High-Dose Influenza Vaccine in Nursing Homes

• Hospitalization rate per NH resident, by vaccination group [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  [Vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for this cohort, therefore data analysis will be completed by December 2016.]
  
  

• Change in activities of daily living (ADL) scores per NH resident by vaccination group [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  [Vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for this cohort, therefore data analysis will be completed by December 2016.]
  
  
• Total influenza mortality per nursing home based on vaccination status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  [Vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for this cohort, therefore data analysis will be completed by December 2016.]
  
  

• Difference in hospitalization claims based on staff vaccination status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  Effect on clinical outcomes of nursing home residents based on staff vaccine uptake. [Staff vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for the NH cohort, therefore data analysis will be completed by December 2016.]
  
  

SUMMARY: This study includes estimated 6782 Medicare-certified nursing homes (NHs) co-located within 50 miles of the 122 cities reporting to Center for Disease Control and Prevention (CDC) weekly influenza surveillance. In total, 1000 facilities will be enrolled for random assignment to either 1) the licensed high dose (HD) trivalent influenza vaccine (Fluzone HD [HD vaccine]),or 2) the standard dose (SD) trivalent influenza vaccine (Fluzone [SD vaccine]) for their residents and free SD vaccine vs. usual care (no free vaccine) for staff.

BACKGROUND: Lower respiratory tract infection (LRI), which includes pneumonia, bronchitis, and tracheobronchitis, is the leading cause of mortality and hospitalization in older adults, and NH residents. Often, the signs and symptoms of pneumonia, in particular, are not apparent in elderly patients, making diagnosis more complicated. In addition, clinician visits to these residents are few and sporadic and radiological facilities are not readily available. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks in which influenza peaks each year.

Influenza is the most common viral infection of older adults. Influenza and pneumonia account for the majority of infectious morbidity and mortality in late life, and possibly for at least some of temporally associated—and vaccine preventable—vascular mortality such as heart attacks and strokes. Influenza can cause more than just viral pneumonia because it results in a systemic inflammatory response that is thrombogenic. Some experts believe that influenza vaccine can prevent thrombotic outcomes, such as strokes and heart attacks, mechanistically by reducing the overall inflammatory response through targeted priming of the immune system.

Influenza vaccination has been associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. Also, influenza vaccination rates vary substantially between NHs.

OBJECTIVES: The primary objective is to estimate the differences in all-cause hospitalization rates during flu season experienced by long stay nursing home residents in facilities using the HD vaccine vs. usual care vaccination nursing homes. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline experienced during the influenza season by long stay nursing home residents of facilities using the HD vaccine vs. the level of functional decline experienced by residents of usual care nursing homes.