NCT02836301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

July 14, 2016

Last Update Submit

November 20, 2019

Conditions

Organ Donation

Outcome Measures

Primary Outcomes (1)

  • RA Assisted and Observed Immediate Registration

    1 Day

Secondary Outcomes (5)

  • Confirmed Registration NYS DOH aggregate data by video group

    1 Day

  • Number pf participants who viewed "How To Register" Video

    1 Day

  • Number of participants who accepted Information/ Registry Forms

    1 Day

  • Organ Donation Beliefs (ODBI) Questionnaire

    1 Day

  • Emotional State (PANAS-CAT) Questionnaire

    1 Day

Study Arms (6)

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.

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.

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.

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.

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.

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.

Behavioral: Unresolved Ending

Interventions

Control ending - UpliftingBEHAVIORAL

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.

Documentary-UpliftingTestimonials-Uplifting
Negative Consequences EndingBEHAVIORAL

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.

Documentary-NegativeTestimonials-Negative
Unresolved EndingBEHAVIORAL

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

Documentary-UnresolvedTestimonials-Unresolved

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

    PMID: 34253089DERIVED

Study Officials

  • Stephen Wall, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 19, 2016

Study Start

May 21, 2015

Primary Completion

July 15, 2017

Study Completion

December 1, 2017

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

US(1)