Children become ill quite often, mainly caused by infections, most of which can be managed safely in the community without the need for antibiotics. However, many children are prescribed antibiotics which contributes to antimicrobial resistance and reinforces health-seeking behaviour. General practitioners (GP) often cite diagnostic uncertainty as a reason to prescribe antibiotics. We aim to strengthen the assessment of acutely ill children in primary care, by introducing an evidence-based diagnostic algorithm that can help GPs decide when to withhold antibiotic treatment. A recent review of the literature showed that using C-reactive protein (CRP) as a point-of-care test i.e. performed in the GP surgery reduces antibiotic prescriptions up to 44% in children if guidance is provided. We interviewed parents and clinicians who took part in a study on point-of-care CRP and found general support for the test but the doctors wanted specific guidance on how to deal with the test result. We propose a study, where children (6 month to 12 years of age) will be randomised to (a) a diagnostic algorithm with CRP testing, safety netting and specific guidance on when to prescribe antibiotics or (b) usual care, alongside the existing evidence-based antibiotic prescribing guidelines. CRP testing will be done using a finger prick test (result within 4 minutes). The CRP level will then be given to the clinician who will communicate the result to the child/parents. We aim to recruit 6111 children and will collect data from the child's medical record and parents directly. We will describe how the intervention has worked in practice and how clinicians/parents have experienced these consultations. The findings of this study could change the practice of GPs and might be of great interest to parents and childcare providers.
| Summary of results |
|---|
| Childhood illnesses are a normal part of life, and most of the time, they do not require antibiotics. However, in many cases, doctors prescribe antibiotics even when they are not necessary. This happens partly because it is not always easy to tell whether an illness is serious or not. As a result, doctors may prescribe antibiotics as a precaution. This overuse of antibiotics can lead to several problems, including higher healthcare costs, more frequent visits to the doctor, and the spread of ‘resistant’ bacteria (i.e. germs against which antibiotic drugs no longer work), which is a major global health concern. In the ARON trial, we tested a new decision support tool to help doctors make better decisions when treating sick children. This tool combines a simple decision tree, a quick blood test (for a marker of inflammation called C-reactive protein (CRP)), and a booklet to help parents identify situations where professional help is required. Important factors in the decision tree were a fever of more than 40°C or shortness of breath, and the doctor’s ‘gut feeling’ that something was wrong. This decision tree was developed from our previous work and is proven to help exclude a serious infection. Testing for the inflammation marker CRP is performed using a device at the family doctor’s practice with a drop of blood from a tiny finger prick (result within 4 minutes). This gives doctors more confidence in deciding when not to prescribe antibiotics. To measure the effect of the decision support tool, about 7000 children were split into two groups. In one of the groups (‘intervention group’), the family doctor used the tool when deciding on the treatment; the other group (‘control group’) just received usual care, without use of the tool. We found that using this tool could avoid one out of every four antibiotic prescriptions, without leading to any negative effects, such as longer illness, more additional treatments, or more hospitalisations. In other words, doctors were able to safely prescribe fewer antibiotics while still providing effective care. This research shows the importance of providing doctors and parents with the right tools and information to manage childhood illnesses. By promoting smarter antibiotic use, we can protect children’s health today and help prevent the spread of antibiotic-resistant bacteria for future generations. |
| Title | Impact of a diagnostic algorithm including clinically guided point-of-care C-reactive protein testing and safety netting advice on antibiotic prescribing rate and further management of acutely ill children presenting to ambulatory care: multicentre, cluster-randomized, parallel group pragmatic trial |
|
Participants (P) |
Children aged 6 months to 12 years of age with an acute illness episode presenting to in-hours general practice or out-of-hospital community paediatrics offices |
|
Intervention (I) |
Diagnostic algorithm including a point of care CRP test |
|
Control (C) |
Diagnosis and Treatment/Management as per usual care |
|
Outcome (O) |
Antibiotic prescribing rate at index consultation |
|
Trial Design |
Multicentre, cluster-randomized, parallel group pragmatic trial |
|
Sample Size |
122 GPs including 6111 children |
|
Trial duration |
33 months from FPI to CSR |
|
Budget |
€2,980,000 |
|
Sponsor |
UZ Leuven |
|
Chief Investigator |
Prof Dr Jan Y Verbakel |
|
Participating Investigators |
Academic centres for general practice of KU Leuven, U Liege, U Gent, VUB, U Antwerp, UC Louvain |
|
Lead Dutch speaking GPs |
Prof Dr An De Sutter |
|
Lead French speaking GPs |
Dr Louise Joly |
|
External partner |
Abbott Rapid Diagnostics BV |
| Protocol | Download publication BMJ Open |
| Results | Download report |
For timelines and recruitment, see dashboard
Clinicaltrials.gov: NCT04470518
2018 Investigator led
