Organ DonationNCT02836301
RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education
A study testing Negative Consequences Ending and Unresolved Ending in people with Organ Donation, run by NYU Langone Health at 1 site in United States.
Trial summary
Investigators will evaluate organ donation educational videos with a 2x3 single blinded Randomized Control Trial (RCT) in partnership with our 26 Latino Owned Barbershops (LOBs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Organ Donation
- What is being tested?
- Negative Consequences Ending and Unresolved Ending
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2015to 1 Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dominican and Puerto Rican Latinos.
- Participants who pefer to speak Spanish.
- Participants who reside locally in NYC, New Jersey, or Connecticut, (tri-state area) for at least four weeks (28 days) in a year.
- Participants able to understand the verbal consent process.
Who cannot join
- Persons who are visually impaired and are unable to watch the videos.
- Persons who are hearing impaired and are unable to hear the audio on the videos.
- Persons who are cognitively impaired and thus are unable to provide consent to register for organ donation by signing the New York State Organ Donor Registry application.
- Persons who self-report to be registered in the New York State Organ Donor Registry.
- Persons who previously are enrolled in this randomized controlled trial.
- Persons psychologically unfit or who refuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Optimizing Educational Video Designs to Improve Minority Organ Donor Registration - Aim 2 Randomized Trial Comparing Testimonials Versus Documentary Videos
Investigators will evaluate organ donation educational videos with a 2x3 single blinded Randomized Control Trial (RCT) in partnership with our 26 Latino Owned Barbershops (LOBs). The testimonial video about Uncontrolled Donation after Circulatory Determination of Death (uDCDD) with an uplifting ending will serve as control. Experimental videos may include live uDCDD footage, differing endings, or combinations. Video production will be informed by the entertainment education model and produced with experts including an Academy Award winning filmmaker. The primary outcome is whether participants immediately enroll in the NY State Organ Donor Registry (either online or by our RA mailing in the official form with prepaid postage). Investigators hypothesize that each video will induce differences in registration compared to the control and that there is an interaction effect with video genre and story outcome.
- Conditions
- Organ Donation
- Being tested
- Control ending - Uplifting, Negative Consequences Ending, Unresolved Ending
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control ending - UpliftingBehavioural
The control ending is emotionally uplifting. In this video, the decedent previously registered as an organ donor through online registration and discussed his decision with family. The scene cuts to the family affirming the deceased's wish. In the next scene, the donor family and recipient meet for the first time, ending with a plea from both parties for viewers to register for donation.
Negative Consequences EndingBehavioural
A sad ending where the decedent did not register or discuss their position with family; family is asked to consider donation as an option, but they do not agree. The patient with kidney failure misses the window of opportunity, and the final scene is of both families grieving at their respective family members' grave plots…a missed opportunity.
Unresolved EndingBehavioural
In this ending, the team checks for registration status, and while searching, the scene cuts to physicians discussing the death with family and whether they might consider preservation and organ donation. The video then cuts to the potential recipient and family hoping for a kidney transplant before it is too late. The story ends without resolution, leaving viewers to contemplate how they might respond in the same situation
| Study group | Role | What they receive |
|---|---|---|
| Testimonials-Uplifting | Active comparator | 2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. Receives: Behavioral: Control ending - Uplifting |
| Testimonials-Negative | Active comparator | 2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. Receives: Behavioral: Negative Consequences Ending |
| Testimonials-Unresolved | Active comparator | 2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. Receives: Behavioral: Unresolved Ending |
| Documentary-Uplifting | Experimental | 2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. Receives: Behavioral: Control ending - Uplifting |
| Documentary-Negative | Experimental | 2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. Receives: Behavioral: Negative Consequences Ending |
| Documentary-Unresolved | Experimental | 2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. Receives: Behavioral: Unresolved Ending |
What is being measured
The primary outcome is the main question the study is designed to answer.
RA Assisted and Observed Immediate Registration
Measured: 1 Day
Secondary outcomes (5)
Confirmed Registration NYS DOH aggregate data by video group
Measured: 1 Day
Number pf participants who viewed "How To Register" Video
RA assisted / observed
Measured: 1 Day
Number of participants who accepted Information/ Registry Forms
Measured: 1 Day
Organ Donation Beliefs (ODBI) Questionnaire
Measured: 1 Day
Emotional State (PANAS-CAT) Questionnaire
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start21 May 2015
- Primary completion15 Jul 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organ DonationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Wall, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836301
- Sponsor's protocol ID
- 16-00454
- Status last verified
- Nov 2019
- First submitted
- 14 Jul 2016
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wall SP, Castillo P, Shuchat Shaw F, Norman E, Martinez-Lopez N, Lopez-Rios M, Paulino H, Homer B, Plass JL, Ravenell JE. Including Medical Footage and Emotional Content in Organ Donation Educational Videos for Latinx Viewers. Health Educ Behav. 2022 Jun;49(3):424-436. doi: 10.1177/10901981211022240. Epub 2021 Jul 12.
PubMed 34253089
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Educational Video Designs to Improve Minority Organ Donor Registration - Aim 2 Randomized Trial Comparing Testimonials Versus Documentary Videos
- ClinicalTrials.gov ID
- NCT02836301
- Acronym / sponsor ID
- 16-00454
- Conditions
- Organ Donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 21 May 2015 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 19 Jul 2016 (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.
Investigators will evaluate organ donation educational videos with a 2x3 single blinded Randomized Control Trial (RCT) in partnership with our 26 Latino Owned Barbershops (LOBs). The testimonial video about Uncontrolled Donation after Circulatory Determination of Death (uDCDD) with an uplifting ending will serve as control. Experimental videos may include live uDCDD footage, differing endings, or combinations. Video production will be informed by the entertainment education model and produced with experts including an Academy Award winning filmmaker. The primary outcome is whether participants immediately enroll in the NY State Organ Donor Registry (either online or by our RA mailing in the official form with prepaid postage). Investigators hypothesize that each video will induce differences in registration compared to the control and that there is an interaction effect with video genre and story outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Testimonials-Uplifting | Active comparator | Behavioral: Control ending - Uplifting2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. |
| Testimonials-Negative | Active comparator | Behavioral: Negative Consequences Ending2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. |
| Testimonials-Unresolved | Active comparator | Behavioral: Unresolved Ending2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. |
| Documentary-Uplifting | Experimental | Behavioral: Control ending - Uplifting2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. |
| Documentary-Negative | Experimental | Behavioral: Negative Consequences Ending2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. |
| Documentary-Unresolved | Experimental | Behavioral: Unresolved Ending2x3 matrix for the RCT comparing the control genre of only testimonials (G0) versus the experimental genre (G1) of a documentary with live footage along with the testimonials. The story ending (E) will serve as the cofactor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dominican and Puerto Rican Latinos.
- Participants who pefer to speak Spanish.
- Participants who reside locally in NYC, New Jersey, or Connecticut, (tri-state area) for at least four weeks (28 days) in a year.
- Participants able to understand the verbal consent process.
Key exclusion criteria (6 listed)
- Persons who are visually impaired and are unable to watch the videos.
- Persons who are hearing impaired and are unable to hear the audio on the videos.
- Persons who are cognitively impaired and thus are unable to provide consent to register for organ donation by signing the New York State Organ Donor Registry application.
- Persons who self-report to be registered in the New York State Organ Donor Registry.
- Persons who previously are enrolled in this randomized controlled trial.
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 |
|---|---|---|
| Control ending - UpliftingThe control ending is emotionally uplifting. In this video, the decedent previously registered as an organ donor through online registration and discussed his decision with family. The scene cuts to the family affirming the deceased's wish. In the next scene, the donor family and recipient meet for the first time, ending with a plea from both parties for viewers to register for donation. | Behavioural | Documentary-Uplifting, Testimonials-Uplifting |
| Negative Consequences EndingA sad ending where the decedent did not register or discuss their position with family; family is asked to consider donation as an option, but they do not agree. The patient with kidney failure misses the window of opportunity, and the final scene is of both families grieving at their respective family members' grave plots…a missed opportunity. | Behavioural | Documentary-Negative, Testimonials-Negative |
| Unresolved EndingIn this ending, the team checks for registration status, and while searching, the scene cuts to physicians discussing the death with family and whether they might consider preservation and organ donation. The video then cuts to the potential recipient and family hoping for a kidney transplant before it is too late. The story ends without resolution, leaving viewers to contemplate how they might respond in the same situation | Behavioural | Documentary-Unresolved, Testimonials-Unresolved |
Primary outcome
RA Assisted and Observed Immediate Registration
Time frame: 1 Day
5 secondary outcomes
Confirmed Registration NYS DOH aggregate data by video group
Time frame: 1 Day
Number pf participants who viewed "How To Register" Video
Time frame: 1 Day
Number of participants who accepted Information/ Registry Forms
Time frame: 1 Day
Organ Donation Beliefs (ODBI) Questionnaire
Time frame: 1 Day
Emotional State (PANAS-CAT) Questionnaire
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 34253089Wall SP, Castillo P, Shuchat Shaw F, Norman E, Martinez-Lopez N, Lopez-Rios M, Paulino H, Homer B, Plass JL, Ravenell JE. Including Medical Footage and Emotional Content in Organ Donation Educational Videos for Latinx Viewers. Health Educ Behav. 2022 Jun;49(3):424-436. doi: 10.1177/10901981211022240. Epub 2021 Jul 12.
- Individual participant dataSharing planned: Undecided
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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.
Stephen Wall, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Consequences Ending and Unresolved Ending in people with Organ Donation, run by NYU Langone Health 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Nov 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
RA Assisted and Observed Immediate Registration (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836301, which also lists 1 linked publication.
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 22 Nov 2019.