NCT03276390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,836

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

4.1 years

First QC Date

September 5, 2017

Last Update Submit

September 30, 2022

Conditions

ESRD

Keywords

health disparitiesliving donation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of Hispanic living kidney donors

    Post-intervention exposure up to 3.5 years

  • number of Hispanic ESRD patients added to the waiting list

    Post-intervention exposure up to 3.5 years

  • number of Hispanic potential donors per potential recipient

    Post-intervention exposure up to 3.5 years

Other Outcomes (1)

  • satisfaction with culturally competent care

    in year 1-2 and year 4.5

Study Arms (2)

Intervention study site

ACTIVE COMPARATOR

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)

No intervention study site

NO INTERVENTION

Exposure to routine transplant evaluation at the two control sites.

Interventions

Hispanic Kidney Transplant Program (HKTP)BEHAVIORAL

The HKTP entails culturally targeted education in Spanish about transplantation, outreach to dialysis patients by bicultural health care providers.

Intervention study site

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic Arizon

Phoenix, Arizona, 85054, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (7)

  • 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.

    PMID: 29769080BACKGROUND

  • 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.

    PMID: 32282660RESULT

  • Gordon EJ, Romo E, Amortegui 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. 2020 Dec;23(6):1450-1465. doi: 10.1111/hex.13124. Epub 2020 Oct 9.

    PMID: 33037746RESULT

  • Gordon EJ, Uriarte JJ, Anderson N, Romo E, Caicedo JC, Shumate M. Implementation and modification of an organizational-level intervention: a prospective analysis. Implement Sci Commun. 2022 Jun 3;3(1):59. doi: 10.1186/s43058-022-00296-0.

    PMID: 35659156DERIVED

  • Gordon EJ, Lee J, Kang R, Caicedo JC. Impact of having potential living donors on ethnic/racial disparities in access to kidney transplantation. Am J Transplant. 2022 Oct;22(10):2433-2442. doi: 10.1111/ajt.17090. Epub 2022 May 24.

    PMID: 35524363DERIVED

  • Gordon EJ, Uriarte JJ, Lee J, Kang R, Shumate M, Ruiz R, Mathur AK, Ladner DP, Caicedo JC. Effectiveness of a culturally competent care intervention in reducing disparities in Hispanic live donor kidney transplantation: A hybrid trial. Am J Transplant. 2022 Feb;22(2):474-488. doi: 10.1111/ajt.16857. Epub 2021 Oct 17.

    PMID: 34559944DERIVED

  • Alhalel N, Francone NO, Salazar AM, Primeaux S, Ruiz R, Caicedo JC, Gordon EJ. Patients' perceptions of a culturally targeted Hispanic Kidney Transplant Program: A mixed methods study. Clin Transplant. 2019 Jun;33(6):e13577. doi: 10.1111/ctr.13577. Epub 2019 May 23.

    PMID: 31034642DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elisa J Gordon, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Juan Carlos J Caicedo, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Two group comparison (intervention vs. control) and pre-post comparison (within each site).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 8, 2017

Study Start

January 18, 2017

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

US(4)