At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating diagnostic algorithm for Infection. Completed, enrolled 6,750 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). 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)).