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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-02

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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STEPS Health System Surveillance and Outreach intervention

Group Type EXPERIMENTAL

STEPS Health System Outreach intervention

Intervention Type BEHAVIORAL

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

Usual Kidney Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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STEPS Health System Outreach intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No