Optimizing antibiotic prescribing for acutely ill children in primary care (ernie2 study protocol, part b): A cluster randomized, Factorial controlled trial evaluating the effect of a point-of-care c-reactive protein test and a brief intervention combined with written safety net advice

Abstract

Background: Despite huge public campaigns, there is still overconsumption of antibiotics in children with self-limitingdiseases. Possible explanations may be the physicians' and parents' uncertainty about the gravity of the disease andinadequate communication between physicians and parents leading to lack of reassurance for the parents. In this paperwe describe the design and methods of a trial aiming to rationalize antibiotic prescribing by decreasing this uncertaintyand parental anxiety.Methods/Design: Acutely ill children without suspected serious disease consulting their family physician will beconsecutively included in a four-armed cluster randomized factorial controlled trial. The intervention will consist aPoint-of-Care C-reactive protein test and/or a brief intervention with safety net advice. The control group will receiveusual care. We intend to include 2560 patients in 88 family practices. Patients will be followed up until cure. The primaryoutcome measure is the immediate antibiotic prescribing rate. Secondary outcomes are: comparison between groupsof speed of clinical recovery, parental concern, parental perception of the quality of the communication, parentalsatisfaction, use of medication, use of diagnostic tests and medical services during the illness episode, andcost-effectiveness of the interventions. Besides this, we will observationally analyse data of the children includedin the large ERNIE2-trial, but excluded in the cluster randomized trial, namely children suspected of serious diseasepresenting in primary care and children who initially present at the out-patient paediatric clinic or emergencydepartment. 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. Discussion: This is a unique multifaceted intervention, in that it targets both physicians and parents by aimingspecifically at their uncertainty and concerns during the consultation. Both interventions are easy to implementwithout special training. When proven effective, they could offer a feasible way to decrease inappropriate antibioticprescribing for children in family practice and thus avoid emergence of bacterial resistance, side effects andunnecessary 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 registration: ClinicalTrials.gov Identifier: NCT02024282.