<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/NCT04464603</url>
  </required_header>
  <id_info>
    <org_study_id>InterFACE</org_study_id>
    <nct_id>NCT04464603</nct_id>
  </id_info>
  <brief_title>Impact of a mHealth Supportive Tool on Cardiopulmonary Resuscitation' Situational Awareness</brief_title>
  <acronym>InterFACE</acronym>
  <official_title>Impact of a Shared Decision-making mHealth Tool on Caregivers' Team Situational Awareness, Communication Effectiveness, and Performance During Pediatric Cardiopulmonary Resuscitation: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pediatric Clinical Research Platform</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pediatric Clinical Research Platform</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>
      This study will be a prospective, single-center, randomized controlled trial in a tertiary&#xD;
      pediatric emergency department with two parallel groups of voluntary pediatric physicians and&#xD;
      nurses. The impact of a mHealth supportive tool will be compared with conventional&#xD;
      communication methods on situational awareness, leadership, team communication effectiveness&#xD;
      and performance during standardized, simulation-based, pediatric in-hospital cardiac arrest&#xD;
      scenario using a high-fidelity manikin. Thirty-six participants will be randomized (1:1). The&#xD;
      primary endpoint is the situational awareness score measured with the situation awareness&#xD;
      global assessment technique (SAGAT) instrument.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effective team communication, coordination, and situational awareness by cardiac arrest team&#xD;
      members are critical components to deliver optimal cardiopulmonary arrest resuscitation care.&#xD;
      But the complexity of care during cardiopulmonary resuscitation (CPR), numerous providers&#xD;
      involved, miscommunication, and exogenous factors can all contribute to wresting patients&#xD;
      care, thus jeopardizing their survival. The aim of this trial is to investigate whether a&#xD;
      mHealth supportive tool (the interconnected and focused mobile apps on patient care&#xD;
      environment [InterFACE]) developed as a collaborative platform to support CPR providers in&#xD;
      real-time and share patient-centered information would increase situational awareness during&#xD;
      pediatric CPR and improve team communication and performance.&#xD;
&#xD;
      This clinical trial will be a prospective, single-center, randomized controlled trial in a&#xD;
      tertiary pediatric emergency department (&gt;33,000 consultations/year) with two parallel groups&#xD;
      of voluntary pediatric emergency fellows, residents and nurses.&#xD;
&#xD;
      Situational Awareness (SA), leadership, communication skills and team performance will be&#xD;
      compared using a shared mHealth supportive tool (&quot;InterFACE&quot;, group A) or conventional team&#xD;
      interactions (group B) during standardized simulation-based pediatric in-hospital cardiac&#xD;
      arrest scenario (p-IHCA) and life-threatening trauma scenarios using a high-fidelity manikin.&#xD;
      InterFACE consists of a dual, interconnected mHealth tool composed primarily of a mobile&#xD;
      device app, namely &quot;Guiding Pad&quot; (PMID: 32292179), interfaced to a remote large liquid&#xD;
      crystal display (LCD) screen installed in the shock room and situated above the patient's&#xD;
      head.&#xD;
&#xD;
      Thirty-six participants will be randomized 1:1 (each team will comprise six participants,&#xD;
      i.e. a total of 6 teams). The teams will be asked to perform consecutively two 20-min highly&#xD;
      realistic, scripted CPR scenarios on a high-fidelity WiFi manikin (Laerdal SimBaby, Laerdal&#xD;
      Medical, Stavanger, Norway) using either the mHealth tool or conventional methods. The&#xD;
      scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS&#xD;
      guidelines.&#xD;
&#xD;
      In this simulation-based study, each team member will answer the SAGAT queries specific to&#xD;
      their roles. Leadership will be measured with the resuscitation team leader evaluation (RTLE)&#xD;
      instrument. Effective teamwork and communication will be measured with the team emergency&#xD;
      assessment measure (TEAM) instrument. The SUS instruments will be used to measure the&#xD;
      usability of the mHealth tool. For the trauma scenario, the modified non-technical skills&#xD;
      scale for trauma (T-NOTECHS) will not be used due to the serious risk of assessment bias with&#xD;
      this instrument, as emphasized by the consensus-based standards for the selection of health&#xD;
      measurement instruments (COSMIN).&#xD;
&#xD;
      Data collection will be carried out by the responsive simulator detectors (Laerdal SimBaby)&#xD;
      and the two GoPro video cameras. The set-up of both cameras will be standardized. The&#xD;
      recorded videos will be safely stored in duplicate on secured hard-disk drives in a locked&#xD;
      room. As all scenarios will be fully video-recorded, all actions, communications and&#xD;
      interactions will be recorded and later scored by two raters to allow outcomes analysis and&#xD;
      for the calculation of interrater reliability. All actions performed with the app will be&#xD;
      automatically saved locally in log files for further analysis. This study offers the major&#xD;
      advantage to observe a unique 60-min period per resuscitation team. Therefore, neither&#xD;
      follow-up nor retention plans will be necessary. The resuscitation algorithm is highly&#xD;
      standardized and deviation from the algorithm is a parameter of interest in this study. Data&#xD;
      collection will be carried out using the REDCap database (REDCap, Vanderbilt University,&#xD;
      Nashville, TN, USA).&#xD;
&#xD;
      This clinical trial will assess the impact of a collaborative mHealth tool to increase&#xD;
      situational awareness and effective team communication during in-hospital pediatric&#xD;
      resuscitation. As research in this area is scarce, the results generated from this study will&#xD;
      be of great importance and may be sufficient to change and improve in-hospital pediatric&#xD;
      emergency care practice in an era of communication technologies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2023</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>A prospective, single center, randomized controlled trial</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Blinding to the outcomes will be maintained during recruitment to minimize preparation bias. Allocation concealment will be ensured with an allocation software and will not be released until the participants start the scenario. A post-scenario video review will be done without blinding by two reviewers, but undertaken independently with each blinded to the other's reviews. In the case of disagreement, a third independent evaluator will help reach a consensus. The data analyst will be blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Situational awareness</measure>
    <time_frame>40 minutes</time_frame>
    <description>Situational awareness (SA) will be measured using retrospective video review by the SA global assessment technique (SAGAT) instrument for each scenario, both as the score of each SAGAT at an individual level and at the team level (given as the sum of individual SAGAT scores for each team; TSAGAT). The SAGAT responses for categorical variables will be scored as either correct (1) or incorrect (0) by two of the investigators, irrespective of whether they agreed completely with the true answer. For numerical responses, answers will be considered correct based upon a 10% pre-defined tolerance range settled by the research investigators around the true value. The scores will be expressed as percentages in conjunction with absolute n/N values. Higher SA scores will denote higher SA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resuscitation team leader evaluation</measure>
    <time_frame>40 minutes</time_frame>
    <description>Leadership will be measured using the 12-item RTLE instrument developed by Grant et al. that encompasses four leadership concepts: (1) the physical and verbal leader's position; (2) communication and delegating skills; (3) ability to assess, adapt and anticipate; and (4) ability to ask for internal and external help. This instrument comprises 12 items rated on a 4-point Likert scale from 0 (not performed) to 3 (performed well) to score leadership and communication skills. A not applicable (N/A) category is also available for those items not relevant to the scenario. For the purpose of this trial, items 1 and 12 will be removed as the leader will be clearly identified from the beginning of the scenario and teams will not be advised to ask for external help. Therefore, the total item score will range from 0 to 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Team Emergency Assessment Measure</measure>
    <time_frame>40 minutes</time_frame>
    <description>Teamwork performance will be measured using the 11-item Team Emergency Assessment Measure (TEAM) tool that stands out as the most valid and reliable instrument to use in emergency departments. TEAM comprises 11 items rated on a 5-point Likert scale from 0 (never/hardly) to 4 (always/nearly always), which are summed up into a total item score ranging from 0 to 44. The final score obtained allows to assess the performance of the emergency medical team based on three categories: leadership (items 1 and 2); teamwork (items 3 to 9); and task management (items 10 and 11). Items 8 and 9 relate to SA perception and projection, respectively. Furthermore, the team's overall performance is rated through a twelfth item on a global rating scale of 1 to 10 (higher score denotes better performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication dosage errors</measure>
    <time_frame>40 minutes</time_frame>
    <description>Errors in drug dose administration (in milligrams) will be measured in each allocation group as a deviation from the 2018 AHA PALS cardiac arrest algorithm. An emergency medication dose administration error is defined as a deviation from the correct weight dose of more than 10%. Errors will be also measured both as the percentage deviation from the amount of delivered drug compared with the correct weight dose as prescribed by the physician and the absolute deviations from that dose.&#xD;
Moreover, defibrillations (in Joules) and the number of shocks will be also measured during the first scenario. For the second scenario, errors in fluid resuscitation volumes (in milliliters) will be measured as a deviation from the 2018 ATLS guidelines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to critical life-saving maneuvers</measure>
    <time_frame>40 minutes</time_frame>
    <description>The elapsed time in seconds between the end of the clinical statement by the study investigator to: (1) cardiac arrest or hypotensive shock recognition; (2) initiation of chest compression; (3) time to each defibrillation attempt; (4) time to administration of intravenous drugs, volume expansion with 0.9% sodium chloride or blood transfusion; and (5) time interval between defibrillation attempts will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System usability scale</measure>
    <time_frame>10 minutes</time_frame>
    <description>Usability testing of the mHealth tool InterFACE will be assessed using the System Usability Scale (SUS) instrument. The SUS instrument consists of a 10-item questionnaire with five response options for each item, based on their level of agreement ranging from 1 (strongly disagree) to 5 (strongly agree). For odd-numbered statements 1, 3, 5, 7, 9 (positively-worded items), the score contribution is equal to the scale position minus 1. For even-numbered statements 2, 4, 6, 8, 10 (negatively-worded items), the score contribution is equal to 5 minus the scale position. Each score contribution will fall within the range of 0 to 4. The participant's scores for each item are then added up together and multiplied by 2.5 to convert the original scores of 0-40 to 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Team effectiveness</measure>
    <time_frame>40 minutes</time_frame>
    <description>Team effectiveness will be also measured as the time spent by the team to achieve the pre-designed goals set out by the AHA for the PALS course and the American College of Surgeons for the ATLS course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress perceived and satisfaction</measure>
    <time_frame>10 minutes</time_frame>
    <description>A 3-item questionnaire using a 10-point Likert scale will be provided to the participants to measure their perceived stress and satisfaction about the preparation method used during the resuscitation scenario.&#xD;
The questionnaire measures (1) the stress perceived before the scenario starts (On a scale from 1 to 10, how stressed are you now?), (2) the overall stress perceived at the end of the scenario (On a scale of 1 to 10, how stressed [maximum reached] were you during the scenario?), and (3) the satisfaction about the supportive method used during the resuscitation scenario (On a scale of 1 to 10, how satisfied were you with your supported experience?)&#xD;
Scale ranges: from 0 (minimum score) to 10 (maximum score), increments are integers between 0 to 10. For stress, higher values represent a worse score, whereas for satisfaction higher values represent a better score. No subscales will be combined.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Cardiopulmonary Arrest</condition>
  <condition>Pediatric ALL</condition>
  <condition>Resuscitation</condition>
  <arm_group>
    <arm_group_label>Arm A (InterFACE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants that will use the mHeath InterFACE tool during the simulation-based pediatric scenario.&#xD;
Each participant will have to do 2 consecutive scenarios (PALS, ATLS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (Conventional methods)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants that will use conventional methods during the simulation-based pediatric scenario.&#xD;
Each participant will have to do 2 consecutive scenarios (PALS, ATLS).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InterFACE (mHealth tool)</intervention_name>
    <description>Participants will be asked to perform consecutively two 20-min highly realistic, scripted CPR scenarios (first: PALS-based scenario, second: ATLS-based scenario) on a high-fidelity WiFi manikin.&#xD;
Within each scenario, 3 separate &quot;freeze&quot; periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS guidelines.&#xD;
Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills.&#xD;
Participants allocated to Arm A will not be allowed to use any other cognitive support.</description>
    <arm_group_label>Arm A (InterFACE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional methods</intervention_name>
    <description>Participants will be asked to perform consecutively two 20-min scripted CPR scenarios (PALS and ATLS-based scenario) on a high-fidelity WiFi manikin.&#xD;
Within each scenario, 3 separate &quot;freeze&quot; periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and 2018 ATLS guidelines.&#xD;
Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills.&#xD;
Participants allocated to group B will be allowed to use the PALS pocket reference cards and a conventional calculator, but not any other cognitive support or mHealth tool.</description>
    <arm_group_label>Arm B (Conventional methods)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any physician performing a fellowship in the pediatric emergency department.&#xD;
&#xD;
          -  Any postgraduate residents pursuing a &lt;5 years residency in pediatrics.&#xD;
&#xD;
          -  To be registered nurses from the PED.&#xD;
&#xD;
          -  To have previously completed a standardized 15-min introductory course on the use of&#xD;
             the InterFACE tool dispensed by the study investigators.&#xD;
&#xD;
          -  Participation agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To have not undergone the standardized 15-min introductory course on the use of the&#xD;
             InterFACE tool dispensed by the study investigators.&#xD;
&#xD;
          -  Participation to a simulation in the past month is an exclusion criterion to avoid a&#xD;
             recent training effect.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan N Siebert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Johan N Siebert, MD</last_name>
    <phone>+41 79 553 40 72</phone>
    <email>Johan.Siebert@hcuge.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Frederic Ehrler, PhD</last_name>
    <email>Frederic.Ehrler@hcuge.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Geneva Children's Hospital, Geneva University Hospitals</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <contact>
      <last_name>Johan N Siebert, MD</last_name>
      <phone>+41 (0)22 372 45 55</phone>
      <email>Johan.Siebert@hcuge.ch</email>
    </contact>
    <contact_backup>
      <last_name>Frederic Ehrler, PhD</last_name>
      <phone>+41 (0)22 372 86 97</phone>
      <email>Frederic.Ehrler@hcuge.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Frederic Ehrler, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sergio Manzano, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cyril Sahyoun, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Oliver Sanchez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Delphine S Courvoisier, Prof, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurence Lacroix, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Siebert JN, Lacroix L, Cantais A, Manzano S, Ehrler F. The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial. J Med Internet Res. 2020 May 27;22(5):e17792. doi: 10.2196/17792.</citation>
    <PMID>32292179</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pediatric Clinical Research Platform</investigator_affiliation>
    <investigator_full_name>Johan Siebert, MD</investigator_full_name>
    <investigator_title>MD, Deputy Head</investigator_title>
  </responsible_party>
  <keyword>Information technologies</keyword>
  <keyword>Situation Awareness</keyword>
  <keyword>Teamwork</keyword>
  <keyword>Leadership</keyword>
  <keyword>Mobile applications</keyword>
  <keyword>Biomedical Technology</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>IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives at the Geneva Children's Hospital. The datasets used or analyzed during the current trial will be available from the corresponding author upon reasonable request. Only deidentified/anonymized data will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Available from 1 month to 10 years after trial publication.</ipd_time_frame>
    <ipd_access_criteria>From the corresponding author upon reasonable request.</ipd_access_criteria>
  </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/NCT04464603
org study id: InterFACE
nct id: NCT04464603
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be a prospective, single-center, randomized controlled trial in a tertiary
      pediatric emergency department with two parallel groups of voluntary pediatric physicians and
      nurses. The impact of a mHealth supportive tool will be compared with conventional
      communication methods on situational awareness, leadership, team communication effectiveness
      and performance during standardized, simulation-based, pediatric in-hospital cardiac arrest
      scenario using a high-fidelity manikin. Thirty-six participants will be randomized (1:1). The
      primary endpoint is the situational awareness score measured with the situation awareness
      global assessment technique (SAGAT) instrument.
Effective team communication, coordination, and situational awareness by cardiac arrest team
      members are critical components to deliver optimal cardiopulmonary arrest resuscitation care.
      But the complexity of care during cardiopulmonary resuscitation (CPR), numerous providers
      involved, miscommunication, and exogenous factors can all contribute to wresting patients
      care, thus jeopardizing their survival. The aim of this trial is to investigate whether a
      mHealth supportive tool (the interconnected and focused mobile apps on patient care
      environment [InterFACE]) developed as a collaborative platform to support CPR providers in
      real-time and share patient-centered information would increase situational awareness during
      pediatric CPR and improve team communication and performance.

      This clinical trial will be a prospective, single-center, randomized controlled trial in a
      tertiary pediatric emergency department (>33,000 consultations/year) with two parallel groups
      of voluntary pediatric emergency fellows, residents and nurses.

      Situational Awareness (SA), leadership, communication skills and team performance will be
      compared using a shared mHealth supportive tool ("InterFACE", group A) or conventional team
      interactions (group B) during standardized simulation-based pediatric in-hospital cardiac
      arrest scenario (p-IHCA) and life-threatening trauma scenarios using a high-fidelity manikin.
      InterFACE consists of a dual, interconnected mHealth tool composed primarily of a mobile
      device app, namely "Guiding Pad" (PMID: 32292179), interfaced to a remote large liquid
      crystal display (LCD) screen installed in the shock room and situated above the patient's
      head.

      Thirty-six participants will be randomized 1:1 (each team will comprise six participants,
      i.e. a total of 6 teams). The teams will be asked to perform consecutively two 20-min highly
      realistic, scripted CPR scenarios on a high-fidelity WiFi manikin (Laerdal SimBaby, Laerdal
      Medical, Stavanger, Norway) using either the mHealth tool or conventional methods. The
      scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS
      guidelines.

      In this simulation-based study, each team member will answer the SAGAT queries specific to
      their roles. Leadership will be measured with the resuscitation team leader evaluation (RTLE)
      instrument. Effective teamwork and communication will be measured with the team emergency
      assessment measure (TEAM) instrument. The SUS instruments will be used to measure the
      usability of the mHealth tool. For the trauma scenario, the modified non-technical skills
      scale for trauma (T-NOTECHS) will not be used due to the serious risk of assessment bias with
      this instrument, as emphasized by the consensus-based standards for the selection of health
      measurement instruments (COSMIN).

      Data collection will be carried out by the responsive simulator detectors (Laerdal SimBaby)
      and the two GoPro video cameras. The set-up of both cameras will be standardized. The
      recorded videos will be safely stored in duplicate on secured hard-disk drives in a locked
      room. As all scenarios will be fully video-recorded, all actions, communications and
      interactions will be recorded and later scored by two raters to allow outcomes analysis and
      for the calculation of interrater reliability. All actions performed with the app will be
      automatically saved locally in log files for further analysis. This study offers the major
      advantage to observe a unique 60-min period per resuscitation team. Therefore, neither
      follow-up nor retention plans will be necessary. The resuscitation algorithm is highly
      standardized and deviation from the algorithm is a parameter of interest in this study. Data
      collection will be carried out using the REDCap database (REDCap, Vanderbilt University,
      Nashville, TN, USA).

      This clinical trial will assess the impact of a collaborative mHealth tool to increase
      situational awareness and effective team communication during in-hospital pediatric
      resuscitation. As research in this area is scarce, the results generated from this study will
      be of great importance and may be sufficient to change and improve in-hospital pediatric
      emergency care practice in an era of communication technologies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective, single center, randomized controlled trial
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Blinding to the outcomes will be maintained during recruitment to minimize preparation bias. Allocation concealment will be ensured with an allocation software and will not be released until the participants start the scenario. A post-scenario video review will be done without blinding by two reviewers, but undertaken independently with each blinded to the other's reviews. In the case of disagreement, a third independent evaluator will help reach a consensus. The data analyst will be blinded to group allocation.
measure: Situational awareness
time frame: 40 minutes
description: Situational awareness (SA) will be measured using retrospective video review by the SA global assessment technique (SAGAT) instrument for each scenario, both as the score of each SAGAT at an individual level and at the team level (given as the sum of individual SAGAT scores for each team; TSAGAT). The SAGAT responses for categorical variables will be scored as either correct (1) or incorrect (0) by two of the investigators, irrespective of whether they agreed completely with the true answer. For numerical responses, answers will be considered correct based upon a 10% pre-defined tolerance range settled by the research investigators around the true value. The scores will be expressed as percentages in conjunction with absolute n/N values. Higher SA scores will denote higher SA.
measure: Resuscitation team leader evaluation
time frame: 40 minutes
description: Leadership will be measured using the 12-item RTLE instrument developed by Grant et al. that encompasses four leadership concepts: (1) the physical and verbal leader's position; (2) communication and delegating skills; (3) ability to assess, adapt and anticipate; and (4) ability to ask for internal and external help. This instrument comprises 12 items rated on a 4-point Likert scale from 0 (not performed) to 3 (performed well) to score leadership and communication skills. A not applicable (N/A) category is also available for those items not relevant to the scenario. For the purpose of this trial, items 1 and 12 will be removed as the leader will be clearly identified from the beginning of the scenario and teams will not be advised to ask for external help. Therefore, the total item score will range from 0 to 30.
measure: Team Emergency Assessment Measure
time frame: 40 minutes
description: Teamwork performance will be measured using the 11-item Team Emergency Assessment Measure (TEAM) tool that stands out as the most valid and reliable instrument to use in emergency departments. TEAM comprises 11 items rated on a 5-point Likert scale from 0 (never/hardly) to 4 (always/nearly always), which are summed up into a total item score ranging from 0 to 44. The final score obtained allows to assess the performance of the emergency medical team based on three categories: leadership (items 1 and 2); teamwork (items 3 to 9); and task management (items 10 and 11). Items 8 and 9 relate to SA perception and projection, respectively. Furthermore, the team's overall performance is rated through a twelfth item on a global rating scale of 1 to 10 (higher score denotes better performance).
measure: Medication dosage errors
time frame: 40 minutes
description: Errors in drug dose administration (in milligrams) will be measured in each allocation group as a deviation from the 2018 AHA PALS cardiac arrest algorithm. An emergency medication dose administration error is defined as a deviation from the correct weight dose of more than 10%. Errors will be also measured both as the percentage deviation from the amount of delivered drug compared with the correct weight dose as prescribed by the physician and the absolute deviations from that dose.
Moreover, defibrillations (in Joules) and the number of shocks will be also measured during the first scenario. For the second scenario, errors in fluid resuscitation volumes (in milliliters) will be measured as a deviation from the 2018 ATLS guidelines.
measure: Time to critical life-saving maneuvers
time frame: 40 minutes
description: The elapsed time in seconds between the end of the clinical statement by the study investigator to: (1) cardiac arrest or hypotensive shock recognition; (2) initiation of chest compression; (3) time to each defibrillation attempt; (4) time to administration of intravenous drugs, volume expansion with 0.9% sodium chloride or blood transfusion; and (5) time interval between defibrillation attempts will be measured.
measure: System usability scale
time frame: 10 minutes
description: Usability testing of the mHealth tool InterFACE will be assessed using the System Usability Scale (SUS) instrument. The SUS instrument consists of a 10-item questionnaire with five response options for each item, based on their level of agreement ranging from 1 (strongly disagree) to 5 (strongly agree). For odd-numbered statements 1, 3, 5, 7, 9 (positively-worded items), the score contribution is equal to the scale position minus 1. For even-numbered statements 2, 4, 6, 8, 10 (negatively-worded items), the score contribution is equal to 5 minus the scale position. Each score contribution will fall within the range of 0 to 4. The participant's scores for each item are then added up together and multiplied by 2.5 to convert the original scores of 0-40 to 0-100.
measure: Team effectiveness
time frame: 40 minutes
description: Team effectiveness will be also measured as the time spent by the team to achieve the pre-designed goals set out by the AHA for the PALS course and the American College of Surgeons for the ATLS course.
measure: Stress perceived and satisfaction
time frame: 10 minutes
description: A 3-item questionnaire using a 10-point Likert scale will be provided to the participants to measure their perceived stress and satisfaction about the preparation method used during the resuscitation scenario.
The questionnaire measures (1) the stress perceived before the scenario starts (On a scale from 1 to 10, how stressed are you now?), (2) the overall stress perceived at the end of the scenario (On a scale of 1 to 10, how stressed [maximum reached] were you during the scenario?), and (3) the satisfaction about the supportive method used during the resuscitation scenario (On a scale of 1 to 10, how satisfied were you with your supported experience?)
Scale ranges: from 0 (minimum score) to 10 (maximum score), increments are integers between 0 to 10. For stress, higher values represent a worse score, whereas for satisfaction higher values represent a better score. No subscales will be combined.
arm group label: Arm A (InterFACE)
arm group type: Experimental
description: Participants that will use the mHeath InterFACE tool during the simulation-based pediatric scenario.
Each participant will have to do 2 consecutive scenarios (PALS, ATLS).
arm group label: Arm B (Conventional methods)
arm group type: Active Comparator
description: Participants that will use conventional methods during the simulation-based pediatric scenario.
Each participant will have to do 2 consecutive scenarios (PALS, ATLS).
intervention type: Device
intervention name: InterFACE (mHealth tool)
description: Participants will be asked to perform consecutively two 20-min highly realistic, scripted CPR scenarios (first: PALS-based scenario, second: ATLS-based scenario) on a high-fidelity WiFi manikin.
Within each scenario, 3 separate "freeze" periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS guidelines.
Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills.
Participants allocated to Arm A will not be allowed to use any other cognitive support.
arm group label: Arm A (InterFACE)
intervention type: Other
intervention name: Conventional methods
description: Participants will be asked to perform consecutively two 20-min scripted CPR scenarios (PALS and ATLS-based scenario) on a high-fidelity WiFi manikin.
Within each scenario, 3 separate "freeze" periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and 2018 ATLS guidelines.
Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills.
Participants allocated to group B will be allowed to use the PALS pocket reference cards and a conventional calculator, but not any other cognitive support or mHealth tool.
arm group label: Arm B (Conventional methods)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Johan N Siebert, MD
role: Principal Investigator
affiliation: Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
last name: Johan N Siebert, MD
phone: +41 79 553 40 72
email: Johan.Siebert@hcuge.ch
last name: Frederic Ehrler, PhD
email: Frederic.Ehrler@hcuge.ch
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country: Switzerland
citation: Siebert JN, Lacroix L, Cantais A, Manzano S, Ehrler F. The Impact of a Tablet App on Adherence to American Heart Association Guidelines During Simulated Pediatric Cardiopulmonary Resuscitation: Randomized Controlled Trial. J Med Internet Res. 2020 May 27;22(5):e17792. doi: 10.2196/17792.
PMID: 32292179
responsible party type: Principal Investigator
investigator affiliation: Pediatric Clinical Research Platform
investigator full name: Johan Siebert, MD
investigator title: MD, Deputy Head
mesh term: Heart Arrest
sharing ipd: Yes
ipd description: IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives at the Geneva Children's Hospital. The datasets used or analyzed during the current trial will be available from the corresponding author upon reasonable request. Only deidentified/anonymized data will be shared.
ipd info type: Study Protocol
ipd time frame: Available from 1 month to 10 years after trial publication.
ipd access criteria: From the corresponding author upon reasonable request.