Optimising Diagnosis and Antibiotic Prescribing for Acutely Ill Children in Primary Care (ERNIE2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Katholieke Universiteit Leuven
Sponsor:
Collaborators:
National Institute for Health and Disability Insurance (RIZIV), Belgium
Research Foundation Flanders
Information provided by (Responsible Party):
Jan Verbakel, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT02024282
First received: September 20, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Sepsis
Bacteraemia
Meningitis
Abscess
Pneumonia
Osteomyelitis
Cellulitis
Gastro-enteritis With Dehydration
Complicated Urinary Tract Infection
Viral Respiratory Infection Complicated With Hypoxia
Device: Use of C-reactive protein (CRP) point of care test
Other: Brief intervention and parent leaflet
Device: Finger Pulse Oximeter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: 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."

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Serious infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Parental satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Parental concern [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Use of other diagnostic tests and medical services (including re-consultation) [ Time Frame: within the first 10 days after consultation ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Impact of the communicator style on the effect of the intervention (interaction) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
usual care 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.
Other Name: pulse oximetry
Active Comparator: 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.

Device: Use of C-reactive protein (CRP) point of care test
Other Name: C-Reactive protein measurement on a Afinion AS100 Analyzer (by Axis-Shield, Norway)
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.
Other Name: pulse oximetry
Active Comparator: Brief intervention and parent leaflet 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.
Other Name: pulse oximetry
Active Comparator: CRP POC test and brief intervention & parent leaflet
Combination of CRP POC test and the brief intervention & parent information leaflet intervention groups (factorial design)
Device: Use of C-reactive protein (CRP) point of care test
Other Name: C-Reactive protein measurement on a Afinion AS100 Analyzer (by Axis-Shield, Norway)
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.
Other Name: pulse oximetry

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024282

Contacts
Contact: Jan Y Verbakel, MD jan.verbakel@med.kuleuven.be
Contact: Frank Buntinx, PhD frank.buntinx@med.kuleuven.be

Locations
Belgium
Universitaire Ziekenhuizen Gent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Frans De Baets, PhD       Frans.Debaets@ugent.be   
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Dominique Bullens, PhD       dominique.bullens@med.kuleuven.be   
Sponsors and Collaborators
Katholieke Universiteit Leuven
National Institute for Health and Disability Insurance (RIZIV), Belgium
Research Foundation Flanders
Investigators
Principal Investigator: Jan Y Verbakel, MD Katholieke Universiteit Leuven
Principal Investigator: Marieke Lemiengre, MD UGent
Study Director: Frank Buntinx, PhD Katholieke Universiteit Leuven
Study Chair: Bert Aertgeerts, PhD Katholieke Universiteit Leuven
Study Chair: An de Sutter, PhD UGent
  More Information

Publications:

Responsible Party: Jan Verbakel, Research Assistant & PhD Student, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT02024282     History of Changes
Other Study ID Numbers: S54664, CGV 2012/135
Study First Received: September 20, 2013
Last Updated: December 30, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Cellulitis
Bacteremia
Communicable Diseases
Dehydration
Gastroenteritis
Infection
Meningitis
Osteomyelitis
Respiratory Tract Infections
Urinary Tract Infections
Bacterial Infections
Bone Diseases
Bone Diseases, Infectious
Central Nervous System Diseases
Central Nervous System Infections
Connective Tissue Diseases
Digestive System Diseases
Gastrointestinal Diseases
Inflammation
Metabolic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pathologic Processes
Respiratory Tract Diseases
Sepsis
Skin Diseases, Infectious
Suppuration
Systemic Inflammatory Response Syndrome
Urologic Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on October 21, 2014