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/NCT05967624</url>
    </required_header>
    <id_info>
      <org_study_id>H-38282</org_study_id>
      <secondary_id>5K23HL145126-03</secondary_id>
      <nct_id>NCT05967624</nct_id>
    </id_info>
    <brief_title>Prehospital Telemedicine Feasibility/Acceptability Pilot</brief_title>
    <official_title>Feasibility and Acceptability of a Low-cost, Mobile Telemedicine Platform for Remote Assessment of Children Transported by Ambulance</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Boston Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Teleconsultation, or the use of video telecommunications technology to deliver expert&#xD;
        recommendations for care remotely, has been used to improve the safety and quality of&#xD;
        emergency care for children in hospital-based acute care settings by providing real-time&#xD;
        access to remote pediatric physician experts. Whether extending teleconsultation as a patient&#xD;
        safety intervention to emergency medical systems (EMS) outside hospitals can similarly&#xD;
        benefit sick and injured children in the community is unknown. Advances in mobile technology&#xD;
        have made teleconsultation more accessible and affordable for EMS systems. However, this&#xD;
        intervention has been underutilized by EMS partially due to the lack of prehospital research&#xD;
        supporting its efficacy for pediatric applications.&#xD;
  &#xD;
        In prior simulation studies, the investigators found high intervention acceptance among key&#xD;
        stakeholder groups (pediatric emergency physicians and paramedics), and demonstrated that it&#xD;
        was feasible to integrate video communication into prehospital clinical workflows involving&#xD;
        critical care delivery in high-risk pediatric scenarios. These initial simulation studies&#xD;
        were conducted in a controlled prehospital setting in static ambulances using infant&#xD;
        simulator manikins to minimize risk to children and providers. Demonstrating feasibility and&#xD;
        acceptability with real children in moving ambulances is the next step to build the necessary&#xD;
        evidence base to support future planned prehospital efficacy trials with children.&#xD;
  &#xD;
        The investigators hypothesize that remote respiratory assessment of children by medical&#xD;
        control physicians (expert physicians) using a mobile teleconsultation platform is acceptable&#xD;
        to users (physicians and transport providers), and technically feasible in real transports.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        An open-label, nonrandomized, pilot feasibility trial will be conducted of children with&#xD;
        respiratory distress transported by the Boston Children's Hospital (BCH) critical care&#xD;
        transport team that also serves Boston Medical Center (BMC). Transport providers will&#xD;
        initiate a video-call from the ambulance to medical control physician on call who will be at&#xD;
        a geographically distant location. The physician will view streamed video of the child and&#xD;
        complete a brief respiratory assessment checklist tool to determine video quality, a&#xD;
        feasibility measure.&#xD;
  &#xD;
        The investigators will measure acceptability (primary outcome) and feasibility (secondary&#xD;
        outcomes) on a validated questionnaire administered to users after each call. In this pilot&#xD;
        study, efficacy will not be tested; all decision making will occur according to usual care&#xD;
        protocols.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Agreement in assessment of respiratory distress</measure>
      <time_frame>6 months</time_frame>
      <description>Each subject will be remotely assessed by a Medical Control Physician using the HIPAA-compliant Zoom Pro web application pre-loaded on a tablet device. The remote medical control physician and the transport team member at the patient bedside in the ambulance will score the Respiratory Observation Checklist simultaneously. The range for agreement is 0 to 1.0, where 0=no agreement and 1 is perfect agreement. The following scale: 0.01-0.20=none to slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial, 0.81-1.0=almost perfect agreement will be used.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total Usability Score</measure>
      <time_frame>6 months</time_frame>
      <description>The total usability score is measured by the Telehealth Usability Questionnaire (TUQ). This 21-item questionnaire is a validated measure of all the key usability characteristics of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). Users rate items on 7-point Likert-scales (1=disagree to 7=agree) in 6 separate domains (usefulness, ease of use and learnability, interface quality, interaction quality, reliability, satisfaction and future use). The investigators modified this questionnaire to specifically address the usability of the study telemedicine platform. The total usability score is the total mean score for all 21 questions (maximum possible score=7).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Video quality</measure>
      <time_frame>6 months</time_frame>
      <description>This will be measured by TUQ items #11 and #14 within the &quot;Interaction Quality&quot; domain. Users will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and standard deviation (SD) for each item will be reported. HIgher scores suggest higher quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Audio quality</measure>
      <time_frame>6 months</time_frame>
      <description>This will be measured by TUQ items #12 and #13 within the &quot;Interaction Quality&quot; domain. Users will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and SD for each item will be reported. HIgher scores suggest higher quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Success of video-call connection</measure>
      <time_frame>6 months</time_frame>
      <description>The number of attempts transport team providers make to successfully connect with the medical control physician via video-call will be recorded. Adequate success of video-call connection is defined as ≤2 attempts to achieve a video-call connection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of successful tablet mounts</measure>
      <time_frame>6 months</time_frame>
      <description>Study investigators will note any problems with tablet mounts in the ambulance cabin (e.g., location makes call activation difficult), as well as specific qualitative comments from participants regarding tablet mount strategy. If no problems are noted the tablet mount will be considered successful and the proportion of successful table mounts will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of calls with adequate video quality for assessment</measure>
      <time_frame>6 months</time_frame>
      <description>This will be measured as the proportion of video-calls where clinicians are able to observe all ten items on the Respiratory Observation Checklist. This checklist tool has been previously validated for rapid, reliable assessment of children by teleconsultants in emergency settings. Medical control physicians will score 9 observable signs and a global assessment of respiratory distress dichotomously (present/absent).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to arrival at referring facility</measure>
      <time_frame>6 months</time_frame>
      <description>This is the time interval (minutes) from when BCH receives the patient transport request from the referring facility to the time the transport team arrives at the referring facility. This will be abstracted from transport records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scene time</measure>
      <time_frame>6 months</time_frame>
      <description>This is the time interval (minutes) from when the BCH transport team arrives at the referring facility to when the transport team leaves the referring facility. This will be abstracted from transport records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to arrival at destination facility</measure>
      <time_frame>6 months</time_frame>
      <description>This is the time interval (minutes) from when the BCH transport team leaves the referring facility to the time of arrival at BCH/BMC (the destination facility). This will be abstracted from transport records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total transport time</measure>
      <time_frame>6 months</time_frame>
      <description>This time interval encompasses the time from when the transport team is dispatched to the referring facility to when they arrive at the destination (receiving facility). This will be abstracted from transport records.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Respiratory Distress Syndrome</condition>
    <arm_group>
      <arm_group_label>Teleconsultation group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Teleconsultation</intervention_name>
      <description>Each subject will be remotely assessed by a Medical Control Physician (MCP) using FaceTime and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.</description>
      <arm_group_label>Teleconsultation group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children in New England transported by the Boston Children Hospital for respiratory&#xD;
               illness from any cause&#xD;
  &#xD;
            -  Clinically stable for transportation [e.g., need supplemental oxygen, medications, or&#xD;
               are stable on mechanical ventilation]&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with non-respiratory complaints&#xD;
  &#xD;
            -  Children whose illness is anticipated by providers to be acutely life-threatening&#xD;
               during transportation [e.g., requiring emergency resuscitation procedures in the&#xD;
               ambulance]&#xD;
  &#xD;
            -  Non-English speaking parents/guardians&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tehnaz Boyle, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Boston Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tehnaz Boyle, MD PhD</last_name>
      <phone>617-414-6382</phone>
      <email>tehnaz.boyle@bmc.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>Boston Children's Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Monica Kleinman, MD</last_name>
        <phone>617-355-7327</phone>
        <email>monica.kleinman@childrens.harvard.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Boston Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02118</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Tehnaz Boyle, MD PhD</last_name>
        <phone>617-414-6382</phone>
        <email>tehnaz.boyle@bmc.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Teleconsultation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Distress Syndrome</mesh_term>
      <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05967624
  org study id: H-38282
  secondary id: 5K23HL145126-03
  nct id: NCT05967624
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Teleconsultation, or the use of video telecommunications technology to deliver expert
        recommendations for care remotely, has been used to improve the safety and quality of
        emergency care for children in hospital-based acute care settings by providing real-time
        access to remote pediatric physician experts. Whether extending teleconsultation as a patient
        safety intervention to emergency medical systems (EMS) outside hospitals can similarly
        benefit sick and injured children in the community is unknown. Advances in mobile technology
        have made teleconsultation more accessible and affordable for EMS systems. However, this
        intervention has been underutilized by EMS partially due to the lack of prehospital research
        supporting its efficacy for pediatric applications.
  
        In prior simulation studies, the investigators found high intervention acceptance among key
        stakeholder groups (pediatric emergency physicians and paramedics), and demonstrated that it
        was feasible to integrate video communication into prehospital clinical workflows involving
        critical care delivery in high-risk pediatric scenarios. These initial simulation studies
        were conducted in a controlled prehospital setting in static ambulances using infant
        simulator manikins to minimize risk to children and providers. Demonstrating feasibility and
        acceptability with real children in moving ambulances is the next step to build the necessary
        evidence base to support future planned prehospital efficacy trials with children.
  
        The investigators hypothesize that remote respiratory assessment of children by medical
        control physicians (expert physicians) using a mobile teleconsultation platform is acceptable
        to users (physicians and transport providers), and technically feasible in real transports.
  An open-label, nonrandomized, pilot feasibility trial will be conducted of children with
        respiratory distress transported by the Boston Children's Hospital (BCH) critical care
        transport team that also serves Boston Medical Center (BMC). Transport providers will
        initiate a video-call from the ambulance to medical control physician on call who will be at
        a geographically distant location. The physician will view streamed video of the child and
        complete a brief respiratory assessment checklist tool to determine video quality, a
        feasibility measure.
  
        The investigators will measure acceptability (primary outcome) and feasibility (secondary
        outcomes) on a validated questionnaire administered to users after each call. In this pilot
        study, efficacy will not be tested; all decision making will occur according to usual care
        protocols.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Agreement in assessment of respiratory distress
  time frame: 6 months
  description: Each subject will be remotely assessed by a Medical Control Physician using the HIPAA-compliant Zoom Pro web application pre-loaded on a tablet device. The remote medical control physician and the transport team member at the patient bedside in the ambulance will score the Respiratory Observation Checklist simultaneously. The range for agreement is 0 to 1.0, where 0=no agreement and 1 is perfect agreement. The following scale: 0.01-0.20=none to slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial, 0.81-1.0=almost perfect agreement will be used.
  measure: Total Usability Score
  time frame: 6 months
  description: The total usability score is measured by the Telehealth Usability Questionnaire (TUQ). This 21-item questionnaire is a validated measure of all the key usability characteristics of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). Users rate items on 7-point Likert-scales (1=disagree to 7=agree) in 6 separate domains (usefulness, ease of use and learnability, interface quality, interaction quality, reliability, satisfaction and future use). The investigators modified this questionnaire to specifically address the usability of the study telemedicine platform. The total usability score is the total mean score for all 21 questions (maximum possible score=7).
  measure: Video quality
  time frame: 6 months
  description: This will be measured by TUQ items #11 and #14 within the "Interaction Quality" domain. Users will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and standard deviation (SD) for each item will be reported. HIgher scores suggest higher quality.
  measure: Audio quality
  time frame: 6 months
  description: This will be measured by TUQ items #12 and #13 within the "Interaction Quality" domain. Users will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and SD for each item will be reported. HIgher scores suggest higher quality.
  measure: Success of video-call connection
  time frame: 6 months
  description: The number of attempts transport team providers make to successfully connect with the medical control physician via video-call will be recorded. Adequate success of video-call connection is defined as ≤2 attempts to achieve a video-call connection.
  measure: Proportion of successful tablet mounts
  time frame: 6 months
  description: Study investigators will note any problems with tablet mounts in the ambulance cabin (e.g., location makes call activation difficult), as well as specific qualitative comments from participants regarding tablet mount strategy. If no problems are noted the tablet mount will be considered successful and the proportion of successful table mounts will be reported.
  measure: Proportion of calls with adequate video quality for assessment
  time frame: 6 months
  description: This will be measured as the proportion of video-calls where clinicians are able to observe all ten items on the Respiratory Observation Checklist. This checklist tool has been previously validated for rapid, reliable assessment of children by teleconsultants in emergency settings. Medical control physicians will score 9 observable signs and a global assessment of respiratory distress dichotomously (present/absent).
  measure: Time to arrival at referring facility
  time frame: 6 months
  description: This is the time interval (minutes) from when BCH receives the patient transport request from the referring facility to the time the transport team arrives at the referring facility. This will be abstracted from transport records.
  measure: Scene time
  time frame: 6 months
  description: This is the time interval (minutes) from when the BCH transport team arrives at the referring facility to when the transport team leaves the referring facility. This will be abstracted from transport records.
  measure: Time to arrival at destination facility
  time frame: 6 months
  description: This is the time interval (minutes) from when the BCH transport team leaves the referring facility to the time of arrival at BCH/BMC (the destination facility). This will be abstracted from transport records.
  measure: Total transport time
  time frame: 6 months
  description: This time interval encompasses the time from when the transport team is dispatched to the referring facility to when they arrive at the destination (receiving facility). This will be abstracted from transport records.
  arm group label: Teleconsultation group
  arm group type: Experimental
  description: Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
  intervention type: Other
  intervention name: Teleconsultation
  description: Each subject will be remotely assessed by a Medical Control Physician (MCP) using FaceTime and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.
  arm group label: Teleconsultation group
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 17 Years
  healthy volunteers: No
  last name: Tehnaz Boyle, MD PhD
  role: Principal Investigator
  affiliation: Boston Medical Center
  last name: Tehnaz Boyle, MD PhD
  phone: 617-414-6382
  email: tehnaz.boyle@bmc.gov
  facility: 
  contact: 
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  sharing ipd: No