<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/NCT03000829</url>
  </required_header>
  <id_info>
    <org_study_id>COPILOT-SIMULATION</org_study_id>
    <nct_id>NCT03000829</nct_id>
  </id_info>
  <brief_title>Code Blue Outcomes &amp; Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation</brief_title>
  <acronym>COPILOT-Sim</acronym>
  <official_title>Code Blue Outcomes &amp; Process Improvement Through Leadership Optimization Using Teleintensivists-Simulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter randomized trial will employ in-situ cardiac arrest simulations (&quot;mock&#xD;
      codes&quot;) to test whether using telemedicine technology to add an intensive care physician as&#xD;
      the &quot;copilot&quot; for cardiac arrest resuscitation teams influences chest compression quality,&#xD;
      resuscitation protocol adherence, team function, and provider experience.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Only 15-30% of patients who suffer in-hospital cardiac arrest (IHCA) survive to hospital&#xD;
      discharge. Factors associated with lower mortality and improved function include provision of&#xD;
      high-quality, minimally-interrupted chest compressions and swift defibrillation of eligible&#xD;
      arrhythmias. Unfortunately, resuscitation teams provide suboptimal care to 25-40% of IHCA&#xD;
      victims. A dedicated IHCA team &quot;copilot&quot; may improve resuscitation team performance by&#xD;
      providing the team leader with parallel analysis, situational awareness augmentation, action&#xD;
      checking, protocol verification, and error correction. Critical care physician involvement&#xD;
      via a telemedicine link could allow experienced specialists to fill the &quot;copilot&quot; role in a&#xD;
      cost and resource-efficient manner, particularly in smaller hospitals with fewer available&#xD;
      physicians.&#xD;
&#xD;
      The current study will evaluate how consultation by an off-site intensive care physician via&#xD;
      a telemedicine link influences local IHCA teams' quality of care, team function and provider&#xD;
      experience during simulated cardiac arrest events (&quot;mock codes&quot;).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fraction of pulseless time with no chest compressions</measure>
    <time_frame>From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from onset of shockable rhythm to defibrillation</measure>
    <time_frame>From onset of simulated VF or VT until first defibrillation or end of simulation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of chest compressions with complete release</measure>
    <time_frame>From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of chest compressions at target rate</measure>
    <time_frame>From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first dose of epinephrine</measure>
    <time_frame>From initiation of simulation through termination of simulation, an average of 15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall ACLS protocol adherence (using checklist adapted from McEvoy ACLS assessment tool)</measure>
    <time_frame>From initiation of simulation through termination of simulation, an average of 15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACLS protocol errors (using checklist adapted from McEvoy ACLS assessment tool)</measure>
    <time_frame>From initiation of simulation through termination of simulation, an average of 15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Team Emergency Assessment Measure score</measure>
    <time_frame>From initiation of simulation through termination of simulation, an average of 15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Types of input by telemedical intensivist copilot</measure>
    <time_frame>From initiation of simulation through termination of simulation, an average of 15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opinions of study subjects about experience participating in simulated cardiac arrest, using a locally-developed and validated survey instrument</measure>
    <time_frame>Immediately after simulation</time_frame>
    <description>Measured domains: understanding of telemedicine intensivist copilot's role, beliefs about telemedicine intensivist copilot's ability to integrate with on site team, ability to influence on-site team performance, comfort with telemedicine intensivist copilot's role, and function of telemedicine interface</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short form State-Trait Anxiety Inventory score</measure>
    <time_frame>Immediately after simulation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of telemedicine audiovisual connection problems per intervention group simulation event</measure>
    <time_frame>From initiation of simulation through termination of simulation, an average of 15 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1001</enrollment>
  <condition>Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Tele-intensivist consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Simulated &quot;observation&quot; by ICU physician by displaying a silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site participants will be told that an intensive care physician is observing the mock code.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tele-intensivist consultation</intervention_name>
    <description>Standardized consultation to on-site cardiac arrest team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart</description>
    <arm_group_label>Tele-intensivist consultation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simulated &quot;observation&quot; by ICU physician</intervention_name>
    <description>Display of silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site cardiac arrest team will be told that an intensive care physician is observing the mock code.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria (on-site cardiac arrest team):&#xD;
&#xD;
          -  Are 18 years of age or older&#xD;
&#xD;
        Inclusion criteria (teleintensivist cardiac arrest team copilot):&#xD;
&#xD;
          -  Are 18 years of age or older&#xD;
&#xD;
          -  Are a board-certified or board-eligible critical care physician&#xD;
&#xD;
          -  Provide clinical care through the Intermountain Healthcare Telecritical Care program&#xD;
&#xD;
        Exclusion criteria (both groups):&#xD;
&#xD;
          -  Are under 18 years of age&#xD;
&#xD;
          -  Are a member of the study research team&#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>Ithan Peltan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American Fork Hospital</name>
      <address>
        <city>American Fork</city>
        <state>Utah</state>
        <zip>84003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Orthopedic Specialty Hospital</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McKay-Dee Hospital</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park City Hospital</name>
      <address>
        <city>Park City</city>
        <state>Utah</state>
        <zip>84060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverton Hospital</name>
      <address>
        <city>Riverton</city>
        <state>Utah</state>
        <zip>84065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LDS Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Code blue</keyword>
  <keyword>Code team</keyword>
  <keyword>Crisis team leadership</keyword>
  <keyword>Cardiopulmonary resuscitation</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Simulation</keyword>
  <keyword>Mock code</keyword>
  <keyword>In-hospital cardiac arrest</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized data will be available, after relevant IRB approval, by application to the principal investigator and Intermountain Office of Research.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>January 27, 2022</submitted>
    <returned>March 29, 2022</returned>
    <submitted>January 25, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03000829
org study id: COPILOT-SIMULATION
nct id: NCT03000829
lead sponsor: 
has dmc: No
This multicenter randomized trial will employ in-situ cardiac arrest simulations ("mock
      codes") to test whether using telemedicine technology to add an intensive care physician as
      the "copilot" for cardiac arrest resuscitation teams influences chest compression quality,
      resuscitation protocol adherence, team function, and provider experience.
Only 15-30% of patients who suffer in-hospital cardiac arrest (IHCA) survive to hospital
      discharge. Factors associated with lower mortality and improved function include provision of
      high-quality, minimally-interrupted chest compressions and swift defibrillation of eligible
      arrhythmias. Unfortunately, resuscitation teams provide suboptimal care to 25-40% of IHCA
      victims. A dedicated IHCA team "copilot" may improve resuscitation team performance by
      providing the team leader with parallel analysis, situational awareness augmentation, action
      checking, protocol verification, and error correction. Critical care physician involvement
      via a telemedicine link could allow experienced specialists to fill the "copilot" role in a
      cost and resource-efficient manner, particularly in smaller hospitals with fewer available
      physicians.

      The current study will evaluate how consultation by an off-site intensive care physician via
      a telemedicine link influences local IHCA teams' quality of care, team function and provider
      experience during simulated cardiac arrest events ("mock codes").
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Fraction of pulseless time with no chest compressions
time frame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
measure: Time from onset of shockable rhythm to defibrillation
time frame: From onset of simulated VF or VT until first defibrillation or end of simulation
measure: Fraction of chest compressions with complete release
time frame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
measure: Fraction of chest compressions at target rate
time frame: From initiation of intervention or placebo control until completion of two complete cycles of CPR (an average of 4 minutes)
measure: Time to first dose of epinephrine
time frame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: Overall ACLS protocol adherence (using checklist adapted from McEvoy ACLS assessment tool)
time frame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: ACLS protocol errors (using checklist adapted from McEvoy ACLS assessment tool)
time frame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: Team Emergency Assessment Measure score
time frame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: Types of input by telemedical intensivist copilot
time frame: From initiation of simulation through termination of simulation, an average of 15 minutes
measure: Opinions of study subjects about experience participating in simulated cardiac arrest, using a locally-developed and validated survey instrument
time frame: Immediately after simulation
description: Measured domains: understanding of telemedicine intensivist copilot's role, beliefs about telemedicine intensivist copilot's ability to integrate with on site team, ability to influence on-site team performance, comfort with telemedicine intensivist copilot's role, and function of telemedicine interface
measure: Short form State-Trait Anxiety Inventory score
time frame: Immediately after simulation
measure: Presence of telemedicine audiovisual connection problems per intervention group simulation event
time frame: From initiation of simulation through termination of simulation, an average of 15 minutes
arm group label: Tele-intensivist consultation
arm group type: Experimental
description: Standardized consultation to on-site cardiac arrest response team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart
arm group label: Control
arm group type: Placebo Comparator
description: Simulated "observation" by ICU physician by displaying a silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site participants will be told that an intensive care physician is observing the mock code.
intervention type: Other
intervention name: Tele-intensivist consultation
description: Standardized consultation to on-site cardiac arrest team by off-site intensivist via two-way audiovisual link using a mobile telemedicine cart
arm group label: Tele-intensivist consultation
intervention type: Other
intervention name: Simulated "observation" by ICU physician
description: Display of silent, pre-recorded, non-interactive videotape of an ICU physician. The on-site cardiac arrest team will be told that an intensive care physician is observing the mock code.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ithan Peltan, MD
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Arrest
sharing ipd: Yes
ipd description: Anonymized data will be available, after relevant IRB approval, by application to the principal investigator and Intermountain Office of Research.
submitted: January 27, 2022
returned: March 29, 2022
submitted: January 25, 2023