RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education

November 20, 2019 updated by: NYU Langone Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Testimonials-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.
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.
Active Comparator: Testimonials-Negative
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
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.
Active Comparator: Testimonials-Unresolved
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
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
Experimental: Documentary-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.
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.
Experimental: Documentary-Negative
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
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.
Experimental: Documentary-Unresolved
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RA Assisted and Observed Immediate Registration
Time Frame: 1 Day
1 Day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Stephen Wall, MD, New York University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2015

Primary Completion (Actual)

July 15, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

November 22, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 16-00454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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