Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: Lessons learned.

ABSTRACT: Influenza severity increases and vaccine effectiveness decreases with age. High-dose influenza vaccine (HD) with quadruple the antigen of standard-dose (SD) vaccine is more efficacious in community-dwelling persons 65 years and older. We evaluated the feasibility of recruiting and randomizing Medicare certified nursing homes (NHs) for a pragmatic cluster-randomized trial comparing HD vs. SD (NCT1720277). Residents were long-stay and at least 65 years old. NH leadership agreed to standard of care random assignment with HD (Fluzone® High-Dose) or SD (Fluzone®) influenza vaccine for their facility for the 2012-2013 influenza season. We used Minimum Data Set (MDS) 3.0 and Vital Status records for pre-specified clinical outcomes: 1) all-cause hospitalization, 2) NH mortality, and 3) functional

SUBMITTER: Gravenstein S 

PROVIDER: S-EPMC5861801 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature