<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/NCT03013530</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0296</org_study_id>
    <nct_id>NCT03013530</nct_id>
  </id_info>
  <brief_title>Assessment of Factors Involved in the Decision-making for ICU Patients' Care</brief_title>
  <official_title>Assessment of Factors Involved in the Decision-making for ICU Patients' Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      A new law about the advance directives (AD) has been recently voted in France on February 2,&#xD;
      2016. This &quot; Claeys-Leonetti &quot; law has made the AD more binding, as in other countries. This&#xD;
      should lead to a greater respect of the human autonomy principle. However, the interpretation&#xD;
      of these guidelines is often difficult and may differ between doctors. Indeed, the&#xD;
      subjectivity of these interpretations could lead to different medical decisions by&#xD;
      physicians.&#xD;
&#xD;
      The investigators intend to assess the effect of advance directives (AD) on decision making&#xD;
      in care by intensivists, using a simulated (hypothetical) situation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational simulation (hypothetical) study of intensivist decisions for selected real&#xD;
      patients.&#xD;
&#xD;
      Each patient writes advance directives (AD) after receiving clear information (videos and&#xD;
      interview with an independent intensivist).&#xD;
&#xD;
      Intensivists answer to 5 questions for two simulations (hypothetical) models (scenario) on&#xD;
      pneumonia and occlusive syndrome, in 3 times: without the AD, with AD, and with AD by knowing&#xD;
      the drafting conditions (information from intensivist).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">May 2, 2018</completion_date>
  <primary_completion_date type="Actual">May 2, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients</measure>
    <time_frame>at day 1</time_frame>
    <description>Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients, in 3 times: without AD first, then with AD and AD with knowing they were made with an intensivist, in this order</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of answers to 5 questions for the 2 scenarios for each of the 20 patients between the 3 scenarios submission time for each intensivist (intra-individual variability).</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison for each question</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the concordance between the AD and the intensivists's answers. Direct comparison for objective criteria (organ replacement) between the patients's AD and intensivists's answers. And expert opinion for subjective criteria</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drafting time for the realization of the AD</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Decision Making</condition>
  <arm_group>
    <arm_group_label>Patients with chronic disease</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Decision making for ICU patients' care</intervention_name>
    <description>Study of factors involved in the decision-making for ICU patients' care. Effect of advance directives (AD).</description>
    <arm_group_label>Patients with chronic disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        ICU patients' care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for patients :&#xD;
&#xD;
          -  20 patients with chronic diseases or 80 years old patient or older,&#xD;
&#xD;
          -  4 patients with chronic cardiac failure challenged in heart transplant&#xD;
&#xD;
          -  4 patients with chronic renal failure challenged in kidney transplant&#xD;
&#xD;
          -  4 COPD patients in terminal stage&#xD;
&#xD;
          -  4 patients with lung cancer challenged in surgery&#xD;
&#xD;
          -  4 patients, 80 years old or older, without cognitive impairment&#xD;
&#xD;
        Inclusion criteria for physician :&#xD;
&#xD;
          -  Working in Intensive Care Unit (ICU)&#xD;
&#xD;
          -  From the 10 ICUs involved in the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria for physician :&#xD;
&#xD;
          -  Decline to participate&#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_official>
    <last_name>Alexandre LAUTRETTE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intensive care unit</keyword>
  <keyword>Triage and Therapy.</keyword>
  <keyword>Advance Directives (AD).</keyword>
  <keyword>Simulation model of real situations. (hypothetical scenario)</keyword>
  <keyword>Intensivist physician.</keyword>
  <!-- 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/NCT03013530
org study id: CHU-0296
nct id: NCT03013530
lead sponsor: 
A new law about the advance directives (AD) has been recently voted in France on February 2,
      2016. This " Claeys-Leonetti " law has made the AD more binding, as in other countries. This
      should lead to a greater respect of the human autonomy principle. However, the interpretation
      of these guidelines is often difficult and may differ between doctors. Indeed, the
      subjectivity of these interpretations could lead to different medical decisions by
      physicians.

      The investigators intend to assess the effect of advance directives (AD) on decision making
      in care by intensivists, using a simulated (hypothetical) situation.
Observational simulation (hypothetical) study of intensivist decisions for selected real
      patients.

      Each patient writes advance directives (AD) after receiving clear information (videos and
      interview with an independent intensivist).

      Intensivists answer to 5 questions for two simulations (hypothetical) models (scenario) on
      pneumonia and occlusive syndrome, in 3 times: without the AD, with AD, and with AD by knowing
      the drafting conditions (information from intensivist).
observational model: Other
time perspective: Cross-Sectional
measure: Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients
time frame: at day 1
description: Intensivists's answers to 5 questions for the 2 scenarios for each of the 20 patients, in 3 times: without AD first, then with AD and AD with knowing they were made with an intensivist, in this order
measure: Comparison of answers to 5 questions for the 2 scenarios for each of the 20 patients between the 3 scenarios submission time for each intensivist (intra-individual variability).
time frame: at day 1
measure: Comparison for each question
time frame: at day 1
measure: Assessment of the concordance between the AD and the intensivists's answers. Direct comparison for objective criteria (organ replacement) between the patients's AD and intensivists's answers. And expert opinion for subjective criteria
time frame: at day 1
measure: Drafting time for the realization of the AD
time frame: at day 1
arm group label: Patients with chronic disease
intervention type: Procedure
intervention name: Decision making for ICU patients' care
description: Study of factors involved in the decision-making for ICU patients' care. Effect of advance directives (AD).
arm group label: Patients with chronic disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre LAUTRETTE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor