How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes

NCT05597982 | Withdrawn

• 1 other identifier: 20-387 Supplement
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Diseases; Social Determinants of Health

Keywords

Transplant

Outcome Measures

Primary Outcomes (1)

• Time to Transplant

  Time from evaluation initiation to receipt of transplant

  Through study completion, an average of 2-3 years

Secondary Outcomes (1)

• Type of transplant received

  Through study completion, an average of 2-3 years

Other Outcomes (2)

• Patient Reported Quality of Life using the PROMIS Scale v1.2 Global Health

  Through study completion, an average of 2-3 years

• Satisfaction with service using the Client Satisfaction Questionnaire

  Through study completion, an average of 2-3 years

Study Arms (2)

KTFT

EXPERIMENTAL

Other: Kidney Transplant Fast Track (KTFT)

PN

EXPERIMENTAL

Other: Peer Navigation (PN)

Interventions

Kidney Transplant Fast Track (KTFT) OTHER

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.

KTFT

Peer Navigation (PN) OTHER

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.

PN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 28, 2022
• Study Start: July 31, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share