Reducing Disparities in Access to Kidney Transplantation Regional Study: A Randomized Trial in the Southeastern United States.

Key points: Declines in referral mirror national trends; however, declines were less for some groups receiving the intervention, warranting long-term follow-up. The findings provide important context for future modification and scale-up of multilevel, multicomponent interventions in dialysis settings.

Background: The Southeastern United States has among the lowest rates of kidney transplantation nationally and has documented racial and socioeconomic disparities in transplant access. We assessed the effectiveness and implementation of a multicomponent intervention aimed at increasing access and reducing disparities in access to early transplant steps in Georgia, North Carolina, and South Carolina.

Methods: The Reducing Disparities in Access to Kidney Transplantation Regional Study randomized 440 dialysis facilities in Georgia, North Carolina, and South Carolina to receive the Reducing Disparities in Access to Kidney Transplantation Regional educational and quality intervention or standard of care in 2018. The primary outcome was a change in dialysis facility-level transplant referral within 1 year of dialysis start after intervention, with secondary outcomes examining changes in evaluation start within 6 months of referral and waitlisting within 1 year of evaluation start. A process evaluation included a postimplementation survey ( N =220) and semistructured interviews of staff ( N =4). Generalized linear mixed-effects models assessed intervention effectiveness overall and in race subgroups.

Results: Among the 25,586 patients with ESKD treated in 440 dialysis facilities, referral rates decreased across both intervention arms 1 year after intervention; however, a greater decrease in referrals was observed among control (11.2% to 9.2%) versus intervention (11.2% to 10.5%) facilities. We observed no significant difference in the likelihood of referral among Black patients in intervention versus control facilities after intervention (adjusted odds ratio, 1.12; 95% confidence interval, 0.94 to 1.33); however, a significant increase in referral was observed among White patients in intervention facilities after intervention (odds ratio, 1.24; 95% confidence interval, 1.02 to 1.51). Interviews highlighted the importance of tailored interventions, federal mandates, and implementation challenges for large pragmatic trials.

Conclusions: Postintervention declines in referral mirror national trends; however, these declines were less for some groups receiving the intervention, warranting long-term follow-up. These findings provide important context for future modification and scale-up of multilevel, multicomponent interventions in dialysis settings.

Clinical trial registry name and registration number: The study protocol is available on ClinicalTrials.gov (identifier: NCT02389387 ).