Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: CHILI Cluster RCT
Condition: Antibiotic Prescriptions; Infection
MeSH terms: Hyperthermia; Fever
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): GP-parent information-exchange tool
Intervention type(s): Behavioral
Intervention description(s): 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 name(s): Interactive booklet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antibiotics; Children; General Practitioner; GP; After-hours care; Out-of-hours care; Booklet; Primary Health Care; Child