An interventional study of Hispanic Kidney Transplant Program (HKTP) in ESRD, sponsored by Northwestern University. Completed at 4 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Northwestern University · Not applicable, Interventional, and Health services research
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.
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:
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.
Exclusion Criteria:
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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.
Behavioral: Hispanic Kidney Transplant Program (HKTP)
Exposure to routine transplant evaluation at the two control sites.
The HKTP entails culturally targeted education in Spanish about transplantation, outreach to dialysis patients by bicultural health care providers.
Ratio of Hispanic to non-Hispanic white LDKTs
A center-level variable. This is a metric of disparity
Time frame: Post-intervention exposure up to 3.5 years
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
Time frame: Post-intervention exposure up to 3.5 years
number of Hispanic ESRD patients added to the waiting list
A center-level variable.
Time frame: Post-intervention exposure up to 3.5 years
number of Hispanic potential donors per potential recipient
A center-level variable.
Time frame: Post-intervention exposure up to 3.5 years
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.
Time frame: in year 1-2 and year 4.5
Plan to share: Undecided
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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