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.
1 other identifier
interventional
1,440
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 3, 2016
CompletedFirst Posted
Study publicly available on registry
February 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMay 15, 2018
May 1, 2018
3.1 years
February 3, 2016
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Immediate Registrations
Enrollment number in the the NY State Organ Donor Registry
1 Day
Secondary Outcomes (4)
Number of Confirmed Registrations
1 Day
Number of participants that viewed "How To Register" Video
1 Day
Accepted Information Score
1 Day
Organ Donation Beliefs (ODBI) Survey Score
1 Day
Other Outcomes (1)
Participant Demographics
1 Day
Study Arms (3)
Control Group
ACTIVE COMPARATORParticipant will watch an educational video produced in partnership with the community of black men including customers, employers and owners of BOBs.
Targeted Intervention
ACTIVE COMPARATORParticipants 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.
Tailored Intervention
ACTIVE COMPARATORParticipants will watch videos with content individualized to participant's pre-intervention ODBI scores representing their organ donation beliefs
Interventions
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.
Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +7 more criteria
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Wall, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2016
First Posted
February 8, 2016
Study Start
February 1, 2015
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
May 15, 2018
Record last verified: 2018-05