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High-Dose Influenza Vaccine in Nursing Homes
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Influenza | Biological: HD Vaccine Biological: SD Vaccine Biological: Free Vaccine Biological: Usual Care | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes |
- Hospitalization rate [ Time Frame: up to 1 year ]
- Change in activities of daily living (ADL) scores [ Time Frame: up to 1 year ]
- Facility-level mortality rate [ Time Frame: up to 1 year ]
- Hospitalization rate based on vaccine type and influenza strain [ Time Frame: Up to 3 years ]
- Cost difference between vaccine types [ Time Frame: up to 3 years ]
- Effect of facility policies on staff vaccination rates [ Time Frame: up to 3 years ]
- Difference in hospitalization claims based on staff vaccination status [ Time Frame: up to 1 year ]Effect on clinical outcomes of nursing home residents based on staff vaccine uptake.
| Enrollment: | 823 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HD Vaccine (Residents) + Free Vaccine (Staff)
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
Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.
Other Name: Fluzone High-Dose
Biological: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Other Name: Fluzone
|
|
Experimental: HD Vaccine (Residents) + Usual Care (Staff)
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
Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.
Other Name: Fluzone High-Dose
Biological: Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
|
|
Active Comparator: SD Vaccine (Residents) + Free Vaccine (Staff)
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
Nursing home residents are allocated to receive standard-dose vaccine.
Other Name: Fluzone
Biological: Free Vaccine
Nursing home facilities are provided free standard-dose vaccine for their staff.
Other Name: Fluzone
|
|
Active Comparator: SD Vaccine (Residents) + Usual Care (Staff)
NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and not provided free vaccine for the staff.
|
Biological: SD Vaccine
Nursing home residents are allocated to receive standard-dose vaccine.
Other Name: Fluzone
Biological: Usual Care
Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01815268
| United States, Ohio | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University | |
| Providence, Rhode Island, United States, 02912 | |
| United States, Virginia | |
| Insight Therapeutics, LLC | |
| Norfolk, Virginia, United States, 23510 | |
| Principal Investigator: | Stefan Gravenstein, MD, MPH | Case Western Reserve University |
| Principal Investigator: | Vincent Mor, PhD | Brown University |
| Principal Investigator: | Ed Davidson, PharmD, MPH | Insight Therapeutics, LLC |
More Information
Additional Information:
Publications:
Study Data/Documents: Study Protocol
We have published our study design and rationale in Clinical Trials Journal. Citation is below.
Stefan Gravenstein, Roshani Dahal, Pedro L Gozalo, H Edward Davidson, Lisa F Han, Monica Taljaard, and Vincent Mor. A cluster randomized controlled trial comparing relative effectiveness of two licensed influenza vaccines in US nursing homes: Design and rationale. Clin Trials 1740774515625976, first published on February 11, 2016 doi:10.1177/1740774515625976
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Insight Therapeutics, LLC |
| ClinicalTrials.gov Identifier: | NCT01815268 History of Changes |
| Other Study ID Numbers: |
GRC75-EXT |
| Study First Received: | March 11, 2013 |
| Last Updated: | December 16, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Insight Therapeutics, LLC:
|
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 CDC US city |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 21, 2017