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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
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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.
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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.
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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.
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Behavioral: Organ Donation Education: Blended Messaging
The blended messaging video intervention will be shown |
- 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.
- 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).

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

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
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | James Rodrigue, PhD | Beth Israel Deaconess Medical Center |
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 |