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Completed

NCT Number: NCT02836301

RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education

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.

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Key information

Conditions

Organ Donation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Control ending - Uplifting

Behavioral

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 Ending

Behavioral

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 Ending

Behavioral

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

Primary outcomes

  1. RA Assisted and Observed Immediate Registration

    Time frame: 1 Day

Secondary outcomes

  1. Confirmed Registration NYS DOH aggregate data by video group

    Time frame: 1 Day

  2. Number pf participants who viewed "How To Register" Video

    Time frame: 1 Day

    RA assisted / observed

  3. Number of participants who accepted Information/ Registry Forms

    Time frame: 1 Day

  4. Organ Donation Beliefs (ODBI) Questionnaire

    Time frame: 1 Day

  5. Emotional State (PANAS-CAT) Questionnaire

    Time frame: 1 Day

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Optimizing Educational Video Designs to Improve Minority Organ Donor Registration - Aim 2 Randomized Trial Comparing Testimonials Versus Documentary Videos

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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