N/A
Completed N=56,332
Disparities in National Kidney Allocation Policy
Kidney Disorders
Source: ClinicalTrials.gov NCT02879812 ↗
Enrolled (actual)
56,332
Serious AEs
—
Results posted
Sep 2020
Primary outcomePrimary: Proportion of Incident Patients Waitlisted — 1.39; 1.33; 1.25; 1.30 adjusted mean proportion of patients
Summary
The purpose of the current study is to test a systems-level approach to disseminate a multicomponent, multilevel intervention consisting of educational materials about transplantation and the new kidney allocation system targeting dialysis facility medical directors, staff, and patients. Roughly 750 dialysis facilities in up to 18 End Stage Renal Disease Network regions across the United States will be randomized to receive intervention materials. The overall goal of the study is to extend the influence of the national allocation policy in reducing disparities in early steps in kidney transplant access.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Incident Patients Waitlisted |
1.39; 1.33; 1.25; 1.30 | — |
| PRIMARY Proportion of Black and White Incident Patients Waitlisted |
0.87; 1.12; 1.07; 1.15; 1.54; 1.42 | — |
| PRIMARY Proportion of Prevalent Patients Waitlisted During the Baseline Period |
2.68; 2.72 | — |
| PRIMARY Proportion of Prevalent Patients Waitlisted During the Post-Intervention Time Period |
2.75; 2.56 | — |
| PRIMARY Proportion of Black and White Prevalent Patients Waitlisted During the Baseline Period |
2.52; 2.71; 2.66; 2.67 | — |
| PRIMARY Proportion of Black and White Prevalent Patients Waitlisted During the Post-Intervention Time Period |
2.78; 2.56; 2.69; 2.51 | — |
| SECONDARY Knowledge About the Kidney Allocation System |
2.31; 2.45; 3.41; 3.07 | — |
| SECONDARY Percentage of Facilities With Increases or No Change/Decreases in Staff Training |
76; 72; 24; 28 | — |
| SECONDARY Percentage of Facilities With Increases or No Change/Decreases in Patient Education |
46; 54; 54; 46 | — |
| SECONDARY Percentage of Facilities With Increases or No Change/Decreases in Intent to Refer Patients for Kidney Transplantation |
27; 23; 73; 77 | — |
Eligibility Criteria
Inclusion Criteria
- Dialysis facilities with at least 25 patients composed of at least 10% African American and 10% Caucasian
Exclusion Criteria
- Dialysis facilities with wait listing rates above the national tertile
Data sourced from ClinicalTrials.gov (NCT02879812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.