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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02024282 on ClinicalTrials.gov