Evidence map›Paper›PMID 36494824›Full record

ArticleTrials2022

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 and 12 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Tailored interventions to address determinants of practice.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 6 institutions in 1 country.

Amrish PatelSchool of Economics, University of East Anglia, Norwich, UK. amrish.patel@uea.ac.uk.ORCID http://orcid.org/0000-0002-2374-6409
Erika SimsNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Jeanette BlacklockSchool of Healthcare, University of Leicester, Leicester, UK.
Linda BirtLOROS Associate Professor in Palliative Care and Frailty, University of Leicester, Leicester, UK.
Veronica BionNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Allan ClarkSchool of Medicine, University of East Anglia, Norwich, UK.
Alys GriffithsInstitute of Population Health, University of Liverpool, Liverpool, UK.
Cecile GuillardNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Amber HammondNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Richard HollandLeicester Medical School, University of Leicester, Leicester, UK.
Andy JonesSchool of Medicine, University of East Anglia, Norwich, UK.
Liz JonesInstitute of Population Health, University of Liverpool, Liverpool, UK.
Thando Katangwe-ChigambaNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Jennifer PitcherSchool of Economics, University of East Anglia, Norwich, UK.
Po RubyNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Sion ScottSchool of Healthcare, University of Leicester, Leicester, UK.
Adam P WagnerNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Saiqa AhmedPatient and Public Involvement Representative, NIHR Applied Research Collaboration North West Coast (ARC NWC), Liverpool, UK.
Wasim BaqirPharmacy Integration Programme, NHS England and Improvement, London, UK.
Luke CookAskham Village Community, Doddington, UK.
Tony DeanNorfolk Local Pharmaceutical Committee, Great Bircham, UK.
David WrightSchool of Healthcare, University of Leicester, Leicester, UK.
University of East Anglia · GBUniversity of Leicester · GBUniversity of Liverpool · GBDoddington Hospital · GBNHS EnglandNIHR Research Delivery Network · GB

Funding

Public Health Research Programme NIHR133455
6 · The paper itself

Abstract

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.

Indexed as

Influenza, HumanAgedCost-Benefit AnalysisHospitalizationHumansRandomized Controlled Trials as TopicVaccinationCare homesEmployeesInfluenza vaccinationLong-term care facilitiesNursing homesRandomised controlled trialResidential homesStaff

Identifiers

PMID36494824
PMCPMC9733011
OpenAlexW4311678536

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.