Tissue and Organ ProcurementNCT02585921
Organ Donation Interventions Among High Students
A study testing Video Interventions and Donation Discussion Education in people with Tissue and Organ Procurement and Adolescent Behavior, run by Case Western Reserve University at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 15 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue and Organ Procurement, Adolescent Behavior, Communication
- What is being tested?
- Video Interventions and Donation Discussion Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 872 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Not previously consented to organ donation
- Attending high school or GED-granting school
Who cannot join
- Non-English speaking
- Visually impaired
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: 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.
Read the 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.
- Being tested
- Video Interventions, Donation Discussion Education
- Keywords
- Urban Health
- Medical subject headings
- Adolescent Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video InterventionsBehavioural
Participants will watch 2 5-minute videos and then discuss them as a group.
Donation Discussion EducationBehavioural
Participants will learn techniques for introducing and discussing organ donation with parents and guardians.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Video Interventions; Behavioral: Donation Discussion Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who consent to donate organs
Consent on the electronic donor registry
Measured: 1 month
Secondary outcomes (2)
Proportion of participants who reported having donation discussions with their parents
Proportion of participants who reported having donation discussions with their parents
Measured: 1 month
Proportion of participants' parents who consent to donate organs
Proportion of participants' parents who consent to donate organs
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion31 May 2017
- Study completionFeb 2019
Why it stopped: Enrollment completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue and Organ ProcurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryl Thornton, Case Western Reserve University
- Investigators
- John D Thornton, MD, MPH, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585921
- Sponsor's protocol ID
- 1 R39OT26989-01-00
- Other IDs
- R39OT26989-
- Status last verified
- Dec 2021
- First submitted
- 22 Oct 2015
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining, Expanding, and Evaluating Multiple Evidence-based Organ Donation Interventions
- ClinicalTrials.gov ID
- NCT02585921
- Acronym / sponsor ID
- 1 R39OT26989-01-00
- Keywords
- Urban Health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment completed.
- Enrolment
- 872 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 31 May 2017 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health & Wellness | No intervention | –Following enrollment, participants will learn about health and wellness. |
| Organ Donation Video Education | Experimental | Behavioral: Video InterventionsFollowing recruitment, participants will watch and discuss videos about organ donation. |
| Organ Donation Discussion Education | Experimental | Behavioral: Donation Discussion EducationFollowing recruitment, participants will learn techniques to introduce and discuss the topic of organ donation with parents or guardians. |
| Both Video and Discussion Education | Experimental | Behavioral: Video Interventions, Behavioral: Donation Discussion EducationFollowing 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. |
Who may qualify
- Ages
- 15 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Not previously consented to organ donation
- Attending high school or GED-granting school
Key exclusion criteria (3 listed)
- Non-English speaking
- Visually impaired
- Cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video InterventionsParticipants will watch 2 5-minute videos and then discuss them as a group. | Behavioural | Both Video and Discussion Education, Organ Donation Video Education |
| Donation Discussion EducationParticipants will learn techniques for introducing and discussing organ donation with parents and guardians. | Behavioural | Both Video and Discussion Education, Organ Donation Discussion Education |
Primary outcome
Proportion of participants who consent to donate organs
Time frame: 1 month
Consent on the electronic donor registry
2 secondary outcomes
Proportion of participants who reported having donation discussions with their parents
Time frame: 1 month
Proportion of participants' parents who consent to donate organs
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Enrollment completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Thornton, MD, MPH principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Interventions and Donation Discussion Education in people with Tissue and Organ Procurement and Adolescent Behavior, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who consent to donate organs (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.