Dr. Schaffhausen receives NIH R01 Award to study shared decision making for kidney transplant candidates

Hennepin Healthcare Investigator Cory Schaffhausen, PhD, has received a three-year Research Project Grant Program (R01) award of $815,173 from the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases to study shared decision making (SDM) for kidney transplant candidates to plan for an organ offer decision. In the SDM model, transplant candidates and their healthcare providers work together to make joint decisions about care and whether or not to accept an organ when it becomes available.

Dr. Schaffhausen is an investigator at HHRI, assistant professor at University of Minnesota Medical School, and human-centered design engineer at the Scientific Registry of Transplant Recipients (SRTR), a data registry located at Hennepin Healthcare that analyzes outcomes for organ transplant donors and recipients across the U.S.

The Shared decision making for kidney transplant candidates to plan for an organ offer decision project began in December 2022. It focuses on a shared decision making approach to help patients plan for a future organ offer. Shared decision making is a key component of patient-centered health care. Patients waiting for a kidney transplant often face poor outcomes and increased burden of care on dialysis. During this time, transplant centers and patients may turn down organ offers because patients and providers lack effective interventions to help patients make informed offer decisions. Among candidates who have received at least one donor offer, over 30 percent of patients die on the list after offers to them are declined. The shared decision making process is one in which clinicians and patients can work together to make decisions and select tests, treatments and care plans based on clinical evidence that balances risks and expected outcomes with patient preferences and values.

The proposed research will provide pilot data using a randomized trial of usual care compared to the SDM intervention using the Donor Plan Donor Call (DPDC) tool with patients and providers at two sites and there will be two aims:

• The pilot randomized trial will determine the impact and quality of SDM for patients to plan for an organ offer. The primary outcome will be willingness to accept donor organs at increased risk of discard. Secondary analyses will include changes in decisional conflict, knowledge, patient hope and distress, and duration of time spent making a decision.
• The study will evaluate the acceptability of SDM with DPDC, barriers to adoption of the intervention, and other leading indications of implementation success with patients and providers.

This research will allow Dr. Schaffhausen to improve the intervention and implementation to facilitate a fully powered multi-center randomized trial. This proposal fills a critical need to improve donor offer decisions to reduce patient mortality, the negative health effects from time on dialysis, and discards of viable donor kidneys.

The R01 is the original and historically oldest grant mechanism used by NIH, providing support for health-related research and development. The grant supports a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing the investigator’s specific interest and competencies. Please join us in congratulating Dr. Schaffhausen on his new award.