Cargando…

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

INTRODUCTION: Children 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) testi...

Descripción completa

Detalles Bibliográficos
Autores principales: Verbakel, Jan Yvan Jos, De Burghgraeve, Tine, Van den Bruel, Ann, Coenen, Samuel, Anthierens, Sibyl, Joly, Louise, Laenen, Annouschka, Luyten, Jeroen, De Sutter, An
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8724812/
https://www.ncbi.nlm.nih.gov/pubmed/34980633
http://dx.doi.org/10.1136/bmjopen-2021-058912
_version_ 1784625989164204032
author Verbakel, Jan Yvan Jos
De Burghgraeve, Tine
Van den Bruel, Ann
Coenen, Samuel
Anthierens, Sibyl
Joly, Louise
Laenen, Annouschka
Luyten, Jeroen
De Sutter, An
author_facet Verbakel, Jan Yvan Jos
De Burghgraeve, Tine
Van den Bruel, Ann
Coenen, Samuel
Anthierens, Sibyl
Joly, Louise
Laenen, Annouschka
Luyten, Jeroen
De Sutter, An
author_sort Verbakel, Jan Yvan Jos
collection PubMed
description INTRODUCTION: Children 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 ANALYSIS: The 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 DISSEMINATION: The 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 NUMBER: ClinicalTrials.gov Identifier: NCT04470518. Protocol V.2.0 date 2 October 2020. (Pre-results)
format Online
Article
Text
id pubmed-8724812
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-87248122022-01-18 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, Jan Yvan Jos De Burghgraeve, Tine Van den Bruel, Ann Coenen, Samuel Anthierens, Sibyl Joly, Louise Laenen, Annouschka Luyten, Jeroen De Sutter, An BMJ Open General practice / Family practice INTRODUCTION: Children 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 ANALYSIS: The 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 DISSEMINATION: The 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 NUMBER: ClinicalTrials.gov Identifier: NCT04470518. Protocol V.2.0 date 2 October 2020. (Pre-results) BMJ Publishing Group 2022-01-03 /pmc/articles/PMC8724812/ /pubmed/34980633 http://dx.doi.org/10.1136/bmjopen-2021-058912 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle General practice / Family practice
Verbakel, Jan Yvan Jos
De Burghgraeve, Tine
Van den Bruel, Ann
Coenen, Samuel
Anthierens, Sibyl
Joly, Louise
Laenen, Annouschka
Luyten, Jeroen
De Sutter, An
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic General practice / Family practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8724812/
https://www.ncbi.nlm.nih.gov/pubmed/34980633
http://dx.doi.org/10.1136/bmjopen-2021-058912
work_keys_str_mv AT verbakeljanyvanjos antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial
AT deburghgraevetine antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial
AT vandenbruelann antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial
AT coenensamuel antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial
AT anthierenssibyl antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial
AT jolylouise antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial
AT laenenannouschka antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial
AT luytenjeroen antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial
AT desutteran antibioticprescribingrateafteroptimalnearpatientcreactiveproteintestinginacutelyillchildrenpresentingtoambulatorycarearonprojectprotocolforaclusterrandomizedpragmatictrial