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

Human Vaccines & Immunotherapeutics
Stefan GravensteinVincent Mor

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 decline. Intent-to-treat analyses were performed at the resident-level using Cox proportional hazards, multivariable Poisson, and logistic regression models accounting for clustering by facility. We randomized 39 NHs (19 SD and 20 HD), coordinated vaccine delivery, implemented web-based data collection, and accessed MDS data, demonstrating feasibility. There were 2,957 eligible residents (SD 1496; HD 1461); characteristics were similar between...Continue Reading

References

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Citations

Mar 20, 2018·Human Vaccines & Immunotherapeutics·Susanna Esposito
Jan 29, 2019·Expert Review of Vaccines·Sandrine I SamsonRosalind Hollingsworth
Jul 11, 2019·Expert Review of Vaccines·Charlotte SwitzerMark Loeb
Jun 27, 2020·Journal of the American Geriatrics Society·Heather G AlloreThomas G Travison
Aug 14, 2020·Deutsche medizinische Wochenschrift·Anja KwetkatHans Jürgen Heppner
Feb 8, 2021·Vaccine·Mia DiacoSandrine I Samson
Mar 20, 2021·Vaccine·Manish SadaranganiSoren Gantt
Feb 20, 2019·Journal of the American Medical Directors Association·Theresa I ShiremanStefan Gravenstein
Nov 3, 2021·Journal of Medical Economics·Richard MattockFabián P Alvarez

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Methods Mentioned

BETA
MDS

Clinical Trials Mentioned

NCT01720277

Software Mentioned

OSCAR

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