A Culturally Targeted Transplant Program

Not Applicable

Completed

• Conditions: ESRD
• Interventions: Behavioral: Hispanic Kidney Transplant Program (HKTP)

• Registration Number: NCT03276390
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2017-01-18
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-08
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11836

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention study site	Hispanic Kidney Transplant Program (HKTP)	Exposure to the intervention, which is the Northwestern Medicine (TM) Hispanic Kidney Transplant Program, a culturally targeted program for Hispanic potential recipients for transplant evaluation that is implemented into the 2 study sites. The intervention study site will provide the intervention to its Hispanic patients. The intervention study will will also provide the routine care (control arm) to all other patients. For the purposes of this study, Hispanic potential recipients recruited into the study will be exposed to this intervention. Non-Hispanic Whites recruited into the study will not be exposed to this intervention.

Primary Outcome Measures

Name	Time	Method
Ratio of Hispanic to non-Hispanic white LDKTs	Post-intervention exposure up to 3.5 years	A center-level variable. This is a metric of disparity

Secondary Outcome Measures

Name	Time	Method
number of Hispanic ESRD patients added to the waiting list	Post-intervention exposure up to 3.5 years	A center-level variable.
Number of Hispanic living kidney donors	Post-intervention exposure up to 3.5 years	A center-level variable. Exposure to the HKTP is expected to increase the number of Hispanic living kidney donors
number of Hispanic potential donors per potential recipient	Post-intervention exposure up to 3.5 years	A center-level variable.

Trial Locations

Locations (4)

Mayo Clinic Arizon; 🇺🇸 Phoenix, Arizona, United States

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States