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

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

Background: The 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/design: The 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. Discussion: This study should contribute to the growing body of research on reducing antibiotic prescription. Trial registration: ISRCTN, ISRCTN15061174. Registered retrospectively on 13 July 2018

Exploring Physician Perspectives on Using Real-world Care Data for the Development of Artificial Intelligence–Based Technologies in Health Care: Qualitative Study

BackgroundDevelopment of artificial intelligence (AI)–based technologies in health care is proceeding rapidly. The sharing and release of real-world data are key practical issues surrounding the implementation of AI solutions into existing clinical practice. However, data derived from daily patient care are necessary for initial training, and continued data supply is needed for the ongoing training, validation, and improvement of AI-based solutions. Data may need to be shared across multiple institutions and settings for the widespread implementation and high-quality use of these solutions. To date, solutions have not been widely implemented in Germany to meet the challenge of providing a sufficient data volume for the development of AI-based technologies for research and third-party entities. The Protected Artificial Intelligence Innovation Environment for Patient-Oriented Digital Health Solutions (pAItient) project aims to meet this challenge by creating a large data pool that feeds on the donation of data derived from daily patient care. Prior to building this data pool, physician perspectives regarding data donation for AI-based solutions should be studied. ObjectiveThis study explores physician perspectives on providing and using real-world care data for the development of AI-based solutions in health care in Germany. MethodsAs a part of the requirements analysis preceding the pAItient project, this qualitative study explored physician perspectives and expectations regarding the use of data derived from daily patient care in AI-based solutions. Semistructured, guide-based, and problem-centered interviews were audiorecorded, deidentified, transcribed verbatim, and analyzed inductively in a thematically structured approach. ResultsInterviews (N=8) with a mean duration of 24 (SD 7.8) minutes were conducted with 6 general practitioners and 2 hospital-based physicians. The mean participant age was 54 (SD 14.1; range 30-74) years, with an average experience as a physician of 25 (SD 13.9; range 1-45) years. Self-rated affinity toward modern information technology varied from very high to low (5-point Likert scale: mean 3.75, SD 1.1). All participants reported they would support the development of AI-based solutions in research contexts by donating deidentified data derived from daily patient care if subsequent data use was made transparent to them and their patients and the benefits for patient care were clear. Contributing to care optimization and efficiency were cited as motivation for potential data donation. Concerns regarding workflow integration (time and effort), appropriate deidentification, and the involvement of third-party entities with economic interests were discussed. The donation of data in reference to psychosomatic treatment needs was viewed critically. ConclusionsThe interviewed physicians reported they would agree to use real-world care data to support the development of AI-based solutions with a clear benefit for daily patient care. Joint ventures with third-party entities were viewed critically and should focus on care optimization and patient benefits rather than financial interests

Antibiotic prescribing for acute, non-complicated infections in primary care in Germany: baseline assessment in the cluster randomized trial ARena

Background!#!Antimicrobial resistance is fueled by inappropriate use of antibiotics. Global and national strategies support rational use of antibiotics to retain treatment options and reduce resistance. In Germany, the ARena project (Sustainable reduction of antibiotic-induced antimicrobial resistance) intended to promote rational use of antibiotics for acute non-complicated infections by addressing network-affiliated physicians, primary care teams and patients through multiple interacting interventions. The present study documented patterns of antibiotic prescribing for patients with acute non-complicated infections who consulted a physician in these networks at the start of the ARena project. It explored variation across subgroups of patients and draws comparisons to prescribing patterns of non-targeted physicians.!##!Methods!#!This retrospective cross-sectional analysis used mixed logistic regression models to explore factors associated with the primary outcome, which was the percentage of patient cases with acute non-complicated respiratory tract infections consulting primary care practices who were treated with antibiotics. Secondary outcomes concerned the prescribing of different types of antibiotics. Descriptive methods were used to summarize the data referring to targeted physicians in primary care networks, non-targeted physicians (reference group), and patient subgroups.!##!Results!#!Overall, antibiotic prescribing rates were 32.0% in primary care networks and 31.7% in the reference group. General practitioners prescribed antibiotics more frequently than other medical specialist groups (otolaryngologists vs. General practitioners OR = 0.465 CI = [0.302; 0.719], p < 0.001, pediatricians vs. General practitioners: OR = 0.369 CI = [0.135; 1.011], p = 0.053). Quinolone prescribing rates were 9.9% in primary care networks and 8.1% in reference group. Patients with comorbidities had a higher likelihood of receiving an antibiotic and quinolone prescription and were less likely to receive a guideline-recommended substance. Younger patients were less likely to receive antibiotics (OR = 0.771 CI = [0.636; 0.933], p = 0.008). Female gender was more likely to receive an antibiotic prescription (OR = 1.293 CI = [1.201, 1.392], p < 0.001).!##!Conclusion!#!This study provided an overview of observed antibiotic prescribing for acute non-complicated respiratory tract infections in German primary care at the start of the ARena project. Findings indicate potential for improvement and will serve as comparator for the post-interventional outcome evaluation to facilitate describing of potential changes

Climate change mitigation: Qualitative analysis of environmental impact-reducing strategies in German primary care

AbstractBackground The German healthcare system is responsible for 5,2% of the national emissions of greenhouse gases. Therefore, mitigation actions to reduce the carbon footprint are crucial. However, there have been few approaches to achieve this in German primary care.Objectives This study aimed to identify environmental impact-reducing strategies of German primary care practices.Methods During the summer of 2021, a qualitative study was conducted using interviews and focus groups with experts in primary care across Germany, such as physicians, medical assistants, health scientists and experts on the health system level. Verbatim transcribed data were analyzed using Thematic Analysis.Results The sample comprised 26 individual interviews and two focus groups with a total of N = 40 participants. Findings provide a first overview of pursued mitigation strategies and contextual factors influencing their implementation. Strategies referred to the use of water and energy, recycling and waste management, supply chains and procurement, digitisation, mobility, patient care, behavioural changes and system level. Implementing sustainable actions in daily care was considered expensive and often unfeasible due to lack of staff, time and restrictive hygiene regulations. Participants called for more instruction on implementing mitigating actions, for example, through websites, podcasts, guidelines or quality indicators.Conclusion This study’s findings can support the development of future environmental impact-reducing strategies in primary care. Potential options for guidance and support should be considered to facilitate sustainability

Building climate resilience: awareness of climate change adaptation in German outpatient medical practices

Abstract Background Climate change is seen as the biggest health threat of the twenty-first century. Making outpatient medical practices resilient is therefore crucial to protect vulnerable groups and maintain quality of care. Awareness is a precondition for action. This study aims to explore awareness (knowledge, experience and attention) of climate change adaptation among stakeholders of outpatient medical practices. Methods Semi-structured interviews and focus groups with stakeholders of outpatient medical practices were conducted. The qualitative data were analysed in a two-step Thematic Analysis process. Results In total, n = 40 stakeholders participated in two focus groups and 26 interviews. The findings show a mixed degree of awareness in outpatient medical practices. The spectrum ranged from a passive role with curative acting only, handing over responsibility to others and a low perceived self-efficacy to a proactive and responsible implementation of adaptation strategies. Participants who saw the need and responsibility of climate change adaptation in medical practices perceived low additional workload. In general, implementation of climate change adaptation measures and general awareness of climate change adaptation appeared to be depending on a certain tension for change and a higher self-efficacy. Conclusion Medical practices, and specifically primary care, plays a crucial role in climate change adaptation, and awareness needs to be increased further in order to cope with consequences of climate change. To facilitate this, there should be a strong emphasis on climate change adaptation strategies being part of outpatient care provider roles rather than being perceived as an “add-on” to already high workloads

Additional file 1 of Building climate resilience: awareness of climate change adaptation in German outpatient medical practices

Additional file 1: Table S1. List of discussed and experienced adaptation strategies in Outpatient medical practices in Germany

Primary Care Disease Management for Venous Leg Ulceration in German Healthcare: Results of the Ulcus Cruris Care Pilot Study

Despite proven effectiveness, compression therapy is applied in only 20–40% of patients with venous leg ulceration, leading to avoidable chronification and morbidity. The Ulcus Cruris Care project was established to develop a new disease-management concept comparable to existing programs for chronic diseases to support evidence-based treatment of venous leg ulceration. This prospective controlled study assessed its first implementation. Interventional elements comprised online training for general practitioner practices, software support for case management, and educational materials for patients. A total of 20 practices and 40 patients were enrolled in a 1:1 ratio to the intervention and control group. Guideline-conform compression therapy was applied more frequently in the intervention group (19/20 [95%] vs. 11/19 [58%]; p = 0.006). For patients with ulcers existing ≤ 6 months, the healing rate at 12 weeks was 8/11 [73%] (intervention) compared to 4/11 [36%] (control; p = 0.087). Patients after intervention had higher scores for self-help and education in the PACIC-5A questionnaire (42.9 ± 41.6 vs. 11.4 ± 28.8; p = 0.044). Treatment costs were EUR 1.380 ± 1.347 (intervention) and EUR 2.049 ± 2.748 (control; p = 0.342). The results of this study indicate that the Ulcus Cruris Care intervention may lead to a significant improvement in care. Consequently, a broader rollout in German healthcare seems warranted

Evaluating the structural reform of outpatient psychotherapy in Germany (ES-RiP trial) - a qualitative study of provider perspectives

Background: Access to outpatient mental healthcare can be challenging for patients. In Germany, a national structural reform was implemented in 2017 to accelerate and enhance access to outpatient psychotherapy and reduce waiting times. During the first phase of the study 'Evaluation of a structural reform of the outpatient psychotherapy guideline (ES-RiP)' and embedded into a process evaluation, the implementation was to be evaluated through assessing general practitioners' (GPs) and psychotherapists' (PTs) perspectives regarding utilization of provided new measures, and perceived potential for optimization. Particular focus was on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs). Methods: This exploratory cross-sectional qualitative study used on-site and online focus group discussions and semi-structured telephone interviews with GPs and outpatient PTs. Generated data were analyzed using thematic framework analysis. Descriptive statistics were used to analyze participant characteristics collected via a socio-demographic questionnaire. Results: Perspectives on the structural reform were heterogenous. GPs and PTs considered the component of timely initial psychotherapeutic assessment consultations beneficial. GPs disapproved of their deficits in detailed information about the structural reform and exchange with outpatient PTs. Improvement suggestions included structured short information exchange and joint quality circles. The overall number of available outpatient PTs in rural areas was perceived as insufficient. For patients with cMPs, GPs saw patient barriers for therapy access and continuity in low intrinsic motivation, physical impediments and older age. PTs also saw patient challenges regarding low intrinsic motivation and keeping scheduled appointments. They considered post-reform administrative efforts to be high and reported that the regulations (conformity) lead to planning difficulties and financial losses. Reform elements were tailored to fit in with PTs key therapy areas. Stronger networking and joint lectures were suggested as remedy for the currently still limited exchange with GPs. Unlike the GPs, PTs emphasized that accepting patients into psychotherapeutic treatment was independent of a possibly present chronic physical disease. Conclusions: The findings contribute to understanding the integration of the delivered structural reform into daily care processes and provide an indication about reached targets and potential improvements. Further phases of the ES-RiP study can build on the findings and broaden insights