title: 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.
abstract: Fever is the most common reason for a child to be taken to a general practitioner (GP), especially during out-of-hours care. It is mostly caused by self-limiting infections. However, antibiotic prescription rates remain high, especially during out-of-hours care. Anxiety and lack of knowledge among parents, and perceived pressure to prescribe antibiotics amongst GPs, are important determinants of excessive antibiotic prescriptions. An illness-focused interactive booklet has the potential to improve this by providing parents with information about fever self-management strategies. The aim of this study is to develop and determine the effectiveness of an interactive booklet on management of children presenting with fever at Dutch GP out-of-hours cooperatives.
  
  
  
  We are conducting a cluster randomised controlled trial (RCT) with 20 GP out-of-hours cooperatives randomised to 1 of 2 arms: GP access to the illness-focused interactive booklet or care as usual. GPs working at intervention sites will have access to the booklet, which was developed in a multistage process. It consists of a traffic light system for parents on how to respond to fever-related symptoms, as well as information on natural course of infections, benefits and harms of (antibiotic) medications, self-management strategies and 'safety net' instructions. Children < 12 years of age with parent-reported or physician-measured fever are eligible for inclusion. The primary outcome is antibiotic prescribing during the initial consultation. Secondary outcomes are (intention to) (re)consult, antibiotic prescriptions during re-consultations, referrals, parental satisfaction and reassurance. In 6 months, 20,000 children will be recruited to find a difference in antibiotic prescribing rates of 25% in the control group and 19% in the intervention group. Statistical analysis will be performed using descriptive statistics and by fitting two-level (GP out-of-hours cooperative and patient) random intercept logistic regression models.
  
  
  
  This will be the first and largest cluster RCT evaluating the effectiveness of an illness-focused interactive booklet during GP out-of-hours consultations with febrile children receiving antibiotic prescriptions. It is hypothesised that use of the booklet will result in a reduced number of antibiotic prescriptions, improved parental satisfaction and reduced intention to re-consult.
  
  
  
  ClinicalTrials.gov identifier: NCT02594553 . Registered on 26 Oct 2015​, last updated 15 Sept 2016.
authors.affiliation: Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands. eefje.debont@maastrichtuniversity.nl.
authors.forename: Eefje G P M
authors.initials: EG
authors.lastname: de Bont
authors.affiliation: Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.
authors.forename: Geert-Jan
authors.initials: GJ
authors.lastname: Dinant
authors.affiliation: Department of General Practice, Erasmus MC, University Medical Centre Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.
authors.forename: Gijs
authors.initials: G
authors.lastname: Elshout
authors.affiliation: Department of Paediatrics, Maastricht University Medical Centre (MUMC+), P.O. Box 5800, 6212 AZ, Maastricht, The Netherlands.
authors.forename: Gijs
authors.initials: G
authors.lastname: van Well
authors.affiliation: Division of Population Medicine, School of Medicine, Cardiff University, CF14 4YS, Cardiff, UK.
authors.forename: Nick A
authors.initials: NA
authors.lastname: Francis
authors.affiliation: Department of Methodology and Statistics, CAPHRI School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.
authors.forename: Bjorn
authors.initials: B
authors.lastname: Winkens
authors.affiliation: Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, The Netherlands.
authors.forename: Jochen W L
authors.initials: JW
authors.lastname: Cals
mesh_terms: D039602:After-Hours Care; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002648:Child; D002985:Clinical Protocols; D005334:Fever / Q000628:therapy*; D058005:General Practitioners; D006801:Humans; D007239:Infections / Q000628:therapy*; D016015:Logistic Models; D017063:Outcome Assessment, Health Care; D010174:Pamphlets; D011320:Primary Health Care; D018401:Sample Size
chemical_list: D000900:Anti-Bacterial Agents
keywords: Antibiotics; Booklet; Child; General practitioner; Out-of-hours; Primary care