RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education

Not Applicable

Completed

• Conditions: Organ Donation
• Interventions: Behavioral: Control ending - Uplifting; Behavioral: Unresolved Ending; Behavioral: Negative Consequences Ending

• Registration Number: NCT02836301
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-21
• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Primary Completion: 2017-07-15
• Study Completion: 2017-12-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1440

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Documentary-Uplifting	Control ending - Uplifting	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.
Documentary-Unresolved	Unresolved Ending	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.
Testimonials-Uplifting	Control ending - Uplifting	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.
Testimonials-Negative	Negative Consequences Ending	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.
Testimonials-Unresolved	Unresolved Ending	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.
Documentary-Negative	Negative Consequences Ending	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.

Primary Outcome Measures

Name	Time	Method
RA Assisted and Observed Immediate Registration	1 Day

Secondary Outcome Measures

Name	Time	Method
Confirmed Registration NYS DOH aggregate data by video group	1 Day
Emotional State (PANAS-CAT) Questionnaire	1 Day
Number pf participants who viewed "How To Register" Video	1 Day	RA assisted / observed
Number of participants who accepted Information/ Registry Forms	1 Day
Organ Donation Beliefs (ODBI) Questionnaire	1 Day

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States