Clinical trial NCT02676102: RCT Comparing Tailored Versus Targeted Organ Donation Video Education
Official title: Community Based Research to Improve Organ Donor Registration Among Black Men - Aim 2 Randomized Trial Comparing Tailored Versus Targeted Videos.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Transplants
Keywords: barber shops
organ transplant
transplants
organ donor registration
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 1440
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Immediate Registrations
timeFrame: 1 Day
Secondary outcomes:
measure: Number of Confirmed Registrations
timeFrame: 1 Day
measure: Number of participants that viewed "How To Register" Video
timeFrame: 1 Day
measure: Accepted Information Score
timeFrame: 1 Day
measure: Organ Donation Beliefs (ODBI) Survey Score
timeFrame: 1 Day
Other outcomes:
measure: Participant Demographics
timeFrame: 1 Day
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Stephen Wall, MD
role: PRINCIPAL_INVESTIGATOR
References: