<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03793972</url>
  </required_header>
  <id_info>
    <org_study_id>T000718N</org_study_id>
    <nct_id>NCT03793972</nct_id>
  </id_info>
  <brief_title>Triaging and Referring in Adjacent General and Emergency Departments</brief_title>
  <acronym>TRIAGE</acronym>
  <official_title>Triaging and Referring in Adjacent General and Emergency Departments (the TRIAGE-trial): a Cluster Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Research Foundation Flanders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiteit Antwerpen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Patients who might also go to the general practitioner (GP) frequently consult&#xD;
      emergency departments (ED). This leads to additional costs for both government and patient&#xD;
      and a high workload for emergency physicians in Flanders. The Belgian government wants to&#xD;
      address this problem by improved collaboration between EDs and general practice cooperatives&#xD;
      (GPCs).&#xD;
&#xD;
      Intervention: Patients presenting at the ED during out-of-hours (OOH) will be triaged and&#xD;
      allocated to the most appropriate service. For this purpose the Manchester Triage System&#xD;
      (MTS) which is commonly used in Flemish hospitals, will be extended (eMTS). By doing so a&#xD;
      trained nurse will be able to diverge suitable patients towards the GPC.&#xD;
&#xD;
      Methodology: The investigators will conduct a cluster randomised controlled trial in which&#xD;
      eligible ED patients will be diverged to the GPC using the eMTS. The investigators will&#xD;
      collect data using the iCAREdata database. The investigators will study the use of the eMTS,&#xD;
      the effectiveness and effects of triage, work load changes, epidemiology at both departments,&#xD;
      patient safety, health insurance (HIS) and patient expenditures. Furthermore, facilitators&#xD;
      and barriers will be studied and an incident analysis of problem cases will be performed.&#xD;
&#xD;
      Outcome: The primary outcome is the proportion of patients who enter the ED and are handled&#xD;
      by the GP after triage. Secondary outcome measurements are related to safety: referral rate&#xD;
      to the ED by the GP, proportion of patients not following the triage advice and file review&#xD;
      for selected patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Cluster randomised with weekends servings as clusters.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients presenting at the ED but being treated by the GPC after referral</measure>
    <time_frame>Patient flow will be followed for 24 hours after presentation at the ED</time_frame>
    <description>The difference between intervention and control period will be calculated. Treatment at the GPC means having a record at the GPC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and the patient's presenting complaint expressed as the title of a Manchester Triage System presentation</measure>
    <time_frame>Measurement during the triage consultation</time_frame>
    <description>There are 53 different presentations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and the urgency of the patient's presentation as expressed by the Manchester Triage System urgency category,</measure>
    <time_frame>Measurement during the triage consultation</time_frame>
    <description>There are five categories of which the least two urgent ones (green and blue) are in general suitable for primary care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and subjective workload at the ED as juged by the emergency nurse</measure>
    <time_frame>Measurement during the triage consultation</time_frame>
    <description>This urgency has four ordinal categories: uncontrollable busy, busy but under control, normal, quiet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and subjective workload at the GPC.</measure>
    <time_frame>Measurement a the start of the GP consultation</time_frame>
    <description>Workload at the GPC is objectively measured as the number of patients in the waiting room at the time of consultation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and the age of the patient</measure>
    <time_frame>Registered at the time of presentation at the ED</time_frame>
    <description>Age will be measured in years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and the sex of the patient</measure>
    <time_frame>Regisetered at the time of presentation at the ED</time_frame>
    <description>Sex is either male or female</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and the ZIP-code of the patient</measure>
    <time_frame>Registered at the time of presentation at the ED</time_frame>
    <description>There are 2825 possible ZIP-codes but only the ten most frequent in the studied population are relevant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and the social status of the patient</measure>
    <time_frame>Registered at the time of presentation at the ED</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and the season</measure>
    <time_frame>Depends on the time of admission registered at the time of presentation at the ED</time_frame>
    <description>Entire study period of one calendar year will devided in four seasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between the primary outcome and the hour of the day of the patient's presentation</measure>
    <time_frame>Depends on the time of admission registered at the time of presentation at the ED</time_frame>
    <description>A day has twenty-four hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of the primary outcome among the triage nurses,</measure>
    <time_frame>Patient flow will be followed for 24 hours after presentation at the ED</time_frame>
    <description>All nurses get an anonymized ID. The primary outcome will be measured for all nures individually.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of correct triage decisions: patients compliant to a GPC-advice or non-compliant to an ED-advice.</measure>
    <time_frame>Patient flow will be followed for 24 hours after presentation at the ED</time_frame>
    <description>This is the number of patients treated at the GPC to number of patients referred back to the ED by the GP.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of correct triage decisions: patients compliant to an ED-advice or non-compliant to a GPC-advice: opinion of the emergency physician.</measure>
    <time_frame>Registred at the time the emergency physicians finishes routine electronical health record</time_frame>
    <description>The emergency physicians will register their opinion about the ideal location of the patient in the routine electronical health records: ED or GPC.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of correct triage decisions: patients compliant to an ED-advice or non-compliant to a GPC-advice: admissionrate.</measure>
    <time_frame>Registred at the time the emergency physicians finishes routine electronical health record</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients compliant to a GPC advice who get admitted</measure>
    <time_frame>Patient flow will be followed for 24 hours after presentation at the ED</time_frame>
    <description>Admission is registered by the nursing staff in the routine electronical health records.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients who are not compliant to the triage a GPC advice</measure>
    <time_frame>Patient flow will be followed for 24 hours after presentation at the ED</time_frame>
    <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,</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients who are not compliant to the triage an ED advice</measure>
    <time_frame>Patient flow will be followed for 24 hours after presentation at the ED</time_frame>
    <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,</description>
  </other_outcome>
  <other_outcome>
    <measure>Porportion of patients left without being seen at the ED</measure>
    <time_frame>Patient flow will be followed for 24 hours after presentation at the ED</time_frame>
    <description>Proportion of patients registred as left without being seen in the routine electronical health records to the total number of included patients</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9171</enrollment>
  <condition>Triage</condition>
  <arm_group>
    <arm_group_label>Triage with referral to primary care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Triage and referral according to eMTS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triage without referral to primary care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weekends with usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Triage with referral to primary care</intervention_name>
    <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.</description>
    <arm_group_label>Triage with referral to primary care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <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.</description>
    <arm_group_label>Triage without referral to primary care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  availability of a Belgian citizen national insurance number&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients arriving at the ED by an ambulance with a doctor or nurse&#xD;
&#xD;
          -  Patients all ready admitted to an other hospital department&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Veronique Verhoeven, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristeit Antwerpen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Monica</name>
      <address>
        <city>Deurne</city>
        <zip>2100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HuisartsenWachtpost Antwerpen Oost</name>
      <address>
        <city>Deurne</city>
        <zip>2100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
    <investigator_full_name>Veronique Verhoeven</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Triage</keyword>
  <keyword>Primary Health Care</keyword>
  <keyword>Emergency Service, Hospital</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Even the researchers will only have very limited access to individual data. All collected data will be stored in the &quot;iCAREdata&quot; database (see http://www.icaredata.eu/) and as such will be accessible when necessary.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03793972
org study id: T000718N
nct id: NCT03793972
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomised with weekends servings as clusters.
primary purpose: Health Services Research
masking: None (Open Label)
measure: 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
description: The difference between intervention and control period will be calculated. Treatment at the GPC means having a record at the GPC.
measure: 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
description: There are 53 different presentations.
measure: 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
description: There are five categories of which the least two urgent ones (green and blue) are in general suitable for primary care
measure: Association between the primary outcome and subjective workload at the ED as juged by the emergency nurse
time frame: Measurement during the triage consultation
description: This urgency has four ordinal categories: uncontrollable busy, busy but under control, normal, quiet.
measure: Association between the primary outcome and subjective workload at the GPC.
time frame: Measurement a the start of the GP consultation
description: Workload at the GPC is objectively measured as the number of patients in the waiting room at the time of consultation.
measure: Association between the primary outcome and the age of the patient
time frame: Registered at the time of presentation at the ED
description: Age will be measured in years.
measure: Association between the primary outcome and the sex of the patient
time frame: Regisetered at the time of presentation at the ED
description: Sex is either male or female
measure: Association between the primary outcome and the ZIP-code of the patient
time frame: Registered at the time of presentation at the ED
description: There are 2825 possible ZIP-codes but only the ten most frequent in the studied population are relevant
measure: Association between the primary outcome and the social status of the patient
time frame: Registered at the time of presentation at the ED
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.
measure: 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
description: Entire study period of one calendar year will devided in four seasons
measure: 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
description: A day has twenty-four hours
measure: Variation of the primary outcome among the triage nurses,
time frame: Patient flow will be followed for 24 hours after presentation at the ED
description: All nurses get an anonymized ID. The primary outcome will be measured for all nures individually.
measure: 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
description: This is the number of patients treated at the GPC to number of patients referred back to the ED by the GP.
measure: 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
description: The emergency physicians will register their opinion about the ideal location of the patient in the routine electronical health records: ED or GPC.
measure: 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
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
measure: 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
description: Admission is registered by the nursing staff in the routine electronical health records.
measure: 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
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,
measure: 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
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,
measure: 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
description: Proportion of patients registred as left without being seen in the routine electronical health records to the total number of included patients
arm group label: Triage with referral to primary care
arm group type: Experimental
description: Triage and referral according to eMTS.
arm group label: Triage without referral to primary care
arm group type: Active Comparator
description: Weekends with usual care
intervention type: Other
intervention name: Triage with referral to primary care
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.
arm group label: Triage with referral to primary care
intervention type: Other
intervention name: Usual care
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.
arm group label: Triage without referral to primary care
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Veronique Verhoeven, PhD
role: Principal Investigator
affiliation: Univeristeit Antwerpen
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universiteit Antwerpen
investigator full name: Veronique Verhoeven
investigator title: Principal Investigator
mesh term: Emergencies
sharing ipd: No
ipd 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.