Health Promoters and Organ Donation (PdD)

April 29, 2020 updated by: Temple University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

621

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Donor registration
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Communication self-efficacy
Time Frame: 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.
3 months
Knowledge of organ donation
Time Frame: 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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Donation intentions
Time Frame: 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).
3 months
Support for organ donation
Time Frame: 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).
3 months
Perceptions of the Promotoras de Donación eLearning module
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Investigators

  • Principal Investigator: Heather M Gardiner (Traino), PhD, MPH, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

April 27, 2020

Study Completion (ACTUAL)

April 27, 2020

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R39OT29878

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be made available for use by written request to the Principal Investigator. Specifically, focus group and survey data collected from lay health educators and mature Latina will be shared in ways in which participants' privacy and confidentiality are secured. Any identifying information in the data will be redacted before sharing. In an effort to provide further protection from the deductive identification of participants, parties requesting data will be asked to agree to use the data solely for research purposes, to refrain from identifying participants in any manner, to secure the data electronically through encryption and/or password protection, and to return or destroy the data upon completion of the analyses.

IPD Sharing Time Frame

Data from this study will be available after publication of the study's major findings

IPD Sharing Access Criteria

Written request to the Principal Investigator (Heather Gardiner).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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