<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/NCT03799393</url>
  </required_header>
  <id_info>
    <org_study_id>2012-17</org_study_id>
    <nct_id>NCT03799393</nct_id>
  </id_info>
  <brief_title>Buckle Me Up!: A Digital Emergency Department Discharge Intervention for Child Car Safety</brief_title>
  <official_title>Buckle Me Up!: A Computerized, Individually-Tailored Emergency Department Discharge Intervention for Child Car Restraint Safety Education</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lifespan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lifespan</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 explores the utility of a tablet computer-based, individually-tailored application&#xD;
      called Computer Intervention Authoring Software (CIAS) in the Emergency Department for&#xD;
      discharge education on proper child car restraint safety. The investigators hypothesize that&#xD;
      tablet-based, individually-tailored discharge instructions are more effective than current&#xD;
      standard, one-size-fits-all, printed discharge instructions. This is a randomized,&#xD;
      controlled, non-blinded trial of of children age 0-21 years old in the Emergency Department.&#xD;
      Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed&#xD;
      by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed&#xD;
      by the intervention - CIAS, a tablet-based computer program. One week after discharge,&#xD;
      participants in both groups will receive an automatic text message and/or email message with&#xD;
      a link to a web-based survey that will assess: knowledge of appropriate car restraints and&#xD;
      whether the parent/patient engaged in any behavioral changes regarding child car restraint.&#xD;
      These variables will be compared between the control and intervention groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study explores the utility of a tablet computer-based, individually-tailored technology&#xD;
      called Computer Intervention Authoring Software (CIAS) in the Emergency Department for&#xD;
      discharge education on proper child car restraint safety. The investigators hypothesize that&#xD;
      tablet-based, individually-tailored discharge instructions are more effective than current&#xD;
      standard, one-size-fits-all, printed discharge instructions. This is a randomized,&#xD;
      controlled, non-blinded trial of a convenience sample of 200 children age 0-21 years old who&#xD;
      present to the Hasbro Children's Hospital Emergency Department by car and have access to a&#xD;
      smartphone and/or email. Patients will be randomized to receive either (a) a brief&#xD;
      tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief&#xD;
      tablet-based questionnaire followed by the intervention - CIAS, a computer program that&#xD;
      allows families to interact with a tablet computer to receive educational information&#xD;
      customized to the patient. Children 13 years old and above will answer questions themselves&#xD;
      instead of having their parent/guardian answer for them. Both group will be offered&#xD;
      information for the Lifespan Injury Prevention Center's Kohl's Car Seat Program. Both groups&#xD;
      will complete a questionnaire on the usefulness of their discharge education. One week after&#xD;
      discharge, participants in both groups will receive an automatic text message and/or email&#xD;
      message with a link to a web-based survey that will assess: knowledge of appropriate car&#xD;
      restraints and whether the parent/patient engaged in any behavioral changes regarding child&#xD;
      car restraint. These variables will be compared between the control and intervention groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstration of age-appropriate car restraint knowledge</measure>
    <time_frame>one week after enrollment</time_frame>
    <description>Rate of correct response to a post-intervention follow-up survey question regarding age appropriate car restraint for child in control group vs. intervention group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in car restraint knowledge</measure>
    <time_frame>one week after enrollment</time_frame>
    <description>Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Actions taken related to car restraints</measure>
    <time_frame>one week after enrollment</time_frame>
    <description>Rate of parental self-report of actions taken related to changing use of car restraints on post-intervention follow-up survey. This will be a binary variable (NO action taken vs. YES action taken).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of difference types of actions taken related to car restraints</measure>
    <time_frame>one week after enrollment</time_frame>
    <description>Rates of each specific type of actions taken will also be compared between control and intervention groups (e.g. percentage of subjects who purchased a new car restraint device in each group, percentage of patients that had car seat installation checked at a fire department in each group, etc).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with discharge education - CIAS</measure>
    <time_frame>during intervention/enrollment</time_frame>
    <description>For intervention group only - parent/patient satisfaction with education given on discharge based on score on Technology Posttrial Impressions Questionnaire. We will examine 13 individual components scored on an ordinal scale 1 to 5 (poor, fair, good, very good, excellent). Mean total score will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental confidence in type of car restraint</measure>
    <time_frame>one week after enrollment</time_frame>
    <description>Change in parental confidence that child is in the correct type of car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:&#xD;
How confident are you that your child is in the right type of car restraint?&#xD;
1- not at all confident 2- 3- 4- 5- very confident</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental confidence in car restraint installation</measure>
    <time_frame>one week after enrollment</time_frame>
    <description>Change in parental confidence that car restraint is correctly installed, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:&#xD;
How confident are you that your car restraint is installed correctly?&#xD;
1- not at all confident 2- 3- 4- 5- very confident</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental confidence in buckling the car restraint</measure>
    <time_frame>one week after enrollment</time_frame>
    <description>Change in parental confidence that the child is correctly buckled in the car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:&#xD;
How confident are you that your child is correctly buckled into the car restraint?&#xD;
1- not at all confident 2- 3- 4- 5- very confident</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">295</enrollment>
  <condition>Safety Issues</condition>
  <condition>Injuries</condition>
  <condition>Car Accident</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive a brief tablet-based questionnaire followed by standard, paper discharge instructions on car safety. Children ≥13 years old and above will answer questions themselves. They will complete a questionnaire on the usefulness of their discharge education.&#xD;
One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental/CIAS Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Experimental/CIAS Group will receive a brief tablet-based questionnaire followed by the intervention - CIAS, an interactive tablet computer program that gives educational information customized to the patient's age and size. Children ≥13 years old will answer questions and interact with the program themselves. They will complete a questionnaire on the usefulness of their discharge education.&#xD;
One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CIAS (Computer Intervention Authoring Software)</intervention_name>
    <description>This is a digital application that allows families to interact with a tablet computer to receive educational information customized to the patient's age and size. allows authors to develop screening, assessment, and intervention tools for patients without requiring new programming. The CIAS intervention is programmed using tailored branching logic to allow a custom path through the intervention based on the respondent's answers. Delivery of the intervention uses a two-dimensional avatar narrator character that mimics the conversational structure of person-delivered brief interventions.</description>
    <arm_group_label>Experimental/CIAS Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Printed Discharge Instructions</intervention_name>
    <description>Patients/families will receive standard, printed discharge instructions. This is a 5 page general document from our Injury Prevention Center that describes appropriate car restraint safety for all age groups, not specific to the child enrolled.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Children age 0-21 years presenting to the children's emergency department for any chief&#xD;
        complaint whose parent/guardian owns or has access to a car that the child rides in (or for&#xD;
        adolescents 16 years or older, have access to a car themselves).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No access to email or a smart phone&#xD;
&#xD;
          -  Adolescents with significant developmental delay&#xD;
&#xD;
          -  Adolescents who are critically injured&#xD;
&#xD;
          -  No parent/guardian present at time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Duffy, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hasbro Children's Hospital Emergency Department</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lifespan</investigator_affiliation>
    <investigator_full_name>Almaz Dessie</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>injury prevention</keyword>
  <keyword>car safety</keyword>
  <keyword>car seats</keyword>
  <keyword>booster seats</keyword>
  <keyword>car restraints</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 9, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03799393
org study id: 2012-17
nct id: NCT03799393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study explores the utility of a tablet computer-based, individually-tailored application
      called Computer Intervention Authoring Software (CIAS) in the Emergency Department for
      discharge education on proper child car restraint safety. The investigators hypothesize that
      tablet-based, individually-tailored discharge instructions are more effective than current
      standard, one-size-fits-all, printed discharge instructions. This is a randomized,
      controlled, non-blinded trial of of children age 0-21 years old in the Emergency Department.
      Patients will be randomized to receive either (a) a brief tablet-based questionnaire followed
      by standard, paper discharge instructions or (b) a brief tablet-based questionnaire followed
      by the intervention - CIAS, a tablet-based computer program. One week after discharge,
      participants in both groups will receive an automatic text message and/or email message with
      a link to a web-based survey that will assess: knowledge of appropriate car restraints and
      whether the parent/patient engaged in any behavioral changes regarding child car restraint.
      These variables will be compared between the control and intervention groups.
This study explores the utility of a tablet computer-based, individually-tailored technology
      called Computer Intervention Authoring Software (CIAS) in the Emergency Department for
      discharge education on proper child car restraint safety. The investigators hypothesize that
      tablet-based, individually-tailored discharge instructions are more effective than current
      standard, one-size-fits-all, printed discharge instructions. This is a randomized,
      controlled, non-blinded trial of a convenience sample of 200 children age 0-21 years old who
      present to the Hasbro Children's Hospital Emergency Department by car and have access to a
      smartphone and/or email. Patients will be randomized to receive either (a) a brief
      tablet-based questionnaire followed by standard, paper discharge instructions or (b) a brief
      tablet-based questionnaire followed by the intervention - CIAS, a computer program that
      allows families to interact with a tablet computer to receive educational information
      customized to the patient. Children 13 years old and above will answer questions themselves
      instead of having their parent/guardian answer for them. Both group will be offered
      information for the Lifespan Injury Prevention Center's Kohl's Car Seat Program. Both groups
      will complete a questionnaire on the usefulness of their discharge education. One week after
      discharge, participants in both groups will receive an automatic text message and/or email
      message with a link to a web-based survey that will assess: knowledge of appropriate car
      restraints and whether the parent/patient engaged in any behavioral changes regarding child
      car restraint. These variables will be compared between the control and intervention groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Demonstration of age-appropriate car restraint knowledge
time frame: one week after enrollment
description: Rate of correct response to a post-intervention follow-up survey question regarding age appropriate car restraint for child in control group vs. intervention group.
measure: Change in car restraint knowledge
time frame: one week after enrollment
description: Change in rate of correct response pre-intervention vs. post-intervention compared between control group vs. intervention
measure: Actions taken related to car restraints
time frame: one week after enrollment
description: Rate of parental self-report of actions taken related to changing use of car restraints on post-intervention follow-up survey. This will be a binary variable (NO action taken vs. YES action taken).
measure: Rate of difference types of actions taken related to car restraints
time frame: one week after enrollment
description: Rates of each specific type of actions taken will also be compared between control and intervention groups (e.g. percentage of subjects who purchased a new car restraint device in each group, percentage of patients that had car seat installation checked at a fire department in each group, etc).
measure: Satisfaction with discharge education - CIAS
time frame: during intervention/enrollment
description: For intervention group only - parent/patient satisfaction with education given on discharge based on score on Technology Posttrial Impressions Questionnaire. We will examine 13 individual components scored on an ordinal scale 1 to 5 (poor, fair, good, very good, excellent). Mean total score will be calculated.
measure: Parental confidence in type of car restraint
time frame: one week after enrollment
description: Change in parental confidence that child is in the correct type of car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your child is in the right type of car restraint?
1- not at all confident 2- 3- 4- 5- very confident
measure: Parental confidence in car restraint installation
time frame: one week after enrollment
description: Change in parental confidence that car restraint is correctly installed, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your car restraint is installed correctly?
1- not at all confident 2- 3- 4- 5- very confident
measure: Parental confidence in buckling the car restraint
time frame: one week after enrollment
description: Change in parental confidence that the child is correctly buckled in the car restraint, comparing pre- and post-intervention response according to the 1 to 5 ordinal scale:
How confident are you that your child is correctly buckled into the car restraint?
1- not at all confident 2- 3- 4- 5- very confident
arm group label: Control Group
arm group type: Active Comparator
description: The control group will receive a brief tablet-based questionnaire followed by standard, paper discharge instructions on car safety. Children ≥13 years old and above will answer questions themselves. They will complete a questionnaire on the usefulness of their discharge education.
One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint.
arm group label: Experimental/CIAS Group
arm group type: Experimental
description: The Experimental/CIAS Group will receive a brief tablet-based questionnaire followed by the intervention - CIAS, an interactive tablet computer program that gives educational information customized to the patient's age and size. Children ≥13 years old will answer questions and interact with the program themselves. They will complete a questionnaire on the usefulness of their discharge education.
One week after discharge, participants will receive an automatic text message and/or email message with a link to a web-based survey that will assess: knowledge of appropriate car restraints and whether the parent/patient engaged in any behavioral changes regarding child car restraint.
intervention type: Behavioral
intervention name: CIAS (Computer Intervention Authoring Software)
description: This is a digital application that allows families to interact with a tablet computer to receive educational information customized to the patient's age and size. allows authors to develop screening, assessment, and intervention tools for patients without requiring new programming. The CIAS intervention is programmed using tailored branching logic to allow a custom path through the intervention based on the respondent's answers. Delivery of the intervention uses a two-dimensional avatar narrator character that mimics the conversational structure of person-delivered brief interventions.
arm group label: Experimental/CIAS Group
intervention type: Behavioral
intervention name: Standard Printed Discharge Instructions
description: Patients/families will receive standard, printed discharge instructions. This is a 5 page general document from our Injury Prevention Center that describes appropriate car restraint safety for all age groups, not specific to the child enrolled.
arm group label: Control Group
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Duffy, MD, MPH
role: Study Director
affiliation: Associate Professor
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Lifespan
investigator full name: Almaz Dessie
investigator title: Principal Investigator
mesh term: Emergencies
sharing ipd: Undecided
submitted: June 9, 2023