Clinical trial NCT04615819: Access to Kidney Transplantation in Minority Populations
Official title: Access to Kidney Transplantation in Minority Populations (AKT-MP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Diseases
Keywords: Transplant
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: University of Massachusetts, Amherst
name: University of Pittsburgh
First posted: 2020-11-04
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Undergoing kidney transplant evaluation at the University of New Mexico
* Greater than or equal to 18 years of age
* Mentally competent

Exclusion Criteria:

* Children less than 18 years of age are excluded because all research-related measurements are designed for patients over the age of 18. Children less than 18 years of age have dissimilar decision-making authority as a result of their developmental stage and dependency on adult guardians who must make all their transplant-related decisions, as required by all pediatric transplant centers. The proposed study focuses only on adult transplant patients.
* Waitlisted at another transplant center
* Prior kidney transplant
* Incarcerated patients
* Pregnant women
* Active systemic infection
* Non-skin malignancy or melanoma in the past 2 years
* Known cognitive impairment

Primary outcomes:
measure: Rate of KT evaluation completion
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: KT ambivalence
timeFrame: Through study completion, an average of 1 year
measure: Patient Reported Quality of Life
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Larissa Myaskovsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: