Health Promoters and Organ Donation

Not Applicable

Completed

• Conditions: Organ Donation; Donor Designation/Registration
• Interventions: Behavioral: Health Promoters and Organ Donation

• Registration Number: NCT04007419
• Lead Sponsor: Temple University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Status Verified: 2020-04
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 621

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Health Promoters and Organ Donation	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.

Primary Outcome Measures

Name	Time	Method
Donor registration	3 months	The proportion of mature Latina attending the trained lay health educator-led small group sessions who also register their intent to become a posthumous organ, tissue and eye donor

Secondary Outcome Measures

Name	Time	Method
Communication self-efficacy	3 months	Lay health educators will be asked to rate their level of confidence managing 10 communication skills relevant to discussing organ donation and promoting donor registration along numerical scales ranging from 0 (not at all confident) to 100 (totally confident). A global self-efficacy score will be obtained by summing the ratings for each item.
Knowledge of organ donation	3 months	A series of 10 true/false questions previously developed and used to assess knowledge of organ donation in a community sample of Hispanic Americans. A global knowledge score will be created as the sum of all correctly answered questions, ranging from 0 to 10.

Trial Locations

Locations (1)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States