RCT Comparing Tailored Versus Targeted Organ Donation Video Education

Community Based Research to Improve Organ Donor Registration Among Black Men - Aim 2 Randomized Trial Comparing Tailored Versus Targeted Videos.

The primary purpose of this 3-phase mixed methods design study is to investigate how presenting content at varying levels of audience specificity (generic, targeted, and tailored) influences organ donor registration behavior among black men using video-based educational programming produced and distributed in partnership with our network of Black Owned Barbershops (BOBs). Investigators have completed a development phase using digital video interviewing to both derive and provide culturally specific content for the videos. This phase of this investigation is a 3 arm randomized control trial (RCT) phase, in which customers will be randomized to receive the generic, targeted, or tailored video programming delivered with iPads, after which an immediate organ donation opportunity will be offered through registration online or with a mailed in application. The final phase of this investigation will be a failure analysis whereby we will interview a subset of participants who registered or failed to register one month after their educational session to ascertain how the programming impacted their decision (Aim 3 - the subject of a future IRB application).

Study Overview

• Status: Completed
• Conditions: Organ Transplants
• Intervention / Treatment: Behavioral: Control Group; Behavioral: Targeted Intervention; Behavioral: Tailored Intervention

• Study Type: Interventional
• Enrollment (Actual): 1440
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Black men who visit BOBs
• Participants whose primary language is English
• Participants who reside locally in NYC for at least four weeks (28 days) in a year

Exclusion Criteria:

• Women are excluded from this study, as it is focused on black men who visit BOBs, who are among the most in need for transplants, and least likely to register as organ donors.
• Women are excluded from this study, as it is focused on black men who visit BOBs, who are among the most in need for transplants, and least likely to register as organ donors.
• Persons not self-reporting being a black male are excluded. Including other minority groups would preclude conducting this research given its budget and time constraints.
• Children under 18 years old are excluded from this research.
• 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 self report to be registered in the New York State Organ Donor Registry.
• 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 previously are enrolled in this randomized controlled trial. Women are excluded from this study, as it is focused on black men who visit BOBs, who are among the most in need for transplants, and least likely to register as organ donors.
• Persons not self-reporting being a black male are excluded. Including other minority groups would preclude conducting this research given its budget and time constraints.
• Children under 18 years old are excluded from this research.
• 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 self report to be registered in the New York State Organ Donor Registry.
• 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 previously are enrolled in this randomized controlled trial. Persons not self-reporting being a black male are excluded. Including other minority groups would preclude conducting this research given its budget and time constraints.
• Children under 18 years old are excluded from this research.
• 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 self report to be registered in the New York State Organ Donor Registry.
• 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 previously are enrolled in this randomized controlled trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participant will watch an educational video produced in partnership with the community of black men including customers, employers and owners of BOBs.	Behavioral: Control Group; Generic Video about organ donation
Active Comparator: Targeted Intervention; Participants will watch an educational video produced in partnership with the community of black men including customers, employees, and owners of BOBs. Video production was informed by entertainment education models and produced with experts including an Academy Award winning filmmaker.	Behavioral: Targeted Intervention; an educational video produced in partnership with the community of black men including customers, employees, and owners of BOBs. Video production was informed by entertainment education models and produced with experts including an Academy Award winning filmmaker.
Active Comparator: Tailored Intervention; Participants will watch videos with content individualized to participant's pre-intervention ODBI scores representing their organ donation beliefs	Behavioral: Tailored Intervention; Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Immediate Registrations	Enrollment number in the the NY State Organ Donor Registry	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Confirmed Registrations	Post Intervention NY State Department of Health aggregate data by video group	1 Day
Number of participants that viewed "How To Register" Video	Post Intervention research assistant assisted / observed	1 Day
Accepted Information Score	Post Intervention RA assisted / observed	1 Day
Organ Donation Beliefs (ODBI) Survey Score	Pre-Intervention iPad Survey	1 Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Demographics	Age, education, religion, sex, race	1 Day

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Stephen Wall, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: transplants; organ transplant; barber shops; organ donor registration
• Other Study ID Numbers: 14-02109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No