<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/NCT03006549</url>
  </required_header>
  <id_info>
    <org_study_id>2014P000133</org_study_id>
    <nct_id>NCT03006549</nct_id>
  </id_info>
  <brief_title>Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?</brief_title>
  <acronym>EM</acronym>
  <official_title>Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anesthesia Patient Safety Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite increasing interest in emergency manuals (EMs), relatively little is known about&#xD;
      their effectiveness and limitations in the perioperative setting. Prior studies have been&#xD;
      limited in that they evaluated EMs using crises that were tailor-made to match one of their&#xD;
      chapters, and there has been minimal participation by attending surgeons and other&#xD;
      experienced personnel. The Investigators' preliminary experience suggests less-than-expected&#xD;
      EM use and suboptimal usage, which may be due to the simulation scenario falling &quot;halfway&#xD;
      between&quot; two different chapters of the EM, raising the question of whether limitations were&#xD;
      due to the EM content, team dynamics, or inadequate training in the EM use. In this&#xD;
      randomized, prospective, two-center simulation-based study, the investigators utilize&#xD;
      clinical scenarios specifically designed to observe the patterns of use and to test the&#xD;
      limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen,&#xD;
      clinical performance in situations that do not exactly match a specific chapter of that EM,&#xD;
      and that EM usage patterns will identify both strengths and limitations of the tools and its&#xD;
      implementation. The participating healthcare providers consisting of experienced surgeons,&#xD;
      anesthesiologists, and nurses will be randomized into four experimental groups, each exposed&#xD;
      to either a &quot;specific&quot; or &quot;non-specific&quot; simulation scenario, along with or without the&#xD;
      availability of the EM. The major experimental endpoint will be how many &quot;critical actions&quot;&#xD;
      each team performs, scored as the percentage of actions taken from a pre-determined list. The&#xD;
      goal of this study is to improve EM content and use by understanding its limitations during&#xD;
      interprofessional team-training simulations and to study whether EMs enhance or detract from&#xD;
      clinical performance. This is especially a concern in situations that do not exactly match a&#xD;
      specific chapter of the EM, such as cases that are vague and represent multi-factorial&#xD;
      diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen&#xD;
      patient safety by providing guidance for improving EM content, use, and training protocols.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2015</start_date>
  <completion_date type="Actual">May 13, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correct Diagnosis identified during the simulation by the participants through a grading scale tool</measure>
    <time_frame>through scenario completion, an average of 1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical actions taken during the scenario evaluated by a grading scale tool</measure>
    <time_frame>through scenario completion, an average of 1 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Safety Issues</condition>
  <arm_group>
    <arm_group_label>Emergency Manual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>emergency manual present</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Emergency</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>NO emergency manual present</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emergency Manual (Crisis Checklist)</intervention_name>
    <description>participants will have an Emergency Manual available to them during the crisis simulation scenario.</description>
    <arm_group_label>Emergency Manual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthcare providers (anesthesiologists, surgeons, nurses) participating in the crisis&#xD;
             management curriculum at each participating simulation site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those unwilling to be recorded during the simulation scenario&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Urman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>August 2, 2019</last_update_submitted>
  <last_update_submitted_qc>August 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Richard D Urman</investigator_full_name>
    <investigator_title>Associate Professor of Anesthesia</investigator_title>
  </responsible_party>
  <keyword>Emergency Manual</keyword>
  <keyword>Crisis Checklist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT03006549
org study id: 2014P000133
nct id: NCT03006549
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Despite increasing interest in emergency manuals (EMs), relatively little is known about
      their effectiveness and limitations in the perioperative setting. Prior studies have been
      limited in that they evaluated EMs using crises that were tailor-made to match one of their
      chapters, and there has been minimal participation by attending surgeons and other
      experienced personnel. The Investigators' preliminary experience suggests less-than-expected
      EM use and suboptimal usage, which may be due to the simulation scenario falling "halfway
      between" two different chapters of the EM, raising the question of whether limitations were
      due to the EM content, team dynamics, or inadequate training in the EM use. In this
      randomized, prospective, two-center simulation-based study, the investigators utilize
      clinical scenarios specifically designed to observe the patterns of use and to test the
      limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen,
      clinical performance in situations that do not exactly match a specific chapter of that EM,
      and that EM usage patterns will identify both strengths and limitations of the tools and its
      implementation. The participating healthcare providers consisting of experienced surgeons,
      anesthesiologists, and nurses will be randomized into four experimental groups, each exposed
      to either a "specific" or "non-specific" simulation scenario, along with or without the
      availability of the EM. The major experimental endpoint will be how many "critical actions"
      each team performs, scored as the percentage of actions taken from a pre-determined list. The
      goal of this study is to improve EM content and use by understanding its limitations during
      interprofessional team-training simulations and to study whether EMs enhance or detract from
      clinical performance. This is especially a concern in situations that do not exactly match a
      specific chapter of the EM, such as cases that are vague and represent multi-factorial
      diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen
      patient safety by providing guidance for improving EM content, use, and training protocols.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Correct Diagnosis identified during the simulation by the participants through a grading scale tool
time frame: through scenario completion, an average of 1 hour
measure: Clinical actions taken during the scenario evaluated by a grading scale tool
time frame: through scenario completion, an average of 1 hour
arm group label: Emergency Manual
arm group type: Experimental
description: emergency manual present
arm group label: No Emergency
arm group type: No Intervention
description: NO emergency manual present
intervention type: Behavioral
intervention name: Emergency Manual (Crisis Checklist)
description: participants will have an Emergency Manual available to them during the crisis simulation scenario.
arm group label: Emergency Manual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Urman, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Richard D Urman
investigator title: Associate Professor of Anesthesia
mesh term: Emergencies