System Interventions to Achieve Early and Equitable Kidney Transplants (STEPS): Protocol for STEPS, a randomized comparative effectiveness clinical trial

Abstract

The System Interventions to Achieve Early and Equitable Kidney Transplants Study (STEPS) is an ongoing pragmatic clinical trial investigating the effectiveness of an equitable and patient-centered approach to kidney care on equitable access to early kidney transplants for individuals with chronic kidney disease not on dialysis. The STEPS intervention combines active electronic health record surveillance to equitably identify all potentially eligible kidney transplant candidates in three health systems ('STEPS Surveillance') with a 'STEPS Outreach Program' (comprised of equity-conscious patient-centered transplant social worker and transplant coordinator outreach and navigation activities). Identified eligible participants are randomly assigned to receive either (a) Augmented Usual Kidney Care (routine care plus electronic surveillance and best practice alerts), or (b) the STEPS Health System Surveillance and Outreach Intervention plus Augmented Usual Kidney Care to improve access to kidney transplants overall as well as among Black and rural residing individuals. STEPS recruited all planned 1168 participants from March 2022 to March 2024. Outcomes will quantify differences between the study arms in progress toward and completion of kidney transplant evaluations, assessed via medical records, and patient-reported outcomes. Registration of clinical trials This study is registered at ClinicalTrials.gov under the identifier NCT05014256.