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Trial record 1 of 1 for:    NCT03013816
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Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention

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ClinicalTrials.gov Identifier: NCT03013816
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE December 29, 2016
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date January 28, 2019
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
Organ Donation Registration [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
Organ Donation Registration [ Time Frame: 6 months ]
The primary outcome is the adolescent's donor designation (yes-no) at the time of obtaining their first driver's license at the Registry of Motor Vehicles (RMV) office. For most study participants, this decision will occur within 3-6 months of the intervention. We have an established relationship with the Information Technology group in the Massachusetts Department of Transportation. They are able to provide us with de-identified individual-level data on donor designation, age, sex, and census tract identification. Additionally, adolescents will be asked to self-report age, sex, race/ethnicity, and school achievement level ("Mostly…As, Bs, Cs, Ds/Fs").
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Organ Donation Knowledge and Attitudes [ Time Frame: 1 week ]
    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.
  • Parental Commitment [ Time Frame: 6 months ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • Organ Donation Knowledge and Attitudes [ Time Frame: 1 week ]
    Twenty one item questionnaires will be completed by adolescents in the driver's education classroom at pre-intervention, post-intervention and at 1 week follow-up.
  • Parental Commitment [ Time Frame: 6 months ]
    To assess the commitment of parent/legal guardian to authorize donation consent for study participant, parents of enrolled students will be asked to complete a short questionnaire.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
Official Title  ICMJE Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Organ Donor Registration
  • Organ Donation Education
Intervention  ICMJE
  • Behavioral: Organ Donation Education: Testimonial Messaging
    The testimonial messaging video intervention will be shown
  • Behavioral: Organ Donation Education: Informational Messaging
    The informational messaging video intervention will be shown
  • Behavioral: Organ Donation Education: Blended Messaging
    The blended messaging video intervention will be shown
Study Arms  ICMJE
  • Experimental: Testimonial Messaging
    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: Behavioral: Organ Donation Education: Testimonial Messaging
  • Experimental: Informational Messaging
    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.
    Intervention: Behavioral: Organ Donation Education: Informational Messaging
  • Experimental: Blended Messaging
    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: Behavioral: Organ Donation Education: Blended Messaging
Publications * Rodrigue JR, Boger M, DuBay D, Fleishman A. Increasing Organ Donor Designation Rates in Adolescents: A Cluster Randomized Trial. Am J Public Health. 2019 Sep;109(9):1273-1279. doi: 10.2105/AJPH.2019.305178. Epub 2019 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2019)
611
Original Actual Enrollment  ICMJE
 (submitted: January 5, 2017)
548
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Criteria for Classrooms:

Classroom eligibility criteria included: (a) driver education conducted in English, and (b) instructor agreement not to provide or discuss donation information beyond the study video.

Criteria for Adolescent Participants:

Inclusion Criteria:

  • Enrolled in driving school class
  • English speaking
  • Adolescent assent
  • Parental permission to participate

Exclusion Criteria:

  • Prior participation in a driver's education class in which organ donation education was provided
  • Parent permission form not signed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03013816
Other Study ID Numbers  ICMJE 2015P000063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party James Rodrigue, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Rodrigue, PhD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP