Improving outcomes for primary school children at risk of cerebral visual impairment (the CVI project): protocol of a feasibility study for a cluster-randomised controlled trial and health economic evaluation.

INTRODUCTION: Cerebral visual impairment (CVI) refers to a spectrum of brain-related vision problems. CVI is associated with poor educational and mental health outcomes. An intervention has been developed to help children with CVI, involving input from clinicians, teachers and parents. The effectiveness of this intervention needs to be evaluated. This study aims to guide any refinements to the intervention or the design of a future cluster-randomised trial that may be needed. METHODS AND ANALYSIS: This study will include all methods anticipated for a future cluster-randomised controlled trial. Eight primary schools will be recruited and randomised to receive the intervention or carry on with usual practice. The intervention will comprise an information pack for schools and access to a local paediatric ophthalmology clinic (who are prepared to assess them for CVI), for up to 5% of participating children. Outcome assessments will be carried out at baseline (before randomisation) and after 4-5 months of intervention period. Assessments will include children's self-reported quality of life, their learning ability and behaviour as reported by teachers, and family functioning reported by parents. Cost data will include service use, family expenditure on additional support (eg, private appointments and administration) and school spending and resource used in helping children with special educational needs or disability. A process evaluation (PE) will collect additional data relating to the implementation of the intervention and the trial processes, in the school and clinic settings. The protocol for the PE will be reported separately. ETHICS AND DISSEMINATION: Ethical permission was obtained from the University of Bristol Faculty of Health Sciences Ethical Committee. The results will inform the design of a future trial to assess the effectiveness and cost-effectiveness of the intervention and will be shared with participants, CVI-support groups and peer-viewed journals. TRIAL REGISTRATION NUMBER: ISRCTN13762177; Pre-results.

Implementing an Injury Prevention Briefing to aid delivery of key fire safety messages in UK children's centres: qualitative study nested within a multi-centre randomised controlled trial.

BACKGROUND: To improve the translation of public health evidence into practice, there is a need to increase practitioner involvement in initiative development, to place greater emphasis on contextual knowledge, and to address intervention processes and outcomes. Evidence that demonstrates the need to reduce childhood fire-related injuries is compelling but its translation into practice is inconsistent and limited. With this knowledge the Keeping Children Safe programme developed an "Injury Prevention Briefing (IPB)" using a 7 step process to combine scientific evidence with practitioner contextual knowledge. The IPB was designed specifically for children's centres (CCs) to support delivery of key fire safety messages to parents. This paper reports the findings of a nested qualitative study within a clustered randomised controlled trial of the IPB, in which staff described their experiences of IPB implementation to aid understanding of why or how the intervention worked. METHODS: Interviews were conducted with key staff at 24 CCs participating in the two intervention arms: 1) IPB supplemented by initial training and regular facilitation; 2) IPB sent by post with no facilitation. Framework Analysis was applied to these interview data to explore intervention adherence including; exposure or dose; quality of delivery; participant responsiveness; programme differentiation; and staff experience of IPB implementation. This included barriers, facilitators and suggested improvements. RESULTS: 83% of CCs regarded the IPB as a simple, accessible tool which raised awareness, and stimulated discussion and behaviour change. 15 CCs suggested minor modifications to format and content. Four levels of implementation were identified according to content, frequency, duration and coverage. Most CCs (75%) achieved 'extended' or 'essential' IPB implementation. Three universal factors affected all CCs: organisational change and resourcing; working with hard to engage groups; additional demands of participating in a research study. Six specific factors were associated with the implementation level achieved: staff engagement and training; staff continuity; adaptability and flexibility; other agency support; conflicting priorities; facilitation. CCs achieving high implementation levels increased from 58% (no facilitation) to 92% with facilitation. CONCLUSION: Incorporating service provider perspectives and scientific evidence into health education initiatives enhances potential for successful implementation, particularly when supplemented by ongoing training and facilitation.