High Dose Influenza Vaccine in Nursing Home - Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 5/25/2018 |
| Start Date: | September 2012 |
| End Date: | May 2016 |
High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation
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.
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.
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.
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.
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
We found this trial at
2
sites
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