Randomized control trials to study clinical effectiveness of high dose flu vaccine in nursing homes

Case Western Reserve University School of MedicineDec 19 2013

One of the highest risk groups for developing pneumonia or even dying from the flu is the elderly, especially in group settings such as nursing homes.

Stefan Gravenstein, MD, MPH, a geriatrics physician in the Center for Geriatrics and Palliative Care at University Hospitals Case Medical Center and professor of medicine at Case Western Reserve University School of Medicine, is leading one of the largest randomized control trials comparing the clinical effectiveness of high dose and standard dose flu vaccine in nursing homes.

"This year we have enrolled and randomized nearly 800 facilities for the study and dispensed some 150,000 vaccines to them," said Dr. Gravenstein. "We hope to determine whether the high dose vaccine is more effective in reducing hospitalizations and deaths than a standard dose vaccine in nursing homes. In addition, we would like to know how much staff vaccination impacts the risk of hospitalization and mortality outcomes in the residents of these facilities."

Dr. Gravenstein's study began earlier this year and will continue until 2016. About 10 percent of the study's nursing homes are in Ohio.

"Existing evidence indicates that higher doses generate better antibody response to the vaccine in older recipients. No data are available to tell us whether this generates a better clinical outcome, the focus of the present study," said Dr. Gravenstein. "In other words, are the nursing home residents staying healthier and out of the hospital because of the higher dose?"

He also hopes that the experience gained from the approach used for this large-scale study will serve as a model for future studies to evaluate comparative effectiveness.

For example, do differences in standard care processes to prevent a pressure ulcers change outcomes or do different statins lead to different cardiac outcomes? "Using traditional approaches to compare care strategies through randomized controlled trials can be extraordinarily expensive, but when the question is posed through the lens of variations in standards of care, large-scale comparative effectiveness studies can provide the needed evidence in an extremely efficient way."

The study is funded through Insight Therapeutics, located in Norfolk, Va., by an investigator-initiated grant from Sanofi-Pasteur. Dr. Gravenstein is collaborating with colleagues at Brown University in Rhode Island and Eastern Virginia Medical School.