System Interventions to Achieve Early and Equitable Transplants (STEPS) Study

This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: STEPS Health System Outreach intervention

• Study Type: Interventional
• Enrollment (Actual): 1168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to provide oral informed consent
• Male or female, aged 18 to <=75 years
• Presence of CKD (2 eGFRs <60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10%
• English speaking with adequate ability to hear and understand questions over the phone
• Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

• Male or female, aged <18 or > 75 years
• Non-English speaking
• Lack of ability to hear and comprehend verbal communication.
• Patients on dialysis
• Deceased
• Hospice/palliative care
• Prior kidney transplant
• Currently waitlisted at any transplant center
• Self-reported terminal illness or receipt of hospice services

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STEPS Health System Surveillance and Outreach intervention	Behavioral: STEPS Health System Outreach intervention; STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach
No Intervention: Usual Kidney Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health system reported completion of transplant evaluation	Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health system reported initiation of transplant evaluation	Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports	18 months
Live donor inquires to transplant center	the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire	6 months, 12 months, 18 months
Live kidney donor transplants	The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire	6 months, 12 months, 18 months
Placement on deceased kidney donor waitlist	The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS	6 months, 12 months, 18 months
Deceased kidney donor transplants	The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS	6 months, 12 months, 18 months
Patient reported physician discussions	number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire	baseline, 6 months, 12 months, 18 months
Patient reported family discussions	number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire	baseline, 6 months, 12 months, 18 months
Patient reported initiation of transplant evaluation	Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire	baseline, 6 months, 12 months, 18 months
Patient reported completion of transplant evaluation	Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire	baseline, 6 months, 12 months, 18 months
Patient reported identification of a living donor	Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire	baseline, 6 months, 12 months, 18 months
Patient reported kidney transplant knowledge	Number of questions patients correctly answer measured by patient report in questionnaire	baseline, 6 months, 12 months, 18 months
Patient reported empowerment	Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire.	baseline, 6 months, 12 months, 18 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Patient-Centered Outcomes Research Institute; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwell Health; Geisinger Clinic; University of Mississippi Medical Center
• Investigators: Principal Investigator: Ebony Boulware, M.D., Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Boulware LE, Ephraim PL, Shafi T, Green JA, Browne T, Strigo TS, Peskoe S, Wilson J, Lokhnygina Y, Alkon A, Jackson GL, Ellis MJ, Sudan D, Cameron B, Vaitla PK, Cabacungan A, Brubaker L, Obermiller EL, Diamantidis CJ. System Interventions to Achieve Early and Equitable Kidney Transplants (STEPS): Protocol for STEPS, a randomized comparative effectiveness clinical trial. Contemp Clin Trials. 2025 Jun;153:107911. doi: 10.1016/j.cct.2025.107911. Epub 2025 Apr 6.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2022
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Kidney transplant; Living donor kidney transplant
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: IRB00097407; 7U01DK127918-02 (U.S. NIH Grant/Contract); IHS-2020C1-19350-IC (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No