N/A N=56,332 Randomized Health Services Research

Disparities in National Kidney Allocation Policy

Kidney Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02879812 ↗

Enrolled (actual)

56,332

Serious AEs

—

Results posted

Sep 2020

Primary outcome: Primary: Proportion of Incident Patients Waitlisted — 1.39; 1.33; 1.25; 1.30 adjusted mean proportion of patients

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Performance Feedback Reports (Other); Educational Video for Staff (Other); Educational Video for Patients (Other); Educational Webinar (Other); Standard Care (Other); United Network for Organ Sharing (UNOS) Pamphlet (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Aug 2019

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	—

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.

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

View full record on ClinicalTrials.gov →

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.