<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/NCT03013816</url>
  </required_header>
  <id_info>
    <org_study_id>2015P000063</org_study_id>
    <nct_id>NCT03013816</nct_id>
  </id_info>
  <brief_title>Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention</brief_title>
  <official_title>Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Four aims were pursued: (1) Evaluate the effectiveness of video messaging on adolescent donor&#xD;
      designations in comparison to a regionally-matched historical comparison group of&#xD;
      adolescents; (2) Compare the differential effectiveness of three commonly-used donation&#xD;
      messaging strategies (informational, testimonial, and blended) on donor designations; (3)&#xD;
      Examine the impact of donation messaging on changes in secondary outcomes (donation&#xD;
      engagement, knowledge, attitudes, beliefs, likelihood of donor designation, discussion with a&#xD;
      parent) before and after video intervention; and (4) Assess the commitment of parents to&#xD;
      follow their adolescent's donation wishes in the event of death. Our central hypotheses were&#xD;
      that integrating donation video messaging into driver education classes would generate a&#xD;
      higher proportion of donor designations compared to a historical comparison group and that&#xD;
      blended video messaging (informational + testimonials) would yield a higher proportion of&#xD;
      donor designations and more change in secondary outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Organ Donation Registration</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome was donor designation (yes-no) at time of obtaining first driver's license post-intervention. We provided the name, date of birth, last four digits of social security number, residential address, and study identification number of each adolescent to the Massachusetts DoT, which then returned to us a data file containing the donor designation status for each study identification number. For the regionally-matched historical comparison group, the DoT provided a de-identified data file of all adolescents who obtained their first driver's license in the six months prior to study enrollment at six motor vehicle offices.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Organ Donation Knowledge and Attitudes</measure>
    <time_frame>1 week</time_frame>
    <description>Immediately before, shortly after, and 1 week following video messaging exposure, adolescents completed a questionnaire to assess the following donation constructs: engagement (2 questions -- 1-10 scale), knowledge (3 questions -- correct/incorrect total score range 0-3), general attitude (1 question), beliefs (4 questions -- strong disagree-strongly agree scale), designation likelihood (1 question -- 1-10 scale), and willingness to communicate donation decision to a parent (1 question -- 1-10 scale). Adolescents received a $5 gift card for each survey completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Commitment</measure>
    <time_frame>6 months</time_frame>
    <description>One week following the adolescent's exposure to the donation video, we mailed parents a brief questionnaire that included questions about their donor designation status (Yes/No), general donation attitude (1 question -- 1-10 scale), any communication with their adolescent about his/her donor designation intention (Yes/No), and likelihood of following their adolescent's wishes about donation (1 question -- 1-10 scale).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">611</enrollment>
  <condition>Organ Donor Registration</condition>
  <condition>Organ Donation Education</condition>
  <arm_group>
    <arm_group_label>Testimonial Messaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This video features four personal testimonials with strong emotional appeal, including an adolescent kidney transplant recipient, a pediatric liver transplant recipient, a young adult kidney transplant candidate, and an adolescent whose twin brother was a deceased organ donor. There are minimal facts about transplantation or donation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Informational Messaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This video mirrors common educational campaigns and included segments of HRSA's animated video, Organ Donation and Transplantation: How Does it Work? The IM video presents facts about donation, including the current supply-demand problem in transplantation, common reasons for/against donor designation, donation myths, and the importance of communicating with parents about donation. Information about how to register as a donor is also included. The video contains no personal testimonials.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blended Messaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This video features four personal testimonials with strong emotional appeal, including an adolescent kidney transplant recipient, a pediatric liver transplant recipient, a young adult kidney transplant candidate, and an adolescent whose twin brother was a deceased organ donor. There are minimal facts about transplantation or donation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Organ Donation Education: Testimonial Messaging</intervention_name>
    <description>The testimonial messaging video intervention will be shown</description>
    <arm_group_label>Testimonial Messaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Organ Donation Education: Informational Messaging</intervention_name>
    <description>The informational messaging video intervention will be shown</description>
    <arm_group_label>Informational Messaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Organ Donation Education: Blended Messaging</intervention_name>
    <description>The blended messaging video intervention will be shown</description>
    <arm_group_label>Blended Messaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria for Classrooms:&#xD;
&#xD;
        Classroom eligibility criteria included: (a) driver education conducted in English, and (b)&#xD;
        instructor agreement not to provide or discuss donation information beyond the study video.&#xD;
&#xD;
        Criteria for Adolescent Participants:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in driving school class&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Adolescent assent&#xD;
&#xD;
          -  Parental permission to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior participation in a driver's education class in which organ donation education&#xD;
             was provided&#xD;
&#xD;
          -  Parent permission form not signed&#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>
  <overall_official>
    <last_name>James Rodrigue, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>James Rodrigue</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03013816
org study id: 2015P000063
nct id: NCT03013816
lead sponsor: 
has dmc: No
Four aims were pursued: (1) Evaluate the effectiveness of video messaging on adolescent donor
      designations in comparison to a regionally-matched historical comparison group of
      adolescents; (2) Compare the differential effectiveness of three commonly-used donation
      messaging strategies (informational, testimonial, and blended) on donor designations; (3)
      Examine the impact of donation messaging on changes in secondary outcomes (donation
      engagement, knowledge, attitudes, beliefs, likelihood of donor designation, discussion with a
      parent) before and after video intervention; and (4) Assess the commitment of parents to
      follow their adolescent's donation wishes in the event of death. Our central hypotheses were
      that integrating donation video messaging into driver education classes would generate a
      higher proportion of donor designations compared to a historical comparison group and that
      blended video messaging (informational + testimonials) would yield a higher proportion of
      donor designations and more change in secondary outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Organ Donation Registration
time frame: 6 months
description: The primary outcome was donor designation (yes-no) at time of obtaining first driver's license post-intervention. We provided the name, date of birth, last four digits of social security number, residential address, and study identification number of each adolescent to the Massachusetts DoT, which then returned to us a data file containing the donor designation status for each study identification number. For the regionally-matched historical comparison group, the DoT provided a de-identified data file of all adolescents who obtained their first driver's license in the six months prior to study enrollment at six motor vehicle offices.
measure: Organ Donation Knowledge and Attitudes
time frame: 1 week
description: Immediately before, shortly after, and 1 week following video messaging exposure, adolescents completed a questionnaire to assess the following donation constructs: engagement (2 questions -- 1-10 scale), knowledge (3 questions -- correct/incorrect total score range 0-3), general attitude (1 question), beliefs (4 questions -- strong disagree-strongly agree scale), designation likelihood (1 question -- 1-10 scale), and willingness to communicate donation decision to a parent (1 question -- 1-10 scale). Adolescents received a $5 gift card for each survey completed.
measure: Parental Commitment
time frame: 6 months
description: One week following the adolescent's exposure to the donation video, we mailed parents a brief questionnaire that included questions about their donor designation status (Yes/No), general donation attitude (1 question -- 1-10 scale), any communication with their adolescent about his/her donor designation intention (Yes/No), and likelihood of following their adolescent's wishes about donation (1 question -- 1-10 scale).
arm group label: Testimonial Messaging
arm group type: Experimental
description: This video features four personal testimonials with strong emotional appeal, including an adolescent kidney transplant recipient, a pediatric liver transplant recipient, a young adult kidney transplant candidate, and an adolescent whose twin brother was a deceased organ donor. There are minimal facts about transplantation or donation.
arm group label: Informational Messaging
arm group type: Experimental
description: This video mirrors common educational campaigns and included segments of HRSA's animated video, Organ Donation and Transplantation: How Does it Work? The IM video presents facts about donation, including the current supply-demand problem in transplantation, common reasons for/against donor designation, donation myths, and the importance of communicating with parents about donation. Information about how to register as a donor is also included. The video contains no personal testimonials.
arm group label: Blended Messaging
arm group type: Experimental
description: This video features four personal testimonials with strong emotional appeal, including an adolescent kidney transplant recipient, a pediatric liver transplant recipient, a young adult kidney transplant candidate, and an adolescent whose twin brother was a deceased organ donor. There are minimal facts about transplantation or donation.
intervention type: Behavioral
intervention name: Organ Donation Education: Testimonial Messaging
description: The testimonial messaging video intervention will be shown
arm group label: Testimonial Messaging
intervention type: Behavioral
intervention name: Organ Donation Education: Informational Messaging
description: The informational messaging video intervention will be shown
arm group label: Informational Messaging
intervention type: Behavioral
intervention name: Organ Donation Education: Blended Messaging
description: The blended messaging video intervention will be shown
arm group label: Blended Messaging
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Rodrigue, PhD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: James Rodrigue
investigator title: Professor
sharing ipd: No