Clinical trial NCT05597982: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Diseases
Social Determinants of Health
Keywords: Transplant
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 0
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: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Waitlisted or undergoing evaluation at another transplant center
3. Prior kidney transplant
4. Incarcerated patients
5. Pregnant women
6. Active systemic infection
7. Non-skin malignancy or melanoma in the past 2 years
8. Known cognitive impairment

Primary outcomes:
measure: Time to Transplant
timeFrame: Through study completion, an average of 2-3 years
Secondary outcomes:
measure: Type of transplant received
timeFrame: Through study completion, an average of 2-3 years
Other outcomes:
measure: Patient Reported Quality of Life using the PROMIS Scale v1.2 Global Health
timeFrame: Through study completion, an average of 2-3 years
measure: Satisfaction with service using the Client Satisfaction Questionnaire
timeFrame: Through study completion, an average of 2-3 years
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