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

NCT05014256 | Completed DMC

• 3 other identifiers: IRB000974077U01DK127918-02IHS-2020C1-19350-IC
• Study Type: interventional
• Target: 1,168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Keywords

Kidney transplant; Living donor kidney transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Live donor inquires to transplant center

  6 months, 12 months, 18 months

• Live kidney donor transplants

  6 months, 12 months, 18 months

• Placement on deceased kidney donor waitlist

  6 months, 12 months, 18 months

• Deceased kidney donor transplants

  6 months, 12 months, 18 months

• Health system reported initiation of transplant evaluation

  18 months

Study Arms (2)

STEPS Health System Surveillance and Outreach intervention

EXPERIMENTAL

Behavioral: STEPS Health System Outreach intervention

Usual Kidney Care

NO INTERVENTION

Interventions

STEPS Health System Outreach intervention BEHAVIORAL

STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach

STEPS Health System Surveillance and Outreach intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Northwell Health: collaborator
• Geisinger Clinic: collaborator
• University of Mississippi Medical Center: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27101, United States

Location

Related Publications (1)

• 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.

  PMID: 40199386 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebony Boulware, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: April 2, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)