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Completed

NCT Number: NCT05014256

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STEPS Health System Outreach intervention

Behavioral

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

Primary outcomes

  1. Health system reported completion of transplant evaluation

    Time frame: 18 months

    Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports

Secondary outcomes

  1. Live donor inquires to transplant center

    Time frame: 6 months, 12 months, 18 months

    the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire

  2. Live kidney donor transplants

    Time frame: 6 months, 12 months, 18 months

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

  3. Placement on deceased kidney donor waitlist

    Time frame: 6 months, 12 months, 18 months

    The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS

  4. Deceased kidney donor transplants

    Time frame: 6 months, 12 months, 18 months

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

  5. Health system reported initiation of transplant evaluation

    Time frame: 18 months

    Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports

  6. Patient reported physician discussions

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

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

  7. Patient reported family discussions

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

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

  8. Patient reported initiation of transplant evaluation

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

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

  9. Patient reported completion of transplant evaluation

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

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

  10. Patient reported identification of a living donor

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

    Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire

  11. Patient reported kidney transplant knowledge

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

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

  12. Patient reported empowerment

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

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2021
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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