A Culturally Targeted Transplant Program

ESRD Clinical Trial

— HKTP  

Official title:

A Culturally Targeted Transplant Program to Increase Live Donation in Hispanics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276390
• Other study ID #: 1R01DK104876-01
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: September 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11836
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• ESRD

Intervention

Behavioral:
• Hispanic Kidney Transplant Program (HKTP)
The HKTP entails culturally targeted education in Spanish about transplantation, outreach to dialysis patients by bicultural health care providers.

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas
United States	University of Colorado Denver	Denver	Colorado
United States	Houston Methodist Hospital	Houston	Texas
United States	Mayo Clinic Arizon	Phoenix	Arizona

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Gordon EJ, Romo E, Amórtegui 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	satisfaction with culturally competent care	A center-level variable. The CAHPS survey questionnaire will be used. A mean level of satisfaction will be prospectively comparing routine care with culturally competent care.	in year 1-2 and year 4.5
Primary	Ratio of Hispanic to non-Hispanic white LDKTs	A center-level variable. This is a metric of disparity	Post-intervention exposure up to 3.5 years
Secondary	Number of Hispanic living kidney donors	A center-level variable. Exposure to the HKTP is expected to increase the number of Hispanic living kidney donors	Post-intervention exposure up to 3.5 years
Secondary	number of Hispanic ESRD patients added to the waiting list	A center-level variable.	Post-intervention exposure up to 3.5 years
Secondary	number of Hispanic potential donors per potential recipient	A center-level variable.	Post-intervention exposure up to 3.5 years