Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: CHILI Cluster RCT

Study Overview
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Brief Summary
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The CHILI cluster randomised controlled trial (RCT) will investigate whether the use of an interactive information booklet during consultations for febrile children at General Practice (GP) out-of-hours centres can reduce the number of antibiotic prescriptions, improve parental satisfaction and reduce intention to reconsult for childhood fever episodes.

Detailed Description
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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.

Official Title
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Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: the CHILI Cluster Randomised Trial

Conditions
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Antibiotic Prescriptions, Infection

Intervention / Treatment
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* Behavioral: GP-parent information-exchange tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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). | Behavioral: GP-parent information-exchange tool<br>* 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.<br>* Other names: Interactive booklet;|
| No Intervention: Control<br>All GPs working at the participating GP out-of-hours centres that are in the control group will provide care as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic Prescription | Antibiotic prescriptions for febrile children in GP out-of-hours centres during the initial consultation (dichotomous scale; number of participants with an antibiotic prescription). | Baseline (Initial consultation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention to re-consult | Intention to re-consult for similar illnesses among parents, number of parents with the intention to re-consult | Asked within two weeks after initial consultation | 
| Parental satisfaction with care | VAS scale 1-10 | Asked within two weeks after initial consultation | 
| Self-reported adverse events related to the fever episode like hospital admission |  | Asked within two weeks after initial consultation | 
| Antibiotic prescription rates at re-consultations | Prescription rates at re-consultations for the same illness episode (defined as a consultation for the same reason over the last two weeks) | Asked within two weeks after initial consultation | 
| Consultation rates | 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. | During complete study period, during 6 months of study completion | 
| Referral to secondary care | Number of participants with Referral to secondary care during initial consultation | Baseline (during initial consultation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotics, Children, General Practitioner, GP, After-hours care, Out-of-hours care, Booklet, Primary Health Care, Child