Optimising Diagnosis and Antibiotic Prescribing for Acutely Ill Children in Primary Care
NCT02024282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8962
Last updated 2015-02-18
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.
Conditions
- Sepsis
- Bacteraemia
- Meningitis
- Abscess
- Pneumonia
- Osteomyelitis
- Cellulitis
- Gastro-enteritis With Dehydration
- Complicated Urinary Tract Infection
- Viral Respiratory Infection Complicated With Hypoxia
Interventions
- DEVICE
-
Use of C-reactive protein (CRP) point of care test
- OTHER
-
Brief intervention and parent leaflet
Brief interventions are commonly used to give opportunistic advice, discussion, negotiation or encouragement. Mostly they take between 5 to 10 minutes. We developed a brief intervention: we'll ask the clinicians to ask 3 specific questions, namely "Are you concerned?", "What exactly concerns you?" and "Why does this concern you?". This intervention is easy to implement in daily practice and no additional training is required. We developed a parent information leaflet that gives information about what they can do when their child is ill, which signs are important to follow up and when they really should get advice from a clinician. This could make it easier for them to cope with an ill child. The clinician could use this leaflet to give advice and make clear when they have to re-consult their physician to re-evaluate the child. Our hypothesis is that through creating this safety net, the improper demand for antibiotics could be reduced.
- DEVICE
-
Finger Pulse Oximeter
All physicians will be asked to perform a measurement of the oxygen saturation on all children and enter the results on the case report form. The selected device is a clip-on system suitable for use in children, which measures oxygen saturation in the capillary blood as well as the pulse rate.
Sponsors & Collaborators
-
National Institute for Health and Disability Insurance (RIZIV), Belgium
collaborator UNKNOWN -
Research Foundation Flanders
collaborator OTHER -
KU Leuven
lead OTHER
Principal Investigators
-
Jan Y Verbakel, MD · KU Leuven
-
Marieke Lemiengre, MD · UGent
-
Frank Buntinx, PhD · KU Leuven
-
Bert Aertgeerts, PhD · KU Leuven
-
An de Sutter, PhD · UGent
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 1 Month
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- Belgium
Study Locations
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