Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT04470518
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project
Sponsor:
KU Leuven
Organization:
Study Overview
Official Title:
Impact of a Diagnostic Algorithm on Antibiotic Prescribing Rate and Further Management of Acutely Ill Children Presenting to Ambulatory Care: Multicentre, Cluster-randomized, Parallel Group Pragmatic Trial
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARON
Brief Summary:
Impact of clinical guidance \& point-of-care CRP test in children: the ARON project Trial Design: multicentre, cluster-randomized, parallel group pragmatic trial Trial Participants and setting: 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(s) Diagnostic algorithm:
1. Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC
2. YES to any : point-of-care CRP ≥5mg/L: additional testing or refer to secondary care \<5mg/L: safety netting\*, only prescribe antibiotics if advised (guidelines)
3. NO to all : are AB considered? YES : point-of-care CRP ≥5mg/L: safety netting\*, only prescribe antibiotics if advised (guidelines) \<5mg/L: safety netting\*, do not prescribe antibiotics NO: safety netting
\*safety netting advice:
* inform parents on what to expect and what to look out for
* interactive parent information booklet based on previous research
Control: Diagnosis and Treatment/Management as per usual care:
\- guidance on AB prescribing:
o Belgische Commissie voor de Coördinatie van het Antibioticabeleid (BAPCOC) guide (updated November 2019)
o RIZIV consensus meeting report "Antibiotics in children in ambulatory care"
Primary Endpoint: Antibiotic prescribing rate at index consultation
Secondary Endpoint(s)
\- time until full clinical recovery (during follow up (day 1 to day 30))
\- additional investigations (at index consultation and/or during follow up (day 1 to day 30))
\- re-consultation (during follow up (day 1 to day 30))
\- antibiotic prescribing rate (during follow up (day 1 to day 30))
Exploratory endpoints at the index consultation:
* additional investigations (X-Ray, blood tests, urine tests, etc.)
During a follow-up period (day 1 to day 30):
\- referral to hospital
\- additional investigations (X-Ray, blood tests, urine tests, etc.)
* patients with full clinical recovery at day 7 and day 30
* admission to hospital
* mortality
* cost-effectiveness
* patient satisfaction
* qualitative study: endpoints
Planned Sample Size: 7000 Timing of the intervention: Intervention at index consultation (at presentation to primary care) Follow-up duration: 30 days follow-up Duration of the trial (FPI-CSR): 43 months
Intervention(s) Diagnostic algorithm:
1. Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC
2. YES to any : point-of-care CRP ≥5mg/L: additional testing or refer to secondary care \<5mg/L: safety netting\*, only prescribe antibiotics if advised (guidelines)
3. NO to all : are AB considered? YES : point-of-care CRP ≥5mg/L: safety netting\*, only prescribe antibiotics if advised (guidelines) \<5mg/L: safety netting\*, do not prescribe antibiotics NO: safety netting
\*safety netting advice:
* inform parents on what to expect and what to look out for
* interactive parent information booklet based on previous research
Control: Diagnosis and Treatment/Management as per usual care:
\- guidance on AB prescribing:
o Belgische Commissie voor de Coördinatie van het Antibioticabeleid (BAPCOC) guide (updated November 2019)
o RIZIV consensus meeting report "Antibiotics in children in ambulatory care"
Primary Endpoint: Antibiotic prescribing rate at index consultation
Secondary Endpoint(s)
\- time until full clinical recovery (during follow up (day 1 to day 30))
\- additional investigations (at index consultation and/or during follow up (day 1 to day 30))
\- re-consultation (during follow up (day 1 to day 30))
\- antibiotic prescribing rate (during follow up (day 1 to day 30))
Exploratory endpoints at the index consultation:
* additional investigations (X-Ray, blood tests, urine tests, etc.)
During a follow-up period (day 1 to day 30):
\- referral to hospital
\- additional investigations (X-Ray, blood tests, urine tests, etc.)
* patients with full clinical recovery at day 7 and day 30
* admission to hospital
* mortality
* cost-effectiveness
* patient satisfaction
* qualitative study: endpoints
Planned Sample Size: 7000 Timing of the intervention: Intervention at index consultation (at presentation to primary care) Follow-up duration: 30 days follow-up Duration of the trial (FPI-CSR): 43 months
Detailed Description:
The investigators aim to strengthen the assessment of acutely ill children in primary care, by introducing a diagnostic algorithm that can decrease antibiotic prescribing.
In light of the prior evidence and its results so far, the ARON trial will test the impact of a diagnostic algorithm including a standardised clinical assessment, a POC CRP test, and safety netting advice.
Therefore, the investigators propose to assess the clinical and cost-effectiveness of a diagnostic algorithm which includes a decision tree, POC CRP and safety netting advice in acutely ill children aged 6 months to 12 years of age presenting to ambulatory care, on AB prescribing, referral/admission to hospital, additional testing, mortality, and patient satisfaction.
More specifically, the investigators' research question is whether this diagnostic algorithm is able to safely reduce antibiotic prescribing in acutely ill children presenting to ambulatory care.
The decision whether or not to conduct a POC CRP test will depend on the standardized clinical assessment, i.e. a validated clinical decision tree, and subsequently for low-risk children on the intention to prescribe AB.
The investigators will provide clear evidence-based guidance on how to interpret the CRP test result as outlined below.
A process evaluation will examine how clinicians use CRP testing in their practice and how parents experience these consultations.
The investigators propose a study, where children (6 months to 12 years of age) will be randomised to (a) a diagnostic algorithm with CRP testing and specific guidance on when to prescribe AB or (b) usual care. 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.
The investigators aim to recruit 7000 children and will collect data registered by the participating physician, from the child's health record and children/parents directly. The investigators will describe how the intervention has worked in practice and how clinicians/parents have experienced these consultations.
Guidance will be part of a diagnostic algorithm which includes clinically guided POC CRP testing and safety netting advice to inform parents on what to expect and what to look out for.
Individual interviews will be conducted with clinicians and parents taking part in the trial within 30 days after the first contact consultation, to explore the social processes influencing embedding of the intervention within practice, and behaviour change techniques.
These individual telephone interviews will be performed with a selection of parents to address whether their concerns were discussed appropriately and whether their expectations were met and how they experienced the consultation and/or POC CRP testing.
The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).
The findings of this study could change the practice of ambulatory care physicians and might be of great interest to parents and childcare providers. The investigators will publish the findings of this research in academic journals, present at national conferences and discuss results with groups responsible for the national guidance on how to assess acutely ill children (Domus Medica, SSMG).
In light of the prior evidence and its results so far, the ARON trial will test the impact of a diagnostic algorithm including a standardised clinical assessment, a POC CRP test, and safety netting advice.
Therefore, the investigators propose to assess the clinical and cost-effectiveness of a diagnostic algorithm which includes a decision tree, POC CRP and safety netting advice in acutely ill children aged 6 months to 12 years of age presenting to ambulatory care, on AB prescribing, referral/admission to hospital, additional testing, mortality, and patient satisfaction.
More specifically, the investigators' research question is whether this diagnostic algorithm is able to safely reduce antibiotic prescribing in acutely ill children presenting to ambulatory care.
The decision whether or not to conduct a POC CRP test will depend on the standardized clinical assessment, i.e. a validated clinical decision tree, and subsequently for low-risk children on the intention to prescribe AB.
The investigators will provide clear evidence-based guidance on how to interpret the CRP test result as outlined below.
A process evaluation will examine how clinicians use CRP testing in their practice and how parents experience these consultations.
The investigators propose a study, where children (6 months to 12 years of age) will be randomised to (a) a diagnostic algorithm with CRP testing and specific guidance on when to prescribe AB or (b) usual care. 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.
The investigators aim to recruit 7000 children and will collect data registered by the participating physician, from the child's health record and children/parents directly. The investigators will describe how the intervention has worked in practice and how clinicians/parents have experienced these consultations.
Guidance will be part of a diagnostic algorithm which includes clinically guided POC CRP testing and safety netting advice to inform parents on what to expect and what to look out for.
Individual interviews will be conducted with clinicians and parents taking part in the trial within 30 days after the first contact consultation, to explore the social processes influencing embedding of the intervention within practice, and behaviour change techniques.
These individual telephone interviews will be performed with a selection of parents to address whether their concerns were discussed appropriately and whether their expectations were met and how they experienced the consultation and/or POC CRP testing.
The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).
The findings of this study could change the practice of ambulatory care physicians and might be of great interest to parents and childcare providers. The investigators will publish the findings of this research in academic journals, present at national conferences and discuss results with groups responsible for the national guidance on how to assess acutely ill children (Domus Medica, SSMG).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: