Multi-faceted intervention to improve management of antibiotics for children presenting to primary care with acute cough and respiratory tract infection (CHICO): efficient cluster randomised controlled trial

Abstract

Objective To assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections would reduce antibiotic dispensing, without increasing hospital admissions for respiratory tract infection. Design Two arm randomised controlled trial clustered by general practice, using routine outcome data, with qualitative and economic evaluations. Setting English primary care practices using the EMIS electronic medical record system. Participants Children aged 0-9 years presenting with respiratory tract infection at 294 general practices, before and during the covid-19 pandemic. Intervention Elicitation of parental concerns during consultation; a clinician focused prognostic algorithm to identify children at very low, normal, or elevated 30 day risk of hospital admission accompanied by antibiotic prescribing guidance; and a leaflet for carers including safety netting advice. Main outcome measures Rate of dispensed amoxicillin and macrolide antibiotics (superiority comparison) and hospital admissions for respiratory tract infection (non-inferiority comparison) for children aged 0-9 years over 12 months (same age practice list size as denominator). Results Of 310 practices needed, 294 (95%) were randomised (144 intervention and 150 controls) representing 5% of all registered 0-9 year olds in England. Of these, 12 (4%) subsequently withdrew (six owing to the pandemic). Median intervention use per practice was 70 (by a median of 9 clinicians). No evidence was found that antibiotic dispensing differed between intervention practices (155 (95% confidence interval 138 to 174) items/year/1000 children) and control practices (157 (140 to 176) items/year/1000 children) (rate ratio 1.011, 95% confidence interval 0.992 to 1.029; P=0.25). Pre-specified subgroup analyses suggested reduced dispensing in intervention practices with fewer prescribing nurses, in single site (compared with multisite) practices, and in practices located in areas of lower socioeconomic deprivation, which may warrant future investigation. Pre-specified sensitivity analysis suggested reduced dispensing among older children in the intervention arm (P=0.03). A post hoc sensitivity analysis suggested less dispensing in intervention practices before the pandemic (rate ratio 0.967, 0.946 to 0.989; P=0.003). The rate of hospital admission for respiratory tract infections in the intervention practices (13 (95% confidence interval 10 to 18) admissions/1000 children) was non-inferior compared with control practices (15 (12 to 20) admissions/1000 children) (rate ratio 0.952, 0.905 to 1.003). Conclusions This multifaceted antibiotic stewardship intervention for children with respiratory tract infections did not reduce overall antibiotic dispensing or increase respiratory tract infection related hospital admissions. Evidence suggested that in some subgroups and situations (for example, under non-pandemic conditions) the intervention slightly reduced prescribing rates but not in a clinically relevant way. Trial registration ISRCTN11405239ISRCTN registry ISRCTN11405239

Implementation of the CHIldren with acute COugh (CHICO) intervention to improve antibiotics management: a qualitative study in primary care

“… 4 , 5 Improved identification of children at low risk of future hospitalisation could increase the confidence not to prescribe antibiotics. To address this, the CHIldren with COugh (CHICO) cluster randomised controlled trial (RCT) (trial registration number: ISRCTN11405239) 6 , 7 evaluated whether unnecessary antibiotic prescribing could be reduced by providing an intervention to support clinicians’ decision making for antibiotic prescribing in children with RTIs in primary care. 8 , 9 …”

Twenty five years in the making: new evidence impacted by covid

“…To prevent post-randomisation recruitment bias in the fully powered cluster randomised controlled trial (RCT), published in The BMJ , we used routinely collected data, aggregated at GP practice level, to assess effectiveness, making individual patient recruitment and consent unnecessary 9. GP practice randomisation began in October 2018, but the 2020 pandemic lockdowns resulted in more remote assessments (with two STARWAVe factors requiring face-to-face assessment), and a dramatic reduction in respiratory infections 10.…”

Discovering the positives in healthcare

“…8 And discussion with patients, using a prognostic algorithm, and providing information could help GPs identify patients with respiratory tract infections who are at lower risk and do not need immediate antibiotic treatment (doi:10.1136/bmj-2022-072488). 9…”