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CompletedNCT05014256Updated Oct 2, 2026

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

An interventional study of STEPS Health System Outreach intervention in Chronic Kidney Diseases, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,168
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Kidney Diseases

Keywords

  • Kidney transplant
  • Living donor kidney transplant
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In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's enrollment of 1,168 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,168 participants (actual)

Study arms

  • Experimental
    STEPS Health System Surveillance and Outreach intervention

    Behavioral: STEPS Health System Outreach intervention

  • No intervention
    Usual Kidney Care

Interventions

  • BehavioralSTEPS Health System Outreach intervention

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

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What researchers measure

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

    Time frame: 18 months

Secondary outcomes

  1. 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

    Time frame: 6 months, 12 months, 18 months

  2. Live kidney donor transplants

    The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire

    Time frame: 6 months, 12 months, 18 months

  3. 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

    Time frame: 6 months, 12 months, 18 months

  4. Deceased kidney donor transplants

    The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS

    Time frame: 6 months, 12 months, 18 months

  5. 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

    Time frame: 18 months

  6. Patient reported physician discussions

    number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire

    Time frame: baseline, 6 months, 12 months, 18 months

  7. Patient reported family discussions

    number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire

    Time frame: baseline, 6 months, 12 months, 18 months

  8. Patient reported initiation of transplant evaluation

    Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire

    Time frame: baseline, 6 months, 12 months, 18 months

  9. Patient reported completion of transplant evaluation

    Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire

    Time frame: baseline, 6 months, 12 months, 18 months

  10. 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

    Time frame: baseline, 6 months, 12 months, 18 months

  11. Patient reported kidney transplant knowledge

    Number of questions patients correctly answer measured by patient report in questionnaire

    Time frame: baseline, 6 months, 12 months, 18 months

  12. 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.

    Time frame: baseline, 6 months, 12 months, 18 months

07

Study locations

1 site
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27101, United States
08

References and documents

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. PubMed 40199386 ↗

Study documents

  • Informed consent form · Jan 17, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05014256
Lead sponsor
Wake Forest University Health Sciences
Collaborators
Northwell Health, Geisinger Clinic, University of Mississippi Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Patient-Centered Outcomes Research Institute
Responsible party
Sponsor
First posted
Aug 20, 2021
Start date
Apr 2, 2022
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Oct 2, 2026

Study contacts

Ebony Boulware, M.D.
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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