Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Treatment for kidney failure, such as dialysis and kidney transplant, can lengthen life. Outcomes are better when patients receive transplants soon after their kidneys start to fail, known as an early transplant. But few patients receive an early kidney transplant. People from Black and rural communities are the least likely to receive early transplants.

To receive an early transplant, patients must complete a transplant assessment. For the assessment, a doctor completes a physical exam and learns the patient’s medical history. The doctor also tells the patient about the benefits and harms of a kidney transplant. But it may be hard for patients to get a transplant assessment. For example, doctors may be slow to refer patients for an assessment. Patients may also lack information on how the transplant assessment works.

In this study, the research team is comparing two ways to help patients with kidney failure complete the transplant assessment and receive an early kidney transplant.

Who can this research help?

Results may help hospital and health system administrators when considering ways to help people with kidney failure receive an early kidney transplant.

What is the research team doing?

The research team is enrolling 1,150 patients who are eligible for an early kidney transplant. Patients are receiving care at one of two health systems in Pennsylvania and North Carolina. The health system in Pennsylvania mainly serves patients who live in rural areas. Almost half of the patients in the North Carolina health system are Black.

The research team is assigning patients by chance to one of two groups. Patients in the first group are receiving a transplant outreach program called STEPS. STEPS has four parts. First, the research team is identifying patients who qualify for a kidney transplant as early as possible. Then, the team is letting patients know that they are eligible for an early transplant and inviting them to the transplant center. The team is also providing information for patients and their families about kidney disease, the kidney transplant process, and ways to overcome barriers to an early transplant. Last, the team is guiding patients through the steps to complete a transplant assessment.

Patients in the second group receive enhanced usual care for kidney disease. In enhanced care, the research team alerts doctors to clinical guidelines. The guidelines recommend that doctors consider early kidney transplants.

The research team is checking medical records to see if patients started and completed a transplant assessment or got a transplant. The team is also looking to see if patients were on a transplant waiting list or were asked about living kidney donors. In addition, the team is looking for differences in these factors by race and residence, including if patients live in rural areas.

At the start of the study and 6, 12, and 18 months later, the research team is surveying patients about:

  • How often they discussed kidney transplant with their families and doctors
  • Their knowledge of the transplant process
  • Their confidence to overcome barriers

Patients with kidney disease, family members, health insurers, and doctors are helping to plan and conduct this study. 

Research methods at a glance

Design ElementDescription
DesignRandomized controlled trial
Population1,150 adults ages 18–75 who are eligible for early kidney transplants and who have estimated glomerular filtration rates of <30 mL/min/1.73m2 or increased risk of disease progression
Interventions/
Comparators
  • STEPS surveillance and outreach program
  • Enhanced usual care for kidney disease
Outcomes

Primary: health system-reported completion of transplant assessment

Secondary: number of patient inquiries to transplant center about live kidney donors; number of live kidney donor transplants; number of patients placed on deceased kidney donor waiting list; number of deceased kidney donor transplants; number of patients who initiate a transplant assessment; patient-reported physician discussions, family discussions, initiation of transplant evaluation, completion of transplant evaluation, identification of a living donor, kidney transplant knowledge, and self-efficacy to overcome barriers

Timeframe  Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary 18-month follow-up for primary outcome

Project Information

Leigh Ebony Boulware, MD, MPH, FACP
Duke University
$7,026,371
Helping Patients Achieve Kidney Transplants through Health System Change

Key Dates

January 2021
December 2026
2021

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 14, 2024