Clinical trial NCT02836301: RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education
Official title: Optimizing Educational Video Designs to Improve Minority Organ Donor Registration - Aim 2 Randomized Trial Comparing Testimonials Versus Documentary Videos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Donation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.


Eligibility criteria: 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.

Primary outcomes:
measure: RA Assisted and Observed Immediate Registration
timeFrame: 1 Day
Secondary outcomes:
measure: Confirmed Registration NYS DOH aggregate data by video group
timeFrame: 1 Day
measure: Number pf participants who viewed "How To Register" Video
timeFrame: 1 Day
measure: Number of participants who accepted Information/ Registry Forms
timeFrame: 1 Day
measure: Organ Donation Beliefs (ODBI) Questionnaire
timeFrame: 1 Day
measure: Emotional State (PANAS-CAT) Questionnaire
timeFrame: 1 Day
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Stephen Wall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.