Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
621 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-09-01
Study Completion Date
2020-04-27
Brief Summary
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Older Hispanics (age 50+ years) are disproportionately overrepresented on the transplant waitlist, but underrepresented as deceased donors and transplant recipients. This application proposes the formative research to design and empirically test an eLearning module, Promotoras de Donación, to train community health workers (i.e., Promotoras), who already provide culturally and linguistically sensitive services to their communities, to discuss and promote organ donation with older Hispanic women in 3 geographically distinct communities across the U.S. The proposed intervention leverages the established and evidence-based Promotoras program to increase rates of donor designation within Hispanic communities across the U.S. and reduce disparities in access to transplantation for this population.
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Detailed Description
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Despite consistently positive attitudes toward organ donation, increasing the number of registered organ donors in the US continues to challenge the professional and research communities. Improving rates of donor designation among ethnic minorities is of particular importance given the need to match donated organs to recipients on blood type and human leukocyte antigens - the best matches are found when the donor and recipient are of the same ethnic background. In Hispanic communities, lay health educators (i.e., Promotoras) are trained to promote behaviors that empower and enable constituents to prevent disease, and increase control over and improve their health. In partnership with leadership of four Promotoras organizations in geographically diverse areas of the U.S. (PA, IL, TX) representing the largest subgroups of the Hispanic population, this pilot study proposes to leverage the preexisting network of lay health educators to advocate for organ donation and promote donor registration (first person consent) among female Hispanics over the age of 50. Specifically, this study will collect the formative data needed to design an educational and behavioral communication eLearning module for Promotoras and test the impact of the training on Promotoras' knowledge of organ donation, confidence discussing and promoting donor registration, and efficacy increasing rates of donor registration among mature and older Hispanic women. Focus group interviews with Hispanic women and Promotoras will identify the information needs and concerns about organ donation registration of these two groups; interviews with lay educators will also gauge interactivity preferences as well as content and design issues for the resulting web-based training (Aim 1). These data will be used to develop an eLearning module to educate Promotoras about organ donation and train them to discuss donation and promote donor registration (Aim 2). A brief quantitative survey will assess the impact of the module on knowledge of organ donation and confidence (communication self-efficacy) discussing donation and promoting donor designation. We will evaluate Promotoras' efficacy promoting organ donation by assessing the number of Hispanic women age 50 and over who register as posthumous organ donors as a proportion of all women attending small group sessions led by trained Promotoras (Aim 3). If effective, the eLearning module could easily be disseminated nationally to train Promotoras to discuss and promote organ donation. Ultimately, this 'train-the-trainer' study has the potential to increase rates of donor registration among Hispanic communities in the U.S. and help to reduce disparities in access to transplantation for this population.
Conditions
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Organ Donation
Donor Designation/Registration
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
The study includes focus group interviews with mature Latina and Promotora to inform the development of a web-based educational and communication intervention, as well as an evaluation of the intervention using a nonrandomized, quasi-experimental pragmatic design, pre-post only with no control group to test the impact of the eLearning module on lay health educators' knowledge of organ donation and confidence holding discussions about and promoting organ donation. Additionally, we will examine the impact of the Promotoras de Donación intervention, which will engage trained lay health educators to lead small group sessions with mature Latina, on the women's attitudes about organ donation and donor registration, and rates of donor registration.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Single Arm
The Promotoras de Donación eLearning module will be launched and 40 participating lay health educators trained. Access to the module will be provided via a link to the website embedded in an announcement email. To assess the impact of the Promotoras de Donación eLearning module on lay health educators' knowledge of organ donation and the need for Hispanic donors, and confidence communicating about donation and promoting the act of donor registration, participating lay health educators will complete a brief online survey upon enrollment (pre) and after completing the module (post). Then, trained lay health educators will hold at least 2 small group sessions with mature Latina (6-8 per session); in all, 80 sessions are anticipated with 480 to 640 mature Latina. Participating mature Latina will complete anonymous paper-pencil surveys before and after each session to assess changes in attitudes toward organ donation and donor registration and intent to register as posthumous organ donors.
Group Type
EXPERIMENTAL
Health Promoters and Organ Donation
Intervention Type
BEHAVIORAL
Promotoras de Donación is a highly engaging and interactive online learning experience, that accommodates multiple learning styles by incorporating a variety of pedagogic approaches. The module consists of two components: a didactic educational component and a skills-based communication component. The didactic component provides basic information about organ donation and transplantation and the need for donors in the Hispanic community, and addresses concerns about donation commonly held by older Latina. The skills-based component provides instruction on the key communication skills needed to effectively engage small groups in discussions about organ donation. This component is intended to build communication self-efficacy or confidence opening the discussion about donation, addressing concerns raised by mature and older women participating in the small group sessions, and promoting the act of donor registration using persuasive, but non-coercive language.
Interventions
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Health Promoters and Organ Donation
Promotoras de Donación is a highly engaging and interactive online learning experience, that accommodates multiple learning styles by incorporating a variety of pedagogic approaches. The module consists of two components: a didactic educational component and a skills-based communication component. The didactic component provides basic information about organ donation and transplantation and the need for donors in the Hispanic community, and addresses concerns about donation commonly held by older Latina. The skills-based component provides instruction on the key communication skills needed to effectively engage small groups in discussions about organ donation. This component is intended to build communication self-efficacy or confidence opening the discussion about donation, addressing concerns raised by mature and older women participating in the small group sessions, and promoting the act of donor registration using persuasive, but non-coercive language.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Promotoras de Donación (PdD)
Eligibility Criteria
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Inclusion Criteria
* Lay health educators (Promotora): Lay health educators must be at least 18 years of age, have completed all required Promotoras training, and have actively worked with the local Hispanic community within 3 months of recruitment.
* Mature Latina: Eligible women must be at least 50 years of age, with no obvious cognitive impairment.
* Mature Latina: Eligible women must be at least 50 years of age, with no obvious cognitive impairment.
Exclusion Criteria
* Lay health educators (Promotora): Untrained lay health educators or those currently in training at their respective organizations will be deemed ineligible, as will individuals who are not actively working as a Promotora at the time of recruitment/enrollment.
* Mature Latina: Hispanic women under the age of 50, or those with obvious cognitive impairment will be deemed ineligible.
* Mature Latina: Hispanic women under the age of 50, or those with obvious cognitive impairment will be deemed ineligible.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Temple University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Heather M Gardiner (Traino), PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Temple University
Locations
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Temple University
Philadelphia, Pennsylvania, United States
Site Status
Countries
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United States
References
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Alolod GP, Gardiner H, Agu C, Turner JL, Kelly PJ, Siminoff LA, Gordon EJ, Norden R, Daly TA, Benitez A, Hernandez I, Guinansaca N, Winther LR, Bergeron CD, Montalvo A, Gonzalez T. A Culturally Targeted eLearning Module on Organ Donation (Promotoras de Donacion): Design and Development. J Med Internet Res. 2020 Jan 13;22(1):e15793. doi: 10.2196/15793.
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Related Links
Access external resources that provide additional context or updates about the study.
https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/
Organ Procurement and Transplantation Network. U.S. Department of Health \& Human Services.
https://www.uniformlaws.org/committees/community-home?CommunityKey=015e18ad-4806-4dff-b011-8e1ebc0d1d0f
Revised Uniform Anatomical Gift Act (2006). Last Revised or Amended in 2009. National Conference of Commissioners of Uniform State Laws
https://donatelife.net/2015-dla-annual-update-released/
Donate Life America. 2015 Annual Update
https://www.organdonor.gov/awareness/materials/50-plus-seniors.html
Health Resources \& Services Administration. Materials for 50+ audiences
https://www.census.gov/newsroom/releases/archives/population/cb12-243.html?cssp=SERP
U.S. Census Bureau. U.S. Census Bureau projections show a slower growing, older, more diverse nation a half century from now
http://factfinder.census.gov
U.S. Census Bureau. American Fact Finder
http://promotores.thinkculturalhealth.hhs.gov
U.S. Department of Health \& Human Services, Office of Minority Health, Think Cultural Health. Promoting Healthy Choices and Community Changes: An E-learning Program for Promotores De Salud
http://www.organdonor.gov
Health Resources \& Services Administration. Donation and transplantation: How does it work?; 2013
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R39OT29878
Identifier Type: -
Identifier Source: org_study_id
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