NCT02585921

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
872

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

October 22, 2015

Last Update Submit

December 31, 2021

Conditions

Tissue and Organ ProcurementAdolescent BehaviorCommunication

Keywords

Urban Health

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants who consent to donate organs

    Consent on the electronic donor registry

    1 month

Secondary Outcomes (2)

  • Proportion of participants who reported having donation discussions with their parents

    1 month

  • Proportion of participants' parents who consent to donate organs

    1 month

Study Arms (4)

Health & Wellness

NO INTERVENTION

Following enrollment, participants will learn about health and wellness.

Organ Donation Video Education

EXPERIMENTAL

Following recruitment, participants will watch and discuss videos about organ donation.

Behavioral: Video Interventions

Organ Donation Discussion Education

EXPERIMENTAL

Following recruitment, participants will learn techniques to introduce and discuss the topic of organ donation with parents or guardians.

Behavioral: Donation Discussion Education

Both Video and Discussion Education

EXPERIMENTAL

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 InterventionsBehavioral: Donation Discussion Education

Interventions

Video InterventionsBEHAVIORAL

Participants will watch 2 5-minute videos and then discuss them as a group.

Both Video and Discussion EducationOrgan Donation Video Education
Donation Discussion EducationBEHAVIORAL

Participants will learn techniques for introducing and discussing organ donation with parents and guardians.

Both Video and Discussion EducationOrgan Donation Discussion Education

Eligibility Criteria

Age15 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Non-English speaking
  • Visually impaired
  • Cognitively impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Adolescent BehaviorCommunication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • John D Thornton, MD, MPH

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 26, 2015

Study Start

October 1, 2015

Primary Completion

May 31, 2017

Study Completion

February 1, 2019

Last Updated

January 14, 2022

Record last verified: 2021-12

Locations

US(1)