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

NCT02024282 | Completed

• 2 other identifiers: S54664CGV 2012/135
• Study Type: interventional
• Target: 8,962
• Locations: 1 country
• Sites: 2

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.

Conditions

Sepsis; Bacteraemia; Meningitis; Abscess; Pneumonia; Osteomyelitis; Cellulitis; Gastro-enteritis With Dehydration; Complicated Urinary Tract Infection; Viral Respiratory Infection Complicated With Hypoxia

Outcome Measures

Primary Outcomes (2)

• Serious infection

  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).

  1 year

• Immediate antibiotic prescribing rates

  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.

  1 year

Secondary Outcomes (5)

• Parental satisfaction

  1 year

• Parental concern

  1 year

• Use of other diagnostic tests and medical services (including re-consultation)

  within the first 10 days after consultation

• Cost-effectiveness

  1 year

• Impact of the communicator style on the effect of the intervention (interaction)

  1 year

Study Arms (4)

usual care

OTHER

Device: Finger Pulse Oximeter

Use of C-reactive protein point of care (CRP POC) test

ACTIVE COMPARATOR

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; Device: Finger Pulse Oximeter

Brief intervention and parent leaflet

ACTIVE COMPARATOR

Other: Brief intervention and parent leaflet; Device: Finger Pulse Oximeter

CRP POC test and brief intervention & parent leaflet

ACTIVE COMPARATOR

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; Device: Finger Pulse Oximeter

Interventions

Use of C-reactive protein (CRP) point of care test DEVICE

Also known as: C-Reactive protein measurement on a Afinion AS100 Analyzer (by Axis-Shield, Norway)

CRP POC test and brief intervention & parent leaflet; Use of C-reactive protein point of care (CRP POC) test

Brief intervention and parent leaflet OTHER

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.

Brief intervention and parent leaflet

Finger Pulse Oximeter DEVICE

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.

Also known as: pulse oximetry

Brief intervention and parent leaflet; CRP POC test and brief intervention & parent leaflet; Use of C-reactive protein point of care (CRP POC) test; usual care

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 1 month to 16 years with an acute illness for a maximum of 5 days are included consecutively.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• National Institute for Health and Disability Insurance (RIZIV), Belgium: collaborator
• Research Foundation Flanders: collaborator

Study Sites (2)

Universitaire Ziekenhuizen Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (27)

• Van den Bruel A, Aertgeerts B, Bruyninckx R, Aerts M, Buntinx F. Signs and symptoms for diagnosis of serious infections in children: a prospective study in primary care. Br J Gen Pract. 2007 Jul;57(540):538-46.

  PMID: 17727746 BACKGROUND

• Bruyninckx R, Aertgeerts B, Bruyninckx P, Buntinx F. Signs and symptoms in diagnosing acute myocardial infarction and acute coronary syndrome: a diagnostic meta-analysis. Br J Gen Pract. 2008 Feb;58(547):105-11. doi: 10.3399/bjgp08X277014.

  PMID: 18307844 BACKGROUND

• Thompson M, Van den Bruel A, Verbakel J, Lakhanpaul M, Haj-Hassan T, Stevens R, Moll H, Buntinx F, Berger M, Aertgeerts B, Oostenbrink R, Mant D. Systematic review and validation of prediction rules for identifying children with serious infections in emergency departments and urgent-access primary care. Health Technol Assess. 2012;16(15):1-100. doi: 10.3310/hta16150.

  PMID: 22452986 BACKGROUND

• Van den Bruel A, Haj-Hassan T, Thompson M, Buntinx F, Mant D; European Research Network on Recognising Serious Infection investigators. Diagnostic value of clinical features at presentation to identify serious infection in children in developed countries: a systematic review. Lancet. 2010 Mar 6;375(9717):834-45. doi: 10.1016/S0140-6736(09)62000-6. Epub 2010 Feb 2.

  PMID: 20132979 BACKGROUND

• Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082.

  PMID: 21653621 BACKGROUND

• Van den Bruel A, Bruyninckx R, Vermeire E, Aerssens P, Aertgeerts B, Buntinx F. Signs and symptoms in children with a serious infection: a qualitative study. BMC Fam Pract. 2005 Aug 26;6:36. doi: 10.1186/1471-2296-6-36.

  PMID: 16124874 BACKGROUND

• Buntinx F, Mant D, Van den Bruel A, Donner-Banzhof N, Dinant GJ. Dealing with low-incidence serious diseases in general practice. Br J Gen Pract. 2011 Jan;61(582):43-6. doi: 10.3399/bjgp11X548974.

  PMID: 21401991 BACKGROUND

• Bjerrum L, Gahrn-Hansen B, Munck AP. C-reactive protein measurement in general practice may lead to lower antibiotic prescribing for sinusitis. Br J Gen Pract. 2004 Sep;54(506):659-62.

  PMID: 15353050 BACKGROUND

• Flood RG, Badik J, Aronoff SC. The utility of serum C-reactive protein in differentiating bacterial from nonbacterial pneumonia in children: a meta-analysis of 1230 children. Pediatr Infect Dis J. 2008 Feb;27(2):95-9. doi: 10.1097/INF.0b013e318157aced.

  PMID: 18174874 BACKGROUND

• Cals JW, Chappin FH, Hopstaken RM, van Leeuwen ME, Hood K, Butler CC, Dinant GJ. C-reactive protein point-of-care testing for lower respiratory tract infections: a qualitative evaluation of experiences by GPs. Fam Pract. 2010 Apr;27(2):212-8. doi: 10.1093/fampra/cmp088. Epub 2009 Dec 18.

  PMID: 20022909 BACKGROUND

• Francis NA, Butler CC, Hood K, Simpson S, Wood F, Nuttall J. Effect of using an interactive booklet about childhood respiratory tract infections in primary care consultations on reconsulting and antibiotic prescribing: a cluster randomised controlled trial. BMJ. 2009 Jul 29;339:b2885. doi: 10.1136/bmj.b2885.

  PMID: 19640941 BACKGROUND

• Kerr J, Swann IJ, Pentland B. A survey of information given to head-injured patients on direct discharge from emergency departments in Scotland. Emerg Med J. 2007 May;24(5):330-2. doi: 10.1136/emj.2006.044230.

  PMID: 17452698 BACKGROUND

• Parsley J, Fletcher L, Mabrook AF. Head injury instructions: a time to unify. J Accid Emerg Med. 1997 Jul;14(4):238-9. doi: 10.1136/emj.14.4.238.

  PMID: 9248913 BACKGROUND

• Zemek RL, Bhogal SK, Ducharme FM. Systematic review of randomized controlled trials examining written action plans in children: what is the plan? Arch Pediatr Adolesc Med. 2008 Feb;162(2):157-63. doi: 10.1001/archpediatrics.2007.34.

  PMID: 18250241 BACKGROUND

• Almond S, Mant D, Thompson M. Diagnostic safety-netting. Br J Gen Pract. 2009 Nov;59(568):872-4; discussion 874. doi: 10.3399/bjgp09X472971. No abstract available.

  PMID: 19861036 BACKGROUND

• Chu H, Cole SR. Sample size calculation using exact methods in diagnostic test studies. J Clin Epidemiol. 2007 Nov;60(11):1201-2; author reply 1202. doi: 10.1016/j.jclinepi.2006.09.015. Epub 2007 Aug 3. No abstract available.

  PMID: 17938064 BACKGROUND

• Flahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol. 2005 Aug;58(8):859-62. doi: 10.1016/j.jclinepi.2004.12.009.

  PMID: 16018921 BACKGROUND

• Carley S, Dosman S, Jones SR, Harrison M. Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J. 2005 Mar;22(3):180-1. doi: 10.1136/emj.2003.011148.

  PMID: 15735264 BACKGROUND

• Lewis CC, Scott DE, Pantell RH, Wolf MH. Parent satisfaction with children's medical care. Development, field test, and validation of a questionnaire. Med Care. 1986 Mar;24(3):209-15. doi: 10.1097/00005650-198603000-00003.

  PMID: 3951263 BACKGROUND

• Seid M, Stevens GD, Varni JW. Parents' perceptions of pediatric primary care quality: effects of race/ethnicity, language, and access. Health Serv Res. 2003 Aug;38(4):1009-31. doi: 10.1111/1475-6773.00160.

  PMID: 12968814 BACKGROUND

• Bos DAG, De Burghgraeve T, De Sutter A, Buntinx F, Verbakel JY. Clinical prediction models for serious infections in children: external validation in ambulatory care. BMC Med. 2023 Apr 18;21(1):151. doi: 10.1186/s12916-023-02860-4.

  PMID: 37072778 DERIVED

• De Rop L, De Burghgraeve T, De Sutter A, Buntinx F, Verbakel JY. Point-of-care C-reactive protein test results in acute infections in children in primary care: an observational study. BMC Pediatr. 2022 Nov 4;22(1):633. doi: 10.1186/s12887-022-03677-5.

  PMID: 36333682 DERIVED

• Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Bullens DMA, Shinkins B, Van den Bruel A, Buntinx F. Point-of-care C reactive protein to identify serious infection in acutely ill children presenting to hospital: prospective cohort study. Arch Dis Child. 2018 May;103(5):420-426. doi: 10.1136/archdischild-2016-312384. Epub 2017 Dec 21.

  PMID: 29269559 DERIVED

• Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Shinkins B, Perera R, Mant D, Van den Bruel A, Buntinx F. Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial. BMC Med. 2016 Oct 6;14(1):131. doi: 10.1186/s12916-016-0679-2.

  PMID: 27716201 DERIVED

• Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Bullens DM, Shinkins B, Van den Bruel A, Buntinx F. Validating a decision tree for serious infection: diagnostic accuracy in acutely ill children in ambulatory care. BMJ Open. 2015 Aug 7;5(8):e008657. doi: 10.1136/bmjopen-2015-008657.

  PMID: 26254472 DERIVED

• Lemiengre MB, Verbakel JY, De Burghgraeve T, Aertgeerts B, De Baets F, Buntinx F, De Sutter A; ERNIE 2 collaboration. Optimizing antibiotic prescribing for acutely ill children in primary care (ERNIE2 study protocol, part B): a cluster randomized, factorial controlled trial evaluating the effect of a point-of-care C-reactive protein test and a brief intervention combined with written safety net advice. BMC Pediatr. 2014 Oct 2;14:246. doi: 10.1186/1471-2431-14-246.

  PMID: 25277543 DERIVED

• Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Bullens DM, Aertgeerts B, Buntinx F; ERNIE 2 collaboration. Diagnosing serious infections in acutely ill children in ambulatory care (ERNIE 2 study protocol, part A): diagnostic accuracy of a clinical decision tree and added value of a point-of-care C-reactive protein test and oxygen saturation. BMC Pediatr. 2014 Oct 2;14:207. doi: 10.1186/1471-2431-14-207.

  PMID: 25277457 DERIVED

MeSH Terms

Conditions

Sepsis; Toxemia; Meningitis; Abscess; Pneumonia; Osteomyelitis; Cellulitis

Interventions

Crisis Intervention; Oximetry

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Nervous System Diseases; Suppuration; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Skin Diseases, Infectious; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Jan Y Verbakel, MD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Marieke Lemiengre, MD

  UGent

  PRINCIPAL INVESTIGATOR

• Frank Buntinx, PhD

  KU Leuven

  STUDY DIRECTOR

• Bert Aertgeerts, PhD

  KU Leuven

  STUDY CHAIR

• An de Sutter, PhD

  UGent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant & PhD Student

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: December 31, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

BE (2)