Evaluation of a complex intervention to improve antibiotic prescribing for CHIldren presenting to primary care with acute COugh and respiratory tract infection: the CHICO randomised controlled trial
Problem
Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development of antimicrobial resistance. Our aim was to assess whether embedding a multifaceted intervention into general practice for children (aged 0-9 years) presenting with acute cough and RTI would reduce antibiotic dispensing without impacting (non-inferiority) on hospital attendance for RTI.
Approach
The GP-led intervention included: (1) explicit elicitation of parental concerns, (2) the results of a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. Intervention practices were compared with usual care over a 12 month period. This phase III ‘efficient’ trial used routinely collected data at the practice level, thus avoiding individual patient consent and post-randomisation recruitment bias. The intervention was embedded in practices using Egton Medical Information Systems (EMIS) web medical records. The practices were recruited using the NIHR Clinical Research Network (CRN). The co-primary outcomes were the practice rate of dispensed paediatric formulations for all indications of amoxicillin and macrolide antibiotics, and the hospital admission rate for RTIs using routinely collected data by Clinical Commissioning Groups (CCGs). The primary analysis was based on the intention-to treat principle.
Findings
Of the 310 practices required 294 (95%) were recruited (144 intervention and 150 controls) representing 336,496 registered 0-9 year-olds (5% of all 0-9 year-old children in England) from 47 CCGs. Included practices were slightly larger, had slightly lower baseline dispensing rates and were more deprived than the English average. Of the 294 practices 12 (4%) subsequently withdrew (6 because of lack of resources during the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians). The antibiotic dispensing rate in the intervention arm (0.155 [95% CI 0.135-0.179]) compared to the control arm (0.154 [95% CI 0.130-0.182]) was not significantly different (IRR: 1.011 (95% CI: 0.992-1.029); p=0.258). Sensitivity analyses (per protocol, excluding pilot practices, by age, clustering at the PCN level) and a priori sub-group analyses (proportion of locums or nurses, practice size, level of deprivation, previous dispensing rates) revealed no strong underlying differences although lower dispensing levels during the pandemic made this difficult to assess. The rate of hospitalisation over 12 months for RTI in the intervention group (0.019 [95% CI 0.014-0.026)]) compared to the control group (0.021 [95% CI 0.014-0.029) was non-inferior (RR: 0.952 [95% CI: 0.905-1.003]).
Consequences
There was no difference in hospitalisation rate or dispensing levels although the rate of intervention usage maybe an explanatory factor.