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

Cathy Williams*, Anna Pease, Trudy Goodenough, Katie Breheny, Daisy Gaunt, Parisa Sinai, Rose Watanabe

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

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Abstract

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.
Original languageEnglish
Article numbere044830
Number of pages8
JournalBMJ Open
Volume11
Issue number5
DOIs
Publication statusPublished - 5 May 2021

Bibliographical note

Funding Information:
Contributors CW: designed and led the study, with input from all authors; AP and TG: led and designed the process evaluation; PS: provided governance support; RW: managed the databases; KB: designed and led the economic evaluation; DG: provided statistical support. All authors contributed to and approved the final manuscript. Funding This study presents independent research funded by the National Institute for Health Research (NIHR) Senior Fellowship award SRF_2015_08_005.

Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.

Structured keywords

  • BRTC

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