A University of Cincinnati College of Medicine physician-researcher has received a five-year, $2.5 million R01 grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health (NIH), marking a major career milestone.
Natalie Kreitzer, MD , an associate professor of clinical medicine and vice chair of research in the Department of Emergency Medicine , will use the funding to support a multisite, randomized clinical trial testing CG-Well 2, a web- and telephone-based caregiver wellness intervention. Caregivers face high rates of anxiety, depression and burnout, and the program is designed to reduce psychological distress and improve coping among family caregivers of individuals with moderate-to-severe traumatic brain injury (TBI).
TBI is a disruption in normal brain function caused by a forceful bump, blow, jolt or penetrating object to the head. TBI can result from motor vehicle collisions, assaults, gunshot wounds and falls, particularly among older adults.
"From my experience in the neuro intensive care unit (ICU), I've developed a deep interest in working with patients who have suffered traumatic brain injuries and with their family members, who often become their caregivers," said Kreitzer, who completed a neurocritical care fellowship at UC and is a member of the UC Stroke Team .
CG-Well — short for CareGiver Well — was developed based on earlier studies. It’s an evidence-based approach that delivers structured wellness content through web modules and phone coaching. The intervention includes 43 modules, available online and in print, tailored to address families’ unmet needs during recovery.
“The topics focus on common issues likely to arise for families in the first six months after a TBI, including coping with stress, navigating the Family and Medical Leave Act (FMLA), transitioning from the ICU to a rehabilitation facility or long-term acute care (LTAC), and preparing the home for a loved one's return,” said Kreitzer.
The CG-Well 2 trial will build on Kreitzer's earlier project, CG-Well 1, which enrolled 100 family caregivers and was funded by a five-year NIH K23 grant (a career development award).
"It was a positive trial," Kreitzer said. "Caregivers enrolled in CG-Well reported greater satisfaction and fewer symptoms of psychological stress than those who received the control intervention."
The CG-Well 2 trial will rigorously evaluate the intervention as a scalable program, beginning within the first two weeks after a patient's injury and continuing through the transition from hospital to home. It will also evaluate patient outcomes and the intervention’s feasibility, acceptability and cost.
The first six months after a TBI can be especially intense for caregivers, who may experience changes in a loved one’s behavior while managing caregiving demands and making decisions about treatment and rehabilitation. The trial will also examine effects on caregiver health and well-being, as well as caregiving appraisal, or how a caregiver perceives their situation.
Trial participants will be randomly assigned to one of two groups. One group will receive regular phone calls from a trained interventionist with a social work or nursing background who will check in and guide caregivers through the tailored modules.
Researchers will compare the results with those of a second group who will not receive the modules. The second group will have access only to publicly available information, and their phone calls will involve active listening — but no tailored intervention or advice.
The trial will enroll up to 354 patient-caregiver pairs at four U.S. sites: the University of Cincinnati, Ohio State University in Columbus, Washington University in St. Louis and the University of Washington in Seattle. Enrollment is expected to begin in early 2027.
Kreitzer’s co-investigators at UC include Stephanie Fink, lead coordinator and clinical research project manager in the Department of Emergency Medicine; Heidi Sucharew, PhD, research professor in the Department of Emergency Medicine; Brad Kurowski, MD, professor-affiliate in the Department of Pediatrics and Cincinnati Children’s Division of Rehabilitation Medicine; Shari Wade, PhD, professor-affiliate in the Department of Pediatrics and director of research at Cincinnati Children’s Division of Rehabilitation Medicine; and Tamilyn Bakas, PhD, professor and endowed chair in the College of Nursing.