For older adults, a hospital admission or major surgery includes risk of developing delirium — a complication not only marked by confusion or agitation, but also associated with prolonged hospitalization, cognitive and functional decline, and increased mortality.
A new study led by the Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, a Harvard Medical School affiliate, and the University of Michigan Medical School Department of Anesthesiology will test whether family caretaker support provided at the hospital bedside can reduce risk of delirium and its related complications and improve outcomes for patients and their families. The Patient-Centered Outcomes Research Institute (PCORI) has approved $13.25 million in funding to support the study.
“More than 2.6 million older adults develop delirium in the U.S. each year, often leading to loss of independence, considerable health care costs, and distress for patients and families,” said Sharon Inouye, M.D., MPH, professor of medicine, Harvard Medical School. “We are thrilled to receive support from PCORI to determine if caregivers could provide extra support in combating delirium.”
One current approach to reducing delirium is the Hospital Elder Life Program (HELP). Used in hospitals for more than 20 years, HELP includes interventions like providing orienting communication, walking and exercise, activities to stimulate the brain like word games, proper nutrition and fluids, and adequate sleep.
Researchers for this study will combine HELP with family involvement. The new program, FAM-HELP, will provide family members with information about delirium so they can recognize it early and help prevent it. The program also will provide training for a family member or caretaker to assist with HELP interventions and provide an extra layer of emotional comfort, social support, and daily communication.
“Studies have shown that delirium can be prevented by implementing HELP interventions — but we haven’t yet studied whether involving family members along with hospital staff in HELP might further reduce risk,” said Phillip Vlisides, M.D., assistant professor and executive director of neuroscience research, Department of Anesthesiology, University of Michigan.
“We’re eager to work with patients, their caregivers, and their health care providers to understand how family involvement may impact the prevention of delirium and improve family-centered outcomes.”
The research team will collaborate with eight hospitals across the country to enroll 3,000 adults age 70 and older who are admitted to the hospital for medical or surgical care with an expected hospital stay of at least three days. Hospitals selected for the study have implemented HELP as standard care and represent broad geographic and demographic diversity.
In the randomized trial, half of patients will receive HELP interventions and half will receive FAM-HELP support. The research team aims to:
- Compare the effectiveness of HELP and FAM-HELP for reducing the incidence and severity of delirium;
- Compare the effectiveness of HELP and FAM-HELP for improving patient-reported outcomes, including health-related quality of delirium, and delirium burden and family-reported outcomes like delirium burden, caregiver stress, and caregiver engagement; and
- Test the effects of HELP and FAM-HELP on health care system-related outcomes, such as falls and length of stay.
The study is expected to be completed over five years. Funding for the study has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.