A Culturally Targeted Transplant Program (HKTP)

September 30, 2022 updated by: Elisa Gordon, Northwestern University

A Culturally Targeted Transplant Program to Increase Live Donation in Hispanics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11836

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizon
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Denver
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-intervention exposure up to 3.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-intervention exposure up to 3.5 years
number of Hispanic ESRD patients added to the waiting list
Time Frame: Post-intervention exposure up to 3.5 years
A center-level variable.
Post-intervention exposure up to 3.5 years
number of Hispanic potential donors per potential recipient
Time Frame: Post-intervention exposure up to 3.5 years
A center-level variable.
Post-intervention exposure up to 3.5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
in year 1-2 and year 4.5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

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

Investigators

  • Principal Investigator: Elisa J Gordon, PhD, Northwestern University
  • Principal Investigator: Juan Carlos J Caicedo, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 18, 2017

Primary Completion (ACTUAL)

February 28, 2021

Study Completion (ACTUAL)

February 28, 2021

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (ACTUAL)

September 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R01DK104876-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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