Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
1 other identifier
interventional
611
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 29, 2016
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 28, 2019
January 1, 2019
3.3 years
December 29, 2016
January 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Organ Donation Registration
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.
6 months
Secondary Outcomes (2)
Organ Donation Knowledge and Attitudes
1 week
Parental Commitment
6 months
Study Arms (3)
Testimonial Messaging
EXPERIMENTALThis 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.
Informational Messaging
EXPERIMENTALThis 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.
Blended Messaging
EXPERIMENTALThis 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.
Interventions
The testimonial messaging video intervention will be shown
The informational messaging video intervention will be shown
The blended messaging video intervention will be shown
Eligibility Criteria
You may qualify if:
- Enrolled in driving school class
- English speaking
- Adolescent assent
- Parental permission to participate
You may not qualify if:
- Prior participation in a driver's education class in which organ donation education was provided
- Parent permission form not signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 31318603DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
James Rodrigue, PhD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 29, 2016
First Posted
January 9, 2017
Study Start
June 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
January 28, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share