Open Access Study protocol

Converting habits of antibiotic prescribing for respiratory tract infections in German primary care – the cluster-randomized controlled CHANGE-2 trial

Attila Altiner1, Reinhard Berner2, Annette Diener1*, Gregor Feldmeier1, Anna Köchling1, Christin Löffler1, Helmut Schröder3, Achim Siegel4, Anja Wollny1 and Winfried V Kern5

Author Affiliations

1 Institute of General Practice, Rostock University Medical Center, 18055, Rostock, Germany

2 Centre for Pediatrics and Adolescents, Carl Gustav Carus University Hospital Dresden, 01307, Dresden, Germany

3 AOK Research Institute (WIdO), 10178, Berlin, Germany

4 Division of General Practice, Department of Medicine, University Medical Center Freiburg, 79110, Freiburg, Germany

5 Division of Infectious Diseases, Department of Medicine, University Medical Center Freiburg, 79106, Freiburg, Germany

For all author emails, please log on.

BMC Family Practice 2012, 13:124  doi:10.1186/1471-2296-13-124

Published: 20 December 2012

Abstract

Background

With an average prescription rate of 50%, in German primary care antibiotics are still too frequently prescribed for respiratory tract infections. The over-prescription of antibiotics is often explained by perceived patient pressure and fears of a complicated disease progression. The CHANGE-2 trial will test the effectiveness of two interventions to reduce the rate of inappropriate antibiotic prescriptions for adults and children suffering from respiratory tract infections in German primary care.

Methods/Design

The study is a three-arm cluster-randomized controlled trial that measures antibiotic prescription rates over three successive winter periods and reverts to administrative data of the German statutory health insurance company AOK. More than 30,000 patients in two regions of Germany, who visit their general practitioner or pediatrician for respiratory tract infections will be included. Interventions are: A) communication training for general practitioners and pediatricians and B) intervention A plus point-of-care testing. Both interventions are tested against usual care. Outcome measure is the physicians’ antibiotic prescription rate for respiratory tract infections derived from data of the health insurance company AOK. Secondary outcomes include reconsultation rate, complications, and hospital admissions.

Discussion

Major aim of the study is to improve the process of decision-making and to ensure that patients who are likely to benefit from antibiotics are treated accordingly. Our approach is simple to implement and might be used rapidly among general practitioners and pediatricians. We expect the results of this trial to have major impact on antibiotic prescription strategies and practices in Germany, both among general practitioners and pediatricians.

Trial registration

The study is registered at the Current Controlled Trials Ltd (ISRCTN01559032)

Keywords:
Antibiotic prescribing; Respiratory tract infections; Primary care; Randomized controlled trial