<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/NCT02994004</url>
  </required_header>
  <id_info>
    <org_study_id>8989</org_study_id>
    <nct_id>NCT02994004</nct_id>
  </id_info>
  <brief_title>Exploring Medical Decisions Using Functional MRI</brief_title>
  <official_title>Medical Decision-making Under Budgetary Constraint: an fMRI Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hospital physicians are increasingly facing budgetary constraints that might have an impact&#xD;
      on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might&#xD;
      translate into role conflict and ambiguity. We explore the medical decision-makingprocess of&#xD;
      physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated&#xD;
      medical decisions during fMRI acquisitions, with and without explicit budgetary constraints.&#xD;
      We will compare the fMRI data between the 2 modalities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brain activation patterns measured by Functional magnetic resonance imaging</measure>
    <time_frame>up to study completion, usually 2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of role conflict, measured by the Kahn questionnaire (Kahn et al., 1964)</measure>
    <time_frame>up tu study completion, usually 2 weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">34</enrollment>
  <condition>F-MRI Brain Imaging Data</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hospital physicians&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospital physicians&#xD;
&#xD;
          -  working in the CHU of Montpellier&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra indication to f-MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregoire MERCIER, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Montpellier Hospital</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>September 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hospital, medical decision-making, role conflict, f-MRI</keyword>
  <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/NCT02994004
org study id: 8989
nct id: NCT02994004
lead sponsor: 
has dmc: No
Hospital physicians are increasingly facing budgetary constraints that might have an impact
      on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might
      translate into role conflict and ambiguity. We explore the medical decision-makingprocess of
      physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated
      medical decisions during fMRI acquisitions, with and without explicit budgetary constraints.
      We will compare the fMRI data between the 2 modalities.
time perspective: Prospective
measure: Brain activation patterns measured by Functional magnetic resonance imaging
time frame: up to study completion, usually 2 weeks
measure: Level of role conflict, measured by the Kahn questionnaire (Kahn et al., 1964)
time frame: up tu study completion, usually 2 weeks
intervention type: Other
intervention name: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregoire MERCIER, MD, PhD
role: Principal Investigator
affiliation: University Montpellier Hospital
responsible party type: Sponsor
sharing ipd: No