Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Kidney Diseases
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ESKD overcome barriers to transplant listi...

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 ESKD 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 ESKD 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 ESKD 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.

Tracking Information

NCT #
NCT04615819
Collaborators
  • Case Western Reserve University
  • University of Massachusetts, Amherst
  • University of Pittsburgh
Investigators
Principal Investigator: Larissa Myaskovsky, PhD University of New Mexico