Cluster randomised control trial protocol for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FLUCARE).
Amrish Patel, Erika Sims, Jeanette Blacklock, Linda Birt, Veronica Bion, Allan Clark, Alys Griffiths, Cecile Guillard, Amber Hammond, Richard Holland, Andy Jones, Liz Jones, Thando Katangwe-Chigamba, Jennifer Pitcher, Po Ruby, Sion Scott, Adam P Wagner, Saiqa Ahmed, Wasim Baqir, Luke Cook, Tony Dean, David Wright
Author Information
Amrish Patel: School of Economics, University of East Anglia, Norwich, UK. amrish.patel@uea.ac.uk. ORCID
Erika Sims: Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Jeanette Blacklock: School of Healthcare, University of Leicester, Leicester, UK.
Linda Birt: LOROS Associate Professor in Palliative Care and Frailty, University of Leicester, Leicester, UK.
Veronica Bion: Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Allan Clark: School of Medicine, University of East Anglia, Norwich, UK.
Alys Griffiths: Institute of Population Health, University of Liverpool, Liverpool, UK.
Cecile Guillard: Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Amber Hammond: Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Richard Holland: Leicester Medical School, University of Leicester, Leicester, UK.
Andy Jones: School of Medicine, University of East Anglia, Norwich, UK.
Liz Jones: Institute of Population Health, University of Liverpool, Liverpool, UK.
Thando Katangwe-Chigamba: Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Jennifer Pitcher: School of Economics, University of East Anglia, Norwich, UK.
Po Ruby: Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Sion Scott: School of Healthcare, University of Leicester, Leicester, UK.
Adam P Wagner: Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Saiqa Ahmed: Patient and Public Involvement Representative, NIHR Applied Research Collaboration North West Coast (ARC NWC), Liverpool, UK.
Wasim Baqir: Pharmacy Integration Programme, NHS England and Improvement, London, UK.
Luke Cook: Askham Village Community, Doddington, UK.
Tony Dean: Norfolk Local Pharmaceutical Committee, Great Bircham, UK.
David Wright: School of Healthcare, University of Leicester, Leicester, UK.
The care home staff influenza vaccination rate in England is significantly lower than the 75% World Health Organisation recommendation. This represents a substantial potential for resident harm. Barriers to staff vaccination stem from individual and organisational levels. Existing interventions address some but not all barriers and are not underpinned by behavioural science theory. This study aims to estimate the effectiveness and cost-effectiveness of a theory-informed intervention to improve care home staff vaccination rates compared to routine practice.Set in care homes with both nursing and residential focus, and a range of ownership status, only homes providing long stay care to older people with a staff vaccination rate below 40% are eligible to participate. Participation expressions of interest will be sought using a variety of approaches prior to seeking consent.The primary outcome measure is the proportion of staff vaccinated at 6 months, with secondary outcome measures being proportion vaccinated at 3 months, numbers of staff sick days, general practitioner and nurse visits to care home, care home resident hospitalisations and mortality.Based on the assumptions that the mean cluster (care home) size is 54 staff, a coefficient of variation of 0.48, control vaccination rate is 55%, intervention 75%, intra-cluster correlation coefficient of 0.2 and with 90% power, and 20% attrition, we require 39 care homes per arm.Blocked randomisation will be at the level of care home, stratified by the proportion of non-white care home staff, and implemented by Norwich Clinical Trials Unit.The intervention comprises co-designed information videos and posters, provision of in-house staff vaccination clinics, and incentive scheme and monthly data collection on trial outcomes. Beyond usual practice, the control arm will additionally contribute monthly data.Data will be collected at the start, monthly and at 6 months, and analysis will be blind to allocation. Statistical analysis will use the intention-to-treat principle with the difference in vaccination rates between groups compared using a random effect logistic regression model at the staff-level.This will be the first study to use a theory-informed intervention designed to comprehensively address identified barriers to care home staff influenza vaccination.Trial registration: ISRCTN ISRCTN22729870 . Registered on 24 August 22. Secondary identifiers: R209939, IRAS 316820, CPMS 53812.
