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Publication - Dr Niamh Redmond

    The CHICO (Children’s Cough) Trial protocol

    A feasibility randomised controlled trial investigating the clinical and cost effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection

    Citation

    Turnbull, S, Redmond, NM, Lucas, P, Cabral, C, Ingram, J, Hollinghurst, S, Hay, A, Peters, T, Horwood, J, Little, P, Francis, N & Blair, P, 2015, ‘The CHICO (Children’s Cough) Trial protocol: A feasibility randomised controlled trial investigating the clinical and cost effectiveness of a complex intervention to improve the management of children presenting to primary care with acute respiratory tract infection’. BMJ Open, vol 5.

    Abstract

    Introduction
    While most respiratory tract infections (RTIs) will resolve without treatment, many children will receive antibiotics and some will develop severe symptoms requiring hospitalisation. There have been calls for evidence to reduce uncertainty regarding the identification of children who will and will not benefit from antibiotics. The aim of this feasibility trial is to test recruitment and the acceptance of a complex behavioural intervention designed to reduce antibiotic prescribing and to inform how best to conduct a larger trial.
    Methods and analysis
    The CHICO trial is a single-centre feasibility cluster randomised controlled trial comparing a web-based, within-consultation, behavioural intervention with usual care for children presenting to GP practices with RTI and acute cough. The trial aims to recruit at least 300 children between October 2014 and April 2015, in a single area in South West England. Following informed consent, demographic information will be recorded and symptoms and signs measured. Parents/carers of recruited children will be followed up on a weekly basis to establish symptom duration, resource use and cost of the illness to the parent, until the child’s cough has resolved or up to 8 weeks, whichever occurs soonest. A review of medical notes including clinical history, primary care re-consultation and hospitalisations will be undertaken two months after recruitment. The trial feasibility will be assessed by: determining acceptability of the intervention to clinicians and parent/carers; quantifying differential recruitment and follow-up; determining intervention fidelity; success in gathering the data necessary to conduct a cost effectiveness analysis; and by collecting data about antibiotic prescribing rates to inform the sample size needed for a fully powered RCT.

    Ethics and dissemination
    The study was approved by the North West – Haydock Research Ethics Committee, UK (reference number: 14/NW/1034). The findings from this feasibility trial will be disseminated through research conferences and peer-reviewed journals.

    Trial registration: ISRCTN23547970
    UKCRN study ID: 16891

    Full details in the University publications repository