Organ Donation Interventions Among High Students

Combining, Expanding, and Evaluating Multiple Evidence-based Organ Donation Interventions

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.

Study Overview

• Status: Terminated
• Conditions: Communication; Adolescent Behavior; Tissue and Organ Procurement
• Intervention / Treatment: Behavioral: Video Interventions; Behavioral: Donation Discussion Education

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.

• Study Type: Interventional
• Enrollment (Actual): 872
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non-English speaking
• Visually impaired
• Cognitively impaired

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Health & Wellness; Following enrollment, participants will learn about health and wellness.
Experimental: Organ Donation Video Education; Following recruitment, participants will watch and discuss videos about organ donation.	Behavioral: Video Interventions; Participants will watch 2 5-minute videos and then discuss them as a group.
Experimental: Organ Donation Discussion Education; Following recruitment, participants will learn techniques to introduce and discuss the topic of organ donation with parents or guardians.	Behavioral: Donation Discussion Education; Participants will learn techniques for introducing and discussing organ donation with parents and guardians.
Experimental: Both Video and Discussion Education; Following recruitment, participants will watch and discuss videos about organ donation and then learn techniques to introduce and discuss the topic of organ donation with parents and guardians.	Behavioral: Video Interventions; Participants will watch 2 5-minute videos and then discuss them as a group.; Behavioral: Donation Discussion Education; Participants will learn techniques for introducing and discussing organ donation with parents and guardians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who consent to donate organs	Consent on the electronic donor registry	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who reported having donation discussions with their parents	Proportion of participants who reported having donation discussions with their parents	1 month
Proportion of participants' parents who consent to donate organs	Proportion of participants' parents who consent to donate organs	1 month

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: John D Thornton, MD, MPH, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 31, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Urban Health
• Other Study ID Numbers: 1 R39OT26989-01-00; R39OT26989- (Other Grant/Funding Number: Health Resources and Services Administration)