xml: <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/NCT05983640</url>
    </required_header>
    <id_info>
      <org_study_id>2023P000222</org_study_id>
      <nct_id>NCT05983640</nct_id>
    </id_info>
    <brief_title>Just in Time Cardio Pulmonary Resuscitation Trial</brief_title>
    <acronym>JITCPR-T</acronym>
    <official_title>Just in Time Cardio Pulmonary Resuscitation Trial (JITCPR-T): Comparison of a Brief Video to Traditional CPR Training: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brigham and Women's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>American Heart Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Brigham and Women's Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        The objective is to evaluate the effectiveness of a Just in Time (JiT) video as compared to&#xD;
        the AHA Heartsaver® Course and no training (control) in ability to correctly perform CPR. The&#xD;
        secondary objective is to assess skill retention 3-9 months after the AHA Heartsaver course&#xD;
        with and without JiT Video use. The goal of this work is to study the effectiveness of this&#xD;
        new JiT video to improve objective knowledge- and performance-based measures of effective&#xD;
        OHCA response, as well as subjective ratings of preparedness and likeliness to respond,&#xD;
        compared to the standard AHA Heartsaver® CPR AED Training course.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The first responder phase of out-of-hospital cardiac arrest (OHCA) response is most often led&#xD;
        by bystanders with limited resources and no medical training. Bystanders play a critical role&#xD;
        in the initial measures of the cardiac arrest chain of survival-activation of emergency&#xD;
        medical services (EMS), initiation of cardiopulmonary resuscitation (CPR), and administration&#xD;
        of defibrillation when indicated. Early bystander response, early bystander CPR, and&#xD;
        defibrillation in under 8 minutes are associated with increased survival to hospital&#xD;
        discharge.&#xD;
  &#xD;
        Despite the clear importance of early bystander response to OHCA, rates of bystander CPR&#xD;
        remain low with only one-third of OHCA patients receiving bystander CPR. Lay people with CPR&#xD;
        training are more likely to perform CPR than those without training. Prior studies comparing&#xD;
        traditional in-person training programs for CPR versus technology-enabled self-instruction&#xD;
        (TESI) formats have demonstrated superiority or equivalency of TESI to prepare lay bystanders&#xD;
        in OHCA response. Shorter duration and more convenient access to TESI in light of these&#xD;
        findings provide a promising opportunity to increase public preparedness to participate in&#xD;
        OHCA management at greater scales and lower costs. However, CPR-specific skills and knowledge&#xD;
        deteriorate within 3 to 6 months of initial training, and time, location, and duration have&#xD;
        all been perceived as barriers to completing CPR training.&#xD;
  &#xD;
        The objective is to evaluate the effectiveness of a Just in Time (JiT) video as compared to&#xD;
        the AHA Heartsaver® CPR AED Training Course and no training (control) in ability to correctly&#xD;
        perform CPR. The secondary objectives are the evaluation participate interaction with the JiT&#xD;
        video and to assess skill retention 3-9 months after the AHA Heartsaver course with and&#xD;
        without JiT Video use. The goal of this work is to study the effectiveness of this new JiT&#xD;
        video to improve objective knowledge- and performance-based measures of effective OHCA&#xD;
        response, as well as subjective ratings of preparedness and likeliness to respond, compared&#xD;
        to the standard AHA Heartsaver® CPR AED Training course.&#xD;
  &#xD;
        This is a prospective, randomized, three arm, open-label trial will two rounds of data&#xD;
        collection. In the first round, participants will be randomized to one of three arms (no&#xD;
        training, AHA course, JiT video) and assessed on CPR skills and knowledge. All participants&#xD;
        will then be exposed to the other conditions (completion of the AHA Heartsaver® CPR AED&#xD;
        Training course and viewing of the JiT video). During the second round, approximately 3-12&#xD;
        months later, the investigators will test the effectiveness of the JiT video at prompting&#xD;
        correct CPR skills after previous training versus no prompting.&#xD;
  &#xD;
        Specific aim 1: Determine the efficacy of an abbreviated JiT video-based curriculum in&#xD;
        achieving competence in CPR by lay-persons as compared to individuals trained by the AHA&#xD;
        Heartsaver® CPR AED Training course.&#xD;
  &#xD;
        Hypothesis 1: Participants in the abbreviated JiT video-based curriculum will have no&#xD;
        difference in measures of objective knowledge, objective performance, and subjective&#xD;
        preparedness to administer CPR compared to participants in the in-person AHA Heartsaver® CPR&#xD;
        AED Training course, but superior results compared to controls.&#xD;
  &#xD;
        Specific aim 2: Determine how participants interact with a JiT CPR education video during a&#xD;
        simulated cardiac arrest. This is an exploratory, qualitative aim.&#xD;
  &#xD;
        Specific aim 3: Determine retention of CPR skills using the abbreviated JiT video between&#xD;
        3-12 months after initial training, as compared to retention from the AHA Heartsaver® CPR AED&#xD;
        Training course alone without a refresher.&#xD;
  &#xD;
        Hypothesis 3: Participants who view the abbreviated JiT video during reassessment will have&#xD;
        no differences in measures of objective knowledge, objective performance, and subjective&#xD;
        preparedness to administer CPR compared to those without the video 3-12 months after initial&#xD;
        training, but superior results compared to controls.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 27, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Prospective, randomized, three arm, parallel, open-label trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Performance of correct cardiopulmonary resuscitation (CPR) (Objective Performance)</measure>
      <time_frame>Measured within 2 hours of randomization, during the intervention</time_frame>
      <description>Correct CPR will be measured by successful completion of all five of the following actions:&#xD;
  Calling for 9-1-1 (as measured by verbalizing action to examiner)&#xD;
  Calling for automated external defibrillator (as measured by verbalizing action to examiner)&#xD;
  Placing hand in correct position on manikin chest (as measured by examiner)&#xD;
  Compressing at a rate of 100-120 per minute (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)&#xD;
  Compressing to a depth of at least 2 inches (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CPR knowledge (Objective Knowledge)</measure>
      <time_frame>Measured immediately after skill evaluation completion</time_frame>
      <description>Knowledge regarding CPR skills will be measured by an 8-question multiple choice assessment, based on the American Heart Association HeartSaver curriculum. The assessment will test participants' understanding of when to perform CPR on a victim and how to perform CPR correctly (e.g., hand placement, compression rate, and compression depth). The assessment will be scored as 1 point per correct answer, with a range of 0-8 points (higher score indicates better knowledge).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in willingness to respond (Subjective Preparedness)</measure>
      <time_frame>Measured within 1 hour before and immediately after skill evaluation completion</time_frame>
      <description>Participants will complete pre/post 6-question assessments to determine the change in their likelihood and confidence in providing CPR in different situations. Items will be scored on a 5-point Likert-type scale (very unlikely to very likely) for likelihood to perform CPR (for a stranger, close relative for friend, or if requested by a trained professional and confidence in identifying cardiac arrest, performing CPR, and using an AED. Change in willingness to respond will be measured by examining the within-person change from pre and post assessments.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Cardiopulmonary Arrest With Successful Resuscitation</condition>
    <condition>Educational Problems</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Assessment without training or video prompt</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Just in time video</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Assessment with JiT video available</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AHA Course</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Assessment after completion of CPR training course</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Video</intervention_name>
      <description>Just in time training video on hands only CPR</description>
      <arm_group_label>Just in time video</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>AHA course</intervention_name>
      <description>AHA Heartsaver CPR course</description>
      <arm_group_label>AHA Course</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Employee of Gillette Stadium&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 18 years&#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>Eric Goralnick, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Brigham and Women's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eric Goralnick, MD, MS</last_name>
      <phone>(617) 525-8495</phone>
      <email>egoralnick@bwh.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gillette Stadium</name>
        <address>
          <city>Foxboro</city>
          <state>Massachusetts</state>
          <zip>02035</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</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>Eric Goralnick</investigator_full_name>
      <investigator_title>Associate Professor of Emergency Medicine</investigator_title>
    </responsible_party>
    <keyword>Youtube</keyword>
    <keyword>Video Education</keyword>
    <keyword>Public Empowerment</keyword>
    <keyword>CPR</keyword>
    <keyword>AED</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Arrest</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983640
  org study id: 2023P000222
  nct id: NCT05983640
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective is to evaluate the effectiveness of a Just in Time (JiT) video as compared to
        the AHA Heartsaver® Course and no training (control) in ability to correctly perform CPR. The
        secondary objective is to assess skill retention 3-9 months after the AHA Heartsaver course
        with and without JiT Video use. The goal of this work is to study the effectiveness of this
        new JiT video to improve objective knowledge- and performance-based measures of effective
        OHCA response, as well as subjective ratings of preparedness and likeliness to respond,
        compared to the standard AHA Heartsaver® CPR AED Training course.
  The first responder phase of out-of-hospital cardiac arrest (OHCA) response is most often led
        by bystanders with limited resources and no medical training. Bystanders play a critical role
        in the initial measures of the cardiac arrest chain of survival-activation of emergency
        medical services (EMS), initiation of cardiopulmonary resuscitation (CPR), and administration
        of defibrillation when indicated. Early bystander response, early bystander CPR, and
        defibrillation in under 8 minutes are associated with increased survival to hospital
        discharge.
  
        Despite the clear importance of early bystander response to OHCA, rates of bystander CPR
        remain low with only one-third of OHCA patients receiving bystander CPR. Lay people with CPR
        training are more likely to perform CPR than those without training. Prior studies comparing
        traditional in-person training programs for CPR versus technology-enabled self-instruction
        (TESI) formats have demonstrated superiority or equivalency of TESI to prepare lay bystanders
        in OHCA response. Shorter duration and more convenient access to TESI in light of these
        findings provide a promising opportunity to increase public preparedness to participate in
        OHCA management at greater scales and lower costs. However, CPR-specific skills and knowledge
        deteriorate within 3 to 6 months of initial training, and time, location, and duration have
        all been perceived as barriers to completing CPR training.
  
        The objective is to evaluate the effectiveness of a Just in Time (JiT) video as compared to
        the AHA Heartsaver® CPR AED Training Course and no training (control) in ability to correctly
        perform CPR. The secondary objectives are the evaluation participate interaction with the JiT
        video and to assess skill retention 3-9 months after the AHA Heartsaver course with and
        without JiT Video use. The goal of this work is to study the effectiveness of this new JiT
        video to improve objective knowledge- and performance-based measures of effective OHCA
        response, as well as subjective ratings of preparedness and likeliness to respond, compared
        to the standard AHA Heartsaver® CPR AED Training course.
  
        This is a prospective, randomized, three arm, open-label trial will two rounds of data
        collection. In the first round, participants will be randomized to one of three arms (no
        training, AHA course, JiT video) and assessed on CPR skills and knowledge. All participants
        will then be exposed to the other conditions (completion of the AHA Heartsaver® CPR AED
        Training course and viewing of the JiT video). During the second round, approximately 3-12
        months later, the investigators will test the effectiveness of the JiT video at prompting
        correct CPR skills after previous training versus no prompting.
  
        Specific aim 1: Determine the efficacy of an abbreviated JiT video-based curriculum in
        achieving competence in CPR by lay-persons as compared to individuals trained by the AHA
        Heartsaver® CPR AED Training course.
  
        Hypothesis 1: Participants in the abbreviated JiT video-based curriculum will have no
        difference in measures of objective knowledge, objective performance, and subjective
        preparedness to administer CPR compared to participants in the in-person AHA Heartsaver® CPR
        AED Training course, but superior results compared to controls.
  
        Specific aim 2: Determine how participants interact with a JiT CPR education video during a
        simulated cardiac arrest. This is an exploratory, qualitative aim.
  
        Specific aim 3: Determine retention of CPR skills using the abbreviated JiT video between
        3-12 months after initial training, as compared to retention from the AHA Heartsaver® CPR AED
        Training course alone without a refresher.
  
        Hypothesis 3: Participants who view the abbreviated JiT video during reassessment will have
        no differences in measures of objective knowledge, objective performance, and subjective
        preparedness to administer CPR compared to those without the video 3-12 months after initial
        training, but superior results compared to controls.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, randomized, three arm, parallel, open-label trial
  primary purpose: Other
  masking: None (Open Label)
  measure: Performance of correct cardiopulmonary resuscitation (CPR) (Objective Performance)
  time frame: Measured within 2 hours of randomization, during the intervention
  description: Correct CPR will be measured by successful completion of all five of the following actions:
  Calling for 9-1-1 (as measured by verbalizing action to examiner)
  Calling for automated external defibrillator (as measured by verbalizing action to examiner)
  Placing hand in correct position on manikin chest (as measured by examiner)
  Compressing at a rate of 100-120 per minute (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
  Compressing to a depth of at least 2 inches (as measured by examiner and through CPR manikin equipped with Laerdal QCPR software)
  measure: CPR knowledge (Objective Knowledge)
  time frame: Measured immediately after skill evaluation completion
  description: Knowledge regarding CPR skills will be measured by an 8-question multiple choice assessment, based on the American Heart Association HeartSaver curriculum. The assessment will test participants' understanding of when to perform CPR on a victim and how to perform CPR correctly (e.g., hand placement, compression rate, and compression depth). The assessment will be scored as 1 point per correct answer, with a range of 0-8 points (higher score indicates better knowledge).
  measure: Change in willingness to respond (Subjective Preparedness)
  time frame: Measured within 1 hour before and immediately after skill evaluation completion
  description: Participants will complete pre/post 6-question assessments to determine the change in their likelihood and confidence in providing CPR in different situations. Items will be scored on a 5-point Likert-type scale (very unlikely to very likely) for likelihood to perform CPR (for a stranger, close relative for friend, or if requested by a trained professional and confidence in identifying cardiac arrest, performing CPR, and using an AED. Change in willingness to respond will be measured by examining the within-person change from pre and post assessments.
  arm group label: Control
  arm group type: No Intervention
  description: Assessment without training or video prompt
  arm group label: Just in time video
  arm group type: Experimental
  description: Assessment with JiT video available
  arm group label: AHA Course
  arm group type: Active Comparator
  description: Assessment after completion of CPR training course
  intervention type: Other
  intervention name: Video
  description: Just in time training video on hands only CPR
  arm group label: Just in time video
  intervention type: Other
  intervention name: AHA course
  description: AHA Heartsaver CPR course
  arm group label: AHA Course
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eric Goralnick, MD, MS
  role: Principal Investigator
  affiliation: Brigham and Women's Hospital
  last name: Eric Goralnick, MD, MS
  phone: (617) 525-8495
  email: egoralnick@bwh.harvard.edu
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Brigham and Women's Hospital
  investigator full name: Eric Goralnick
  investigator title: Associate Professor of Emergency Medicine
  mesh term: Heart Arrest