Validation of a Vital Signs and Symptoms Decision Tree and the Effect of a Point-of- Care CRP Test, Oxygen Saturation, a Brief Intervention and a Parent Leaflet on Diagnosing, Antibiotic Prescribing Rate and Parental Satisfaction in Acutely Ill Children in Primary Care."
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- KU Leuven
- Enrollment
- 8,962
- Locations
- 2
- Primary Endpoint
- Serious infection
Study Overview
Brief Summary
Acute illness is the most common presentation of children attending ambulatory care settings. Serious infections (e.g. meningitis, sepsis, pyelonephritis, pneumonia) are rare, but their impact is quite large (increased morbidity, mortality, induced fear in parents and defensive behaviour in clinicians). Early recognition and adequate referral of serious infections are essential to avoid complications (e.g. hearing loss after bacterial meningitis) and their accompanied mortality. Secondly, we aim to reduce the number of investigations, referrals, treatments and hospitalisations in children who are diagnosed with a non-serious infection. Apart from the cost-effectiveness, this could lead to less traumatic experiences for the child and less fear induction for the concerned parent. Finally, we aim to support the clinicians to rationalise their antibiotic prescribing behaviour, resulting in a reduction of antibiotic resistance in the long run.
Detailed Description
This study is a combination of a diagnostic and an intervention study. In a previous study, our research team constructed a decision tree, based on signs and symptoms, to identify serious infections in acutely ill children in primary care. This decision tree had an excellent sensitivity of 97% for the detection of serious infections, but would have lead to 12% of all acutely ill children to be referred, which is unacceptably high.
Our main research questions are:
- In addition to measuring clinical signs and symptoms, can new or existing technology help identify serious infections in acutely ill children in ambulatory care? Translated to our study design: "After applying the decision tree, can we further reduce the number of false positives (and thus increase the specificity) and maintain the same level of sensitivity with a C-reactive Protein Point-of-Care test or pulse oximetry?
- After excluding children with serious illnesses by applying the decision tree, can a Point-of-Care CRP test, a brief intervention together with a parent leaflet, or both, have effect on:
A. Primary outcome measure:
- Serious infection
- Immediate antibiotic prescribing rates
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 1 Month to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 1 month to 16 years with an acute illness for a maximum of 5 days are included consecutively.
Exclusion Criteria
- •Children are excluded if the acute episode was caused by a merely traumatic or neurological illness, intoxication, psychiatric or behavioural problem without somatic cause, or an exacerbation of a known chronic condition. If a physician includes children twice in the study within 5 days, the second registration is considered a repeated measurement on the same subject and is subsequently excluded from the analysis.
Arms & Interventions
Brief intervention and parent leaflet
Intervention: Brief intervention and parent leaflet (Other)
Brief intervention and parent leaflet
Intervention: Finger Pulse Oximeter (Device)
usual care
Intervention: Finger Pulse Oximeter (Device)
Use of C-reactive protein point of care (CRP POC) test
CRP analysis will be performed during the consultation in accordance with the manufacturer's instructions.
The CRP point of care test will be performed in case of a positive decision tree (irrespective of the intervention group) and also in case of a negative decision tree by clinicians of intervention group 1 and 2. Because no reliable cut-off points for CRP are known currently (as this is the aim of this study) for acute infections in children in primary care (nor for referral, nor for prescription of antibiotics), clinicians will not be given guidance on the interpretation of the CRP results.
We will not impose restrictions on the clinicians about treatment, other technical investigations nor referrals.
The device distributor will provide technical assistance. All clinicians will be trained in the use of the CRP device prior to the start of the study.
Intervention: Use of C-reactive protein (CRP) point of care test (Device)
Use of C-reactive protein point of care (CRP POC) test
CRP analysis will be performed during the consultation in accordance with the manufacturer's instructions.
The CRP point of care test will be performed in case of a positive decision tree (irrespective of the intervention group) and also in case of a negative decision tree by clinicians of intervention group 1 and 2. Because no reliable cut-off points for CRP are known currently (as this is the aim of this study) for acute infections in children in primary care (nor for referral, nor for prescription of antibiotics), clinicians will not be given guidance on the interpretation of the CRP results.
We will not impose restrictions on the clinicians about treatment, other technical investigations nor referrals.
The device distributor will provide technical assistance. All clinicians will be trained in the use of the CRP device prior to the start of the study.
Intervention: Finger Pulse Oximeter (Device)
CRP POC test and brief intervention & parent leaflet
Combination of CRP POC test and the brief intervention & parent information leaflet intervention groups (factorial design)
Intervention: Use of C-reactive protein (CRP) point of care test (Device)
CRP POC test and brief intervention & parent leaflet
Combination of CRP POC test and the brief intervention & parent information leaflet intervention groups (factorial design)
Intervention: Finger Pulse Oximeter (Device)
Outcomes
Primary Outcomes
Serious infection
Time Frame: 1 year
To verify if the child had a serious infection after consulting the primary care physician, the research team will consult all hospital records within the referral region of the physicians to check whether the child was admitted to hospital with a serious infections, based on the appropriate reference standards. In case of referral and/or hospitalisation, the primary care and hospital clinicians will be contacted to reconstruct the illness episode (reason for referral/hospitalisation, diagnosis, time to cure).
Immediate antibiotic prescribing rates
Time Frame: 1 year
The recruiting physicians are asked to fill out whether and which kind of antibiotics they prescribed during the assessment of the sick child. The registration forms will be assessed at 1 year, when the study recruitment phase ends.
Secondary Outcomes
- Cost-effectiveness(1 year)
- Parental concern(1 year)
- Parental satisfaction(1 year)
- Use of other diagnostic tests and medical services (including re-consultation)(within the first 10 days after consultation)
- Impact of the communicator style on the effect of the intervention (interaction)(1 year)
Investigators
Jan Verbakel
Research Assistant & PhD Student
KU Leuven