The CHIldren with COugh Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Respiratory tract infections; Infections and Infestations; Other infectious diseases

• Registration Number: ISRCTN11405239
• Lead Sponsor: niversity of Bristol

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33782018/ (added 31/03/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35777876/ (added 04/07/2022) 2023 Results article in https://doi.org/10.1136/bmj-2022-072488 (added 27/04/2023) 2023 Results article in https://doi.org/10.3310/ucth3411 (added 11/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-20
• Study Completion: 2021-12-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

The CHICO RCT will recruit GP practices from 15 Clinical Commissioning Groups (CCGs) from demographically diverse regions across England. The population studied will be all children aged 0-9 years registered at practices using the EMISWeb system. The recruitment of practices will be via CCGs using established channels of communication. An internal pilot phase lasting 3 months and using 3 CCGs will help establish best practice for recruiting and communicating with practices before widening to the remaining CCGs over a staggered 4-month recruitment period.

Exclusion Criteria

Practices will be asked directly whether they are participating in any antimicrobial stewardship activities during the study period and these will be recorded. If these activities involve concurrent intervention studies where there is potential to confound or modify the effects of our intervention, these practices will be excluded.

Children aged 10-14 were considered for inclusion but at this age an increasing number are given antibiotics in tablet form and given the much lower consultation rate in older children the research team decided to exclude this group from the study population.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The annual rate of dispensed amoxicillin and macrolide prescribed for children (aged 0-9 years registered at the start of the designated period) at each practice over a 12-month period<br>2. The rate of hospital admission for RTI amongst children aged 0-9 years over a 12-month period

Secondary Outcome Measures

Name	Time	Method
1. ED attendance rates for RTI over a 12-month period<br>2. The costs to the NHS of using the CHICO intervention in a cost-consequence analysis<br>3. Proportion of locums used in the practice<br>4. Practice antibiotic dispensing rates in 12 months prior to recruitment<br>5. Effects of the CHICO intervention on practices with GP prescribers only and those with nurse prescribers as well<br>6. Effects of the CHICO intervention on different child age groups (5-year epochs)<br>7. Use of the CHICO intervention by practice and over time in terms of both usage over a 12-month period and seasonality<br>8. The acceptability and the use of the intervention, how it was embedded into practice and whether it was used, assessed using qualitative interviews with clinicians. The CCG staff interviews will be exploring how well practices embedded the intervention into their systems and daily life from their perspective