Antibiotic prescribing rate after optimal near-patient C-reactive protein testing in acutely ill children presenting to ambulatory care (ARON project): protocol for a cluster-randomized pragmatic trial

Abstract

IntroductionChildren become ill quite often, mainly because of infections, most of which can be managed in the community. Many children are prescribed antibiotics which contributes to antimicrobial resistance and reinforces health-seeking behaviour. Point-of-care C reactive protein (POC CRP) testing, prescription guidance and safety-netting advice can help safely reduce antibiotic prescribing to acutely ill children in ambulatory care as well as save costs at a systems level.Methods and analysisThe ARON (Antibiotic prescribing Rate after Optimal Near-patient testing in acutely ill children in ambulatory care) trial is a pragmatic cluster randomized controlled superiority trial with a nested process evaluation and will assess the clinical and cost effectiveness of a diagnostic algorithm, which includes a standardised clinical assessment, a POC CRP test, and safety-netting advice, in acutely ill children aged 6 months to 12 years presenting to ambulatory care. The primary outcome is antibiotic prescribing at the index consultation; secondary outcomes include clinical recovery, reconsultation, referral/admission to hospital, additional testing, mortality and patient satisfaction. We aim to recruit a total sample size of 6111 patients. All outcomes will be analysed according to the intent-to-treat approach. We will use a mixed-effect logistic regression analysis to account for the clustering at practice level.Ethics and disseminationThe study will be conducted in compliance with the principles of the Declaration of Helsinki (current version), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. Ethics approval for this study was obtained on 10 November 2020 from the Ethics Committee Research of University Hospitals Leuven under reference S62005. We will ensure that the findings of the study will be disseminated to relevant stakeholders other than the scientific world including the public, healthcare providers and policy-makers. The process evaluation that is part of this trial may provide a basis for an implementation strategy. If our intervention proves to be clinically and cost-effective, it will be essential to educate physicians about introducing the diagnostic algorithm including POC CRP testing and safety-netting advice in their daily practice.Trial registration numberClinicalTrials.gov Identifier: NCT04470518. Protocol V.2.0 date 2 October 2020. (Pre-results)

Point-of-care C-reactive protein test results in acute infections in children in primary care: an observational study

“…On the other hand, a review of Verbakel et al [8] stated that POC CRP test in ambulatory care accompanied by clinical guidance can reduce the immediate antibiotic prescribing rate, and another study showed that normal CRP levels discourage immediate antibiotic prescribing, even when EBM practice guidelines advise differently, and elevated CRP levels did not increase antibiotic prescribing [21]. Currently the EPIcentre team, led by Prof. Dr. Jan Verbakel, is performing a multicentre, cluster-randomized trial in ambulatory care, in which the impact of a diagnostic algorithm, including clinically guided POC CRP testing and safety netting advice on antibiotic prescribing rate and the further management of acutely ill children is investigated [50].…”

Safety-netting in the consultation

“…None of the studies or the review used the phrase “safety-netting”; hence their omission from the aforementioned literature review. Newer trials have started adopting the term 9. However, the inconsistencies in previous studies, plus the fact that these patient leaflets contain other information besides safety-netting advice, and the variable verbal content in the trial arms, mean the effectiveness of the leaflets cannot directly be attributed to safety-netting alone.…”