<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/NCT03036969</url>
  </required_header>
  <id_info>
    <org_study_id>EPICS-8</org_study_id>
    <nct_id>NCT03036969</nct_id>
  </id_info>
  <brief_title>EPICS-8: Reasons for Emergency Department Utilization by Patients With Non-urgent Conditions</brief_title>
  <acronym>EPICS-8</acronym>
  <official_title>Emergency Processes in Clinical Structures - EPICS-8: Gründe für Die Inanspruchnahme Der Notaufnahme Durch Patienten Mit Blauer, grüner Oder Gelber Triagekategorie Und Ambulantem Behandlungsbedarf</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zentralinstitut für die Kassenärztliche Versorgung in Deutschland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:&#xD;
&#xD;
      Emergency Departments (EDs) are an important interface between primary and secondary health&#xD;
      care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. The&#xD;
      reasons for ED utilization by patients with non-urgent conditions are nearly unknown in&#xD;
      Germany and will be investigated in this project.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:&#xD;
&#xD;
      Emergency Departments (EDs) are an important interface between primary and the secondary&#xD;
      health care system in Germany. The number of outpatient visits in the ED´s is still&#xD;
      increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly&#xD;
      unknown in Germany and will be explored in this project.&#xD;
&#xD;
      EPICS-8 is a pilot study to establish a research structure for the linkage of ED-data with&#xD;
      data of the primary health care sector. Data linkage will be conducted for patients with the&#xD;
      Manchester Triage System categories blue, green and yellow. A secondary aim of the EPICS-8&#xD;
      study is to develop a valid questionnaire for the assessment of reasons for ED utilization by&#xD;
      non-urgent patients.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      Establishing of a research structure for the linkage of inhospital-data with data from the&#xD;
      primary health care System. Records of 5,000 patients who attended one of the two EDs at the&#xD;
      Charité University Medicine Berlin will be linked to Primary health care data.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        1. Development and testing of a questionaire for the identification of reasons for&#xD;
           emergency department utilization by patients with non-urgent conditions (n=100)&#xD;
&#xD;
        2. Characterization and quantification of non-urgent emergencies&#xD;
&#xD;
        3. Explorative analysis of patient pathways and influencing factors for ED-visits with&#xD;
           non-urgent conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with linkable records</measure>
    <time_frame>05/2016 - 05/2018</time_frame>
    <description>The Primary outcome will be the proportion of patients with successful record linkage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Valid Questionnaire</measure>
    <time_frame>05/2016 - 05/2017</time_frame>
    <description>A patients questionnaire for the assessment of Emergency Department utilization by non-urgent patients will be developed. The outcome of this work package will be a valid patient questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of non-urgent ED patients</measure>
    <time_frame>During the study period</time_frame>
    <description>Descriptive analysis of demographic characteristics of ED patients with non-urgent conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical characteristics of non-urgent ED patients</measure>
    <time_frame>During the study period</time_frame>
    <description>Descriptive analysis of clinical characteristics of ED patients with non-urgent conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient pathways for ED-Visits</measure>
    <time_frame>10/2017 - 05/2018</time_frame>
    <description>Explorative analysis of patient pathways for ED-visits with non-urgent conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influencing factors for ED-Visits</measure>
    <time_frame>10/2017 - 05/2018</time_frame>
    <description>Explorative analysis of influencing factors for ED-visits with non-urgent conditions</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Non-urgent Emergencies</condition>
  <arm_group>
    <arm_group_label>Non-urgent emergencies</arm_group_label>
    <description>Outpatients in the Emergency Department with the MTS-Triage category blue, green or yellow</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult men and women who are discharged after emergency treatment (outpatients) with an&#xD;
        initial Manchester Triage Category of blue, green or yellow.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Eligibility criteria for record linkage:&#xD;
&#xD;
          -  Age&gt;= 18 years&#xD;
&#xD;
          -  Outpatients&#xD;
&#xD;
          -  MTS-Triage category blue, green or yellow&#xD;
&#xD;
          -  Treatment in one of the two participating EDs&#xD;
&#xD;
        Eligibility criteria for questionnaire pretest:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;= 18 years&#xD;
&#xD;
          -  Outpatients&#xD;
&#xD;
          -  MTS-Triage category blue, green or yellow&#xD;
&#xD;
          -  Treatment in one of the two participating EDs&#xD;
&#xD;
          -  Eligibility to understand the study purposes and give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  no sufficient German language skills&#xD;
&#xD;
          -  patients with legal representatives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>115 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Möckel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Möckel, MD</last_name>
    <email>martin.moeckel@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Johann Frick, M A</last_name>
    <phone>004930450553027</phone>
    <email>johann.frick@charite.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charité Universitätsmedizin - Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Möckel, MD</last_name>
      <email>martin.moeckel@charite.de</email>
    </contact>
    <contact_backup>
      <last_name>Johann Frick, M A</last_name>
      <phone>004930450553027</phone>
      <email>johann.frick@charite.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Martin Moeckel</investigator_full_name>
    <investigator_title>Univ.-Prov.</investigator_title>
  </responsible_party>
  <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>
  </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/NCT03036969
org study id: EPICS-8
nct id: NCT03036969
lead sponsor: 
collaborator: 
has dmc: No
EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:

      Emergency Departments (EDs) are an important interface between primary and secondary health
      care sectors in Germany. The number of outpatient visits in the ED´s is still increasing. The
      reasons for ED utilization by patients with non-urgent conditions are nearly unknown in
      Germany and will be investigated in this project.
EPICS-8: Reasons for Emergency Department utilization by patients with non-urgent conditions:

      Emergency Departments (EDs) are an important interface between primary and the secondary
      health care system in Germany. The number of outpatient visits in the ED´s is still
      increasing. The reasons for ED utilization by patients with non-urgent conditions are nearly
      unknown in Germany and will be explored in this project.

      EPICS-8 is a pilot study to establish a research structure for the linkage of ED-data with
      data of the primary health care sector. Data linkage will be conducted for patients with the
      Manchester Triage System categories blue, green and yellow. A secondary aim of the EPICS-8
      study is to develop a valid questionnaire for the assessment of reasons for ED utilization by
      non-urgent patients.

      Primary objective:

      Establishing of a research structure for the linkage of inhospital-data with data from the
      primary health care System. Records of 5,000 patients who attended one of the two EDs at the
      Charité University Medicine Berlin will be linked to Primary health care data.

      Secondary objectives:

        1. Development and testing of a questionaire for the identification of reasons for
           emergency department utilization by patients with non-urgent conditions (n=100)

        2. Characterization and quantification of non-urgent emergencies

        3. Explorative analysis of patient pathways and influencing factors for ED-visits with
           non-urgent conditions.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with linkable records
time frame: 05/2016 - 05/2018
description: The Primary outcome will be the proportion of patients with successful record linkage.
measure: Valid Questionnaire
time frame: 05/2016 - 05/2017
description: A patients questionnaire for the assessment of Emergency Department utilization by non-urgent patients will be developed. The outcome of this work package will be a valid patient questionnaire.
measure: Demographic characteristics of non-urgent ED patients
time frame: During the study period
description: Descriptive analysis of demographic characteristics of ED patients with non-urgent conditions
measure: Clinical characteristics of non-urgent ED patients
time frame: During the study period
description: Descriptive analysis of clinical characteristics of ED patients with non-urgent conditions
measure: Patient pathways for ED-Visits
time frame: 10/2017 - 05/2018
description: Explorative analysis of patient pathways for ED-visits with non-urgent conditions
measure: Influencing factors for ED-Visits
time frame: 10/2017 - 05/2018
description: Explorative analysis of influencing factors for ED-visits with non-urgent conditions
arm group label: Non-urgent emergencies
description: Outpatients in the Emergency Department with the MTS-Triage category blue, green or yellow
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 115 Years
healthy volunteers: No
last name: Martin Möckel, MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
last name: Martin Möckel, MD
email: martin.moeckel@charite.de
last name: Johann Frick, M A
phone: 004930450553027
email: johann.frick@charite.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Martin Moeckel
investigator title: Univ.-Prov.
mesh term: Emergencies
sharing ipd: No