Clinical trial NCT02585921: Organ Donation Interventions Among High Students
Official title: Combining, Expanding, and Evaluating Multiple Evidence-based Organ Donation Interventions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tissue and Organ Procurement
Adolescent Behavior
Communication
Keywords: Urban Health
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 872
Sex: ALL
Minimum age (years): 15
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The number of persons actively waiting on the national solid organ waiting list continues to rise while the number donating organs has failed to keep pace. This is a particular problem for some portions of northeastern Ohio where the donation rate is as low as 32%. Adolescents are an important group for organ donation efforts as they have not yet applied for a driver's license and represent the majority of future donors. Yet many organ donation interventions have not targeted adolescents. The investigators propose to utilize existing high school teen summits developed by our Consortium partners to evaluate the effectiveness of existing donation interventions. Together, the investigators will conduct a randomized controlled 2x2 factorial trial to evaluate the independent and combined effects of two donor education interventions on consent for organ donation on the electronic Ohio Donor Registry. One thousand six hundred students over the age of 15.5 years from Cleveland-area high schools will be enrolled.

Detailed description: Over 74,000 people are actively waiting for a solid organ to improve and extend their lives yet each year the number of deceased donors remains less than 11,000.1 Substantial changes are needed to increase the number of donated organs or many persons in need of a transplant will die without receiving one. The major limiting factor to organ donation remains the low consent rate.2 Increasing consent for organ donation will likely increase both the availability of organs and, by extension, increase the duration and quality of life of those waiting.3,4 While most people who consent to organ donation do so while obtaining their driver's licenses at the bureau of motor vehicles,5,6 the bureau of motor vehicles' staff generally do not have the training to provide sufficient information to answer questions regarding donation. As a result, bureau of motor vehicle patrons may not be receiving the information necessary to allay their fears and concerns sufficiently enough to provide informed consent for donation. We have previously demonstrated that adolescents have concerns regarding organ donation that stem from lack of knowledge about the process and from a paucity of discussions regarding organ donation with their parents.7 We and others have also found that efforts to increase consent for organ donation among adolescents must address altruism regarding donation and the positive effects of donation.8,9. We incorporated these findings into the development of a video intervention tailored towards adolescents. In a community-based randomized trial, we found that the video was effective in increasing consent for organ donation.10 This project incorporated the successful aspects of these multiple organ donation interventions to facilitate consent for organ donation among adolescents.

Our consortium partners, the Cleveland branch of the Minority Organ and Tissue Transplant Education Program (Cleveland MOTTEP), Lifebanc (the Organ Procurement Organization for Northeast Ohio), the Cleveland Eye Bank, and the Kidney Foundation of Ohio, had been collaborating to conduct twice yearly organ donation summits for adolescents for almost 10 years. The summits were 1-day meetings of 100 - 150 students from 5 high schools in Cleveland and the surrounding neighborhoods. The goals of the summits were to increase knowledge and awareness of organ and tissue donation and transplantation, as well as to assist in chronic disease prevention. While the summits have become a mainstay in the community, they have been limited in scope, devoid of a uniform curriculum, variable in execution, and have lacked formal evaluation.

The purpose of this study was to expand on the existing high school education summits by creating and implementing a uniform, validated organ donation curriculum based on successful best practices with integration of successful organ donation video interventions and by rigorously evaluating the effect of the individual and combined components. We employed a 2x2 factorial randomized design to explore the independent and combined effects of the interventions.

Eligibility criteria: Inclusion Criteria:

* Not previously consented to organ donation
* Attending high school or GED-granting school

Exclusion Criteria:

* Non-English speaking
* Visually impaired
* Cognitively impaired

Primary outcomes:
measure: Proportion of participants who consent to donate organs
timeFrame: 1 month
Secondary outcomes:
measure: Proportion of participants who reported having donation discussions with their parents
timeFrame: 1 month
measure: Proportion of participants' parents who consent to donate organs
timeFrame: 1 month
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: John D Thornton, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: