The CHICO (Children's Cough) Study
Research type
Research Study
Full title
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.
IRAS ID
149549
Contact name
Peter S Blair
Contact email
Sponsor organisation
University of Bristol
Clinicaltrials.gov Identifier
RP-PG-0608-10018, NIHR PGfAR reference number; 2014-000903-28, EuradRCT reference number
Research summary
Respiratory tract infections (RTIs) in children present a major health problem to health services internationally. There is clinical uncertainty in primary care regarding the diagnosis and best management of RTIs, parents feel they are not listened too and accurate information on symptom duration is not provided. We have designed a complex behavioural intervention, evidenced-based from the NIHR-funded TARGET Programme (of which this study is a part), which aims to change clinicians approach to conducting children's RTI consultations; it addresses parental concerns, provides a clinical prediction rule to identify the child's risk of hospitalisation and personalised information regarding symptom relief and clinical management.
This feasibility trial aims to assess whether the intervention is acceptable to clinicians and adequately recruits practices and patients to inform a much larger, national, trial of the intervention in primary care.
The study population is GP practices in the Bristol and West of England CRN locality. Practices will be recruited and randomly allocated into an 'intervention' or a 'control (usual care)'. Recruiting clinicians will then, in turn, recruit children aged = 3 months and < 12 years, presenting to primary care with a cough with RTI of 28 days (or less) via the group allocation process. The research will be undertaken as part of the normal care consultation.
Recruited parents and children will also provide weekly follow up data on symptoms, treatment, health resources and re-consultations until their symptoms have resolved or up to a maximum of 8 weeks, whichever is soonest. Once completed, their involvement in the study will be completed. Reviews of the recruited children's medical noted will be examined for re-consultations, hospitalisations and antibiotic prescriptions in the 30 days after recruitment. Interviews will be conducted with some clinicians and parents who have had experience of the intervention to understand their views.
REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/1034
Date of REC Opinion
13 Jun 2014
REC opinion
Favourable Opinion