PdD: Health Promoters and Organ Donation

Sponsor

Temple University (Other)

Overall Status

Completed

CT.gov ID

NCT04007419

Collaborator

(none)

621

Enrollment

Location

Arm

43.8

Actual Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Organ Donation Donor Designation/Registration	Behavioral: Health Promoters and Organ Donation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

621 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Promotoras de Donación: Leveraging Community Health Workers to Increase Donor Registration of Older Hispanics

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Apr 27, 2020

Actual Study Completion Date :

Apr 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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. Other Names: Promotoras de Donación (PdD)

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Other Names:

Promotoras de Donación (PdD)

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Donation intentions [3 months]
A single, 4-point Likert-type item will agreement with the following statement: I plan to register as an organ donor in the next month (1-strongly disagree/4-strongly agree). The two categories representing agreement and disagreement, respectively, will be collapsed to create a dichotomous variable indicating intentions to register (1-yes/0-no).
Support for organ donation [3 months]
We will capture participants' general support for organ donation using a single 5-point Likert type item. The question will ask respondents to indicate the extent to which they support organ donation (1-not at all/5-totally).
Perceptions of the Promotoras de Donación eLearning module [3 months]
A series of 10, 4-point Likert-type questions will ascertain perceptions of the web-based eLearning module, including organization, length, realism, and interest in the material covered. A single 5-point Likert-type item will capture respondents' rating of the overall quality of the module (1-poor/5-excellent). Finally, two open-ended questions will ask respondents to indicate their most and least liked aspects of the module.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.