High-Dose Influenza Vaccine in Nursing Homes

Study Overview
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Brief Summary
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The purpose of this study is to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the standard dose trivalent seasonal influenza vaccine.

Detailed Description
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SUMMARY: This nationally representative study samples from estimated 6782 Medicare-certified nursing homes 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 (High-Dose Fluzone [HD vaccine]), or 2) the standard dose (SD) trivalent influenza vaccine (Fluzone [SD vaccine]) for their residents. Additionally, half the facilities will receive free SD vaccine for their staff and the remaining facilities will practice usual care (no free vaccine) for staff. BACKGROUND: Influenza and pneumonia (P&I) are leading infectious causes of hospitalization and mortality in community-dwelling older adults and residents of long-term custodial care facilities or nursing homes (NH), and produce substantial annual health care costs. The elderly incur over 90% of this disease burden and NH residents are especially vulnerable given immune senescence, multimorbidity, and close living quarters. While hospitalization rates for NH residents vary considerably between facilities, most occur during the sixteen weeks of peak influenza activity annually. Influenza vaccination, a mainstay in prevention, is recommended in the U.S. for all individuals six months of age and older. Vaccination associates with reduced rates of stroke, heart attack, hospitalization, and death in non-institutional older adult populations. However, the benefit of influenza vaccine for the elderly in general has been questioned, a salient concern for frail elderly, such as NH residents. Influenza vaccination rates vary substantially between nursing homes. Influenza vaccine response declines with advancing age, indicating the need for a better vaccine. OBJECTIVES: The primary objective is to estimate the differences in all-cause hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using HD vaccine vs. SD vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes.

Official Title
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High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes

Conditions
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Influenza

Intervention / Treatment
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* Biological: HD Vaccine
* Biological: SD Vaccine
* Biological: Free Vaccine
* Biological: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Long-term care facilities within 50 miles of one of the 122 cities that serve as CDC surveillance sites Exclusion Criteria: Facilities already systematically administering HD vaccine to their residents Facilities having fewer than 50 long-stay residents Hospital-based facilities Facilities with more than 20% of the population under age 65 Facilities not submitting Minimum Data Set (MDS) data

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HD Vaccine (Residents) + Free Vaccine (Staff)<br>NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and provided free SD vaccine (Fluzone) for the staff. | Biological: HD Vaccine<br>* Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.<br>* Other names: Fluzone High-Dose;Biological: Free Vaccine<br>* Nursing home facilities are provided free standard-dose vaccine for their staff.<br>* Other names: Fluzone;|
| Experimental: HD Vaccine (Residents) + Usual Care (Staff)<br>NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and not provided free vaccine for the staff. | Biological: HD Vaccine<br>* Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.<br>* Other names: Fluzone High-Dose;Biological: Usual Care<br>* Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.<br>|
| Active Comparator: SD Vaccine (Residents) + Free Vaccine (Staff)<br>NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and provided free standard dose vaccine (Fluzone) for the staff. | Biological: SD Vaccine<br>* Nursing home residents are allocated to receive standard-dose vaccine.<br>* Other names: Fluzone;Biological: Free Vaccine<br>* Nursing home facilities are provided free standard-dose vaccine for their staff.<br>* Other names: Fluzone;|
| Active Comparator: SD Vaccine (Residents) + Usual Care (Staff)<br>NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and not provided free vaccine for the staff. | Biological: SD Vaccine<br>* Nursing home residents are allocated to receive standard-dose vaccine.<br>* Other names: Fluzone;Biological: Usual Care<br>* Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization rate |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activities of daily living (ADL) scores |  | up to 1 year | 
| Facility-level mortality rate |  | up to 1 year | 
| Hospitalization rate based on vaccine type and influenza strain |  | Up to 3 years | 
| Cost difference between vaccine types |  | up to 3 years | 
| Effect of facility policies on staff vaccination rates |  | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDC, Randomized Controlled Trial, Influenza, Influenza vaccine, Flu Vaccine, Fluzone, HD Fluzone, Nursing Home, Hospitalization, Mortality, Health Care worker vaccination, ADL decline, Effectiveness, Elderly, Morbidity, Nursing Home resident, Frail, Institutionalized, Epidemiology, US, city