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Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Organ Donor Registration Organ Donation Education Behavioral: Organ Donation Education: Testimonial Messaging Behavioral: Organ Donation Education: Informational Messaging Behavioral: Organ Donation Education: Blended Messaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 611 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
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.
Behavioral: Organ Donation Education: Testimonial Messaging
The testimonial messaging video intervention will be shown

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.
Behavioral: Organ Donation Education: Informational Messaging
The informational messaging video intervention will be shown

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.
Behavioral: Organ Donation Education: Blended Messaging
The blended messaging video intervention will be shown




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013816


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: James Rodrigue, PhD Beth Israel Deaconess Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Rodrigue, Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03013816    
Other Study ID Numbers: 2015P000063
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No