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A Culturally Targeted Transplant Program

A Culturally Targeted Transplant Program to Increase Live Donation in Hispanics

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03276390
Acronym
HKTP
Enrollment
11836
Registered
2017-09-08
Start date
2017-01-18
Completion date
2021-02-28
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD

Keywords

health disparities, living donation

Brief summary

Hispanic/Latino patients with end-stage renal disease are disproportionately less likely to get a kidney transplant, and specifically, a living donor kidney transplant (LDKT), compared to non-Hispanic whites. Accordingly, without LDKTs, Hispanics experience longer transplant waiting times, shorter patient and graft survival, and worse quality of life. Cultural beliefs and linguistic barriers contribute to the disparity in LDKTs. The objective of the proposed study is to implement and evaluate Northwestern Medicine's® Hispanic Kidney Transplant Program, a culturally-competent transplant center-based intervention, at two transplant centers serving large Hispanic populations. The proposed study will provide valuable knowledge about the potential to rapidly disseminate the HKTP as a novel approach to increase Hispanic LDKTs nationally.

Detailed description

The shortage of organs for kidney transplantation for patients with end-stage renal disease (ESRD) is magnified in Hispanics/Latin Americans. Hispanics have a disproportionately higher prevalence of ESRD, yet receive fewer kidney transplants compared to non-Hispanic whites. Living donor kidney transplant (LDKT) is the treatment of choice for ESRD as it confers better patient and graft survival, shorter waiting time, and better quality of life than deceased donor kidney transplantation. However, compared to their representation on the waiting list, fewer Hispanics received a LDKT than non-Hispanic whites in 2013: 4% versus 10%. Barriers to LDKT for Hispanics include: lack of knowledge, cultural concerns, and language barriers. The disparity will likely worsen without intervention as Hispanics are the largest and fastest growing minority group in the US. Few available culturally competent interventions have led to increased LDKT rates. Interventions rarely address Hispanic cultural concerns, and there are no published models of transplant center-based only programs. The Chicago Northwestern Medicine's® Hispanic Kidney Transplant Program (HKTP), a culturally and linguistically competent program, has increased Hispanic LDKTs. The mean annual ratio of Hispanic to non-Hispanic white LDKTs grew from 0.20 in 2001-2006 to 0.34 in 2008-2013, a 70% increase (p\<0.001). The objective of this study is to implement and evaluate the HKTP, a culturally-competent transplant center-based intervention, at two transplant centers serving large Hispanic populations (Dallas, TX, and Los Angeles, CA), with Northwestern University serving as the Study Coordinating Center. The pre-post HKTP intervention study will evaluate the effect of the HKTP's key culturally sensitive components (outreach, communication, education) on Hispanic LDKT rates, compared to matched controls. The specific aims are to: 1. Implement the HKTP at two transplant centers by conducting a needs assessment of barriers and using a "learning collaborative" model to deliver HKTP protocols, scripts, and materials. 2. Conduct a pre-post HKTP intervention evaluation with matched controls to assess if the HKTP is associated with an increase in: a) the ratio of Hispanic to non-Hispanic white LDKTs as a function of an absolute increase in Hispanic LDKTs, b) ESRD Hispanic patient additions to the waiting list, c) Hispanic potential donors per potential recipient, and d) Hispanic patients' satisfaction with care. 3. Formatively evaluate the fidelity and innovative adaptations to HKTP's outreach, communication, and education at both study sites to identify effective components of the HTKP, using mixed methods. As an exploratory aim, a budget impact analysis will be conducted to construct a business case for transplant centers and permit estimates of HKTP scalability. The proposed study will provide valuable knowledge about the potential to rapidly disseminate the HKTP as a novel approach to increase Hispanic LDKTs nationally, improve health outcomes for Hispanics, and close the LDKT disparity gap.

Interventions

BEHAVIORALHispanic Kidney Transplant Program (HKTP)

The HKTP entails culturally targeted education in Spanish about transplantation, outreach to dialysis patients by bicultural health care providers.

Sponsors

Northwestern University
Lead SponsorOTHER
Mayo Clinic
CollaboratorOTHER
Baylor Health Care System
CollaboratorOTHER
University of Colorado, Denver
CollaboratorOTHER
The Methodist Hospital Research Institute
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Two group comparison (intervention vs. control) and pre-post comparison (within each site).

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Hispanic or non-Hispanic white potential recipients initiating evaluation for a transplant * age 18 or older * The above potential recipients' potential donors initiating evaluation for living donation

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Ratio of Hispanic to non-Hispanic white LDKTsPost-intervention exposure up to 3.5 yearsA center-level variable. This is a metric of disparity

Secondary

MeasureTime frameDescription
Number of Hispanic living kidney donorsPost-intervention exposure up to 3.5 yearsA center-level variable. Exposure to the HKTP is expected to increase the number of Hispanic living kidney donors
number of Hispanic ESRD patients added to the waiting listPost-intervention exposure up to 3.5 yearsA center-level variable.
number of Hispanic potential donors per potential recipientPost-intervention exposure up to 3.5 yearsA center-level variable.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORElisa J Gordon, PhD

Northwestern University

PRINCIPAL_INVESTIGATORJuan Carlos J Caicedo, MD

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026