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| Name | Class |
|---|---|
| Brown University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD Fluzone Vaccine | Experimental | NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents. |
|
| SD Fluzone Vaccine | Active Comparator | NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD Fluzone Vaccine | Biological | 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). |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size | This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Gravenstein, MD, MPH | Case Western Reserve University | Principal Investigator |
| Ed Davidson, PharmD, MPH | Insight Therapeutics, LLC | Principal Investigator |
| Vincent Mor, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown Univeristy | Providence | Rhode Island | 02903 | United States | ||
| Insight Therapeutics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12517228 | Background | 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. doi: 10.1001/jama.289.2.179. | |
| 15367555 | Background | 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. doi: 10.1001/jama.292.11.1333. |
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Cluster--We included nursing homes (NHs) within 50 miles of a CDC surveillance. We identified and contacted individual facilities and organizations. Each recruited NH completed a site feasibility form and was notified of its eligibility based on the exclusion criteria.
Subject--Eligible nursing home residents in each participating facility.
| ID | Title | Description |
|---|---|---|
| FG000 | High-Dose Vaccine for Residents | NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents. |
| FG001 | Standard-dose for Residents | NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Characteristics of participating facilities that met our inclusion criteria and were randomized.
Residents in each participating facility were offered influenza vaccine according to the randomization.
| ID | Title | Description |
|---|---|---|
| BG000 | High-Dose Vaccine for Residents | NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents. |
| BG001 | Standard-dose for Residents |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total All-cause Hospitalizations | The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS). | We identified long-stay nursing home residents and evaluated outcomes (e.g. hospitalizations, functional status). | Posted | Number | events | 1 year |
|
The study did not collect adverse events.
The study did not collect adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Dose Vaccine for Residents | NH facilities randomized to receive high dose trivalent influenza vaccine (High-dose Fluzone) for the residents. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stefan Gravenstein | Brown University and Providence VA Medical Center | 401-863-3172 | Stefan_gravenstein@brown.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| SD Fluzone Vaccine | Biological | Nursing home residents are allocated to receive standard trivalent vaccine (TIV). |
|
|
| Norfolk |
| Virginia |
| 23510 |
| United States |
| 17142257 | Background | 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. doi: 10.1136/bmj.39010.581354.55. Epub 2006 Dec 1. |
| 11382801 | Background | 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. doi: 10.1093/gerona/56.6.m391. |
| 22724499 | Background | Gozalo PL, Pop-Vicas A, Feng Z, Gravenstein S, Mor V. Effect of influenza on functional decline. J Am Geriatr Soc. 2012 Jul;60(7):1260-7. doi: 10.1111/j.1532-5415.2012.04048.x. Epub 2012 Jun 21. |
| 9521230 | Background | 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. doi: 10.1001/archinte.158.6.645. |
| 16368725 | Background | Jackson LA, Jackson ML, Nelson JC, Neuzil KM, Weiss NS. Evidence of bias in estimates of influenza vaccine effectiveness in seniors. Int J Epidemiol. 2006 Apr;35(2):337-44. doi: 10.1093/ije/dyi274. Epub 2005 Dec 20. |
| 16360785 | Background | Simonsen L, Viboud C, Taylor R. Influenza vaccination in elderly people. Lancet. 2005 Dec 17;366(9503):2086. doi: 10.1016/S0140-6736(05)67884-1. No abstract available. |
| 17625497 | Background | 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. |
| 11804444 | Background | Kingston BJ, Wright CV Jr. Influenza in the nursing home. Am Fam Physician. 2002 Jan 1;65(1):75-8, 72. |
| 12583681 | Background | Menec VH, Black C, MacWilliam L, Aoki FY. The impact of influenza-associated respiratory illnesses on hospitalizations, physician visits, emergency room visits, and mortality. Can J Public Health. 2003 Jan-Feb;94(1):59-63. doi: 10.1007/BF03405054. |
| 21496257 | Background | Mor V, Intrator O, Unruh MA, Cai S. Temporal and Geographic variation in the validity and internal consistency of the Nursing Home Resident Assessment Minimum Data Set 2.0. BMC Health Serv Res. 2011 Apr 15;11:78. doi: 10.1186/1472-6963-11-78. |
NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents.
| BG002 | Total | Total of all reporting groups |
| nursing homes |
|
| years |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants | Participants |
|
| Number of residents per nursing home | Mean | Standard Deviation | participants | Participants |
|
| Percent of residents who are long-stay | Mean | Standard Deviation | percent | Participants |
|
| Number of long-stay residents who are over 65 years of age | Mean | Standard Deviation | participants | Participants |
|
| Percent of residents with Medicaid as payer | Mean | Standard Deviation | percent | Participants |
|
| Percent of residents in for-profit nursing facilities | Mean | Standard Deviation | percent | Participants |
|
| Number of nursing facilities that are part of a chain | Number | nursing homes | nursing homes |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Other Pre-specified | Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size | This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine | Nursing home facilities randomized to receive high dose or standard dose vaccine. | Posted | Number | Nursing Homes | 1 year | Nursing Homes | Nursing Homes |
|
|
|
| 249 |
| 1,461 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard-dose for Residents | NH facilities randomized to receive free standard-dose trivalent influenza vaccine (Fluzone) for nursing home residents. | 274 | 1,496 | 0 | 0 | 0 | 0 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |