High Dose Influenza Vaccine in Nursing Home - Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Influenza remains the most common preventable respiratory viral infection of older adults. Older adults incur more than 90% of the disease burden, and those residing in nursing homes are the most affected subset given their immune senescence, multi-morbidity, and close living quarters. Each year, the majority of influenza-related hospitalizations occur during the period with the greatest influenza activity. 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 high-dose 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. Estimating the benefit of influenza vaccination among older adults in long-term care settings using randomized controlled trials requires extensive effort and is costly. Instead, a pragmatic RCT in a nursing home population has several advantages as a model for comparing therapeutic approaches. This clinical trial aims to test the feasibility of our protocol for a subsequent larger study. We aim to demonstrate that we can recruit and enroll facilities; randomly assign and coordinate vaccine delivery; collect data; conduct site audits for data validation; create outcomes using multiple data sources; and conduct analyses.

Official Title
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High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation

Conditions
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Influenza

Intervention / Treatment
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* Biological: HD Fluzone Vaccine
* Biological: SD Fluzone Vaccine


Participation Criteria
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Eligibility Criteria
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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

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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No

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 Fluzone Vaccine<br>NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents. | Biological: HD Fluzone Vaccine<br>* Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).<br>* Other names: Fluzone High Dose influenza vaccine;|
| Active Comparator: SD Fluzone Vaccine<br>NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents. | Biological: SD Fluzone Vaccine<br>* Nursing home residents are allocated to receive standard trivalent vaccine (TIV).<br>* Other names: Fluzone influenza vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total All-cause Hospitalizations | The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Residents' Functional Status | The secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluzone, Randomized Controlled Trial, Influenza, Influenza vaccine, Flu Vaccine, HD Fluzone, Nursing Homes, Hospitalization, Mortality, Health Care worker vaccination, ADL decline, Pilot, Effectiveness