High Dose Influenza Vaccine in Nursing Home

• Total Number of Hospitalization Claims per Nursing Home Based on Vaccination Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  [Linked at the facility level] The primary outcome measure evaluates comparative vaccine effectiveness for hospitalization and mortality of HD vaccine to SD vaccine using Minimum Data Set (MDS).
• Total Influenza Mortality per Nursing Home Based on Vaccination Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  [Linked at the facility level] MDS will be used to determine influenza mortality.

• Change in Activities of Daily Living (ADL) Scores per NH Resident by Vaccination Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  [Linked at the resident level] The secondary outcome measure evaluates comparative vaccine effectiveness for functional status of HD vaccine compared to no or SD vaccine (using MDS). ADL score is a 4 point score (higher is more impaired) for 7 measured domains (maximum 28); 4 point change in composite score is significant. Residents at the highest levels of impairment will be excluded.
• Difference in ADL Duration per NH Resident by Vaccination Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  [Linked at the resident level] Using MDS.
• New Coded Claims for Stroke, Heart Attack or Pneumonia for a NH Resident [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  [Linked at the resident level] Using MDS, Medicare A and B.

The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard dose influenza vaccine.

Lower respiratory tract infection (LRI), which includes pneumonia, bronchitis, and tracheobronchitis, is the leading cause of mortality and hospitalization in older adults and nursing home (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 during which influenza peaks each year.

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. The new HD influenza vaccine is considerably more immunogenic in older adults, and has recently been approved for use in individuals aged 65 years and older. No clinical data yet confirm whether the improved immunogenicity translates into added clinical benefit, such as further reduction in hospitalization or death.

The primary objective is to:

1. 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. facilities using the SD vaccine, as pilot data to inform feasibility, design and power calculation for a subsequent larger study.
2. To develop estimates, at the nursing home resident level, about the relationship between influenza vaccination status (none, SD, HD) and Medicare Minimum Data Set (MDS) coded claims for all-cause hospitalization and overall mortality among the long-stay residents from a single season 2012-2013, for use in a subsequent longitudinal evaluation of national nursing home data and regional publicly reported influenza severity.

• Biological: HD Fluzone Vaccine
• Biological: SD Fluzone Vaccine

• Experimental: HD Fluzone Vaccine
  NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.
  Intervention: Biological: HD Fluzone Vaccine
• Active Comparator: SD Fluzone Vaccine
  NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.
  Intervention: Biological: SD Fluzone Vaccine
• Experimental: Free SD Fluzone Vaccine
  NH facilities randomized to receive free SD influenza vaccine (SD Fluzone) for the staff.
  Intervention: Biological: SD Fluzone Vaccine
• No Intervention: No Free Vaccine
  NH facilities randomized not to receive free influenza vaccine for the staff.

• Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86.
• Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, Fukuda K. Influenza-associated hospitalizations in the United States. JAMA. 2004 Sep 15;292(11):1333-40.
• Hayward AC, Harling R, Wetten S, Johnson AM, Munro S, Smedley J, Murad S, Watson JM. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ. 2006 Dec 16;333(7581):1241. Epub 2006 Dec 1.
• Deguchi Y, Nishimura K. Efficacy of Influenza Vaccine in Elderly Persons in Welfare Nursing Homes: Reduction in Risks of Mortality and Morbidity During an Influenza A (H3N2) Epidemic. J Gerontol A Biol Sci Med Sci. 2001 Jun;56(6):M391-4.
• Barker WH, Borisute H, Cox C. A study of the impact of influenza on the functional status of frail older people. Arch Intern Med. 1998 Mar 23;158(6):645-50.
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• Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007 Jul 13;56(RR-6):1-54.
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Inclusion Criteria:

• Long-term care facilities in one of the 122 cities that serve as Center for Disease Control and Prevention (CDC) surveillance sites

Exclusion Criteria:

• Facilities already systematically administering HD vaccine to their residents
• Facilities for whom over half the residents are on Medicare (short-stay)
• Facilities in which over half the residents are on Medicare Part A (SNF)
• Facilities having fewer than 50 long-stay residents
• Hospital-based facilities
• Facilities with more than 20% of the population under age 65
• Facilities with mandated (employment-dependent) seasonal influenza vaccination
• Facilities not submitting MDS data

• Brown University
• Healthcentric Advisors
• Case Western Reserve University