Evidence map›Paper›PMID 37715262›Full record

ArticleTrials2023

Protocol of the process evaluation of cluster randomised control trial for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FluCare).

Linda Birt, Thando Katangwe-Chigamba, Sion Scott, David J Wright, Adam P Wagner, Erika Sims, Veronica Bion, Carys Seeley, Faisal Alsaif, Allan Clarke and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 14% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. 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

14 authors at 3 institutions in 1 country.

Linda BirtSchool of Healthcare, University of Leicester, Leicester, UK. linda.birt@leicester.ac.uk.ORCID http://orcid.org/0000-0002-4527-4414
Thando Katangwe-ChigambaNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Sion ScottSchool of Healthcare, University of Leicester, Leicester, UK.
David J WrightSchool of Healthcare, University of Leicester, Leicester, UK.
Adam P WagnerNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Erika SimsNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Veronica BionNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Carys SeeleyNorwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
Faisal AlsaifSchool of Pharmacy, University of East Anglia, Norwich, UK.
Allan ClarkeNorwich Medical School, University of East Anglia, Norwich, UK.
Alys GriffithsInstitute of Population Health, University of Liverpool, Liverpool, UK.
Liz JonesInstitute of Population Health, University of Liverpool, Liverpool, UK.
Alison BryantInstitute of Population Health, University of Liverpool, Liverpool, UK.
Amrish PatelSchool of Economics, University of East Anglia, Norwich, UK.
University of East Anglia · GBUniversity of Leicester · GBUniversity of Liverpool · GB

Funding

Public Health Research Programme NIHR133455
6 · The paper itself

Abstract

backgroundInfluenza (flu) vaccination rates in UK care home staff are extremely low. Less than 40% of staff in care homes are vaccinated for influenza (flu), presenting risks to the health of frail residents and potential staff absence from cross-infection. Staff often do not perceive a need for vaccination and are unaware they are entitled to free flu vaccination. The FluCare study, a cluster randomised control trial (RCT), uses behavioural interventions to address barriers. Videos, posters, and leaflets are intended to raise awareness of flu vaccination benefits and debunk myths. On-site staff vaccination clinics increase accessibility. Financial incentives to care homes for improved vaccination rates and regular monitoring influence the environment. This paper outlines the planned process evaluation which will describe the intervention's mechanisms of action, explain any changes in outcomes, identify local adaptations, and inform design of the implementation phase. METHODS/

designA mixed method process evaluation to inform the interpretation of trial findings.

objectives• Describe the intervention as delivered in terms of dose and fidelity, including adaptations and variations across care homes. • Explore the effects of individual intervention components on primary outcomes. • Investigate the mechanisms of impact. • Describe the perceived effectiveness of relevant intervention components (including videos, leaflets, posters, and flu clinics) from participant perspectives (care home manager, care home staff, flu clinic providers). • Describe the characteristics of care homes and participants to assess reach. A purposive sample of twenty care homes (ten in the intervention arm, ten in the control arm) for inclusion in the process evaluation. Data will include (1) study records including care home site profiles, (2) responses to a mechanism of action questionnaire, and (3) semi-structured interviews with care home staff and clinic providers. Quantitative data will be descriptively reported. Interview data will be thematically analysed and then categories mapped to the Theoretical Domains Framework. DISCUSSION: Adopting this systematic and comprehensive process evaluation approach will help ensure data is captured on all aspects of the trial, enabling a full understanding of the intervention implementation and RCT findings.

trial registrationISRCTN ISRCTN22729870. Registered on 24 August 2022.

Indexed as

Influenza, HumanAmbulatory Care FacilitiesBehavior TherapyCost-Benefit AnalysisHumansRandomized Controlled Trials as TopicVaccinationCare homesEmployeesInfluenza vaccinationLong-term care facilitiesNursing homesResidential homesStaff

Identifiers

PMID37715262
PMCPMC10503150
OpenAlexW4386776974

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.