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A Culturally Targeted Transplant Program (HKTP)

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ClinicalTrials.gov Identifier: NCT03276390
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
Mayo Clinic
Baylor Health Care System
University of Colorado, Denver
The Methodist Hospital System
Information provided by (Responsible Party):
Elisa Gordon, 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.

Condition or disease Intervention/treatment Phase
ESRD Behavioral: Hispanic Kidney Transplant Program (HKTP) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11445 participants
Allocation: Non-Randomized
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 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. number of Hispanic ESRD patients added to the waiting list [ Time Frame: Post-intervention exposure up to 3.5 years ]
    A center-level variable.

  3. number of Hispanic potential donors per potential recipient [ Time Frame: Post-intervention exposure up to 3.5 years ]
    A center-level variable.


Other Outcome Measures:
  1. 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
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:

-


Information from the National Library of Medicine

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


Contacts
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Contact: Elisa J Gordon, PhD 3125035563 e-gordon@northwestern.edu
Contact: Juan Carlos Caicedo, MD 312-695-1405 jcaicedo@nm.org

Locations
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United States, Arizona
Mayo Clinic Arizon Recruiting
Phoenix, Arizona, United States, 85054
Contact: Amit Mathur, MD       Mathur.Amit@mayo.edu   
Contact: Julieta Delgado, BA    480-342-1785    Delgado.julieta@mayo.edu   
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Alexander Wiseman, MD    303-724-4830    alexander.wiseman@ucdenver.edu   
Contact: Karissa Feltrow, BA    (303) 724-8781    Karissa.Fetrow@ucdenver.edu   
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Richard Ruiz, MD    817-922-4652    Richard.Ruiz@BSWHealth.org   
Contact: Alice Salazar, BA    214-820-2766    Alice.Salazar@BSWHealth.org   
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ahmed O Gaber, MD       AOGaber@houstonmethodist.org   
Contact: Joy Nolte, RD    713-441-6314    jvnolte@houstonmethodist.org   
Sponsors and Collaborators
Northwestern University
Mayo Clinic
Baylor Health Care System
University of Colorado, Denver
The Methodist Hospital System
Investigators
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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):
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Responsible Party: Elisa Gordon, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03276390     History of Changes
Other Study ID Numbers: 1R01DK104876-01 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Because this is not a randomized clinical trial, the decision was not required as per the NIH grant submission process. Thus, the co-PIs still need to discuss and decide. Additionally, the protocol and other materials will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elisa Gordon, Northwestern University:
health disparities
living donation