Methods/design: A mixed method process evaluation to inform the interpretation of trial findings.
• 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.
- Care homes
- Influenza vaccination
- Long-term care facilities
- Nursing homes
- Residential homes