Peer Navigation + Kidney Transplant Fast Track for Improving Access to Kidney Transplants in Minority Populations

(AKT-MP Trial)

Overseen By Nila S Judd, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Children, Waitlisted, Prior transplant, Incarcerated, Pregnant, Infection, Cancer, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

398 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

How 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. ^{1 2 3 4 6}

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.

Research Team

Larissa Myaskovsky, PhD

Principal Investigator

University of New Mexico

Eligibility 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 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

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

Treatment Details

Interventions

• Kidney Transplant Fast Track (KTFT)
• Peer Navigation (PN)

Trial Overview 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.

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

PN

Group II: Arm 1 Experimental Treatment 1 Intervention

KTFT

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Findings from Research

A randomized controlled trial involving 401 patients showed that a transplant center-based patient navigator did not significantly increase overall waitlisting rates for kidney transplants (32% for intervention vs. 26% for control) but had a notable impact after 500 days, where intervention patients were 3.3 times more likely to be waitlisted.

The navigator also led to a higher number of living donor inquiries (18% vs. 10% in control), indicating that while the immediate effects on waitlisting were limited, the intervention may encourage more patients to consider living donation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplant Center Patient Navigator and Access to Transplantation among High-Risk Population: A Randomized, Controlled Trial. Basu, M., Petgrave-Nelson, L., Smith, KD., et al.[2023]

The Kidney Transplant Equity Index (KTEI) is a new metric that measures how well kidney transplant centers provide access to transplants for minority patients, revealing significant disparities in transplant practices across 249 centers from 2013 to 2018.

High KTEI centers not only transplanted more minority patients but also showed improved patient survival rates, indicating that equitable access to transplants can be achieved without compromising outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Kidney Transplant Equity Index: Improving Racial and Ethnic Minority Access to Transplantation. Delman, AM., Turner, KM., Silski, LS., et al.[2022]

A multilevel quality improvement program significantly improved access to kidney transplants (KTX) for African Americans (AAs) in South Carolina, as evidenced by increased equity in evaluations and waitlisting for transplants from 2017 to 2021.

The Kidney Transplant Equity Index (KTEI) showed notable improvements, with the KTEI for initiated evaluations rising from 0.89 in 2017 to 1.00 in 2021, indicating a reduction in disparities in access to KTX for AAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel Intervention to Improve Racial Equity in Access to Kidney Transplant. Taber, DJ., Su, Z., Gebregziabher, M., et al.[2023]

The study introduces a new metric called the waitlisting rate, which measures the number of patients waitlisted for kidney transplants relative to those referred for evaluation, providing a more comprehensive view of transplant program performance.

Analysis of data from 2012 to 2016 across nine Southeastern transplant programs revealed significant variability in waitlisting rates, indicating that this new metric could highlight disparities in access to transplant programs that are not captured by traditional transplant rate metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kidney transplant program waitlisting rate as a metric to assess transplant access. Paul, S., Melanson, T., Mohan, S., et al.[2023]

Patients from high-risk communities (with a community risk score of 0-40) showed a 22% increased risk of mortality and were less likely to receive living donor transplants, indicating that community factors significantly impact kidney transplant outcomes.

The study analyzed data from 209,198 adult candidates listed for transplantation between 2004-2010, revealing that community risk influences not only waitlist dynamics but also the likelihood of receiving preemptive listings and the type of donor kidneys available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prominent impact of community risk factors on kidney transplant candidate processes and outcomes. Schold, JD., Heaphy, EL., Buccini, LD., et al.[2023]

Racial-ethnic minorities in the U.S. face significant barriers to receiving living donor kidney transplants (LDKT), resulting in lower rates of transplantation compared to majority populations.

The review outlines a conceptual framework of these barriers, which include issues related to potential recipients and donors, healthcare providers, health system structures, and community factors, while also highlighting current initiatives aimed at addressing these disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding and overcoming barriers to living kidney donation among racial and ethnic minorities in the United States. Purnell, TS., Hall, YN., Boulware, LE.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transplant Center Patient Navigator and Access to Transplantation among High-Risk Population: A Randomized, Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Kidney Transplant Equity Index: Improving Racial and Ethnic Minority Access to Transplantation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Multilevel Intervention to Improve Racial Equity in Access to Kidney Transplant. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Kidney transplant program waitlisting rate as a metric to assess transplant access. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Prominent impact of community risk factors on kidney transplant candidate processes and outcomes. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Understanding and overcoming barriers to living kidney donation among racial and ethnic minorities in the United States. [2022]