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High Dose Influenza Vaccine in Nursing Home - Pilot Study

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ClinicalTrials.gov Identifier: NCT01720277
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Stefan Gravenstein, MD, MPH, Brown University

October 15, 2012
November 2, 2012
June 15, 2017
April 18, 2018
April 18, 2018
September 2012
May 2013   (Final data collection date for primary outcome measure)
Total All-cause Hospitalizations [ Time Frame: 1 year ]
The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).
  • Total Number of Hospitalization Claims per Nursing Home Based on Vaccination Status [ Time Frame: 1 year ]
    [Linked at the facility level] The primary outcome measure evaluates comparative vaccine effectiveness for hospitalization and mortality of HD vaccine to SD vaccine using Minimum Data Set (MDS).
  • Total Influenza Mortality per Nursing Home Based on Vaccination Status [ Time Frame: 1 year ]
    [Linked at the facility level] MDS will be used to determine influenza mortality.
Complete list of historical versions of study NCT01720277 on ClinicalTrials.gov Archive Site
Change in Residents' Functional Status [ Time Frame: 1 year ]
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.
  • Change in Activities of Daily Living (ADL) Scores per NH Resident by Vaccination Status [ Time Frame: 1 year ]
    [Linked at the resident level] The secondary outcome measure evaluates comparative vaccine effectiveness for functional status of HD vaccine compared to no or SD vaccine (using MDS). ADL score is a 4 point score (higher is more impaired) for 7 measured domains (maximum 28); 4 point change in composite score is significant. Residents at the highest levels of impairment will be excluded.
  • Difference in ADL Duration per NH Resident by Vaccination Status [ Time Frame: 1 year ]
    [Linked at the resident level] Using MDS.
  • New Coded Claims for Stroke, Heart Attack or Pneumonia for a NH Resident [ Time Frame: 1 year ]
    [Linked at the resident level] Using MDS, Medicare A and B.
Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size [ Time Frame: 1 year ]
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
Not Provided
 
High Dose Influenza Vaccine in Nursing Home - Pilot Study
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: HD Fluzone Vaccine
    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).
    Other Name: Fluzone High Dose influenza vaccine
  • Biological: SD Fluzone Vaccine
    Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
    Other Name: Fluzone influenza vaccine
  • Experimental: HD Fluzone Vaccine
    NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.
    Intervention: Biological: HD Fluzone Vaccine
  • Active Comparator: SD Fluzone Vaccine
    NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.
    Intervention: Biological: SD Fluzone Vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2957
210
May 2016
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01720277
GRC75-HD Nursing Home Pilot
No
Not Provided
Plan to Share IPD: No
Stefan Gravenstein, MD, MPH, Brown University
Insight Therapeutics, LLC
Brown University
Principal Investigator: Stefan Gravenstein, MD, MPH Case Western Reserve University
Principal Investigator: Ed Davidson, PharmD, MPH Insight Therapeutics, LLC
Principal Investigator: Vincent Mor, PhD Brown University
Insight Therapeutics, LLC
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP