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OpenTrials
Completed

NCT Number: NCT03013816

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Organ Donation Education: Testimonial Messaging

Behavioral

The testimonial messaging video intervention will be shown

Organ Donation Education: Informational Messaging

Behavioral

The informational messaging video intervention will be shown

Organ Donation Education: Blended Messaging

Behavioral

The blended messaging video intervention will be shown

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2017
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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