Estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates

Conditions

Influenza vaccination in care home staff Infections and Infestations Influenza and pneumonia

Katangwe-Chigamba T, Alsaif F, Anyiam-Osigwe A, Bion V, Clark A, Garrett H, Griffiths AW, Guillard C, Hammond A, Holland R, Jones L, Patel A, Pitcher J, Risebro H, Scott S, Seeley C, Sims E, Stirling S, Wagner A, Wright D, Birt L.

2025-08-21

10.1186/s12913-025-13298-0

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 Wright, Adam P. Wagner et al. (14 authors)

Trials2023-09-154 citations

10.1186/s13063-023-07613-5

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).

Patel A, Sims E, Blacklock J, Birt L, Bion V, Clark A, Griffiths A, Guillard C, Hammond A, Holland R, Jones A, Jones L, Katangwe-Chigamba T, Pitcher J, Ruby P, Scott S, Wagner AP, Ahmed S, Baqir W, Cook L, Dean T, Wright D.

2022-12-096 citations

10.1186/s13063-022-06925-2

Interventions

In this study the researchers will recruit 78 care homes in England. Stratified randomisation will be used. The sequence will be generated using REDCAP based on stratified randomisation with a binar

information/videos for staff

regular monitoring and feedback

financial incentives for managers. The intervention duration is October 2022 to March 2023, and follow-up data collection (for both arms) will last 1 month after the intervention ends. Added 09/07/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Care homes (CHs): 1. Registered to provide care for older residents, which may include people with dementia 2. Self-reported staff vaccination rate <40% 3. Must be signed up or willing to sign up to the DHSC Capacity Tracker and willing to submit weekly updates on flu vaccine status of staff and residents Added 09/07/2024: Community pharmacies: 1. Has an ongoing relationship with a care home that meets the CH inclusion/exclusion criteria 2. Willing to provide flu vaccinations within the care home to all directly employed care home staff 3. Have adequate staff available to deliver a flu vaccination clinic within the care home

Exclusion criteria

Exclusion criteria: 1. Fewer than 10 staff members (as insufficient qualitative and quantitative data likely to be produced) 2. Participated in the FluCare feasibility trial Added 09/07/2024: 3. Planning a flu vaccination initiative similar to the FluCare intervention 4. Participated in FluCare feasibility or randomised controlled study

Design outcomes

Primary

Measure	Time frame
Staff flu vaccination rate: the total number of staff vaccinated in a flu season over the total number of staff employed at any point throughout that flu season (all directly contracted staff (care staff, cleaners, cooks, administrative staff) + agency staff), measured using anonymised staff data logs on a monthly basis, starting at baseline for 6 months or until the end of March 2023, whichever is the earliest	—

Measure

Time frame

Staff flu vaccination rate: the total number of staff vaccinated in a flu season over the total number of staff employed at any point throughout that flu season (all directly contracted staff (care staff, cleaners, cooks, administrative staff) + agency staff), measured using anonymised staff data logs on a monthly basis, starting at baseline for 6 months or until the end of March 2023, whichever is the earliest

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Secondary

Measure	Time frame
Measured using anonymised staff data logs and aggregated resident data logs on a monthly basis, for 6 months or until the end of March 2023, whichever is the earliest: 1. Staff flu vaccination rate disaggregated by caregiving and non-caregiving roles at the end of November 2. Number of staff sick days 3. GP and nurse visits to care home 4. Care home resident hospitalisations 5. Care home resident mortality Health economic outcomes: 1. Intervention delivery costs We will conduct a within-trial (i.e., up to the 6 months of the trial) cost-consequences analysis (CCA) comparing costs and outcomes between trial arms across different perspectives/stakeholders (e.g., care homes, NHS and staff). CCA is a standard evaluation approach recognized as being particularly useful for evaluating interventions that have impacts on multiple domains of outcome and perspectives. We will determine the resources involved in, and associated costs of, delivering the FluCare intervention. Resources required for intervention delivery are expected to consist primarily of clinician time to deliver the FluCare clinics and the vaccinations. Information on these and other resources will be collected from clinic logs, process evaluation and augmented with expert opinion as needed. Resources will be costed in the most recent cost year for which published NHS and PSS unit costs are available. Process evaluation outcomes: 1. The amount (or dose) of the intervention delivered to each home In Intervention care homes the dose of intervention material will be described - 1.1. No. of times videos played (embedded in videos) 1.2. Where posters displayed and engagement with them (interviews at the end of study) 1.3. No. of pharmacy visits to homes (pharmacist logs completed and returned after each clinic) 1.4. Length and time of pharmacist/healthcare practitioner visits to home (Vaccination log completed and returned after each clinic) 1.5. No. of incentive payments made to homes (study records at	—

Measure

Time frame

Measured using anonymised staff data logs and aggregated resident data logs on a monthly basis, for 6 months or until the end of March 2023, whichever is the earliest: 1. Staff flu vaccination rate disaggregated by caregiving and non-caregiving roles at the end of November 2. Number of staff sick days 3. GP and nurse visits to care home 4. Care home resident hospitalisations 5. Care home resident mortality Health economic outcomes: 1. Intervention delivery costs We will conduct a within-trial (i.e., up to the 6 months of the trial) cost-consequences analysis (CCA) comparing costs and outcomes between trial arms across different perspectives/stakeholders (e.g., care homes, NHS and staff). CCA is a standard evaluation approach recognized as being particularly useful for evaluating interventions that have impacts on multiple domains of outcome and perspectives. We will determine the resources involved in, and associated costs of, delivering the FluCare intervention. Resources required for intervention delivery are expected to consist primarily of clinician time to deliver the FluCare clinics and the vaccinations. Information on these and other resources will be collected from clinic logs, process evaluation and augmented with expert opinion as needed. Resources will be costed in the most recent cost year for which published NHS and PSS unit costs are available. Process evaluation outcomes: 1. The amount (or dose) of the intervention delivered to each home In Intervention care homes the dose of intervention material will be described - 1.1. No. of times videos played (embedded in videos) 1.2. Where posters displayed and engagement with them (interviews at the end of study) 1.3. No. of pharmacy visits to homes (pharmacist logs completed and returned after each clinic) 1.4. Length and time of pharmacist/healthcare practitioner visits to home (Vaccination log completed and returned after each clinic) 1.5. No. of incentive payments made to homes (study records at

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Countries

England, United Kingdom

Contacts

Public ContactErika Sims

e.sims@uea.ac.uk+44 (0)1603597178

Outcome results

None listed