National Institute on Aging grant aims to create roadmap for COVID-19 trials in nursing homes

UMass Medical School has been awarded a grant from the National Institute on Aging to develop a roadmap for developing clinical trials networks to study COVID-19 in nursing homes. Jerry Gurwitz, MD, the Dr. John Meyers Professor of Primary Care Medicine, professor of medicine and family medicine & community health, chief of the Division of Geriatric Medicine and executive director of the Meyers Primary Care Institute, will serve as principal investigator for the project.

Kathleen Mazor, EdD, professor of medicine and associate director of the Meyers Primary Care Institute, and Kouta Ito, MD, assistant professor of medicine, are members of the UMMS research team.

There is an urgent need for evidence-based approaches to infection control, prevention and treatment of COVID-19, especially as nursing home residents make up more than 40 percent of deaths related to the pandemic nationwide, according to analyses of state data by the Kaiser Family Foundation, a nonprofit organization focused on national health issues. The Massachusetts Department of Public Health reports more than 60 percent of deaths from COVID-19 have occurred in long-term care facilities in the state.

The $717,000, one-year grant builds on previous work by UMMS researchers focused on improving the health of the most vulnerable in the geriatric population. COVID-19’s very high morbidity and mortality impact in nursing homes is linked in part to the significant burden of comorbidities, like heart disease, diabetes and lung disease, among residents.

“The most common chronic condition in nursing home residents is multiple chronic conditions, placing these individuals at very high risk for hospitalization and death relating to COVID-19,” said Dr. Gurwitz.

While small clusters of nursing homes around the country serve as sites for research on infection control and prevention, there is no existing national nursing home clinical trials network or consortium to facilitate and expedite studies of strategies and therapeutics to address the ongoing pandemic.

The UMMS team, together with collaborators across the country, will perform an inventory of existing small nursing home research networks; prioritize research questions related to COVID-19 specific to the nursing home setting; and develop and disseminate a roadmap for a national nursing home COVID-19 clinical trials network.

Challenges and recommendations for conducting research in nursing home residents were highlighted in a mini-summit convened by the project team shortly after the grant was awarded, which brought together national policymakers and research leaders, with representatives from the National Institute on Aging.

Nursing homes and other senior care facilities are not like hospitals, Gurwitz explained. “I think there’s a misunderstanding of what these settings are really like, especially on the part of researchers who have never worked in nursing homes. Yes, people receive medical care there, but being a resident of a nursing home does not only have to do with your medical conditions,” he said. “I see people in nursing homes who are there primarily because of functional needs, like difficulties with bathing, dressing, toileting and transferring. It’s not a medical model; it’s a place where people live.”

In addition to the diversity of resident populations, research challenges include the complexities of obtaining consent for research from people with cognitive impairment; communicating with family members; lack of staff to assist with research; a highly regulated environment; and ongoing changes in nursing home ownership and corporate structures. Further, access to nursing homes is extremely challenging now, when even residents’ families can’t visit.

Gurwitz said the project’s goals aren’t only to shed light on how a nursing home research network might be structured for COVID-19, but also “to put some guardrails around what is really realistic in regard to clinical trials in nursing homes, and what might be less or not feasible at all.”