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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 6,750
- 试验地点
- 1
- 主要终点
- Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed)
研究概览
简要总结
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:
- Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC
- 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)
- 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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Owing to study procedures, children, their parents and physicians will not be masked to the practices' random allocation.
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for practices:
- •Being able to recruit acutely ill children (ideally consecutively)
- •Agree to the terms of the clinical study agreement.
排除标准
- •for practices:
- •Currently using a POC CRP device as part of their routine care
- •No practices will be excluded on other grounds than the above. Age, demographics, geographic region will not be used to exclude eligible practices. This will provide us with a real-life, representative subset of ambulatory care physicians.
- •Inclusion criteria for children
- •Children aged 6 months to 12 years, provided informed consent can be obtained
- •presenting with an acute illness episode that started maximum 10 days before the index consultation
- •Exclusion criteria for children
- •Children who were previously included in this trial
- •children with an underlying known chronic condition (e.g. asthma, immune deficiency)
- •clinically unstable warranting immediate care
- •immunosuppressant medication taken in the previous 30 days
- •trauma as the main presenting problem
- •antibiotics taken in the previous 7 days
- •Unwillingness or inability to provide informed consent
研究组 & 干预措施
Intervention: Diagnostic algorithm
diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice
干预措施: diagnostic algorithm (Other)
Usual care
In the control arm, patients will receive 'usual care' left at the discretion of the treating physician.
Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.
They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").
结局指标
主要结局
Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed)
时间窗: This outcome will be registered immediately at the index consultation (immediately after the intervention)
The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician.
次要结局
- Antibiotic Prescribing Rate During Follow-up(This outcome will be checked from the patient health record first day to day 30 after the intervention)
- Clinical Recovery During Follow-up(This outcome will be checked from the diary (via app for parents) from first day after the intervention until day of full clinical recovery (up to maximum 30 days after after the intervention))
- Additional Investigations at Index Consultation and/or During Follow-up(This composite outcome will be registered immediately after the intervention and/or checked from the patient health record from the first day to day 30 after the intervention)
- Re-consultation During Follow-up(This outcome will be checked from the patient health record from first day to day 30 after the intervention)