Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: CHILI Cluster RCT
NCT ID: NCT02594553
Last Updated: 2016-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1262 participants
INTERVENTIONAL
2015-11-30
2016-06-30
Brief Summary
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Detailed Description
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It is hypothesized that the use of such an interactive booklet during consultations for febrile children at GP out-of-hours centres will result in a reduced number of antibiotic prescriptions, improved parental satisfaction and reduced intention to re-consult.
The development of the interactive booklet concerned a three-stage process and is based on extensive qualitative work among parents, GPs and other professionals involved in childhood fever management. The booklet incorporates already existing information about fever, alarm symptoms, advice on use of medication and specific infectious diseases that frequently occur in childhood in combination with fever such as upper respiratory tract infections, and otitis media.
We will perform a cluster-randomised controlled trial at 20 GP out-of-hours centres in the Netherlands. GP out-of-hours centres will be stratified by size, to ensure equal distribution of size between the intervention and control group. The required number of clusters and participants was based on the following assumptions: (1) ICC of 0.01, (2) alpha of 0.05, power of 0.80, (3) proportion of antibiotic prescriptions in control group of 25% and a proportion of 19% in the intervention group (6% minimal clinical relevant difference) and (4) 10% loss to follow-up and 10% efficiency loss based on unequal cluster sizes. Based on a previous cohort study, we estimated to include 1000 children per cluster (GP out-of-hours centre) within six months, resulting in a need for 20 clusters and an effective sample size of 737 patients in the intervention and control group (1474 in total).
The booklet will be used during consultations with febrile children at the GP out-of-hours centres that are randomly allocated by computer to the intervention. The child's symptoms will determine which information and advice parents receive from the GP.
Statistical analysis will be performed based on intention to treat principle by performing multilevel logistic regression analysis using IBM SPSS version 21.0 and MLwiN software. We will determine independent factors associated with antibiotic prescriptions. The same will be done for secondary outcomes.
All data will be obtained, managed and monitored according to the guidelines of Good Clinical Practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
All GPs working at the participating GP out-of-hours centres that are in the intervention group will use the GP-parent information-exchange tool (interactive booklet).
GP-parent information-exchange tool
The booklet incorporates already existing information about fever, alarm symptoms, advices use of medication and specific infectious diseases that frequently occur in childhood in combination with fever such as upper respiratory tract infections, and otitis media. The difference with these existing sources of information is the fact that they until now, were not incorporated into one booklet which can be physically handed over to parents.
Control
All GPs working at the participating GP out-of-hours centres that are in the control group will provide care as usual.
No interventions assigned to this group
Interventions
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GP-parent information-exchange tool
The booklet incorporates already existing information about fever, alarm symptoms, advices use of medication and specific infectious diseases that frequently occur in childhood in combination with fever such as upper respiratory tract infections, and otitis media. The difference with these existing sources of information is the fact that they until now, were not incorporated into one booklet which can be physically handed over to parents.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* GP decides this is a fever-related consultation
Exclusion Criteria
* GP decides this is NOT a fever-related consultation
3 Months
12 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Eefje de Bont, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Research Institute CAPHRI, Department of Family Medicine, Maastricht University
Locations
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Maastricht University
Maastricht, Limburg, Netherlands
Countries
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References
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de Bont EG, Alink M, Falkenberg FC, Dinant GJ, Cals JW. Patient information leaflets to reduce antibiotic use and reconsultation rates in general practice: a systematic review. BMJ Open. 2015 Jun 3;5(6):e007612. doi: 10.1136/bmjopen-2015-007612.
de Bont EG, Lepot JM, Hendrix DA, Loonen N, Guldemond-Hecker Y, Dinant GJ, Cals JW. Workload and management of childhood fever at general practice out-of-hours care: an observational cohort study. BMJ Open. 2015 May 19;5(5):e007365. doi: 10.1136/bmjopen-2014-007365.
de Bont EG, Peetoom KK, Moser A, Francis NA, Dinant GJ, Cals JW. Childhood fever: a qualitative study on GPs' experiences during out-of-hours care. Fam Pract. 2015 Aug;32(4):449-55. doi: 10.1093/fampra/cmv029. Epub 2015 Apr 25.
de Bont EG, Cals JW. [An individual 'traffic light system' for children with fever?]. Ned Tijdschr Geneeskd. 2014;158:A7649. Dutch.
de Bont EG, van Loo IH, Dukers-Muijrers NH, Hoebe CJ, Bruggeman CA, Dinant GJ, Cals JW. Oral and topical antibiotic prescriptions for children in general practice. Arch Dis Child. 2013 Mar;98(3):228-31. doi: 10.1136/archdischild-2012-303134. Epub 2012 Dec 25.
de Bont EG, Loonen N, Hendrix DA, Lepot JM, Dinant GJ, Cals JW. Childhood fever: a qualitative study on parents' expectations and experiences during general practice out-of-hours care consultations. BMC Fam Pract. 2015 Oct 7;16:131. doi: 10.1186/s12875-015-0348-0.
de Bont EGPM, Dinant GJ, Elshout G, van Well G, Francis NA, Winkens B, Cals JWL. Booklet for Childhood Fever in Out-of-Hours Primary Care: A Cluster-Randomized Controlled Trial. Ann Fam Med. 2018 Jul;16(4):314-321. doi: 10.1370/afm.2265.
de Bont EG, Dinant GJ, Elshout G, van Well G, Francis NA, Winkens B, Cals JW. An illness-focused interactive booklet to optimise management and medication for childhood fever and infections in out-of-hours primary care: study protocol for a cluster randomised trial. Trials. 2016 Nov 17;17(1):547. doi: 10.1186/s13063-016-1667-8.
Other Identifiers
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ZonMw GGG - 836021022
Identifier Type: -
Identifier Source: org_study_id
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