<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/NCT03307421</url>
  </required_header>
  <id_info>
    <org_study_id>DEBRIEF-SIM II</org_study_id>
    <nct_id>NCT03307421</nct_id>
  </id_info>
  <brief_title>Team Debriefing With Instructor vs Team Debriefing Without Instructor After Simulating a Vital Emergency in a Multidisciplinary Team</brief_title>
  <acronym>DEBRIEF-SIM2</acronym>
  <official_title>Comparison Between a Team Debriefing With an Instructor and a Team Debriefing Without an Instructor, on Improving Non-technical Skills (TEAM Score) After Simulating a Vital Emergency in a Multidisciplinary Team as Part of the Initial Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ALOUANE Mael</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Comparison between a team debriefing with an instructor and a team debriefing without an&#xD;
      instructor, on improving non-technical skills (TEAM score) after simulating a vital emergency&#xD;
      in a multidisciplinary team as part of the initial training&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In spite of the enthusiasm that the simulation raises, its use remains rather complicated in&#xD;
      the training of the interns in anesthesiologists-resuscitators (DESAR) and nursing&#xD;
      anesthesiologists (EIADE) . Its development has two main limitations: financial and human.&#xD;
      Indeed, it mobilizes the medical and paramedical staff already in place, which is a&#xD;
      difficulty in a context of demographic constraints.&#xD;
&#xD;
      A simulation session typically takes place in 3 stages: briefing, simulation and debriefing.&#xD;
&#xD;
      The debriefing, the pedagogical pillar of the sessions, demonstrated its influence on the&#xD;
      improvement of participants' performances. Different works have tried to define the ideal&#xD;
      debriefing method , but its modalities are yet to be defined. To reduce this time Boet and al&#xD;
      proposed the assisted video debriefing without instructor. Its principle is that the team of&#xD;
      learners will debrief themselves, watching the video recording of their performance. Learners&#xD;
      have as a teaching aid a grid that recalls the principles of team work and the technical&#xD;
      recommendations of the pathology addressed. This debriefing would therefore reduce the&#xD;
      training time and facilitate access to the simulation. However, its pedagogical effectiveness&#xD;
      has not been compared to the &quot;gold standard&quot; instructor-team debriefing on initial training&#xD;
      and long-term acquisition. The objective of this study is therefore to demonstrate the&#xD;
      non-inferiority of a method of debriefing without an instructor (SI) compared to a method of&#xD;
      debriefing of team with instructor (AI) on the improvement of a score of non-technical&#xD;
      competence (TEAM score) after simulation of a vital emergency in a multidisciplinary team as&#xD;
      part of the initial training.&#xD;
&#xD;
      All the DESAR (except the 1st years) and EIADE of the participating centers are eligible.&#xD;
      After information on the study and collection of their written consent, the binomials (DESAR&#xD;
      + EIADE) will be constituted by drawing lots and randomized by stratification by center,&#xD;
      either in debriefing AI or SI.&#xD;
&#xD;
      At D1, they will have a first simulation followed by a debriefing (AI or SI) according to&#xD;
      their randomization and immediately after this debriefing, a second simulation. There will be&#xD;
      no systematic debriefing behind this second session, but a team of trainers will be able to&#xD;
      debrief the binomials that wish to do so. Six months later, the last simulation will take&#xD;
      place, followed for all the pairs of an AI debriefing.&#xD;
&#xD;
      The pairs will be evaluated a posteriori, blinded by trained evaluators, for the 3 sessions&#xD;
      on a non-technical competence score the TEAM Score and a technical skill score specialized in&#xD;
      the pathology encountered. Finally learners will give their self-efficacy before and after&#xD;
      each debriefing, and before the 3rd session.&#xD;
&#xD;
      Throughout the course of the study psychological care will be provided: a clearly identified&#xD;
      person who is specialized in this pedagogical technique will be present and each participant&#xD;
      will have his / her telephone contact details and the usual structures during a psychological&#xD;
      distress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Anticipated">December 12, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>2 parallel groups, stratified by center, randomized by center</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TEAM SCORE</measure>
    <time_frame>6 months</time_frame>
    <description>TEAM Score is a non-technical skills assessment score. This score consists of four items (leadership, teamwork, task management, overall score). Each of these items is rated from 0 to 4, which is a score of 44, to which is added an overall score of 10 points. This score is validated and reflects teamwork skills [30] [31] [32] [33].&#xD;
The scoring of the TEAM score will be carried out by a pair composed of a doctor in anesthesia-resuscitation and a nurse anesthetist trained and trained beforehand. This notation will be done afterwards simulations thanks to the registration of passage of the binomials on simulators.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>technical score</measure>
    <time_frame>6 months</time_frame>
    <description>The T score is a technical skills assessment score adapted to the scenarios of this study and based on the Formalized Recommendations of Experts published by the SFAR and the guidelines of the European Resuscitation Council</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sense of self-efficacy (SEP)</measure>
    <time_frame>6 months</time_frame>
    <description>To evaluate this SEP, we will use a visual analog scale: it will be represented by a horizontal line on which the participants will have to put a vertical line.&#xD;
This scale will be written out of 100, the score will be determined by the distance (in mm) that separates the left side of the horizontal line from the vertical line affixed by the participant. The leftmost part will correspond to 'I feel totally capable', the right part to 'I feel totally incapable'.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>High Fidelity Simulation Training</condition>
  <condition>Simulation Training</condition>
  <arm_group>
    <arm_group_label>debriefing without instructor</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Team debriefing without an instructor will be organized as follows. The pairs of participants will be placed in a room with direct access to the video recording of their passage on the simulator. Two documents will be made available to help participants structure their debriefing: one targeting non-technical skills, based on the TEAM Score, and one recalling recommendations on ACR care. Despite its absence at the time of the debriefing, the instructor will be present during the briefing and during the simulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>debriefing with instructor</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The team debriefing with an instructor will begin immediately after the simulator run and will be governed by the principle of &quot;no judgment&quot; described by Rudolph .&#xD;
A portion of the video of the participants' pass may be reviewed and used to support the debriefing (depending on the utility judged by the debrief). Each center will use its own team of trainers, but it will have a predefined plan and predefined objectives, which are provided in advance in order to obtain a standardized debriefing. Moreover, these trainers will not be beginners but will have some expertise in the pedagogy of simulation. They will have to have a DU in a simulation or pedagogy trainer (recommendations from SofraSim) and will have to carry out 15 debriefings per year</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>debriefing without instructor</intervention_name>
    <description>The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.&#xD;
The sequence of scenarios for each binomial will also be determined by randomization.</description>
    <arm_group_label>debriefing without instructor</arm_group_label>
    <other_name>video assisted</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>debriefing with instructor</intervention_name>
    <description>The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.</description>
    <arm_group_label>debriefing with instructor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Common Inclusion Criteria&#xD;
&#xD;
          -  Men and women of full age (&gt; 18 years)&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
          -  Affiliation to or a beneficiary of a French social security scheme.&#xD;
&#xD;
        Physician Inclusion Criteria&#xD;
&#xD;
          -  Internal from 3rd to 10th semester anesthesia resuscitation of the CHU of Besançon,&#xD;
             Dijon, Lyon or Strasbourg.&#xD;
&#xD;
        Inclusion Criteria IADE&#xD;
&#xD;
          -  IADE students from the nursing school of Besançon, Dijon Lyon or Strasbourg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject without health insurance&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Subject being in the exclusion period of another study or planned by the &quot;National&#xD;
             Volunteer File&quot;.&#xD;
&#xD;
          -  Subject refusing to sign the confidentiality clause&#xD;
&#xD;
          -  Internal first-year anesthesia-resuscitation.&#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>Sophie Depierre</last_name>
    <phone>0381218745</phone>
    <email>sdepierre@chu-besancon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Floriane CICERON, PH</last_name>
      <email>fciceron@chu-besancon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>December 22, 2017</last_update_submitted>
  <last_update_submitted_qc>December 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>simulation</keyword>
  <keyword>debriefing</keyword>
  <keyword>team score</keyword>
  <keyword>multidisciplinarity</keyword>
  <keyword>DEBRIEF sim II</keyword>
  <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/NCT03307421
org study id: DEBRIEF-SIM II
nct id: NCT03307421
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison between a team debriefing with an instructor and a team debriefing without an
      instructor, on improving non-technical skills (TEAM score) after simulating a vital emergency
      in a multidisciplinary team as part of the initial training
In spite of the enthusiasm that the simulation raises, its use remains rather complicated in
      the training of the interns in anesthesiologists-resuscitators (DESAR) and nursing
      anesthesiologists (EIADE) . Its development has two main limitations: financial and human.
      Indeed, it mobilizes the medical and paramedical staff already in place, which is a
      difficulty in a context of demographic constraints.

      A simulation session typically takes place in 3 stages: briefing, simulation and debriefing.

      The debriefing, the pedagogical pillar of the sessions, demonstrated its influence on the
      improvement of participants' performances. Different works have tried to define the ideal
      debriefing method , but its modalities are yet to be defined. To reduce this time Boet and al
      proposed the assisted video debriefing without instructor. Its principle is that the team of
      learners will debrief themselves, watching the video recording of their performance. Learners
      have as a teaching aid a grid that recalls the principles of team work and the technical
      recommendations of the pathology addressed. This debriefing would therefore reduce the
      training time and facilitate access to the simulation. However, its pedagogical effectiveness
      has not been compared to the "gold standard" instructor-team debriefing on initial training
      and long-term acquisition. The objective of this study is therefore to demonstrate the
      non-inferiority of a method of debriefing without an instructor (SI) compared to a method of
      debriefing of team with instructor (AI) on the improvement of a score of non-technical
      competence (TEAM score) after simulation of a vital emergency in a multidisciplinary team as
      part of the initial training.

      All the DESAR (except the 1st years) and EIADE of the participating centers are eligible.
      After information on the study and collection of their written consent, the binomials (DESAR
      + EIADE) will be constituted by drawing lots and randomized by stratification by center,
      either in debriefing AI or SI.

      At D1, they will have a first simulation followed by a debriefing (AI or SI) according to
      their randomization and immediately after this debriefing, a second simulation. There will be
      no systematic debriefing behind this second session, but a team of trainers will be able to
      debrief the binomials that wish to do so. Six months later, the last simulation will take
      place, followed for all the pairs of an AI debriefing.

      The pairs will be evaluated a posteriori, blinded by trained evaluators, for the 3 sessions
      on a non-technical competence score the TEAM Score and a technical skill score specialized in
      the pathology encountered. Finally learners will give their self-efficacy before and after
      each debriefing, and before the 3rd session.

      Throughout the course of the study psychological care will be provided: a clearly identified
      person who is specialized in this pedagogical technique will be present and each participant
      will have his / her telephone contact details and the usual structures during a psychological
      distress.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 parallel groups, stratified by center, randomized by center
primary purpose: Other
masking: Single (Participant)
measure: TEAM SCORE
time frame: 6 months
description: TEAM Score is a non-technical skills assessment score. This score consists of four items (leadership, teamwork, task management, overall score). Each of these items is rated from 0 to 4, which is a score of 44, to which is added an overall score of 10 points. This score is validated and reflects teamwork skills [30] [31] [32] [33].
The scoring of the TEAM score will be carried out by a pair composed of a doctor in anesthesia-resuscitation and a nurse anesthetist trained and trained beforehand. This notation will be done afterwards simulations thanks to the registration of passage of the binomials on simulators.
measure: technical score
time frame: 6 months
description: The T score is a technical skills assessment score adapted to the scenarios of this study and based on the Formalized Recommendations of Experts published by the SFAR and the guidelines of the European Resuscitation Council
measure: sense of self-efficacy (SEP)
time frame: 6 months
description: To evaluate this SEP, we will use a visual analog scale: it will be represented by a horizontal line on which the participants will have to put a vertical line.
This scale will be written out of 100, the score will be determined by the distance (in mm) that separates the left side of the horizontal line from the vertical line affixed by the participant. The leftmost part will correspond to 'I feel totally capable', the right part to 'I feel totally incapable'.
arm group label: debriefing without instructor
arm group type: Other
description: Team debriefing without an instructor will be organized as follows. The pairs of participants will be placed in a room with direct access to the video recording of their passage on the simulator. Two documents will be made available to help participants structure their debriefing: one targeting non-technical skills, based on the TEAM Score, and one recalling recommendations on ACR care. Despite its absence at the time of the debriefing, the instructor will be present during the briefing and during the simulation.
arm group label: debriefing with instructor
arm group type: Other
description: The team debriefing with an instructor will begin immediately after the simulator run and will be governed by the principle of "no judgment" described by Rudolph .
A portion of the video of the participants' pass may be reviewed and used to support the debriefing (depending on the utility judged by the debrief). Each center will use its own team of trainers, but it will have a predefined plan and predefined objectives, which are provided in advance in order to obtain a standardized debriefing. Moreover, these trainers will not be beginners but will have some expertise in the pedagogy of simulation. They will have to have a DU in a simulation or pedagogy trainer (recommendations from SofraSim) and will have to carry out 15 debriefings per year
intervention type: Other
intervention name: debriefing without instructor
description: The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.
The sequence of scenarios for each binomial will also be determined by randomization.
arm group label: debriefing without instructor
other name: video assisted
intervention type: Other
intervention name: debriefing with instructor
description: The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.
arm group label: debriefing with instructor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophie Depierre
phone: 0381218745
email: sdepierre@chu-besancon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No