Access to Kidney Transplantation in Minority Populations (AKT-MP)
Primary Purpose
Kidney Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kidney Transplant Fast Track (KTFT)
Peer Navigation (PN)
Sponsored by
About this trial
This is an interventional supportive care trial for Kidney Diseases focused on measuring Transplant
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
Sites / Locations
- University of New MexicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
KTFT
PN
Outcomes
Primary Outcome Measures
Rate of KT evaluation completion
Completion of evaluation for KT and placement on the transplant waiting list.
Secondary Outcome Measures
KT ambivalence
KT ambivalence will be assessed with the Decisional Conflict Scale, with questions rating from strongly agree to strongly disagree.
Patient Reported Quality of Life
We will use the PROMIS Scale v1.2 Global Health measure to assess quality of life (QOL), which includes items relevant to patients with kidney disease, including overall health, physical limitations, work, pain, energy, and emotional problems.
Full Information
NCT ID
NCT04615819
First Posted
August 7, 2020
Last Updated
December 8, 2022
Sponsor
University of New Mexico
Collaborators
Case Western Reserve University, University of Massachusetts, Amherst, University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT04615819
Brief Title
Access to Kidney Transplantation in Minority Populations
Acronym
AKT-MP
Official Title
Access to Kidney Transplantation in Minority Populations (AKT-MP)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
Case Western Reserve University, University of Massachusetts, Amherst, University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
Transplant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
398 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
KTFT
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
PN
Intervention Type
Other
Intervention Name(s)
Kidney Transplant Fast Track (KTFT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Peer Navigation (PN)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of KT evaluation completion
Description
Completion of evaluation for KT and placement on the transplant waiting list.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
KT ambivalence
Description
KT ambivalence will be assessed with the Decisional Conflict Scale, with questions rating from strongly agree to strongly disagree.
Time Frame
Through study completion, an average of 1 year
Title
Patient Reported Quality of Life
Description
We will use the PROMIS Scale v1.2 Global Health measure to assess quality of life (QOL), which includes items relevant to patients with kidney disease, including overall health, physical limitations, work, pain, energy, and emotional problems.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nila S Judd, BA
Phone
5052726144
Email
njudd@salud.unm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa Myaskovsky, PhD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larissa Myaskovsky, PhD
Email
lmyaskovsky@salud.unm.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Access to Kidney Transplantation in Minority Populations
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