RCT Comparing Tailored Versus Targeted Organ Donation Video Education

Study Overview
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Brief Summary
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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).

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

Conditions
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Organ Transplants

Intervention / Treatment
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* Behavioral: Control Group
* Behavioral: Targeted Intervention
* Behavioral: Tailored Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br>* Generic Video about organ donation<br>|
| Active Comparator: Targeted Intervention<br>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<br>* 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.<br>|
| Active Comparator: Tailored Intervention<br>Participants will watch videos with content individualized to participant's pre-intervention ODBI scores representing their organ donation beliefs | Behavioral: Tailored Intervention<br>* Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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barber shops, organ transplant, transplants, organ donor registration