Wake Forest University School of Medicine has been approved for a Patient-Centered Outcomes Research Institute (PCORI) funding award to extend a study aimed at improving access to kidney transplants for patients with advanced kidney disease.
The five-year study will be led by L. Ebony Boulware, M.D., M.P.H., dean of Wake Forest University School of Medicine, and chief science officer and vice chief academic officer of Advocate Health.
Kidney disease affects more than 800,000 people in the U.S. For patients dealing with kidney failure, a kidney transplant is the best treatment option to help improve outcomes and quality of life.
“We are honored to receive this funding from PCORI, which will help us better understand how to improve the likelihood that all patients receive life-saving kidney transplants,” said Boulware, who is the study’s principal investigator.
Titled Comparing Registry Surveillance and Provider Alerts with and without Patient Outreach, Navigation, and Care Coordination to Improve Behaviors Needed to Facilitate Early Transplants, the study is designed to identify kidney disease early and ensure patients have timely access to kidney transplant care as early as possible. It will provide long-term follow up for the original System Interventions to Achieve Early and Equitable Transplants Long Term (STEPS) study, a randomized comparative effectiveness trial that began in 2020.
The original STEPS study followed patients for 18 months and compared two approaches:
A patient-centered intervention where transplant social workers and nurse transplant coordinators help patients address social and behavioral barriers to seeking and obtaining early and/or live donor kidney transplants.
Usual care, which involves the implementation of an electronic health record registry to identify patients with advanced chronic kidney disease and alerting health care providers to guideline-based recommended kidney care referrals.
However, it typically takes patients more than 18 months to be placed on kidney transplant waiting lists. With funding support from PCORI, the new study will allow researchers to follow patients for a longer time.
The research team plans to recruit 1,080 patients enrolled in the original trial from Duke University Medical Center in Durham, the University of Mississippi Medical Center in Jackson, Mississippi, and Geisinger Health System in Danville, Pennsylvania.
This study is among several PCORI has funded focused on examining the longer-term outcomes of interventions in comparative clinical effectiveness research. The impact of health interventions can take years to appear, but shorter follow-up periods are more common in research. With long-term follow-up funding, this study has the potential to enhance the lives of individuals affected by kidney failure.
The award has been approved pending completion of a business and programmatic review by PCORI and issuance of a formal award contract.
PCORI is a nonprofit organization with a mission to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.
Media contact: Myra Wright, mgwright@wakehealth.edu