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.

Background The implementation of a personal electronic health record (PHR) is a central objective of digitalization policies in the German health care system. Corresponding legislation was passed with the 2015 Act for Secure Digital Communication and Applications in the Health Sector (eHealth Act). However, compared with other European countries, Germany still lags behind concerning the implementation of a PHR. Objective In order to explore potential barriers and facilitators for the adoption of a PHR in routine health care in Germany, this paper aims to identify policies, structures, and practices of the German health care system that influence the uptake and use of a PHR. Methods A total of 33 semistructured interviews were conducted with a purposive sample of experts: 23 interviews with different health care professionals and 10 interviews with key actors of the German health care system who were telematics, eHealth, and information technology experts (eHealth experts). The interviews were transcribed verbatim and subjected to a content analysis. Results From the expert perspective, a PHR was basically considered desirable and unavoidable. At the same time, a number of challenges for implementation in Germany have been outlined. Three crucial themes emerged: (1) documentation standards: prevailing processes of the analog bureaucratic paper world, (2) interoperability: the plurality of actors and electronic systems, and (3) political structure: the lack of clear political regulations and political incentive structures. Conclusions With regard to the implementation of a PHR, an important precondition of a successful digitalization will be the precedent reform of the system to be digitized. Whether the recently passed Act for Faster Appointments and Better Care will be a step in the right direction remains to be seen.

Background Antibiotic prescription rates in primary care in Germany are moderate, but still considered too high. The ARena study (Sustainable reduction of antibiotic-induced antimicrobial resistance) was initiated to foster awareness and understanding of the growing challenge and promotes rational antibiotics use for acute, non-complicated and self-limiting infections. Methods The present study was performed as part of the process evaluation of the ARena study. Interviews were conducted with a purposive sample of physicians participating in the ARena study to identify factors relevant to primary care physicians’ decision-making when prescribing antibiotics for acute non-complicated infections. Generated data were audio-recorded. Pseudonymized verbatim transcripts were coded using a pre-defined framework. The Dual Process Theory was applied to provide understanding of individual health professional factors that induce dysrational prescribing decisions. Results Based on medical as well as non-medical considerations, physicians developed habits in decision making on antibiotics prescribing. They acknowledged inadequate antibiotics prescribing for acute, non-complicated infections in situations involving uncertainty regarding diagnosis, prognosis, continuity of care, patient expectations and when not knowing the patient. Educative efforts empowered physicians to override habitual prescribing. A theory-driven model provides transparency as to how dysrational prescribing decisions occur and suggests remedy by providing new experiences and new recognizable patterns through educative efforts. Conclusions Educational interventions may only change prescribing behaviours if they result in active rational rather than routine-based decision-making on antibiotics prescribing. Trial registration ISRCTN, ISRCTN58150046.

The cluster randomized trial ARena (sustainable reduction of antibiotic-induced antimicrobial resistance, 2017–2020) promoted appropriate use of antibiotics for acute non-complicated infections in primary care networks (PCNs) in Germany. A process evaluation assessed determinants of practice and explored factors associated with antibiotic prescribing patterns. This work describes its findings on uptake and impacts of the complex intervention program and indicates potential implementation into routine care. In a nested mixed-methods approach, a three-wave study-specific survey for participating physicians and medical assistants assessed potential impacts and uptake of the complex intervention program. Stakeholders received a one-time online questionnaire to reflect on network-related aspects. Semi-structured, open-ended interviews, with a purposive sample of physicians, medical assistants and stakeholders, explored program component acceptance for daily practice and perceived sustainability of intervention component effects. Intervention components were perceived to be smoothly integrable into practice routines. The highest uptake was reported for educational components: feedback reports, background information, e-learning modules and disease-specific quality circles (QCs). Participation in PCNs was seen as the motivational factor for guideline-oriented patient care and adoption of new routines. Future approaches to fostering appropriate antibiotics use by targeting health literacy competencies and clinician’s therapy decisions should combine evidence-based information sources, audit and feedback reports and QCs.

Background: Particularly in the context of severe diseases like cancer, many patients wish to include caregivers in the planning of treatment and care. Many caregivers like to be involved but feel insufficiently enabled. This study aimed at providing insight into patients' and caregivers' perspectives on caregivers' roles in managing the patient portal of an electronic personal health record (PHR). Methods: A descriptive qualitative study was conducted comprising two study phases: (1) Usability tests and interviews with patients with cancer and caregivers (2) additional patient interviews after a 3-month-pilot-testing of the PHR. For both study parts, a convenience sample was selected, focusing on current state of health and therapy process and basic willingness to participate and ending up with a mixed sample as well as saturation of data. All interviews were audio-recorded, pseudonymized, transcribed verbatim and qualitatively analyzed. Results: Two main categories emerged from qualitative data: 'Caregivers' role' and 'Graduation of access rights'consisting of four subcategories each. The interviewed patients (n = 22) and caregivers (n = 9) felt that the involvement of caregivers is central to foster the acceptance of a PHR for cancer patients. However, their role varied from providing technical support to representing patients, e.g. if the patient's state of health made this necessary. Heterogeneous opinions emerged regarding the question whether caregivers should receive full or graduated access on a patient's PHR. Conclusions: In order to support the patient and to participate in the care process, caregivers need up-to-date information on the patient's health and treatment. Nevertheless, some patients do not want to share all medical data with caregivers, which might strain the patient-caregiver relationship. This needs to be considered in development and implementation of personal health records. Generally, in the debate on patient portals of a personal health record, paying attention to the role of caregivers is essential. By appreciating the important relationship between patients and caregivers right from the beginning, implementation, of a PHR would be

Background Antimicrobial resistance is an important global health issue. In Germany, the national agenda supports various interventions to convert habits of antibiotic use. In the CHANGE-3 (Converting Habits of Antibiotic Use for Respiratory Tract Infections in German Primary Care) study, digital tools were applied for information delivery: tablet computers in primary care practices, e-learning platforms for medical professionals, and a public website to promote awareness and health literacy among primary care physicians, their teams, and their patients. Objective This study is embedded in the process evaluation of the CHANGE-3 study. The aim of this study was to evaluate the acceptance and uptake of digital devices for the delivery of health-related information to enhance awareness and change habits of antibiotic use in primary care in Germany. Methods This study used a convergent-parallel mixed-methods design. Audio-recorded semistructured telephone interviews were conducted with physicians, nonphysician health professionals, and patients in the CHANGE-3 program. Pseudonymized verbatim transcripts were coded using thematic analysis. In-depth analysis was performed based on the inductive category of information provision via digital information tools. Identified themes were related to the main postulates of Diffusion of Innovations theory (DIT) to provide an explanatory frame. In addition, data generated through a structured survey with physicians and nonphysician health professionals in the program were analyzed descriptively and integrated with the qualitative data to explore the complementarity of the findings. Results Findings regarding the acceptance and uptake of digital devices were related to three postulates of DIT: innovation characteristics, communication channels, and unanticipated consequences. Participants considered the provided digital educative solutions to be supportive for promoting health literacy regarding conversion of habits of antibiotic use. However, health care professionals found it challenging to integrate these solutions into existing routines in primary care and to align them with their professional values. Low technology affinity was a major barrier to the use of digital information in primary care. Patients welcomed the general idea of introducing health-related information in digital formats; however, they expressed concerns about device-related hygiene and the appropriateness of the digital tools for older patients. Conclusions Patients and medical professionals in German primary care are reluctant to use digital devices for information and education. Using a Diffusion of Innovations approach can support assessment of existing barriers and provide information about setting-specific preconditions that are necessary for future tailoring of implementation strategies. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 15061174; http://www.isrctn.com/ISRCTN15061174.

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.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3209-7) contains supplementary material, which is available to authorized users.

BackgroundPersonal electronic health records (PHR) are considered instrumental in improving health care quality and efficiency, enhancing communication between all parties involved and strengthening the patient’s role. Technical architectures, data privacy, and applicability issues have been discussed for many years. Nevertheless, nationwide implementation of a PHR is still pending in Germany despite legal regulations provided by the eHealth Act passed in 2015. Within the information technology for patient-oriented care project funded by the Federal Ministry of Education and Research (2012-2017), a Web-based personal electronic health record prototype (PEPA) was developed enabling patient-controlled information exchange across different care settings. Gastrointestinal cancer patients and general practitioners utilized PEPA during a 3-month trial period. Both patients and physicians authorized by them could view PEPA content online and upload or download files.ObjectiveThis paper aims to outline findings of the posttrial qualitative study carried out to evaluate user-reported experiences, perceptions, and perspectives, focusing on their interpretation of PEPA beyond technical usability and views on a future nationwide implementation.MethodsData were collected through semistructured guide-based interviews with 11 patients and 3 physicians (N=14). Participants were asked to share experiences, views of perceived implications, and perspectives towards nationwide implementation. Further data were generated through free-text fields in a subsequent study-specific patient questionnaire and researcher’s notes. Data were pseudonymized, audiotaped, and transcribed verbatim. Content analysis was performed through the Framework Analysis approach. All qualitative data were systemized by using MAXQDA Analytics PRO 12 (Rel.12.3.1). Additionally, participant characteristics were analyzed descriptively using IBM SPSS Statistics Version 24.ResultsUsers interpreted PEPA as a central medium containing digital chronological health-related documentation that simplifies information sharing across care settings. While patients consider the implementation of PEPA in Germany in the near future, physicians are more hesitant. Both groups believe in PEPA’s concept, but share awareness of concerns about data privacy and older or impaired people’s abilities to manage online records. Patients perceive benefits for involvement in treatment processes and continuity of care but worry about financing and the implementation of functionally reduced versions. Physicians consider integration into primary systems critical for interoperability but anticipate technical challenges, as well as resistance from older patients and colleagues. They omit clear positioning regarding PEPA’s potential incremental value for health care organizations or the provider-patient relationship.ConclusionsDigitalization in German health care will continue to bring change, both organizational and in the physician-patient relationship. Patients endorse and expect a nationwide PEP...