Peer Navigation + Kidney Transplant Fast Track for Improving Access to Kidney Transplants in Minority Populations
(AKT-MP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of New Mexico
Disqualifiers: Children, Waitlisted, Prior transplant, Incarcerated, Pregnant, Infection, Cancer, Cognitive impairment
No Placebo Group
Trial Summary
What is the purpose of this trial?Hispanic/Latino (HL) and American Indian (AI) patients are more likely than whites to have kidney failure, but less likely to complete transplant evaluation or receive a kidney transplant (KT), the best treatment for kidney failure. Using comparative effectiveness research methods, we will conduct a pragmatic randomized trial to compare the efficacy and cost- effectiveness of two approaches to help HL and AI patients overcome barriers to completing transplant evaluation and receiving a KT: a streamlined KT evaluation process and a peer-assisted evaluation program; and, we will determine best practices to assist other transplant centers in implementing the better program. Findings from this work may help reduce disparities in transplant evaluation and KT.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for improving access to kidney transplants in minority populations?
Research shows that using patient navigators, who guide patients through the transplant process, can help minority and low-income patients complete the necessary steps to get on the kidney transplant waiting list, improving their access to transplants.
12345How is the Peer Navigation + Kidney Transplant Fast Track treatment different from other treatments for improving access to kidney transplants?
This treatment is unique because it combines a fast-track process for kidney transplant evaluation with peer navigation, where patients receive guidance from someone who has experienced the transplant process themselves. This approach specifically aims to help minority populations overcome barriers to accessing kidney transplants, which is not typically addressed by standard treatments.
12346Eligibility Criteria
This trial is for adults over 18 with kidney disease, specifically Hispanic/Latino and American Indian patients at the University of New Mexico. They must be mentally competent and not currently waitlisted at another center or have had a previous kidney transplant. Pregnant women, children under 18, incarcerated individuals, those with recent non-skin cancer or cognitive impairments are excluded.Inclusion Criteria
I am 18 years old or older.
I am mentally capable of making my own decisions.
Undergoing kidney transplant evaluation at the University of New Mexico
Exclusion Criteria
I am under 18 years old.
I have had a kidney transplant.
Pregnant women
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo either the Kidney Transplant Fast Track (KTFT) or Peer Navigator (PN) intervention to facilitate kidney transplant evaluation
1 year
Follow-up
Participants are monitored for quality of life and ambivalence towards kidney transplant using PROMIS Scale and Decisional Conflict Scale
1 year
Participant Groups
The study compares two methods to help overcome barriers to getting a kidney transplant: a streamlined evaluation process (KTFT) and peer-assisted support (PN). Participants will be randomly assigned to one of these approaches to see which is more effective and cost-efficient in aiding them through the transplant evaluation process.
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
PN
Group II: Arm 1Experimental Treatment1 Intervention
KTFT
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of New MexicoAlbuquerque, NM
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Who Is Running the Clinical Trial?
University of New MexicoLead Sponsor
University of PittsburghCollaborator
University of Massachusetts, AmherstCollaborator
Case Western Reserve UniversityCollaborator
References
Transplant Center Patient Navigator and Access to Transplantation among High-Risk Population: A Randomized, Controlled Trial. [2023]Barriers exist in access to kidney transplantation, where minority and patients with low socioeconomic status are less likely to complete transplant evaluation. The purpose of this study was to examine the effectiveness of a transplant center-based patient navigator in helping patients at high risk of dropping out of the transplant evaluation process access the kidney transplant waiting list.
The Kidney Transplant Equity Index: Improving Racial and Ethnic Minority Access to Transplantation. [2022]To develop a scalable metric which quantifies kidney transplant (KT) centers' performance providing equitable access to KT for minority patients, based on the individualized prelisting prevalence of end-stage renal disease (ESRD).
Multilevel Intervention to Improve Racial Equity in Access to Kidney Transplant. [2023]African Americans (AAs) have reduced access to kidney transplant (KTX). Our center undertook a multilevel quality improvement endeavor to address KTX access barriers, focused on vulnerable populations. This program included dialysis center patient/staff education, embedding telehealth services across South Carolina, partnering with community providers to facilitate testing/procedures, and increased use of high-risk donors.
Kidney transplant program waitlisting rate as a metric to assess transplant access. [2023]Kidney transplant program performance in the United States is commonly measured by posttransplant outcomes. Inclusion of pretransplant measures could provide a more comprehensive assessment of transplant program performance and necessary information for patient decision-making. In this study, we propose a new metric, the waitlisting rate, defined as the ratio of patients who are waitlisted in a center relative to the person-years referred for evaluation to a program. Furthermore, we standardize the waitlisting rate relative to the state average in Georgia, North Carolina, and South Carolina. The new metric was used as a proof-of-concept to assess transplant-program access compared to the existing transplant rate metric. The study cohorts were defined by linking 2017 United States Renal Data System (USRDS) data with transplant-program referral data from the Southeastern United States between January 1, 2012 and December 31, 2016. Waitlisting rate varied across the 9 Southeastern transplant programs, ranging from 10 to 22 events per 100 patient-years, whereas the program-specific waitlisting rate ratio ranged between 0.76 and 1.33. Program-specific waitlisting rate ratio was uncorrelated with the transplant rate ratio (r = -.15, 95% CI, -0.83 to 0.57). Findings warrant collection of national data on early transplant steps, such as referral, for a more comprehensive assessment of transplant program performance and pretransplant access.
Prominent impact of community risk factors on kidney transplant candidate processes and outcomes. [2023]Numerous factors impact patients' health beyond traditional clinical characteristics. We evaluated the association of risk factors in kidney transplant patients' communities with outcomes prior to transplantation. The primary exposure variable was a community risk score (range 0-40) derived from multiple databases and defined by factors including prevalence of comorbidities, access and quality of healthcare, self-reported physical and mental health and socioeconomic status for each U.S. county. We merged data with the Scientific Registry of Transplant Recipients (SRTR) and utilized risk-adjusted models to evaluate effects of community risk for adult candidates listed 2004-2010 (n = 209 198). Patients in highest risk communities were associated with increased mortality (adjusted hazard ratio [AHR] = 1.22, 1.16-1.28), decreased likelihood of living donor transplantation (adjusted odds ratio [AOR] = 0.90, 0.85-0.94), increased waitlist removal for health deterioration (AHR = 1.36, 1.22-1.51), decreased likelihood of preemptive listing (AOR = 0.85, 0.81-0.88), increased likelihood of inactive listing (AOR = 1.49, 1.43-1.55) and increased likelihood of listing for expanded criteria donor kidneys (AHR = 1.19, 1.15-1.24). Associations persisted with adjustment for rural-urban location; furthermore the independent effects of rural-urban location were largely eliminated with adjustment for community risk. Average community risk varied widely by region and transplant center (median = 21, range 5-37). Community risks are powerful factors associated with processes of care and outcomes for transplant candidates and may be important considerations for developing effective interventions and measuring quality of care of transplant centers.
Understanding and overcoming barriers to living kidney donation among racial and ethnic minorities in the United States. [2022]In the United States, racial-ethnic minorities experience disproportionately high rates of ESRD, but they are substantially less likely to receive living donor kidney transplants (LDKT) compared with their majority counterparts. Minorities may encounter barriers to LDKT at several steps along the path to receiving it, including consideration, pursuit, completion of LDKT, and the post-LDKT experience. These barriers operate at different levels related to potential recipients and donors, health care providers, health system structures, and communities. In this review, we present a conceptual framework describing various barriers that minorities face along the path to receiving LDKT. We also highlight promising recent and current initiatives to address these barriers, as well as gaps in initiatives, which may guide future interventions to reduce racial-ethnic disparities in LDKT.