A commentary published in the Journal of the American Geriatrics Society on March 14 talks about the need for clinical trials among people living in nursing homes.
“The COVID-19 pandemic highlighted the pressing need for trials in nursing homes,” the authors wrote. The report includes a proposed framework with factors that are a must for successful clinical trials among nursing home residents.
The authors cited the nursing home resident deaths from COVID-19 with regard to the small number of residents who participated in clinical trials. “This omission was consequential in that despite evidence that monoclonal antibody treatment reduced hospitalizations and mortality from COVID-19 infection, there were delays delivering these treatments equitably and consistently to nursing home residents because they were not considered in the development of these therapies,” the authors wrote.
Challenges to residents participating in clinical trials include staff turnover, federal regulations, concerns about what staff will need to support residents, and health literacy. Both the intervention and the design of the trial have to take into account the needs of residents and staff, and they must have appropriate outcome measures that align with “what matters most” to residents.
One mechanism that could help is the Long-Term Care Data Cooperative (LTCDC) operated by the National Institute on Aging (NIA). It deals with the barriers to accessing and using medical data, can enhance access to data sources and form a community of nursing home operators participating in trials, the authors wrote.
The framework includes details on trial design, recruiting, equity concerns, engagement, outcomes assessment, and follow up. The model could guide efforts for clinical trials to improve a resident’s quality of life and care, the authors noted.
“Specifically, researchers should anticipate the study’s potential burden on NH staff and residents, which often goes unappreciated, and should proactively identify potential regulatory issues,” the authors concluded.
About 77% of the estimated 1.4 million people in US nursing homes have hypertension while about 49% have depression and 35% have diabetes. A majority have cognitive impairment or Alzheimer’s disease, the authors noted.
