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
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: HD Fluzone Vaccine
Biological: SD Fluzone Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation

Resource links provided by NLM:


Further study details as provided by Insight Therapeutics, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 210
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HD Fluzone Vaccine
NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.
Biological: HD Fluzone Vaccine
Active Comparator: SD Fluzone Vaccine
NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.
Biological: SD Fluzone Vaccine
Experimental: Free SD Fluzone Vaccine
NH facilities randomized to receive free SD influenza vaccine (SD Fluzone) for the staff.
Biological: SD Fluzone Vaccine
No Intervention: No Free Vaccine
NH facilities randomized not to receive free influenza vaccine for the staff.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720277

Locations
United States, Rhode Island
Brown Univeristy
Providence, Rhode Island, United States, 02903
United States, Virginia
Insight Therapeutics
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Insight Therapeutics, LLC
Brown University
Healthcentric Advisors
Case Western Reserve University
Investigators
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
  More Information

Publications:
Gozalo PL, Pop-Vicas A, Feng Z, Gravenstein S, Mor V. The impact of influenza on functional decline. J Amer Geriatr Soc. 2012 Jul;60(7):1260-7.

Responsible Party: Stefan Gravenstein, MD, MPH, Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01720277     History of Changes
Other Study ID Numbers: GRC75-HD Nursing Home Pilot
Study First Received: October 15, 2012
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Insight Therapeutics, LLC:
Randomized Controlled Trial
Influenza
Influenza vaccine
Flu Vaccine
Fluzone
HD Fluzone
Nursing Homes
Hospitalization
Mortality
Health Care worker vaccination
ADL decline
Pilot
Effectiveness

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014