How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes
Primary Purpose
Kidney Diseases, Social Determinants of Health
Status
Withdrawn
Phase
Not Applicable
Locations
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:
- Inclusion across the lifespan - 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 or undergoing evaluation 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
KTFT
PN
Arm Description
Outcomes
Primary Outcome Measures
Time to Transplant
Time from evaluation initiation to receipt of transplant
Secondary Outcome Measures
Type of transplant received
Living or deceased donor kidney transplant received
Full Information
NCT ID
NCT05597982
First Posted
October 20, 2022
Last Updated
July 31, 2023
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT05597982
Brief Title
How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes
Official Title
How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI confirmed this study was withdrawn and did not begin locally.
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Our parent award compares two patient-centered methods to facilitate KT evaluation:
kidney transplant fast track (FT), a streamlined KT evaluation process; and peer navigators (PN), a peer assisted evaluation program that incorporates motivational interviewing. This pragmatic randomized trial uses a comparative effectiveness approach to assess whether FT or PN can help patients overcome barriers to transplant listing. The aims of the parent study are to: (1) compare FT and PN to assess improvements in kidney transplant (KT) related outcomes and cost effectiveness; (2) examine how each approach effects changes in cultural/contextual factors, concerns about, and ambivalence to KT; and (3) develop a framework for widespread implementation of either approach. Recent guidelines encourage using PhenX toolkit measures for kidney-disease research and clinical data reporting, but research to date has been limited by cross sectional or retrospective analyses, and incomplete or missing data on key variables, and show limited clinical application or interventions. In addition to the several PhenX individual social determinants of health (SDOH) already collected for the parent award, we propose to add PhenX structural SDOH, including concentrated poverty, food swamp, race/ethnic segregation, and social vulnerability, to our baseline data collection for all 398 patient participants under the proposed administrative supplement. Also, we will add a third assessment to determine how and whether the intervention affected post-transplant outcomes. We will follow patients via their medical records through receipt of KT to determine time to receive transplant (from time evaluation started), and type of transplant received (living or deceased donor KT). At ~6 months post-KT, participants will complete a third interview to assess KT patient reported outcomes, including health-related quality of life (QOL) and satisfaction with service.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Social Determinants of Health
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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KTFT
Arm Type
Experimental
Arm Title
PN
Arm Type
Experimental
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
Time to Transplant
Description
Time from evaluation initiation to receipt of transplant
Time Frame
Through study completion, an average of 2-3 years
Secondary Outcome Measure Information:
Title
Type of transplant received
Description
Living or deceased donor kidney transplant received
Time Frame
Through study completion, an average of 2-3 years
Other Pre-specified Outcome Measures:
Title
Patient Reported Quality of Life using the PROMIS Scale v1.2 Global Health
Description
We will use Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health measure to assess quality of life (QOL). It includes items relevant to patients with kidney disease, including overall health, physical limitations, work, pain, energy, and emotional problems. The measure is brief, based on extensive item banks, has been validated in general and CKD populations, and is favored by the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group.
Time Frame
Through study completion, an average of 2-3 years
Title
Satisfaction with service using the Client Satisfaction Questionnaire
Description
Assesses patient reported satisfaction with services received by the transplant clinic team using the Client Satisfaction Questionnaire by Attkisson and colleagues. The measure is brief, and has been used in many clinical populations, along with our previous research CKD and kidney transplant studies.
Time Frame
Through study completion, an average of 2-3 years
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:
Inclusion across the lifespan - 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 or undergoing evaluation 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
12. IPD Sharing Statement
Plan to Share IPD
No
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How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes
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