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

Wake Forest University (WFU)

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Behavioral: STEPS Health System Outreach intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05014256

IHS-2020C1-19350-IC (Other Grant/Funding Number)

IRB00097407

7U01DK127918-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,168 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,168 participants in 2 patient groups

STEPS Health System Surveillance and Outreach intervention

Experimental group

Treatment:

Behavioral: STEPS Health System Outreach intervention

Usual Kidney Care

No Intervention group