Sustainable reduction of antibiotic-induced antimicrobial resistance (ARena) in German ambulatory care: study protocol of a cluster randomised trial

Abstract

BackgroundDespite many initiatives to enhance the rational use of antibiotics, there remains substantial room for improvement. The overall aim of this study is to optimise the appropriate use of antibiotics in German ambulatory care in patients with acute non-complicated infections (respiratory tract infections, such as bronchitis, sinusitis, tonsillitis and otitis media), community-acquired pneumonia and non-complicated cystitis, in order to counter the advancing antimicrobial resistance development.MethodsA three-armed cluster randomised trial will be conducted in 14 practice networks in two German federal states (Bavaria and North Rhine-Westphalia) and an added cohort that reflects standard care. The trial is accompanied by a process evaluation.Each arm will receive a different set of implementation strategies. Arm A receives a standard set, comprising of e-learning on communication with patients and quality circles with data-based feedback for physicians, information campaigns for the public, patient information material and performance-based additional reimbursement. Arm B receives this standard set plus e-learning on communication with patients and quality circles with data-based feedback tailored for non-physician health professionals of the practice team and information material for tablet computers (culture sensitive). Arm C receives the standard set as well as a computerised decision support system and quality circles in local multidisciplinary groups.The study aims to recruit 193 practices which will provide data on 23,934 patients each year (47,867 patients in total).The outcome evaluation is based on claims data and refers to established indicators of the European Surveillance of Antimicrobial Consumption Network (ESAC-Net). Primary and secondary outcomes relate to prescribing of antibiotics, which will be analysed in multivariate regression models. The process evaluation is based on interviews with surveys among physicians, non-physician health professionals of the practice team and stakeholders. A patient survey is conducted in one of the study arms. Interview data will be qualitatively analysed using thematic framework analysis. Survey data of physicians, non-physician health professionals of the practice team and patients will use descriptive and exploratory statistics for analysis.DiscussionThe ARena trial will examine the effectiveness of large scale implementation strategies and explore their delivery in routine practice.Trial registrationISRCTN, ISRCTN58150046. Registered 24 August 2017.Electronic supplementary materialThe online version of this article (10.1186/s13012-018-0722-0) contains supplementary material, which is available to authorized users.

Promoting rational antibiotic prescribing for non-complicated infections: understanding social influence in primary care networks in Germany

“…The cluster randomized trial ARena (Sustainable reduction of antibiotic-induced antimicrobial resistance, 2017-2019, trial registration: ISRCTN, ISRCTN58150046) intends to promote the rational and appropriate use of antibiotics for acute non-complicated infections in primary care in Germany [6,7]. Using a multifaceted strategy with multiple interacting intervention components, ARena addresses physician, primary care team and patient knowledge and attitudes about the use of antibiotics [6]. ARena is embedded into 14 PCNs across the German federal states of Bavaria and North-Rhine Westphalia.…”

“…As ARena is not completed yet, assessment of intervention effectiveness is currently pending. With the aim of providing insights into determinants of practice regarding a rational use of antibiotics and to propose explanations referencing identified influences and mechanisms of action, ARena is accompanied by a process evaluation to explore factors and processes leading to impacts on antibiotic prescribing patterns [6].…”

Promoting rational antibiotics prescribing for non-complicated infections: Understanding social influence in primary care networks in Germany

“…Intervention components included e-learning on communication, quality circles and data-based feedback for physicians and care team members, public information campaigns, performance-based additional reimbursement, a computerized decision support system and culture-sensitive information material for patients in print and digital format on tablet computers to be used in waiting areas. Standard care is reflected by an added cohort based on claims-data [6].…”

“…The cluster randomized trial ARena (Sustainable reduction of antibiotic-induced antimicrobial resistance, 2017-2019, trial registration: ISRCTN, ISRCTN58150046) intends to promote the rational and appropriate use of antibiotics for acute non-complicated infections in primary care in Germany [6,7]. Using a multifaceted strategy with multiple interacting intervention components, ARena addresses physician, primary care team and patient knowledge and attitudes about the use of antibiotics [6].…”

“…As ARena is not completed yet, assessment of intervention effectiveness currently is pending. With the aim of providing insights into determinants of practice regarding a rational use of antibiotics and to propose explanations referencing identified influences and mechanisms of action, ARena is accompanied by a process evaluation to explore factors and processes leading to impacts on antibiotics prescribing patterns [6].…”