<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/NCT03261258</url>
  </required_header>
  <id_info>
    <org_study_id>QUENOT 2016</org_study_id>
    <nct_id>NCT03261258</nct_id>
  </id_info>
  <brief_title>Comparison of Criteria for the Designation of a Contact Person in ICU Patients and Close Friends and Relatives</brief_title>
  <acronym>REPERE II/III</acronym>
  <official_title>ICU and Contact Person: Comparison of Criteria for Designation in Patients and Close Friends and Relatives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the vast majority of cases, the person of trust (or contact person) is not designated by&#xD;
      the patient (emergency, severe disease situations, coma, sedation, etc.). The healthcare team&#xD;
      thus identifies a person who 1) may not be the person the patient would have designated and&#xD;
      2) may not be the most suitable to take on this responsibility. Though the first point is not&#xD;
      easy, the main difficulty for the clinician is to know if he is dealing with the &quot;right&#xD;
      person for the job&quot;, meaning a person who is able to take on the responsibility of the&#xD;
      contact person. This is a heavy responsibility in terms of the information given, of passing&#xD;
      on this information to relatives and friends, of consulting the doctors, of help or support&#xD;
      in medical decisions, etc. This responsibility may also be difficult for one person alone to&#xD;
      take on and it may be helpful to share it between several friends or relatives. In a princeps&#xD;
      study (QUENOT, 2015), it was shown that the process used by the healthcare team to designate&#xD;
      a contact person was based on criteria such as knowledge of the wishes and values of the&#xD;
      patient, the strength of the relationship with the patient, and the person of trust&#xD;
      designated before admission to the ICU. However, we do not know what criteria are used by the&#xD;
      patients themselves or those used by their close friends and relatives. This study will make&#xD;
      it possible to determine and to measure the possible differences between the criteria used by&#xD;
      the ICU healthcare team (REPERE I), those used by patients (REPERE III) and finally, those&#xD;
      used by close friends and relatives (REPERE II).&#xD;
&#xD;
      In order to do this, 300 persons (150 patients and 150 relatives/friends) will complete&#xD;
      questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Difference between scores measured (relatives/patients) on the scales for the principal criteria for the designation of a contact person</measure>
    <time_frame>at baseline</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Patients Hospitalised in a Medical ICU</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients hospitalised in the ICU of Dijon CHU Burgundy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Proches</arm_group_label>
    <description>Relatives/close friends of patients hospitalised in the ICU of Dijon CHU Burgundy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>Proches</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the medical ICU of Dijon CHU Burgundy and their relatives/friends.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients and their friends/relatives who have been given information on the study&#xD;
&#xD;
          -  Patients admitted to the ICU according to the criteria defined by decree n° 2002-465&#xD;
             of the law of 5 April 2002 relative to the rights of patients and the quality of the&#xD;
             healthcare system;&#xD;
&#xD;
          -  Patients unable to designate a person of trust on admission;&#xD;
&#xD;
          -  Patients able to designate a person of trust on discharge from the ICU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate;&#xD;
&#xD;
          -  Age &lt; 18 years;&#xD;
&#xD;
          -  Patient/relative under ward of court;&#xD;
&#xD;
          -  Patient/relative presenting a major cognitive disorder ruling out a reliable&#xD;
             interview;&#xD;
&#xD;
          -  Patient and/or relative who cannot be interviewed or who cannot provide information ;&#xD;
&#xD;
          -  Absence of family and/or close friends.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jean-Pierre QUENOT</last_name>
    <phone>03.80.29.36.85</phone>
    <phone_ext>+33</phone_ext>
    <email>jean-pierre.quenot@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Pierre QUENOT</last_name>
      <phone>03 80 29 36 85</phone>
      <phone_ext>+33</phone_ext>
      <email>jean-pierre.quenot@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03261258
org study id: QUENOT 2016
nct id: NCT03261258
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In the vast majority of cases, the person of trust (or contact person) is not designated by
      the patient (emergency, severe disease situations, coma, sedation, etc.). The healthcare team
      thus identifies a person who 1) may not be the person the patient would have designated and
      2) may not be the most suitable to take on this responsibility. Though the first point is not
      easy, the main difficulty for the clinician is to know if he is dealing with the "right
      person for the job", meaning a person who is able to take on the responsibility of the
      contact person. This is a heavy responsibility in terms of the information given, of passing
      on this information to relatives and friends, of consulting the doctors, of help or support
      in medical decisions, etc. This responsibility may also be difficult for one person alone to
      take on and it may be helpful to share it between several friends or relatives. In a princeps
      study (QUENOT, 2015), it was shown that the process used by the healthcare team to designate
      a contact person was based on criteria such as knowledge of the wishes and values of the
      patient, the strength of the relationship with the patient, and the person of trust
      designated before admission to the ICU. However, we do not know what criteria are used by the
      patients themselves or those used by their close friends and relatives. This study will make
      it possible to determine and to measure the possible differences between the criteria used by
      the ICU healthcare team (REPERE I), those used by patients (REPERE III) and finally, those
      used by close friends and relatives (REPERE II).

      In order to do this, 300 persons (150 patients and 150 relatives/friends) will complete
      questionnaires.
observational model: Cohort
time perspective: Prospective
measure: Difference between scores measured (relatives/patients) on the scales for the principal criteria for the designation of a contact person
time frame: at baseline
arm group label: Patients
description: Patients hospitalised in the ICU of Dijon CHU Burgundy
arm group label: Proches
description: Relatives/close friends of patients hospitalised in the ICU of Dijon CHU Burgundy
intervention type: Other
intervention name: Questionnaire
arm group label: Patients
arm group label: Proches
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Pierre QUENOT
phone: 03.80.29.36.85
phone ext: +33
email: jean-pierre.quenot@chu-dijon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor