A Culturally Targeted Transplant Program

NCT ID: NCT03276390

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11836 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2021-02-28

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.

Conditions

ESRD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention study site

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.

Group Type: ACTIVE_COMPARATOR

Hispanic Kidney Transplant Program (HKTP)

Intervention Type: BEHAVIORAL

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

No intervention study site

Exposure to routine transplant evaluation at the two control sites.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hispanic Kidney Transplant Program (HKTP)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Baylor Health Care System

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Elisa Gordon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisa J Gordon, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Juan Carlos J Caicedo, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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

Countries

United States

References

Gordon EJ, Lee J, Kang RH, Caicedo JC, Holl JL, Ladner DP, Shumate MD. A complex culturally targeted intervention to reduce Hispanic disparities in living kidney donor transplantation: an effectiveness-implementation hybrid study protocol. BMC Health Serv Res. 2018 May 16;18(1):368. doi: 10.1186/s12913-018-3151-5.

Reference Type: BACKGROUND

PMID: 29769080 (View on PubMed)

Wang A, Caicedo JC, McNatt G, Abecassis M, Gordon EJ. Financial Feasibility Analysis of a Culturally and Linguistically Competent Hispanic Kidney Transplant Program. Transplantation. 2021 Mar 1;105(3):628-636. doi: 10.1097/TP.0000000000003269.

Reference Type: RESULT

PMID: 32282660 (View on PubMed)

Gordon EJ, Romo E, Amortegui D, Rodas A, Anderson N, Uriarte J, McNatt G, Caicedo JC, Ladner DP, Shumate M. Implementing culturally competent transplant care and implications for reducing health disparities: A prospective qualitative study. Health Expect. 2020 Dec;23(6):1450-1465. doi: 10.1111/hex.13124. Epub 2020 Oct 9.

Reference Type: RESULT

PMID: 33037746 (View on PubMed)

Gordon EJ, Uriarte JJ, Anderson N, Romo E, Caicedo JC, Shumate M. Implementation and modification of an organizational-level intervention: a prospective analysis. Implement Sci Commun. 2022 Jun 3;3(1):59. doi: 10.1186/s43058-022-00296-0.

Reference Type: DERIVED

PMID: 35659156 (View on PubMed)

Gordon EJ, Lee J, Kang R, Caicedo JC. Impact of having potential living donors on ethnic/racial disparities in access to kidney transplantation. Am J Transplant. 2022 Oct;22(10):2433-2442. doi: 10.1111/ajt.17090. Epub 2022 May 24.

Reference Type: DERIVED

PMID: 35524363 (View on PubMed)

Gordon EJ, Uriarte JJ, Lee J, Kang R, Shumate M, Ruiz R, Mathur AK, Ladner DP, Caicedo JC. Effectiveness of a culturally competent care intervention in reducing disparities in Hispanic live donor kidney transplantation: A hybrid trial. Am J Transplant. 2022 Feb;22(2):474-488. doi: 10.1111/ajt.16857. Epub 2021 Oct 17.

Reference Type: DERIVED

PMID: 34559944 (View on PubMed)

Alhalel N, Francone NO, Salazar AM, Primeaux S, Ruiz R, Caicedo JC, Gordon EJ. Patients' perceptions of a culturally targeted Hispanic Kidney Transplant Program: A mixed methods study. Clin Transplant. 2019 Jun;33(6):e13577. doi: 10.1111/ctr.13577. Epub 2019 May 23.

Reference Type: DERIVED

PMID: 31034642 (View on PubMed)

Other Identifiers

1R01DK104876-01

Identifier Type: NIH

Identifier Source: org_study_id

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