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With just about any health condition, early intervention offers the best chance for a positive outcome. The sooner a diagnosis is made, and treatment starts, the better chance a person has for an improved quality of life.

This rings true for the more than 600,000 individuals in the United States who experience kidney failure. However, only a minority of patients with kidney failure begin their treatment journey with the intervention most likely to bring about the best outcome—kidney transplantation.

A PCORI-funded research team led by Leigh Ebony Boulware, M.D., M.P.H., FACP, dean of medicine at Wake Forest University, set out to help patients and families manage the overwhelm they feel at the prospect of needing a kidney transplant for themselves or a family member and help them move past the obstacles many face on the road to kidney health.

Roadblocks to Early Transplants

Kidney transplantation is usually the best treatment for patients with kidney failure, and studies show patients’ outcomes are better when they receive transplants as early as possible. But fewer than 3 percent of patients with kidney failure start treatment with a transplant.

Why so few? Patients can experience critical roadblocks on the path to receiving early kidney transplants. Factors for patients may include a lack of knowledge about transplantation as an early option, difficulties discussing transplant with their physicians and families, and trouble completing the transplant evaluation process. Late physician referrals and evaluations may also contribute to the lag.

These roadblocks can be worse for Black patients, who have up to four times greater rates of kidney failure compared to other groups, and those living in rural communities.

Also, a shortage of deceased kidney donors in the United States means patients on these waiting lists have to wait up to three to five years for a kidney. Live donor kidney transplants allow patients to bypass these lists, but this method of donation is underutilized and marked by profound racial inequities.

What the Research Team Is Doing

The research team is recruiting patients for the STEPS study, which will help researchers understand how hospital and health insurance leaders can change the ways they work to assist people in getting kidney transplants early and equitably. The STEPS intervention will:

• Identify patients who qualify for kidney transplant as early as possible
• Educate and support patients and their families to help them talk about overcoming roadblocks to early transplants
• Proactively reach out to patients to let them know they are eligible for early transplants and invite them to the transplant center
• Navigate patients through the multistep transplant preparation process

“One of the distinguishing features of the study is its focus on using health center outreach to identify individuals who may be eligible for a kidney transplant early and equitably,” said Boulware. “To do this, we have created health system registries, and we have applied predictive models and clinical algorithms to identify potential candidates.”

The team will randomly assign patients to receive STEPS or their usual kidney care and will compare differences in how these two treatment approaches help patients overcome critical roadblocks to receiving early kidney transplants.

Why This Study Is Important

“This project is significant both for testing an innovative care delivery model for increasing equitable care for kidney transplants and demonstrating unique ways of leveraging electronic health records to reach patients, provide more equitable care and conduct health equity-related comparative clinical effectiveness research across multiple health systems,” said Hillary Bracken, a senior program officer in PCORI’S Healthcare Delivery and Disparities Research Department. Importantly, patient and stakeholder engagement has informed the development and design of the proposed STEPS intervention.    

Leveraging the electronic health records in such innovative ways to measure intervention fidelity may be valuable for future pragmatic comparative effectiveness research studies, Bracken added.

“To our knowledge, this is among the first studies in the nation conducted to understand whether proactive measures to identify potential kidney transplant recipients early and address their often-overlooked social needs can improve access to kidney transplants overall and also address racial disparities in kidney transplantation,” Boulware said.

The study team has exceeded its enrollment target and expects to complete the project in early 2024.