High Dose Influenza Vaccine in Nursing Home

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brown University
Healthcentric Advisors
Case Western Reserve University
Information provided by (Responsible Party):
Stefan Gravenstein, MD, MPH, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01720277
First received: October 15, 2012
Last updated: January 9, 2013
Last verified: January 2013

October 15, 2012
January 9, 2013
September 2012
April 2013   (final data collection date for primary outcome measure)
  • Total Number of Hospitalization Claims per Nursing Home Based on Vaccination Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    [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 ] [ Designated as safety issue: No ]
    [Linked at the facility level] MDS will be used to determine influenza mortality.
Same as current
Complete list of historical versions of study NCT01720277 on ClinicalTrials.gov Archive Site
  • Change in Activities of Daily Living (ADL) Scores per NH Resident by Vaccination Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    [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 ] [ Designated as safety issue: No ]
    [Linked at the resident level] Using MDS.
  • New Coded Claims for Stroke, Heart Attack or Pneumonia for a NH Resident [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    [Linked at the resident level] Using MDS, Medicare A and B.
Same as current
Not Provided
Not Provided
 
High Dose Influenza Vaccine in Nursing Home
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.

Lower respiratory tract infection (LRI), which includes pneumonia, bronchitis, and tracheobronchitis, is the leading cause of mortality and hospitalization in older adults and nursing home (NH) residents. Often, the signs and symptoms of pneumonia, in particular, are not apparent in elderly patients, making diagnosis more complicated. In addition, clinician visits to these residents are few and sporadic and radiological facilities are not readily available. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks during which influenza peaks each year.

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 HD 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.

The primary objective is to:

  1. estimate the differences in all-cause hospitalization rates during flu season experienced by long stay nursing home residents, in facilities using the HD vaccine vs. facilities using the SD vaccine, as pilot data to inform feasibility, design and power calculation for a subsequent larger study.
  2. To develop estimates, at the nursing home resident level, about the relationship between influenza vaccination status (none, SD, HD) and Medicare Minimum Data Set (MDS) coded claims for all-cause hospitalization and overall mortality among the long-stay residents from a single season 2012-2013, for use in a subsequent longitudinal evaluation of national nursing home data and regional publicly reported influenza severity.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: HD Fluzone Vaccine
  • Biological: SD Fluzone 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
  • Experimental: Free SD Fluzone Vaccine
    NH facilities randomized to receive free SD influenza vaccine (SD Fluzone) for the staff.
    Intervention: Biological: SD Fluzone Vaccine
  • No Intervention: No Free Vaccine
    NH facilities randomized not to receive free influenza vaccine for the staff.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
210
September 2013
April 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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01720277
GRC75-HD Nursing Home Pilot
No
Stefan Gravenstein, MD, MPH, Case Western Reserve University
Insight Therapeutics, LLC
  • Brown University
  • Healthcentric Advisors
  • Case Western Reserve 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
Principal Investigator: Gail Patry, RN Healthcentric Advisors
Insight Therapeutics, LLC
January 2013

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