<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/NCT03836534</url>
  </required_header>
  <id_info>
    <org_study_id>PO18168</org_study_id>
    <nct_id>NCT03836534</nct_id>
  </id_info>
  <brief_title>the Observance of Emergency Exit Treatments During the Stay of Care at the Exit of Reims Emergencies</brief_title>
  <official_title>Multicentric Prospective Study of the Observance of Outpatient Treatments in Reims During the Care Continuum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Reims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Reims</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>
      The investigators would like to include patients consulting in a Accident and Emergency&#xD;
      Department (AED) during the permanence of care the week of March 11 to 17, 2018. The data&#xD;
      collection would concern socio-demographic data, their consultation to the AED, the follow-up&#xD;
      given to the consultation and would take place by telephone contact of patients within 48&#xD;
      hours of the consultation.&#xD;
&#xD;
      why patients come to the emergency room, what are they waiting for? what are their main&#xD;
      motivations? what do they do in emergencies, do they follow the treatments and&#xD;
      recommendations?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study of the observance of emergency exit treatments during the permanence of care. This is a&#xD;
      descriptive study with a prospective data collection that does not alter the management of&#xD;
      the patient. The study is epidemiological, cross-sectional, prospective inclusion.&#xD;
&#xD;
      The investigators would like to include patients consulting in a AED during the permanence of&#xD;
      care the week of March 11 to 17, 2018. The data collection would concern socio-demographic&#xD;
      data, their consultation to the AED, the follow-up given to the consultation and would take&#xD;
      place by telephone contact of patients within 48 hours of the consultation.&#xD;
&#xD;
      The objective is to study the follow-up given by the consultation to the emergencies, in&#xD;
      terms of compliance, follow-up of the recommendations, the objective sought by the patient&#xD;
      coming to the emergency department.&#xD;
&#xD;
      Understand the motivation of the consultation and why the treatment was not followed where&#xD;
      appropriate.&#xD;
&#xD;
      Is there a sociodemographic explanation or is it the health network that results in the&#xD;
      saturation of emergency services? Does the system still meet the expectations of people using&#xD;
      it?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 18, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>adherence to treatment</measure>
    <time_frame>2 days</time_frame>
    <description>Number of Participants who visited of the drugstore after emergency visit</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">274</enrollment>
  <condition>Patient Coming to the Emergency Department for Any Reason</condition>
  <arm_group>
    <arm_group_label>patient coming to the emergency department</arm_group_label>
    <description>the group studied only concern adult adults consulting in the emergency departments and leaving after their consultations, during the permanence of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>adherence to treatment of patients coming out of emergencies</intervention_name>
    <description>Phone contact of patients within 48 hours of the consultation</description>
    <arm_group_label>patient coming to the emergency department</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the group studied only concern adults consulting in the emergency and leaving after their&#xD;
        consultations, durning the permanence of care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults&#xD;
&#xD;
          -  consultation during the early stages of care&#xD;
&#xD;
          -  leaving after consultation&#xD;
&#xD;
          -  agrees to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  minor patients&#xD;
&#xD;
          -  permanently off care&#xD;
&#xD;
          -  hospitalized patients&#xD;
&#xD;
          -  refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Undecided</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/NCT03836534
org study id: PO18168
nct id: NCT03836534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators would like to include patients consulting in a Accident and Emergency
      Department (AED) during the permanence of care the week of March 11 to 17, 2018. The data
      collection would concern socio-demographic data, their consultation to the AED, the follow-up
      given to the consultation and would take place by telephone contact of patients within 48
      hours of the consultation.

      why patients come to the emergency room, what are they waiting for? what are their main
      motivations? what do they do in emergencies, do they follow the treatments and
      recommendations?
Study of the observance of emergency exit treatments during the permanence of care. This is a
      descriptive study with a prospective data collection that does not alter the management of
      the patient. The study is epidemiological, cross-sectional, prospective inclusion.

      The investigators would like to include patients consulting in a AED during the permanence of
      care the week of March 11 to 17, 2018. The data collection would concern socio-demographic
      data, their consultation to the AED, the follow-up given to the consultation and would take
      place by telephone contact of patients within 48 hours of the consultation.

      The objective is to study the follow-up given by the consultation to the emergencies, in
      terms of compliance, follow-up of the recommendations, the objective sought by the patient
      coming to the emergency department.

      Understand the motivation of the consultation and why the treatment was not followed where
      appropriate.

      Is there a sociodemographic explanation or is it the health network that results in the
      saturation of emergency services? Does the system still meet the expectations of people using
      it?
observational model: Case-Only
time perspective: Prospective
measure: adherence to treatment
time frame: 2 days
description: Number of Participants who visited of the drugstore after emergency visit
arm group label: patient coming to the emergency department
description: the group studied only concern adult adults consulting in the emergency departments and leaving after their consultations, during the permanence of care
intervention type: Behavioral
intervention name: adherence to treatment of patients coming out of emergencies
description: Phone contact of patients within 48 hours of the consultation
arm group label: patient coming to the emergency department
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: Undecided