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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

Overview
Journal Trials
Publisher Biomed Central
Date 2016 Nov 19
PMID 27855719
Citations 7
Authors
Affiliations
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Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial Registration: ClinicalTrials.gov identifier: NCT02594553 . Registered on 26 Oct 2015​, last updated 15 Sept 2016.

Citing Articles

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Parental and clinician agreement of illness severity in children with RTIs: secondary analysis of data from a prospective cohort study.

van der Werf E, Redmond N, Turnbull S, Thornton H, Thompson M, Little P Br J Gen Pract. 2019; 69(681):e236-e245.

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Safety netting for primary care: evidence from a literature review.

Jones D, Dunn L, Watt I, Macleod U Br J Gen Pract. 2018; 69(678):e70-e79.

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How do general practitioners and pharmacists experience antibiotic use in out-of-hours primary care? An exploratory qualitative interview study to inform a participatory action research project.

Colliers A, Coenen S, Remmen R, Philips H, Anthierens S BMJ Open. 2018; 8(9):e023154.

PMID: 30269072 PMC: 6169767. DOI: 10.1136/bmjopen-2018-023154.


Booklet for Childhood Fever in Out-of-Hours Primary Care: A Cluster-Randomized Controlled Trial.

de Bont E, Dinant G, Elshout G, van Well G, Francis N, Winkens B Ann Fam Med. 2018; 16(4):314-321.

PMID: 29987079 PMC: 6037513. DOI: 10.1370/afm.2265.


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