RCT Comparing Tailored Versus Targeted Organ Donation Video Education

NCT ID: NCT02676102

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-03-31

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).

Conditions

Organ Transplants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control Group

Participant will watch an educational video produced in partnership with the community of black men including customers, employers and owners of BOBs.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: BEHAVIORAL

Generic Video about organ donation

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.

Group Type: ACTIVE_COMPARATOR

Targeted Intervention

Intervention Type: BEHAVIORAL

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

Participants will watch videos with content individualized to participant's pre-intervention ODBI scores representing their organ donation beliefs

Group Type: ACTIVE_COMPARATOR

Tailored Intervention

Intervention Type: BEHAVIORAL

Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).

Interventions

Control Group

Generic Video about organ donation

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Tailored Intervention

Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Wall, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

14-02109

Identifier Type: -

Identifier Source: org_study_id