Converting habits of antibiotic use for respiratory tract infections in German primary care \u2013 study protocol of the cluster-randomized controlled CHANGE-3 trial

Anja Wollny,Christin Löffler,Petra Kaufmann-Kolle,Martina Kamradt,Dorothea Weber,Attila Altiner,Tonia Brand,Joachim Szecsenyi,Mirko Leyh,Lorenz Uhlmann,Arwed Voss,Michel Wensing,Katharina Garbe,Regina Poß-Doering

doi:10.1186/s13063-019-3209-7

Abstract

BackgroundThe overuse of antibiotics is a major cause for the worldwide rise of antibiotic resistance. Although it is well known that acute respiratory tract infections (ARTI) are mainly caused by viruses and are often self limiting, antibiotics are too frequently prescribed in primary care. CHANGE-3 examines whether a complex intervention focusing on improving communication and provision of prescribing feedback reduces antibiotic use in patients suffering from ARTI.Methods/designThe CHANGE-3 trial is a cluster-randomized controlled trial nested within a web-based public campaign conducted in two regions in Germany. A total of 114 medical practices will be included. Practices randomized to the intervention will receive a practice-specific antibiotic-prescription feedback and an educational outreach visit. During the visit the whole practice team will receive an introduction to e-learning modules addressing patient-centered communication on antibiotics. Furthermore, the practices will receive tablet PCs with information on antibiotics and the treatment of ARTI to be presented to patients. Practices randomized to the control will provide care as usual. The primary outcome measure is the antibiotic prescribing rate for patients with a history of ARTI. Data collected before the intervention, during the intervention and after the intervention will be compared. The use of narrow- vs. broad-spectrum antibiotics will be analyzed as a secondary outcome. A process evaluation is also part of the trial.DiscussionThis study should contribute to the growing body of research on reducing antibiotic prescription.Trial registrationISRCTN, ISRCTN15061174. Registered retrospectively on 13 July 2018.

Highlights

The overuse of antibiotics is a major cause for the worldwide rise of antibiotic resistance
This study should contribute to the growing body of research on reducing antibiotic prescription
As a controlled CHANGE-3 trial (cRCT), CHANGE-3 aims at improving antibiotic prescription among acute respiratory tract infections (ARTI) patients cared for in general practice

Summary

Introduction

The overuse of antibiotics is a major cause for the worldwide rise of antibiotic resistance. In Germany, approximately 40–45% of all antibiotics prescribed in human medicine stem from primary care, with acute respiratory tract infections (ARTI) [3] being the most common cause. Among both experts and non-professionals it is well known that ARTI are primarily caused by viruses and are mostly self-limiting, in too many cases antibiotics are prescribed [4,5,6]. The main reasons for the inadequate prescription of antibiotics in primary care include a misleading safety culture and general practitioners’ (GPs) misconception that patients would expect an antibiotic prescription [7, 8] This leads to over-prescribing of broad-spectrum antibiotics such as quinolones and cephalosporins [3]. This eventually leads to increasing rates of antibiotic resistance, avoidable side effects and drug interactions as well as unnecessary direct and indirect costs, e.g., for hospital admissions [9,10,11,12,13]

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