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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: James Rodrigue, PhD; Beth Israel Deaconess Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: James Rodrigue, Professor, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03013816
• Other Study ID Numbers: 2015P000063
• First Posted: January 9, 2017
• Last Update Posted: January 28, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No