<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/NCT02242682</url>
  </required_header>
  <id_info>
    <org_study_id>527345</org_study_id>
    <nct_id>NCT02242682</nct_id>
  </id_info>
  <brief_title>Video Education: Capitalizing on Caregiver Time Spent in the Pediatric Emergency Department Waiting Room</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if video education is an effective means of&#xD;
      caregiver education in the waiting room of a pediatric emergency department (ED). This will&#xD;
      be tested with the showing of a child passenger safety video.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: Difference in caregiver knowledge on a questionnaire</measure>
    <time_frame>day 0 in the ED</time_frame>
    <description>A knowledge questionnaire will be completed by caregivers in control and intervention groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>up to 4 weeks after enrollment</time_frame>
    <description>A knowledge questionnaire for caregivers will be given at phone follow up 4 weeks after initial enrollment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Child Passenger Seat Safety</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of subjects will not be exposed to a video during their time in the ED waiting room</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Child passenger safety video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of subjects will be exposed to a video during their time in the ED waiting room</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Child passenger safety video</intervention_name>
    <arm_group_label>Child passenger safety video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caregivers of patients presenting to Children's Hospital of Wisconsin for treatment&#xD;
&#xD;
          -  family use of automobile for transportation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-English speaking caregivers&#xD;
&#xD;
          -  triage level 1 or 2 or requiring immediate medical attention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.chop.edu/service/car-seat-safety-for-kids/car-seat-safety-by-age/for-your-4-to-8-year-old-child.html</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Wheeler JG, Fair M, Simpson PM, Rowlands LA, Aitken ME, Jacobs RF. Impact of a waiting room videotape message on parent attitudes toward pediatric antibiotic use. Pediatrics. 2001 Sep;108(3):591-6. doi: 10.1542/peds.108.3.591.</citation>
    <PMID>11533323</PMID>
  </reference>
  <reference>
    <citation>Dunn RA, Shenouda PE, Martin DR, Schultz AJ. Videotape increases parent knowledge about poliovirus vaccines and choices of polio vaccination schedules. Pediatrics. 1998 Aug;102(2):e26. doi: 10.1542/peds.102.2.e26.</citation>
    <PMID>9685472</PMID>
  </reference>
  <reference>
    <citation>Macy ML, Davis MM, Clark SJ, Stanley RM. Parental health literacy and asthma education delivery during a visit to a community-based pediatric emergency department: a pilot study. Pediatr Emerg Care. 2011 Jun;27(6):469-74. doi: 10.1097/PEC.0b013e31821c98a8.</citation>
    <PMID>21629152</PMID>
  </reference>
  <reference>
    <citation>Shenoi R, Saz EU, Jones JL, Ma L, Yusuf S. An emergency department intervention to improve knowledge of child passenger safety. Pediatr Emerg Care. 2010 Dec;26(12):881-7. doi: 10.1097/PEC.0b013e3181fe909f.</citation>
    <PMID>21088639</PMID>
  </reference>
  <reference>
    <citation>Schnellinger M, Finkelstein M, Thygeson MV, Vander Velden H, Karpas A, Madhok M. Animated video vs pamphlet: comparing the success of educating parents about proper antibiotic use. Pediatrics. 2010 May;125(5):990-6. doi: 10.1542/peds.2009-2916. Epub 2010 Apr 12.</citation>
    <PMID>20385634</PMID>
  </reference>
  <reference>
    <citation>Uherick L, Gorelick MH, Biechler R, Brixey SN, Melzer-Lange M. Validation of two child passenger safety questionnaires. Inj Prev. 2010 Oct;16(5):343-7. doi: 10.1136/ip.2009.022681. Epub 2010 Aug 30.</citation>
    <PMID>20805618</PMID>
  </reference>
  <reference>
    <citation>Durbin DR, Elliott MR, Winston FK. Belt-positioning booster seats and reduction in risk of injury among children in vehicle crashes. JAMA. 2003 Jun 4;289(21):2835-40. doi: 10.1001/jama.289.21.2835.</citation>
    <PMID>12783914</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>June 16, 2015</last_update_submitted>
  <last_update_submitted_qc>June 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Nina Muhammad</investigator_full_name>
    <investigator_title>Pediatric Emergency Medicine Fellow</investigator_title>
  </responsible_party>
  <!-- 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/NCT02242682
org study id: 527345
nct id: NCT02242682
lead sponsor: 
has dmc: No
The purpose of this study is to determine if video education is an effective means of
      caregiver education in the waiting room of a pediatric emergency department (ED). This will
      be tested with the showing of a child passenger safety video.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Care Provider)
measure: Efficacy: Difference in caregiver knowledge on a questionnaire
time frame: day 0 in the ED
description: A knowledge questionnaire will be completed by caregivers in control and intervention groups
measure: Retention
time frame: up to 4 weeks after enrollment
description: A knowledge questionnaire for caregivers will be given at phone follow up 4 weeks after initial enrollment
arm group label: Control
arm group type: No Intervention
description: This group of subjects will not be exposed to a video during their time in the ED waiting room
arm group label: Child passenger safety video
arm group type: Experimental
description: This group of subjects will be exposed to a video during their time in the ED waiting room
intervention type: Other
intervention name: Child passenger safety video
arm group label: Child passenger safety video
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://www.chop.edu/service/car-seat-safety-for-kids/car-seat-safety-by-age/for-your-4-to-8-year-old-child.html
description: Related Info
citation: Wheeler JG, Fair M, Simpson PM, Rowlands LA, Aitken ME, Jacobs RF. Impact of a waiting room videotape message on parent attitudes toward pediatric antibiotic use. Pediatrics. 2001 Sep;108(3):591-6. doi: 10.1542/peds.108.3.591.
PMID: 11533323
citation: Dunn RA, Shenouda PE, Martin DR, Schultz AJ. Videotape increases parent knowledge about poliovirus vaccines and choices of polio vaccination schedules. Pediatrics. 1998 Aug;102(2):e26. doi: 10.1542/peds.102.2.e26.
PMID: 9685472
citation: Macy ML, Davis MM, Clark SJ, Stanley RM. Parental health literacy and asthma education delivery during a visit to a community-based pediatric emergency department: a pilot study. Pediatr Emerg Care. 2011 Jun;27(6):469-74. doi: 10.1097/PEC.0b013e31821c98a8.
PMID: 21629152
citation: Shenoi R, Saz EU, Jones JL, Ma L, Yusuf S. An emergency department intervention to improve knowledge of child passenger safety. Pediatr Emerg Care. 2010 Dec;26(12):881-7. doi: 10.1097/PEC.0b013e3181fe909f.
PMID: 21088639
citation: Schnellinger M, Finkelstein M, Thygeson MV, Vander Velden H, Karpas A, Madhok M. Animated video vs pamphlet: comparing the success of educating parents about proper antibiotic use. Pediatrics. 2010 May;125(5):990-6. doi: 10.1542/peds.2009-2916. Epub 2010 Apr 12.
PMID: 20385634
citation: Uherick L, Gorelick MH, Biechler R, Brixey SN, Melzer-Lange M. Validation of two child passenger safety questionnaires. Inj Prev. 2010 Oct;16(5):343-7. doi: 10.1136/ip.2009.022681. Epub 2010 Aug 30.
PMID: 20805618
citation: Durbin DR, Elliott MR, Winston FK. Belt-positioning booster seats and reduction in risk of injury among children in vehicle crashes. JAMA. 2003 Jun 4;289(21):2835-40. doi: 10.1001/jama.289.21.2835.
PMID: 12783914
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Nina Muhammad
investigator title: Pediatric Emergency Medicine Fellow