<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/NCT04469036</url>
  </required_header>
  <id_info>
    <org_study_id>1623230</org_study_id>
    <nct_id>NCT04469036</nct_id>
  </id_info>
  <brief_title>Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center</brief_title>
  <official_title>Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</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>
      More than 41 million children, or 55 percent of all children in the United States, live more&#xD;
      than 30 minutes away from a pediatric trauma center. The management of pediatric trauma&#xD;
      requires medical expertise that is only available at Level I pediatric trauma centers, which&#xD;
      are specialized pediatric referral hospitals located in large urban cities. Smaller hospitals&#xD;
      lack pediatric trauma expertise and resources to properly care for these children. When a&#xD;
      small hospital receives a child with trauma, the standard of care is to conduct a telephone&#xD;
      consultation to a pediatric trauma specialist, err on the side of safety, and transfer the&#xD;
      child to the regional Level I pediatric trauma center.&#xD;
&#xD;
      A newer model of care, the Virtual Pediatric Trauma Center (VPTC), uses live video, or&#xD;
      telemedicine, to bring the expertise of a Level I pediatric trauma center virtually to&#xD;
      patients at any hospital emergency department. While the VPTC model is being used more&#xD;
      frequently, the advantages and disadvantages of these two systems of care remain unknown,&#xD;
      particularly with regard to parent/family-centered outcomes.&#xD;
&#xD;
      The goal of this study is to optimize the patient and family experience and to minimize&#xD;
      distress, healthcare utilization, and out-of-pocket costs following the injury of a child.&#xD;
      The results of this project will help to optimize communication, confidence, and shared&#xD;
      decision making between parents/families and clinical staff from both the transferring and&#xD;
      receiving hospitals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 30, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">February 29, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>Stepped-wedge</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CAHPS Communication Subscale</measure>
    <time_frame>3 days after emergency department visit</time_frame>
    <description>19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey; specifically, we will report the following measures: Communication between you and your child's nurses (composite measure); Communication between you and your child's doctors (composite measure); Communication about your child's medicines (composite measure); Keeping you informed about your child's care (composite measure) Privacy when talking with doctors, nurses, and other providers (single-item measure); Preparing you and your child to leave the hospital (composite measure); Keeping you informed about your child's care in the Emergency Room (single-item measure). Higher scores are better; 0 (minimum) - 100 (maximum)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State-Trait Anxiety Inventory Form Y</measure>
    <time_frame>3 days after emergency department visit</time_frame>
    <description>State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. Responses for the State Anxiety scale assess intensity of current feelings &quot;at this moment&quot;: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transfer Rates</measure>
    <time_frame>48 hours after emergency department visit</time_frame>
    <description>Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day healthcare utilization</measure>
    <time_frame>30 days after emergency department visit</time_frame>
    <description>Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty healthcare visits, and diagnostics; these rates will be compared between the control and intervention groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-day Out of Pocket Costs</measure>
    <time_frame>3 days after emergency department visit</time_frame>
    <description>The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day Out of Pocket Costs</measure>
    <time_frame>30 days after emergency department visit</time_frame>
    <description>The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory Form Y</measure>
    <time_frame>30 days after emergency department visit</time_frame>
    <description>State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. Responses for the State Anxiety scale assess intensity of current feelings &quot;at this moment&quot;: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">380</enrollment>
  <condition>Trauma</condition>
  <condition>Injuries</condition>
  <arm_group>
    <arm_group_label>Telephone consultation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Telephone consultation to a pediatric trauma specialist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual Pediatric Trauma Center</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Virtual Pediatric Trauma Center (VPTC), uses live video, or telehealth, to bring the expertise of a Level I pediatric trauma center virtually to patients at a hospital emergency department.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Pediatric Trauma Center</intervention_name>
    <description>Telehealth</description>
    <arm_group_label>Virtual Pediatric Trauma Center</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (&lt;18 years old) with an acute injury at the time of a transfer&#xD;
             consultation call to UC Davis Trauma Surgery, Orthopedic Surgery, or Neurosurgery from&#xD;
             eleven outside emergency departments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California-Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/improving-family-centered-pediatric-trauma-care-standard-of-care-versus-the-virtual-pediatric-trauma-center-774878/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The study team is determining whether or not to share IPD.</ipd_description>
  </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/NCT04469036
org study id: 1623230
nct id: NCT04469036
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
More than 41 million children, or 55 percent of all children in the United States, live more
      than 30 minutes away from a pediatric trauma center. The management of pediatric trauma
      requires medical expertise that is only available at Level I pediatric trauma centers, which
      are specialized pediatric referral hospitals located in large urban cities. Smaller hospitals
      lack pediatric trauma expertise and resources to properly care for these children. When a
      small hospital receives a child with trauma, the standard of care is to conduct a telephone
      consultation to a pediatric trauma specialist, err on the side of safety, and transfer the
      child to the regional Level I pediatric trauma center.

      A newer model of care, the Virtual Pediatric Trauma Center (VPTC), uses live video, or
      telemedicine, to bring the expertise of a Level I pediatric trauma center virtually to
      patients at any hospital emergency department. While the VPTC model is being used more
      frequently, the advantages and disadvantages of these two systems of care remain unknown,
      particularly with regard to parent/family-centered outcomes.

      The goal of this study is to optimize the patient and family experience and to minimize
      distress, healthcare utilization, and out-of-pocket costs following the injury of a child.
      The results of this project will help to optimize communication, confidence, and shared
      decision making between parents/families and clinical staff from both the transferring and
      receiving hospitals.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Stepped-wedge
primary purpose: Health Services Research
masking: None (Open Label)
measure: CAHPS Communication Subscale
time frame: 3 days after emergency department visit
description: 19 questions from the Communication with Parent Subscale of the Consumer Assessment of Healthcare Providers and Systems Child Hospital Survey; specifically, we will report the following measures: Communication between you and your child's nurses (composite measure); Communication between you and your child's doctors (composite measure); Communication about your child's medicines (composite measure); Keeping you informed about your child's care (composite measure) Privacy when talking with doctors, nurses, and other providers (single-item measure); Preparing you and your child to leave the hospital (composite measure); Keeping you informed about your child's care in the Emergency Room (single-item measure). Higher scores are better; 0 (minimum) - 100 (maximum)
measure: State-Trait Anxiety Inventory Form Y
time frame: 3 days after emergency department visit
description: State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
measure: Transfer Rates
time frame: 48 hours after emergency department visit
description: Transfer rates from the referring emergency department to the trauma center will be compared between the control and intervention groups
measure: 30-day healthcare utilization
time frame: 30 days after emergency department visit
description: Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty healthcare visits, and diagnostics; these rates will be compared between the control and intervention groups
measure: 3-day Out of Pocket Costs
time frame: 3 days after emergency department visit
description: The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
measure: 30-day Out of Pocket Costs
time frame: 30 days after emergency department visit
description: The iMTA Productivity Cost Questionnaire (iPCQ) will be used, which includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work
measure: State-Trait Anxiety Inventory Form Y
time frame: 30 days after emergency department visit
description: State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. Responses for the State Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms.
arm group label: Telephone consultation
arm group type: No Intervention
description: Telephone consultation to a pediatric trauma specialist
arm group label: Virtual Pediatric Trauma Center
arm group type: Experimental
description: The Virtual Pediatric Trauma Center (VPTC), uses live video, or telehealth, to bring the expertise of a Level I pediatric trauma center virtually to patients at a hospital emergency department.
intervention type: Other
intervention name: Virtual Pediatric Trauma Center
description: Telehealth
arm group label: Virtual Pediatric Trauma Center
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
url: https://studypages.com/s/improving-family-centered-pediatric-trauma-care-standard-of-care-versus-the-virtual-pediatric-trauma-center-774878/
description: Learn more or sign up for the study here!
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: Undecided
ipd description: The study team is determining whether or not to share IPD.