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

Verbakel, JYJ; De Burghgraeve, T; Van den Bruel, A; Coenen, S; Anthierens, S; Joly, L; Laenen, A; Luyten, J; De Sutter, A

Journal article

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)

Publication status:: Published

Peer review status:: Peer reviewed

Actions

Email

Email this record

Send the bibliographic details of this record to your email address.

Your Email
Please enter the email address that the record information will be sent to.

-
Your message (optional)
Please add any additional information to be included within the email.
Share
Cite

Cite this record

APA Style

Verbakel, J. Y. J., De Burghgraeve, T., Van den Bruel, A., Coenen, S., Anthierens, S., Joly, L., Laenen, A., Luyten, J., & De Sutter, A. (2022). 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. BMJ Open, 12(1), e058912–e058912.

MLA Style

Verbakel, JYJ, et al. “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.” BMJ Open, vol. 12, no. 1, 2022, pp. e058912–e058912.

Chicago Style

Verbakel, JYJ, T De Burghgraeve, A Van den Bruel, et al. 2022. “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.” BMJ Open 12 (1): e058912–e058912.
Print