finishes routine electronical health record
Other Proportion of patients compliant to a GPC advice who get admitted Admission is registered by the nursing staff in the routine electronical health records. Patient flow will be followed for 24 hours after presentation at the ED
Other Proportion of patients who are not compliant to the triage a GPC advice 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, Patient flow will be followed for 24 hours after presentation at the ED
Other Proportion of patients who are not compliant to the triage an ED advice 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, Patient flow will be followed for 24 hours after presentation at the ED
Other Porportion of patients left without being seen at the ED Proportion of patients registred as left without being seen in the routine electronical health records to the total number of included patients Patient flow will be followed for 24 hours after presentation at the ED
Primary 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
Secondary 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. Measurement during the triage consultation
Secondary 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 Measurement during the triage consultation
Secondary 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. Measurement during the triage consultation
Secondary 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. Measurement a the start of the GP consultation
Secondary Association between the primary outcome and the age of the patient Age will be measured in years. Registered at the time of presentation at the ED
Secondary Association between the primary outcome and the sex of the patient Sex is either male or female Regisetered at the time of presentation at the ED
Secondary 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 Registered at the time of presentation at the ED
Secondary 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. Registered at the time of presentation at the ED
Secondary Association between the primary outcome and the season Entire study period of one calendar year will devided in four seasons Depends on the time of admission registered at the time of presentation at the ED
Secondary Association between the primary outcome and the hour of the day of the patient's presentation A day has twenty-four hours Depends on the time of admission registered at the time of presentation at the ED
Secondary 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. Patient flow will be followed for 24 hours after presentation at the ED
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