<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/NCT02199210</url>
  </required_header>
  <id_info>
    <org_study_id>SIMPROJECT-MT</org_study_id>
    <nct_id>NCT02199210</nct_id>
  </id_info>
  <brief_title>Exploring Self-regulatory Processes in Anesthesiologists During Massive Transfusion</brief_title>
  <official_title>Optimizing Intra-Operative Massive Transfusion: Probing for Forethought</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the project is to investigate the function of self-regulatory processes in&#xD;
      anesthesiologists and how application of these processes influence performance in a crisis&#xD;
      situation.The investigators intend to explore specifically the first phase of&#xD;
      self-regulation, i.e. the forethought phase which describes processes related to strategic&#xD;
      planning, goal setting, goal orientation, and outcome expectation. The investigators&#xD;
      hypothesize that prompting forethought before engaging in a simulated massive transfusion&#xD;
      crisis situation will result in better task performance in anesthesiologists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct 3 studies building on each other.&#xD;
&#xD;
        -  Pilot Study: the purpose of this study is to develop measurement tools for forethought,&#xD;
           performance and a tool for prompting forethought. This study will include 2 attending&#xD;
           anesthesiologists and 2 anesthesia residents (PGY2, 5).&#xD;
&#xD;
        -  Study I: the purpose of this study is to validate the measurement tools for forethought,&#xD;
           performance and the tool for prompting forethought. This will include 6 attending&#xD;
           anesthesiologists, 6 PGY5 and 6 PGY2 anesthesia residents.&#xD;
&#xD;
        -  Study II: the purpose of this study is to investigate if prompting forethought in&#xD;
           anesthesia residents will result in better performance in a simulated massive&#xD;
           transfusion than no prompting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance in managing simulated massive transfusion scenario</measure>
    <time_frame>Each individual's performance will be video recorded and subsequently evaluated within 8 weeks.</time_frame>
    <description>Task specific performance tool will be developed in the Pilot study and will be validated in Study I. Each performance will be video recorded and two independent, blinded rater will evaluate the videos and assess performance. Performance assessment tool will be numerical including a 1-5 point scale for each performance element and a Global Rating Scale. Difference between massive transfusion management performance will be compared in anesthesia residents whose forethought is prompted to residents who don't receive prompting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between forethought scores and performance scores.</measure>
    <time_frame>Forethought scores and performance scores will be determined within 8 weeks after individuals participated in the study.</time_frame>
    <description>The investigators will determine if quality of forethought relates to quality of performance in anesthesia residents managing the simulated massive transfusion scenario. The Pilot study and Study I will be used to develop and validate a scoring form for forethought. This will include scores (1-5) for each forethought elements (strategic planning, goal setting, goal orientation, imaginary, outcome expectation) and a GRS (1-5).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Development and validation of measurement tools for forethought, performance and a tool for prompting forethought.</measure>
    <time_frame>Within 4 weeks after completion of Pilot study and Study I.</time_frame>
    <description>In the Pilot study, think-aloud protocol will be used to identify forethought elements in experts (attending anesthesiologists) and non-expert (anesthesia residents). The real-time interviews will be used to design the measurement tool for forethought and also to develop a tool for prompting forethought. Equally, performance in a simulated massive transfusion scenario in experts and non-experts will be used to develop a scoring format for performance. The provisional scoring format then will be reviewed by experts and the research group. Study I will determine construct and predictive validity and reproducibility (inter-rater reliability) of these measurement scores.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Self-regulation</condition>
  <condition>Forethought</condition>
  <condition>Performance</condition>
  <arm_group>
    <arm_group_label>Prompting forethought</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A demographic questionnaire will be filled out by each participant. After randomization, participants will be presented with the background information of the simulated scenario.Subsequently:&#xD;
participants forethought will be prompted and each participant will be asked to report his/her forethought,&#xD;
participants then will be asked to manage a simulated massive transfusion scenario,&#xD;
at completion of the scenario, each participant will undergo individualized debriefing and a syllabus on massive transfusion will be briefly discussed with them and also provided as a reading material for learning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No prompting</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A demographic questionnaire will be filled out by each participants. After randomization, participants will be presented with the background information of the simulated scenario.Subsequently:&#xD;
participants will sit and wait for a predetermined time before entering into the simulator,&#xD;
participants then will be asked to manage a simulated massive transfusion scenario,&#xD;
at completion of the scenario, each participant will be interviewed about their thought process before entering to the simulation room,&#xD;
each participant will undergo individualized debriefing and a syllabus on massive transfusion will be briefly discussed with them and also provided as a reading material for learning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prompting forethought</intervention_name>
    <description>Participants will be asked questions which elicit specific forethought elements related to the given clinical situation. These are elements that relate to strategic planning, goal setting, goal orientation, imagery, outcome expectation. These context specific questions will be determined in the Pilot study and validated in Study I.</description>
    <arm_group_label>Prompting forethought</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pilot study: attending anesthesiologists at St. Michael's Hospital , PGY5, PGY2&#xD;
             anesthesia residents at University of Toronto&#xD;
&#xD;
          -  Study I: attending anesthesiologists at St. Michael's Hospital, PGY5, PGY2 anesthesia&#xD;
             residents at University of Toronto&#xD;
&#xD;
          -  Study II: PGY2, PGY3, PGY4 anesthesia residents at University of Toronto&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to take part in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John G Laffey, MD, FCARCSI</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Michael's Hospital, University of Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Charlotte Ringsted, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Wilson Center, University Health Network, University of Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>John G Laffey, MD, FCARCSI</last_name>
    <phone>(416) 864-5071</phone>
    <email>laffeyj@smh.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maya J Contreras, PhD, FCARCSI</last_name>
    <phone>(416) 864-5071</phone>
    <email>contrerasm@smh.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>John G Laffey, MD, FCARCSI</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maya J Contreras, PhD, FCARCSI</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Katerina Pavenski, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Zimmermann BJ. Development of adaptation of expertise: The role of self-regulatory processes and beliefs. In: Ericsson KA, ed. The Cambridge Handbook of Expertise and Expert Performance: Cambridge Unicersity Press 2006:705-22.</citation>
  </reference>
  <reference>
    <citation>Ericsson KA. Protocol analysis and expert thought: concurrent verbalisations of thinking during experts' performance on representative tasks. In: Ericsson KA, ed. The Cambridge Handbook of Expertise and Expert Performance: Cambridge University Press 2006:223-41.</citation>
  </reference>
  <reference>
    <citation>Artino AR Jr, Cleary TJ, Dong T, Hemmer PA, Durning SJ. Exploring clinical reasoning in novices: a self-regulated learning microanalytic assessment approach. Med Educ. 2014 Mar;48(3):280-91. doi: 10.1111/medu.12303.</citation>
    <PMID>24528463</PMID>
  </reference>
  <reference>
    <citation>Cleary TJ, Sandars J. Assessing self-regulatory processes during clinical skill performance: a pilot study. Med Teach. 2011;33(7):e368-74. doi: 10.3109/0142159X.2011.577464.</citation>
    <PMID>21696270</PMID>
  </reference>
  <reference>
    <citation>Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.</citation>
    <PMID>22691145</PMID>
  </reference>
  <reference>
    <citation>Dzik WH, Blajchman MA, Fergusson D, Hameed M, Henry B, Kirkpatrick AW, Korogyi T, Logsetty S, Skeate RC, Stanworth S, MacAdams C, Muirhead B. Clinical review: Canadian National Advisory Committee on Blood and Blood Products--Massive transfusion consensus conference 2011: report of the panel. Crit Care. 2011;15(6):242. doi: 10.1186/cc10498. Epub 2011 Dec 8.</citation>
    <PMID>22188866</PMID>
  </reference>
  <reference>
    <citation>Cotton BA, Dossett LA, Au BK, Nunez TC, Robertson AM, Young PP. Room for (performance) improvement: provider-related factors associated with poor outcomes in massive transfusion. J Trauma. 2009 Nov;67(5):1004-12. doi: 10.1097/TA.0b013e3181bcb2a8.</citation>
    <PMID>19901661</PMID>
  </reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>August 9, 2016</last_update_submitted>
  <last_update_submitted_qc>August 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Massive transfusion protocols</keyword>
  <keyword>Self-regulatory learning</keyword>
  <keyword>Forethought</keyword>
  <keyword>Clinical expertise</keyword>
  <keyword>Simulation</keyword>
  <keyword>Education</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/NCT02199210
org study id: SIMPROJECT-MT
nct id: NCT02199210
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the project is to investigate the function of self-regulatory processes in
      anesthesiologists and how application of these processes influence performance in a crisis
      situation.The investigators intend to explore specifically the first phase of
      self-regulation, i.e. the forethought phase which describes processes related to strategic
      planning, goal setting, goal orientation, and outcome expectation. The investigators
      hypothesize that prompting forethought before engaging in a simulated massive transfusion
      crisis situation will result in better task performance in anesthesiologists.
The investigators will conduct 3 studies building on each other.

        -  Pilot Study: the purpose of this study is to develop measurement tools for forethought,
           performance and a tool for prompting forethought. This study will include 2 attending
           anesthesiologists and 2 anesthesia residents (PGY2, 5).

        -  Study I: the purpose of this study is to validate the measurement tools for forethought,
           performance and the tool for prompting forethought. This will include 6 attending
           anesthesiologists, 6 PGY5 and 6 PGY2 anesthesia residents.

        -  Study II: the purpose of this study is to investigate if prompting forethought in
           anesthesia residents will result in better performance in a simulated massive
           transfusion than no prompting.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Performance in managing simulated massive transfusion scenario
time frame: Each individual's performance will be video recorded and subsequently evaluated within 8 weeks.
description: Task specific performance tool will be developed in the Pilot study and will be validated in Study I. Each performance will be video recorded and two independent, blinded rater will evaluate the videos and assess performance. Performance assessment tool will be numerical including a 1-5 point scale for each performance element and a Global Rating Scale. Difference between massive transfusion management performance will be compared in anesthesia residents whose forethought is prompted to residents who don't receive prompting.
measure: Correlation between forethought scores and performance scores.
time frame: Forethought scores and performance scores will be determined within 8 weeks after individuals participated in the study.
description: The investigators will determine if quality of forethought relates to quality of performance in anesthesia residents managing the simulated massive transfusion scenario. The Pilot study and Study I will be used to develop and validate a scoring form for forethought. This will include scores (1-5) for each forethought elements (strategic planning, goal setting, goal orientation, imaginary, outcome expectation) and a GRS (1-5).
measure: Development and validation of measurement tools for forethought, performance and a tool for prompting forethought.
time frame: Within 4 weeks after completion of Pilot study and Study I.
description: In the Pilot study, think-aloud protocol will be used to identify forethought elements in experts (attending anesthesiologists) and non-expert (anesthesia residents). The real-time interviews will be used to design the measurement tool for forethought and also to develop a tool for prompting forethought. Equally, performance in a simulated massive transfusion scenario in experts and non-experts will be used to develop a scoring format for performance. The provisional scoring format then will be reviewed by experts and the research group. Study I will determine construct and predictive validity and reproducibility (inter-rater reliability) of these measurement scores.
arm group label: Prompting forethought
arm group type: Experimental
description: A demographic questionnaire will be filled out by each participant. After randomization, participants will be presented with the background information of the simulated scenario.Subsequently:
participants forethought will be prompted and each participant will be asked to report his/her forethought,
participants then will be asked to manage a simulated massive transfusion scenario,
at completion of the scenario, each participant will undergo individualized debriefing and a syllabus on massive transfusion will be briefly discussed with them and also provided as a reading material for learning.
arm group label: No prompting
arm group type: No Intervention
description: A demographic questionnaire will be filled out by each participants. After randomization, participants will be presented with the background information of the simulated scenario.Subsequently:
participants will sit and wait for a predetermined time before entering into the simulator,
participants then will be asked to manage a simulated massive transfusion scenario,
at completion of the scenario, each participant will be interviewed about their thought process before entering to the simulation room,
each participant will undergo individualized debriefing and a syllabus on massive transfusion will be briefly discussed with them and also provided as a reading material for learning.
intervention type: Other
intervention name: Prompting forethought
description: Participants will be asked questions which elicit specific forethought elements related to the given clinical situation. These are elements that relate to strategic planning, goal setting, goal orientation, imagery, outcome expectation. These context specific questions will be determined in the Pilot study and validated in Study I.
arm group label: Prompting forethought
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: John G Laffey, MD, FCARCSI
role: Principal Investigator
affiliation: St. Michael's Hospital, University of Toronto
last name: Charlotte Ringsted, PhD
role: Principal Investigator
affiliation: The Wilson Center, University Health Network, University of Toronto
last name: John G Laffey, MD, FCARCSI
phone: (416) 864-5071
email: laffeyj@smh.ca
last name: Maya J Contreras, PhD, FCARCSI
phone: (416) 864-5071
email: contrerasm@smh.ca
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
country: Canada
citation: Zimmermann BJ. Development of adaptation of expertise: The role of self-regulatory processes and beliefs. In: Ericsson KA, ed. The Cambridge Handbook of Expertise and Expert Performance: Cambridge Unicersity Press 2006:705-22.
citation: Ericsson KA. Protocol analysis and expert thought: concurrent verbalisations of thinking during experts' performance on representative tasks. In: Ericsson KA, ed. The Cambridge Handbook of Expertise and Expert Performance: Cambridge University Press 2006:223-41.
citation: Artino AR Jr, Cleary TJ, Dong T, Hemmer PA, Durning SJ. Exploring clinical reasoning in novices: a self-regulated learning microanalytic assessment approach. Med Educ. 2014 Mar;48(3):280-91. doi: 10.1111/medu.12303.
PMID: 24528463
citation: Cleary TJ, Sandars J. Assessing self-regulatory processes during clinical skill performance: a pilot study. Med Teach. 2011;33(7):e368-74. doi: 10.3109/0142159X.2011.577464.
PMID: 21696270
citation: Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.
PMID: 22691145
citation: Dzik WH, Blajchman MA, Fergusson D, Hameed M, Henry B, Kirkpatrick AW, Korogyi T, Logsetty S, Skeate RC, Stanworth S, MacAdams C, Muirhead B. Clinical review: Canadian National Advisory Committee on Blood and Blood Products--Massive transfusion consensus conference 2011: report of the panel. Crit Care. 2011;15(6):242. doi: 10.1186/cc10498. Epub 2011 Dec 8.
PMID: 22188866
citation: Cotton BA, Dossett LA, Au BK, Nunez TC, Robertson AM, Young PP. Room for (performance) improvement: provider-related factors associated with poor outcomes in massive transfusion. J Trauma. 2009 Nov;67(5):1004-12. doi: 10.1097/TA.0b013e3181bcb2a8.
PMID: 19901661
responsible party type: Sponsor