A Culturally Targeted Transplant Program (HKTP)
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|ClinicalTrials.gov Identifier: NCT03276390|
Recruitment Status : Completed
First Posted : September 8, 2017
Last Update Posted : October 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|ESRD||Behavioral: Hispanic Kidney Transplant Program (HKTP)||Not Applicable|
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:
- 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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11836 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two group comparison (intervention vs. control) and pre-post comparison (within each site).|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Culturally Targeted Transplant Program to Increase Live Donation in Hispanics|
|Actual Study Start Date :||January 18, 2017|
|Actual Primary Completion Date :||February 28, 2021|
|Actual Study Completion Date :||February 28, 2021|
Active Comparator: 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.
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.
No Intervention: No intervention study site
Exposure to routine transplant evaluation at the two control sites.
- Ratio of Hispanic to non-Hispanic white LDKTs [ Time Frame: Post-intervention exposure up to 3.5 years ]A center-level variable. This is a metric of disparity
- Number of Hispanic living kidney donors [ Time Frame: 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 ESRD patients added to the waiting list [ Time Frame: Post-intervention exposure up to 3.5 years ]A center-level variable.
- number of Hispanic potential donors per potential recipient [ Time Frame: Post-intervention exposure up to 3.5 years ]A center-level variable.
- satisfaction with culturally competent care [ Time Frame: in year 1-2 and year 4.5 ]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.
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|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276390
|United States, Arizona|
|Mayo Clinic Arizon|
|Phoenix, Arizona, United States, 85054|
|United States, Colorado|
|University of Colorado Denver|
|Denver, Colorado, United States, 80045|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Elisa J Gordon, PhD||Northwestern University|
|Principal Investigator:||Juan Carlos J Caicedo, MD||Northwestern University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Elisa Gordon, Professor, Northwestern University|
|Other Study ID Numbers:||
1R01DK104876-01 ( U.S. NIH Grant/Contract )
|First Posted:||September 8, 2017 Key Record Dates|
|Last Update Posted:||October 3, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|