- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594553
Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: CHILI Cluster RCT (CHILI)
Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: the CHILI Cluster Randomised Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A GP-parent information exchange tool in the form of an interactive booklet has the potential to provide parents with information about symptoms and fever management and consistent information during GP consultations. Thereby enhancing their self-management and providing them with safety net advice when they return home.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Limburg
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Maastricht, Limburg, Netherlands, 6229 HA
- Maastricht University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between three months and twelve years
- GP decides this is a fever-related consultation
Exclusion Criteria:
- Age under 3 months or over 12 years
- GP decides this is NOT a fever-related consultation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
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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 Names:
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No Intervention: Control
All GPs working at the participating GP out-of-hours centres that are in the control group will provide care as usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antibiotic Prescription
Time Frame: Baseline (Initial consultation)
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Antibiotic prescriptions for febrile children in GP out-of-hours centres during the initial consultation (dichotomous scale; number of participants with an antibiotic prescription).
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Baseline (Initial consultation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention to re-consult
Time Frame: Asked within two weeks after initial consultation
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Intention to re-consult for similar illnesses among parents, number of parents with the intention to re-consult
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Asked within two weeks after initial consultation
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Parental satisfaction with care
Time Frame: Asked within two weeks after initial consultation
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VAS scale 1-10
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Asked within two weeks after initial consultation
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Self-reported adverse events related to the fever episode like hospital admission
Time Frame: Asked within two weeks after initial consultation
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Asked within two weeks after initial consultation
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Antibiotic prescription rates at re-consultations
Time Frame: Asked within two weeks after initial consultation
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Prescription rates at re-consultations for the same illness episode (defined as a consultation for the same reason over the last two weeks)
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Asked within two weeks after initial consultation
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Consultation rates
Time Frame: During complete study period, during 6 months of study completion
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Consultation rates of fever related consultations of children below the age of 12 years between intervention and control groups, through 6 months of study completion.
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During complete study period, during 6 months of study completion
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Referral to secondary care
Time Frame: Baseline (during initial consultation)
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Number of participants with Referral to secondary care during initial consultation
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Baseline (during initial consultation)
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Collaborators and Investigators
Investigators
- Principal Investigator: Eefje de Bont, MD, MSc, Research Institute CAPHRI, Department of Family Medicine, Maastricht University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZonMw GGG - 836021022
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