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

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Diseases; Social Determinants of Health
• Intervention / Treatment: Other: Kidney Transplant Fast Track (KTFT); Other: Peer Navigation (PN)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larissa Myaskovsky, PhD; Email: lmyaskovsky@salud.unm.edu
• Study Contact Backup: Name: Nila S. Judd; Phone Number: 5052726144; Email: njudd@salud.unm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KTFT	Other: Kidney Transplant Fast Track (KTFT); 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.
Experimental: PN	Other: Peer Navigation (PN); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Transplant	Time from evaluation initiation to receipt of transplant	Through study completion, an average of 2-3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of transplant received	Living or deceased donor kidney transplant received	Through study completion, an average of 2-3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Quality of Life using the PROMIS Scale v1.2 Global Health	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.	Through study completion, an average of 2-3 years
Satisfaction with service using the Client Satisfaction Questionnaire	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.	Through study completion, an average of 2-3 years

Collaborators and Investigators

• Sponsor: University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Transplant
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: 20-387 Supplement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No