NCT04615819

Access to Kidney Transplantation in Minority Populations

Access to Kidney Transplantation in Minority Populations (AKT-MP)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The AKT-MP study will assess whether Kidney Transplant Fast Track (KTFT), a streamlined KT evaluation process, or peer navigators (PN) who were former KT patients to help patients "navigate" their way through KT evaluation, can help vulnerable patients with kidney failure overcome barriers to transplant listing. After culturally and contextually adapting the two interventions, we will use a comparative effectiveness (CER) approach to conduct a pragmatic randomized trial of 398 kidney failure patients to compare the efficacy and effectiveness of the two approaches in disadvantaged groups at a university-affiliated transplant center with large HL and AI kidney failure patient populations, and we will compare results to historic comparison populations (local and national). We will assess facilitators and barriers to widespread implementation and conduct a cost effectiveness analysis. Although it is expected that KTFT will be more effective than PN, KTFT may also be more costly, requiring significant administrative and clinical changes in the transplant center, which may be impractical to maintain. Further, KTFT may lead to more patient ambivalence because the shortened evaluation period will give them less time to consider their treatment options. Thus, an important aspect of the proposed study is to comparative the effectiveness of the two methods. Ultimately, our study will inform transplant programs faced with disparities in KT about which disparity-reducing intervention to use given their particular needs and resources.

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
OTHER	Kidney Transplant Fast Track (KTFT)	Streamlined KT evaluation involving completion of most or all testing on the same day a patient arrives for their first pre-transplant clinic appointment. Or, a transplant clinic scheduler secures testing within a 4 week period.
OTHER	Peer Navigation (PN)	Uses trained, previous KT recipients who meet weekly to monthly with patient participants to provide tailored information and assistance in completing the necessary steps to proceed to transplant.

Timeline

• Start date: 2022-01-11
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2020-11-04
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States