This report summarises the research, as commissioned and as undertaken, and lessons learned in the FIREFLI randomised controlled trial. Due to challenges conducting the study, we were unable to recruit sufficient participants to the trial. Background Fire and rescue services in England routinely carry out home fire safety visits which aim to reduce risk of fire, support independent living and improve quality of life. The visits include a person-centred assessment and providing general advice on health-related topics such as preventing falls. Planned objective To assess the effectiveness and cost-effectiveness of Home Fire Safety Visits (also known as Safe and Well Visits) to reduce falls and improve quality of life in older adults living in the community. Design, setting and participants We designed a multicentre, randomised controlled trial with economic and qualitative evaluations, involving two fire and rescue services in England, to recruit 1156 community dwelling adults aged 65 years and over. Interventions All participants could continue to access routine care from healthcare professionals and were provided with a falls prevention leaflet as part of the trial. The intervention group were additionally offered a Home Fire Safety Visit. The usual care group were offered a visit after they had completed the trial. Blinding was not possible. Participants were randomised 1:1 using a secure web-based system. Main outcomes measures The primary outcomes were (i) the number of falls per participant and (ii) health-related quality of life (EQ-5D-5L) over 12 months from randomisation. Secondary outcomes included fire risk taking behaviours, loneliness, fear of falling and time to first fall. The planned economic evaluation comprised cost-utility and cost-effectiveness analyses. The qualitative study was designed to examine intervention fidelity and acceptability. Results It proved impossible to conduct the trial as planned in the current research landscape. We faced significant delays in setting up and starting recruitment, in large part due to this coinciding with the start of the COVID-19 pandemic. Obtaining regulatory approval took longer than anticipated. Additionally, we were unable to access GP registration data to identify participants as planned and so we had to use Consumer Classification Platform data to identify potential households to send study invitations to. This resulted in a less targeted and non-personalised mail-out as this is not patient level data so the householder names were unavailable. Ultimately, recruitment was much lower than expected. In total, 237 participants were assessed for eligibility and 63 randomised (intervention, n=32; usual care, n=31). The Home Fire Safety Visits were delivered as planned to both groups; however, the planned statistical and health economic analyses could not be conducted due to the limited data. Data from the qualitative evaluation indicated the intervention was largely acceptable to staff and service users. Conclusions Conducting trials in this setting is currently extremely challenging. To facilitate future research, we recommend an urgent review of research governance issues related to the types of personal data that can be used and accessed for research. This review should aim to provide support and avoid creating additional obstacles to research in this area. Future work The evidence for the effectiveness and cost-effectiveness of Home Fire Safety Visits remains inconclusive. Research governance in local authorities needs urgent review. Study registration ClinicalTrials.gov: NCT 04717258 Funding This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research (PHR) programme and will be published in full in Public Health Research; Vol. XX, No. XX. See the NIHR Journals Library website for further project information.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)