Clinical trial NCT05014256: System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
Official title: System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Kidney transplant
Living donor kidney transplant
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Northwell Health
name: Geisinger Clinic
name: University of Mississippi Medical Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Patient-Centered Outcomes Research Institute
First posted: 2021-08-20
Enrollment: 1168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health system reported completion of transplant evaluation
timeFrame: 18 months
Secondary outcomes:
measure: Live donor inquires to transplant center
timeFrame: 6 months
measure: Live donor inquires to transplant center
timeFrame: 12 months
measure: Live donor inquires to transplant center
timeFrame: 18 months
measure: Live kidney donor transplants
timeFrame: 6 months
measure: Live kidney donor transplants
timeFrame: 12 months
measure: Live kidney donor transplants
timeFrame: 18 months
measure: Placement on deceased kidney donor waitlist
timeFrame: 6 months
measure: Placement on deceased kidney donor waitlist
timeFrame: 12 months
measure: Placement on deceased kidney donor waitlist
timeFrame: 18 months
measure: Deceased kidney donor transplants
timeFrame: 6 months
measure: Deceased kidney donor transplants
timeFrame: 12 months
measure: Deceased kidney donor transplants
timeFrame: 18 months
measure: Health system reported initiation of transplant evaluation
timeFrame: 18 months
measure: Patient reported physician discussions
timeFrame: baseline
measure: Patient reported physician discussions
timeFrame: 6 months
measure: Patient reported physician discussions
timeFrame: 12 months
measure: Patient reported physician discussions
timeFrame: 18 months
measure: Patient reported family discussions
timeFrame: baseline
measure: Patient reported family discussions
timeFrame: 6 months
measure: Patient reported family discussions
timeFrame: 12 months
measure: Patient reported family discussions
timeFrame: 18 months
measure: Patient reported initiation of transplant evaluation
timeFrame: baseline
measure: Patient reported initiation of transplant evaluation
timeFrame: 6 months
measure: Patient reported initiation of transplant evaluation
timeFrame: 12 months
measure: Patient reported initiation of transplant evaluation
timeFrame: 18 months
measure: Patient reported completion of transplant evaluation
timeFrame: baseline
measure: Patient reported completion of transplant evaluation
timeFrame: 6 months
measure: Patient reported completion of transplant evaluation
timeFrame: 12 months
measure: Patient reported completion of transplant evaluation
timeFrame: 18 months
measure: Patient reported identification of a living donor
timeFrame: baseline
measure: Patient reported identification of a living donor
timeFrame: 6 months
measure: Patient reported identification of a living donor
timeFrame: 12 months
measure: Patient reported identification of a living donor
timeFrame: 18 months
measure: Patient reported kidney transplant knowledge
timeFrame: baseline
measure: Patient reported kidney transplant knowledge
timeFrame: 6 months
measure: Patient reported kidney transplant knowledge
timeFrame: 12 months
measure: Patient reported kidney transplant knowledge
timeFrame: 18 months
measure: Patient reported empowerment
timeFrame: Baseline
measure: Patient reported empowerment
timeFrame: 6 months
measure: Patient reported empowerment
timeFrame: 12 months
measure: Patient reported empowerment
timeFrame: 18 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ebony Boulware, M.D.
role: PRINCIPAL_INVESTIGATOR
References: