Boulware L Ebony, Ephraim Patti L, Shafi Tariq, Green Jamie A, Browne Teri, Strigo Tara S, Peskoe Sarah, Wilson Jonathan, Lokhnygina Yuliya, Alkon Aviel, Jackson George L, Ellis Matthew J, Sudan Debra, Cameron Blake, Vaitla Pradeep K, Cabacungan Ashley, Brubaker Lauren, Obermiller Emily L, Diamantidis Clarissa J
Wake Forest University School of Medicine, 525 Vine Street, Winston-Salem, NC 27101, USA.
Feinstein Institutes for Medical Research, Northwell Health, 350 Community Dr, Manhasset, NY 11030, USA.
Contemp Clin Trials. 2025 Jun;153:107911. doi: 10.1016/j.cct.2025.107911. Epub 2025 Apr 6.
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.
实现早期公平肾移植的系统干预研究（STEPS）是一项正在进行的实用临床试验，旨在调查一种公平且以患者为中心的肾脏护理方法对于尚未接受透析的慢性肾脏病患者公平获得早期肾移植的有效性。STEPS干预措施包括积极的电子健康记录监测，以公平地识别三个医疗系统中所有潜在符合条件的肾移植候选人（“STEPS监测”），以及一个“STEPS外展项目”（由具有公平意识的以患者为中心的移植社会工作者以及移植协调员的外展和导航活动组成）。确定符合条件的参与者被随机分配接受以下两种治疗之一：（a）强化常规肾脏护理（常规护理加上电子监测和最佳实践警报），或（b）STEPS医疗系统监测和外展干预措施加上强化常规肾脏护理，以改善总体以及黑人和农村居民获得肾移植的机会。STEPS在2022年3月至2024年3月期间招募了所有计划的1168名参与者。研究结果将通过病历评估和患者报告的结果来量化研究组在肾移植评估进展和完成情况方面的差异。临床试验注册 本研究已在ClinicalTrials.gov上注册，标识符为NCT05014256。
