Improving Access to Renal Transplantation for Underserved Black Communities

Northwestern University

Overview

The goal of this clinical trial is to learn whether the African American Transplant Access Program can be successfully replicated at another large kidney transplant program. The main questions it aims to answer are: Does the AATAP intervention increase the number of Black patients who are listed for kidney transplant? Does the AATAP intervention have an effect on Black patient self-efficacy and trust in care team? Researchers will compare kidney transplant listing status after 12 months of patients in the AATAP intervention to usual care patients to see if the AATAP program increases the number of patients listed for transplant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Conditions

Kidney Transplant ESRD (End Stage Renal Disease)

Interventions

AATAP interventionBEHAVIORAL

AATAP is a program created to address the barriers that Black patients face when accessing transplantation. AATAP providers resources in cultural congruency, trust, psychosocial support, and health literacy to provide patients with the individualized support needed to access the kidney transplant waitlist

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * self-identify as Black or African American; * 18 to 75 years of age * have an eGFR \< 20 or End Stage Renal Disease Diagnosis; * screen positive for AATAP via the screener (for poor health literacy or poor medical adherence or psychosocial concerns); * medically eligible to begin transplant evaluation process determined by transplant team Exclusion Criteria: * other racial groups * participants who have previously received a transplant; * pregnant women; * participants who screen negative on the screener; * children less than 18 years old

Locations (1)

Tampa General Hospital

Tampa, Florida, United States

Outcomes

Primary Outcomes

Listing status for each Arm by month 12

Listing (active or inactive) status by month 12

Time frame: 12 months from time of enrollment

Secondary Outcomes

Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale

Scoring/T-Score Metric: The T-score metric is standardized with a mean of 50 and a standard deviation (SD) of 10. This means a T-score of 50 represents the average score of the reference population, and each 10-point deviation represents one standard deviation above or below the mean. Minimum and Maximum Values: The T-score typically ranges from 20 to 80, though this can vary slightly depending on the specific population and scoring method used. Interpretation: Higher T-scores indicate better health outcomes, while lower T-scores indicate worse health outcomes.

Time frame: at enrollment and at 12 months after enrollment

Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)

Scoring: The PKDSMS uses an average score on a five-point Likert scale, where respondents rate their self-management abilities. Minimum and Maximum Values: The scale ranges from 1 to 5, with 1 indicating low self-efficacy and 5 indicating high self-efficacy. Interpretation: Higher scores indicate better self-management and higher confidence in managing kidney dialysis.

Time frame: at enrollment and at 12 months after enrollment

trust in care received by transplant team using Adapted Trust in Physicians Scale

Scoring: This scale typically uses a five-point Likert format, where respondents rate their level of agreement with various statements about their trust in their physicians. The response options range from "strongly disagree" to "strongly agree". Minimum and Maximum Values: The scale ranges from 1 to 5, with 1 indicating low trust and 5 indicating high trust. Interpretation: Higher scores indicate greater trust in the transplant team, while lower scores indicate less trust.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.