System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
Overview
- Phase
- Not Applicable
- Intervention
- STEPS Health System Outreach intervention
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 1168
- Locations
- 1
- Primary Endpoint
- Health system reported completion of transplant evaluation
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
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
- •Hospice/palliative care
- •Prior kidney transplant
- •Currently waitlisted at any transplant center
- •Self-reported terminal illness or receipt of hospice services
Arms & Interventions
STEPS Health System Surveillance and Outreach intervention
Intervention: STEPS Health System Outreach intervention
Usual Kidney Care
Outcomes
Primary Outcomes
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
- Live donor inquires to transplant center(6 months, 12 months, 18 months)
- Live kidney donor transplants(6 months, 12 months, 18 months)
- Placement on deceased kidney donor waitlist(6 months, 12 months, 18 months)
- Deceased kidney donor transplants(6 months, 12 months, 18 months)
- Health system reported initiation of transplant evaluation(18 months)
- Patient reported physician discussions(baseline, 6 months, 12 months, 18 months)
- Patient reported family discussions(baseline, 6 months, 12 months, 18 months)
- Patient reported initiation of transplant evaluation(baseline, 6 months, 12 months, 18 months)
- Patient reported completion of transplant evaluation(baseline, 6 months, 12 months, 18 months)
- Patient reported identification of a living donor(baseline, 6 months, 12 months, 18 months)
- Patient reported kidney transplant knowledge(baseline, 6 months, 12 months, 18 months)
- Patient reported empowerment(baseline, 6 months, 12 months, 18 months)