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

Background Despite 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. Methods A 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. Discussion The ARena trial will examine the effectiveness of large scale implementation strategies and explore their delivery in routine practice. Trial registration ISRCTN, ISRCTN58150046. Registered 24 August 2017. Electronic supplementary material The online version of this article (10.1186/s13012-018-0722-0) contains supplementary material, which is available to authorized users.


Mode of delivery
Single intervention All physicians who participate in ARena.

Location
The content is integrated into a Learning Management System (LMS). The learning platform will be accessible via a user-portal. The learning contents in the learning platform are secured. Access for users can be provided via the specific user-portal. Users (learners) of the physician networks participating at ARena are captured electronically. The learning contents are structured as self-learning courses. The learning platform will be available under the domain "welearn.academy". The correct functioning of video contents is ensured by an early test. The learning contents are generated in HTML5 format using the SCORM standards.

Frequency
Each course lasts about 1 hours and can be completed in the 4th quarter of 2017. 9 Planned tailoring No 10 Fidelity enhancement Component 2 Quality circles with data-based feedback for physicians 1 Short Name Quality circles with data-based feedback for physicians. 2 Goal and rationale Self-reflection by means of practice-specific, data-based feedback reports and evidence-based background information combined with discussion and exchange of experiences in quality circles together with other physicians.
3 Materials Feedback reports are based on the claims data (diagnosis and prescription data) of one's own practice; checklists, patient information; slides for quality circle implementation 4 Procedures Claims-data ( § §295, 300 SGB V) are provided by the participating health insurance companies pseudonymized for practices and anonymized for patients. Participating practices have signed a written informed consent to use their practice specific data, which means that specific claims-data can be allocated to each participating practice. A SFTP (Secure FILE Transfer Protocol) will be used for transmission of data between health insurance and the aQua Institute. Afterwards data will be checked and analyzed using SPSS and evaluated at the operations identification number (BSNR) level. Individualized reporting is enabled by a self-developed software. The benchmark (mean 25% best practices), own network, all networks, control supply (comparison group) are shown for comparison purposes. The background information is guideline-and evidence-based (structured literature research). Established indicators are used.
5 Providers of intervention Physician, pharmacist, psychologist, programmer, medical documentation specialist 6 Mode of delivery Individual and group intervention All physicians who participate in ARena.

Location
The material will be sent by post (practice-specific feedback reports) or are provided in the login area of the project portal (samples, slides) (arena-info.de). 8 Frequency 4x ca. 2 hours in the quarters 2017q4, 2018q2 + q4, 2019q2 9 Planned tailoring 10 Fidelity enhancement Component 3 Information campaigns for the public 1 Short Name Information campaigns for the public.

Goal and rationale
The aim is to reach the public through various media and to raise awareness on the topic of "antibiotics / resistance development". Dissemination of core messages throughout societies. The information material focuses particularly on patients affected by infections and aim to raise awareness for the topic "antibiotics / resistance development".

Materials
Handout / Info-Tips (guideline-based, culture-sensitive) Green slip prescriptions ('Grüne Rezepte', physician recommended, but not subject to prescription medication, usually not reimbursed by health insurer) 4 Procedures The core messages are guideline-based and developed in agreement with the other consortium partners. The material used are from recognized institutions, as well as self-generated ones in order to create a "Corporate Identity ". All material are made available for the participating networks and practices via the ARena portal for free. 5 Providers of intervention Physician, pharmacist, psychologist, journalist, advertising expert. 6 Mode of delivery Group intervention Some of the material is also available via the portal. 7 Location Provision of material for the practices via the ARena portal 8 Frequency 2017q4, 2018q1+q4, 2019q1+q2 9 Planned tailoring 10 Fidelity enhancement Component 5 Performance-based additional reimbursement 1 Short Name P4P, performance-based additional reimbursement 2 Goal and rationale Performance-based additional reimbursement to support rational antibiotics prescription like proposed. 3 Materials claims-data, indicators, amount of money 4 Procedures Primary outcome: patients with acute respiratory infections (bronchitis, tonsillitis, sinusitis or otitis media), which are NOT treated with antibiotics. The target value is empirically determined using claims-data (according to §295, §300 SGB V). Any practice reaching the target value will receive the additional reimbursement. This performance-based additional reimbursement is based on the total sum of the fund assigned in relation to the number of registered insured persons with index diseases in the practices.

Providers of intervention
The distribution key ('Verteilungsschlüssel') is defined by the consortium partners jointly. 6 Mode of delivery Single intervention All participating practices. 7 Location The calculation of the outcomes is carried out by the aQua Institute and the payment of performance-based reimbursement is authorized by the Association of Statutory Health Insurance Physicians of Bavaria ('Kassenärztliche Vereinigung Bayerns').

Frequency
The service provision is provided in the quarters 2018q1 to 2019q2. There is a time shift in terms of additional reimbursement due to reasons of data provision and general reimbursement.
9 Planned tailoring 10 Fidelity enhancement Component 6 E-learning on communication with patients for non-physician health professionals of the practice team 1 Short Name E-learning for medical assistants to promote patient-centered communication.

Goal and rationale
The focus is on exploring patient expectations and shared decision-making in patients with non-complicated, acute infections, which are especially common in ambulatory practices and do not require the use of antibiotics as first choice treatment. The educational objective is to learn how to support the physician in his/her daily practice with patients with non-complicated infections and the rational use of antibiotics.

Materials
Video clips of re-enacted scenes of typical situations in the GP's daily practice, which are relevant for non-physician health professionals of the practice team.

Procedures
Various situations, typical for GP practices, are represented. In addition, the elearning platform comprises background information of interest for medical assistants, which can be displayed by the users, if required. The participation will be documented by an automatically generated personalized certificate.

Providers of intervention
The screenplay is produced at the Institute of General Medicine of the University of Rostock (and, if possible, involving MFAs) and implemented by the Society for Patient-centered Communication mbH (GPZK) in collaboration with a director and actors. The e-learning platform is established at the aQua Institute with the help of an external service provider. 6 Mode of delivery Single intervention Tailored for non-physician health professionals of the practice team from practices participating in intervention group B.

Location
The content is integrated into a Learning Management System (LMS). The learning platform will be accessible via a user-portal. The learning contents on the learning platform are secured. Access for users can be provided via the specific user-portal. The learning contents are structured as self-learning courses. The learning platform will be available under the domain "welearn.academy". The correct functioning of video contents is ensured by an early test. The learning contents are generated in HTML5 format using the SCORM standards.

Frequency
Each course lasts about 1 hour and can be completed in the 4th quarter of 2017. 9 Planned tailoring No 10 Fidelity enhancement Component 7 Quality circles with data-based feedback for non-physician health professionals of the practice team 1 Short Name Quality circles with data-based feedback for medical assistants. 2 Goal and rationale Self-reflection by means of practice-specific, data-based feedback reports, results of the patient survey and evidence-based background information combined with discussion and exchange of experiences in the quality circle together with other medical assistants.
3 Materials Feedback reports tailored for medical assistants, based on claims-data (diagnosis and prescription data) and the results of the patient survey of one's own practice; checklists, patient information; slides for quality circle implementation.

Procedures
Claims-data ( § §295, 300 SGB V) are provided by the participating health insurance companies pseudonymized for practices and anonymized for patient. Participating practices have signed a written informed consent to use their practice specific data, which means that specific claims-data can be allocated to each participating practice. A SFTP (Secure FILE Transfer Protocol) will be used for transmission of data between health insurance and the aQua Institute. Afterwards data will be checked and analyzed using SPSS and evaluated at the operations identification number (BSNR) level. Individualized reporting is enabled by a self-developed software. The background information is guideline-and evidence-based (structured literature research) and relevant for non-physician health professionals of the practice team. 5 Providers of intervention Physician, pharmacist, psychologist, IT-specialist, medical assistant 6 Mode of delivery Individual and group intervention Only for non-physician health professionals of the practice team from participating practices in intervention group B.

Location
The material will be sent by mail (practice-specific feedback) or will be available in the login area of the project portal (samples, slides) (arena-info.de). 8 Frequency 4x ca 2 hours in the quarters 2017q4, 2018q2+q4, 2019q2 9 Planned tailoring 10 Fidelity enhancement Kamradt et al. (2018) Sustainable reduction of antibiotics-induced antimicrobial resistance (ARena) in German ambulatory care: study protocol of a cluster randomized trial -Additional file 1 7 Component 8 Information material available on tablet computers 1 Short Name Information material on tablets 2 Goal and rationale The information material focuses particularly on patients affected by infections and aim to raise awareness for the topic "antibiotics / resistance development".

Materials
Topic-specific explanation videos and information on a tablet PC, multilingualism 4 Procedures The core messages are guideline-based and developed in agreement with the other consortium partners. The material used are from recognized institutions, as well as self-generated ones in order to create a "Corporate Identity ".
5 Providers of intervention Physician, pharmacist, psychologist, journalist, advertising expert. 6 Mode of delivery Group intervention Some of the material is also available via the portal. 7 Location 8 Frequency 2017q4, 2018q1+q4, 2019q1+q2 9 Planned tailoring 10 Fidelity enhancement Component 9 Computerized decision support system (CDSS) 1 Short Name Computerized decision support system (CDSS). 2 Goal and rationale Rational use of antibiotics; critical indication for non-complicated infections; reminders of targeted information for the patient which the physician should give and information on suitable other interventions (non-drug).
3 Materials List of drug codes and diagnoses (reliable as well as suspected diagnoses) as well as prewritten reference texts. Definition of certain case constellations for which reference texts will appear. Cooperation with software producers, specification of the so-called S3C interface; tool activation exclusively in the participating practices. These practices confirm the activation / use towards the aQua Institute.

Procedures
List of diagnosis and drug codes, in which certain instructions are available for the respective practice administration system. Writing of information texts. The considered time interval (reference) is always the current quarter of a year. The following case constellations are defined (see figures):

Scenario 1
Entry of ATC by a physician into the practice administration system Definition of case constellations, in which instructions are given within the practice administration system. The specifications are made available in the form of Excel tables. These tables are the basis for the specifications of the so-called S3C interface by an external service provider. This software tool will be integrated into the practice administration systems during a regular software update. An access restriction (release code) ensures that the IT decision support is only used by participating practices in intervention arm C. 8 Frequency From 2018q3 to 2019q2 9 Planned tailoring 10 Fidelity enhancement Component 10 Quality circles in local multidisciplinary groups 1 Short Name Quality circles in local multidisciplinary groups. 2 Goal and rationale Discussion and exchange of experience between different service providers.

Materials
Slides for the implementation of local multidisciplinary quality circles.

Procedures
The background information is guideline-and evidence-based (structured literature review). The care pathway of patients with non-complicated infections as well as the local situation on antimicrobial resistance is discussed. The meetings are moderated by GPs. 5 Providers of intervention Physician, pharmacist, psychologist 6 Mode of delivery Group interventions for healthcare providers in the geographic area covered by the participating networks in intervention arm C. 7 Location The material are provided in the login area of the project portal (samples, slides) (arena-info.de). 8 Frequency 2x ca 2 hours in the quarters 2018q1+q2 and 2018q4 and 2019q1 respectively 9 Planned tailoring 10 Fidelity enhancement