Abstract
BackgroundDespite huge public campaigns, there is still overconsumption of antibiotics in children with self-limiting diseases. Possible explanations may be the physicians’ and parents’ uncertainty about the gravity of the disease and inadequate communication between physicians and parents leading to lack of reassurance for the parents. In this paper we describe the design and methods of a trial aiming to rationalize antibiotic prescribing by decreasing this uncertainty and parental anxiety.Methods/DesignAcutely ill children without suspected serious disease consulting their family physician will be consecutively included in a four-armed cluster randomized factorial controlled trial. The intervention will consist a Point-of-Care C-reactive protein test and/or a brief intervention with safety net advice. The control group will receive usual care. We intend to include 2560 patients in 88 family practices. Patients will be followed up until cure. The primary outcome measure is the immediate antibiotic prescribing rate. Secondary outcomes are: comparison between groups of speed of clinical recovery, parental concern, parental perception of the quality of the communication, parental satisfaction, use of medication, use of diagnostic tests and medical services during the illness episode, and cost-effectiveness of the interventions. Besides this, we will observationally analyse data of the children included in the large ERNIE2-trial, but excluded in the cluster randomized trial, namely children suspected of serious disease presenting in primary care and children who initially present at the out-patient paediatric clinic or emergency department. We will search for predictors of antibiotic prescribing, speed of clinical recovery, parental concern, parental perception of communication, parental satisfaction, use of medication, diagnostic tests and medical services.DiscussionThis is a unique multifaceted intervention, in that it targets both physicians and parents by aiming specifically at their uncertainty and concerns during the consultation. Both interventions are easy to implement without special training. When proven effective, they could offer a feasible way to decrease inappropriate antibiotic prescribing for children in family practice and thus avoid emergence of bacterial resistance, side effects and unnecessary healthcare costs. Moreover, the observational part of the study will increase our insight in the course, management and parent’s concern of acute illness in children.Trial registrationClinicalTrials.gov Identifier: NCT02024282.
Highlights
Despite huge public campaigns, there is still overconsumption of antibiotics in children with self-limiting diseases
We will collect observational data of the children included in the large ERNIE2-trial, but excluded in the cluster randomized trial, i.e. (1) children suspected of serious disease presenting in primary care and (2) children who initially present at the out-patient paediatric clinic or emergency department
In the scope of the large ERNIE2-trial, we identified C-reactive protein (CRP) as the most probable candidate to detect serious infections in febrile children in ambulatory settings and reduce irrational antibiotic prescribing
Summary
This cluster randomized controlled trial will be the first to evaluate the effect of a POC CRP test and a simple communicative intervention with safety net advice on the antibiotic prescribing rate in acutely ill children not suspected of serious disease in primary care. A clustered randomized controlled trial found that the use of a interactive booklet alone on respiratory tract infections (RTIs) in children could lead to important reductions in antibiotic prescribing and the intention to consult without reducing parental satisfaction with care [39] This intervention is similar, but differs at several points. The booklet focuses on upper respiratory tract infections instead of the general management of ill children and alarm symptoms If these interventions decrease the antibiotic prescribing rate or have favorable effects on parental concern and satisfaction, we will perform a cost-effectiveness analysis to evaluate the consequences of the intervention on the health care budget.
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