Title: A clinical effectiveness investigation of a multi-faceted intervention (incorporating a prognostic algorithm) to improve management of antibiotics for CHIldren presenting to primary care with acute COugh and respiratory tract infection (CHICO): an efficient cluster RCT informed by a feasibility RCT
Funder: Department of Health and Social Care

Abstract: Design The CHICO RCT is a two-arm (intervention vs usual care) trial with randomisation clustered at practice level to investigate antibiotic prescribing and hospitalisation among children with RTI using routinely collected data. Literature Review Recent extensive reviews already conducted will be updated. Setting 310 general practices in 20 CCGs in England. Target population Children aged 0-9 years presenting with acute cough & RTI. Inclusion/exclusion criteria Practices using the EMIS record management software not involved in concurrent antimicrobial stewardship interventional studies that would directly effect the intervention proposed. Health technology being assessed A multi-faceted intervention including a prognostic algorithm to predict hospitalisation (predictors include: age<2 yrs, current asthma, illness duration<4 days, vomiting, fever or high temperature, inter/subcostal recession & wheeze) and a personalised printout for the carer including details of the consultation and safety-netting information. The intervention will be embedded in the practice software system with low-key pop-ups for eligible children. Feedback to clinicians on the frequency of intervention use will be via practice based champions. Measurement of cost and outcomes The co-primary outcomes will be the change in rate of oral liquid antibiotic items (amoxicillin and macrolide) per 100 children aged 0-9 years per practice over 12 months and whether hospital admission rates were equivalent. Secondary outcomes will include Emergency Department attendance, variation in dispensing rates by clinician type, proportion of locums used, dispensing rates prior to the trial, child age groups and over time. A qualitative evaluation will explore the acceptability of the intervention to clinicians and how to roll it out to the NHS. The economic evaluation will be a between-arm comparison of mean NHS costs in a cost-consequence analysis. Sample size calculation Based on 90% power, a two-sided alpha of 0.025, an intra-cluster correlation coefficient of 0.03 and an estimated coefficient of variation of 0.65 (for cluster size variation) suggests 155 practices would be needed in each arm to detect a minimum reduction from 33 (estimated from current CCG routine data) to 29 antibiotics per 100 children aged 0-9 years and hospital admission rates for RTI (estimated currently as ~ 1%) to be no more than 1% different between arms. Difference between current and planned care pathways The current standard patient care pathway will be used in the control arm. Encouraging clinicians via the intervention to adhere more strictly to the current NICE guidelines of a ‘no antibiotic’ strategy may reduce antibiotic prescribing in that arm. Project timetables including recruitment rate The project will start March 2018 and run for 33 months. We will allow 6 months for trial set-up, 21 months for staggered recruitment and data collection within each CCG (including a 3 month internal pilot) and 6 months for data cleaning, analysis, writing and dissemination to November 2020. Expertise in team Co-applicants include 2 senior academic GPs with experience of large trials, a GP with experience of utilising the EMIS system, a Professor of Public Health with experience in using electronic record systems, a senior statistician, a behavioural scientist, a health economist, qualitative researchers, study design experts and a prescribing advisor (national project lead for Antimicrobial Resistance NHS Improvement)

Lay abstract: Background to the research Coughs and colds (also known as respiratory tract infections or ‘RTIs’) are the most common reason that children are taken to family doctors and nurses (from here on ‘clinicians’). Clinicians are not always sure how best to treat them and often use antibiotics ‘just in case’. There are now concerns that clinicians are using antibiotics too often, and that this is increasing the number of resistant bugs (bacteria that can’t be killed by antibiotics). From a 5 year programme of NIHR funded work, we developed an intervention that helps clinicians to know which children are very unlikely to benefit from an antibiotic. We showed that seven symptoms can be used to predict which children will and won’t be hospitalised for their RTI. We wish to see if using a scoring system, listening to parents’ concerns and giving them a personalised leaflet with care and safety advice, reduces the number of antibiotics collected by parents at pharmacies. Our preparatory study of 500 children (conducted as part of our 5 year programme) showed our intervention was quick, technically reliable, widely used and acceptable. Aims of the research We aim to get all clinicians in a group of practices to use the intervention for all children with cough or RTI. We will compare with another group of practices where the clinicians are providing usual care. We will use the data routinely collected by the NHS to work out if antibiotic dispensing levels are different between these groups, while hospitalisation rates stay the same. The main aim of the study is to see if our intervention is effective, safe and easy to use. Design and methods used We will use 20 of the 200 or so Clinical Commissioning Groups (CCGs) in England to recruit 310 practices and half of them will be randomised to use the intervention. We will use ‘practice champions’ (individual pharmacists or clinicians at each practice) in the intervention group to encourage its use and feedback how well they are doing during the study. We will also embed the intervention within the computer systems already used at each practice for ease of access. The main two outcomes will be the rate of dispensing of oral liquid antibiotics for children aged 0-9 years, using routinely reported NHS dispensing data and whether there is any difference in the number of children admitted to hospital for RTIs. This information does not report any patient details. We will also look to see if there are any differences in dispensing rates between different staff, in different ages of the children, the longer the intervention is used and how different this is from earlier dispensing rates before the trail. Patient and public involvement Throughout our 5 year programme we took advice from both our parent and clinician advisory groups on how to develop the intervention, how to collect the data and how to improve the consultation between parents and clinicians. Similar involvement will be included in the full trial. Our newly formed parent advisory group will meet throughout the study and we will also form a clinician and pharmacist advisory group to assist with the study and any changes to delivering the intervention. Dissemination Results will be described in the trial’s final report and as papers in peer-reviewed journals. We will report back to participating CCGs via clinical forums and to clinicians via conferences. If the intervention is successful and acceptable to clinicians and patients, we will explore how to put the intervention into different practice computer systems.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: INFECTION