STEPS Intervention for Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on improving access to kidney transplants for individuals with chronic kidney disease. Researchers aim to ensure equal opportunities for kidney care and transplants, regardless of race. The trial will compare a new program, the STEPS Health System Outreach intervention—which includes additional support from transplant social workers and coordinators—against usual kidney care to determine which approach helps more people receive transplants. Suitable participants are those with chronic kidney disease who are not currently on dialysis, have not had a kidney transplant before, and can understand and communicate in English over the phone. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance kidney transplant access for all.
Do I need to stop taking my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the STEPS Health System Outreach intervention is safe?
Research shows that the STEPS Health System Outreach program, currently under evaluation for its potential to increase kidney transplant access, uses electronic health records and healthcare professional teams. This approach aims to identify individuals needing kidney transplants more equitably. Previous studies have found that healthcare teams managing chronic kidney disease (CKD) can reduce mortality, hospital visits, and kidney health decline. These findings suggest the program might be safe and manageable.
While no specific reports of negative effects from this program exist, using electronic health records and healthcare teams is a common and trusted medical practice. This indicates a level of safety, as these methods have benefited patients in other areas. Prospective participants should discuss any concerns with the research team to understand how these findings might apply to them.12345Why are researchers excited about this trial?
The STEPS Health System Outreach intervention is unique because it focuses on enhancing patient care through a system of surveillance and outreach, rather than introducing a new medication. This approach aims to improve management and outcomes for kidney disease by actively engaging with patients and healthcare providers to ensure timely and coordinated care. Researchers are excited about this method because it could address gaps in patient management that current treatment protocols, like medication and dialysis, might not fully cover. By fostering better communication and proactive care, this intervention has the potential to significantly improve patient outcomes and quality of life.
What evidence suggests that the STEPS Health System Outreach intervention is effective for improving access to kidney transplants?
Research has shown that the STEPS Health System Outreach program, available to participants in this trial, aims to simplify the process for people with chronic kidney disease to receive kidney transplants. Early results suggest that this program identifies patients who may need transplants and guides them through the process. By collaborating with social workers and coordinators, the program emphasizes fairness and meeting patient needs to ensure equal access for all. Initial signs are promising, with an increase in successful kidney transplants. This approach could help close gaps in care and improve outcomes for those with kidney disease.12567
Who Is on the Research Team?
Ebony Boulware, M.D.
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
The STEPS study is for English-speaking adults aged 18 to 75 with chronic kidney disease (CKD), specifically those not on dialysis, without a prior kidney transplant, and not currently waitlisted for one. Participants must be able to hear and understand phone conversations and consent to the study's procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
STEPS Surveillance
A program to identify people who may need a kidney transplant and find people in health systems who may be able to receive kidney transplants early in their care
STEPS Outreach
Transplant social workers and coordinators focus on equality and patient needs to improve access to kidney transplants
Follow-up
Participants are monitored for safety and effectiveness after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- STEPS Health System Outreach intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Duke University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Geisinger Clinic
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Northwell Health
Collaborator
University of Mississippi Medical Center
Collaborator