RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education

Organ Donation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836301
• Other study ID #: 16-00454
• Status: Completed
• Phase: N/A
• Start date: May 21, 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: November 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1440
• Est. completion date: December 1, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Organ Donation

Intervention

Behavioral:
• Control ending - Uplifting
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
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
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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RA Assisted and Observed Immediate Registration		1 Day
Secondary	Confirmed Registration NYS DOH aggregate data by video group		1 Day
Secondary	Number pf participants who viewed "How To Register" Video	RA assisted / observed	1 Day
Secondary	Number of participants who accepted Information/ Registry Forms		1 Day
Secondary	Organ Donation Beliefs (ODBI) Questionnaire		1 Day
Secondary	Emotional State (PANAS-CAT) Questionnaire		1 Day