A counselling intervention for individual strategies to prevent complications and strengthen resources during pregnancy in gynaecological care (AOK-Family +): study protocol for a cluster-randomised controlled trial.

BACKGROUND: Lifestyle-related risk factors can increase complications during pregnancy and negatively impact the health of a mother and her child. Knowledge about these compliances among many pregnant women and women of childbearing age is lacking. In the study AOK-Family + , we propose the evaluation of a newly developed counselling intervention. The intervention aims to raise awareness and to provide relevant information about the impact of lifestyle-related risk factors during pregnancy. The aim of the proposed study is to evaluate the effect of this counselling intervention on women's knowledge of lifestyle-related risk factors during pregnancy and the concomitant healthy behaviours. METHODS: A cluster-randomised trial with three arms in Baden-Wuerttemberg, Germany, is proposed. Pregnant women and women of childbearing age will be allocated to one of three groups: online intervention, on-site intervention, or a waiting-list control. Trained counsellors from AOK Baden-Wuerttemberg, a German statutory health insurer, will conduct the counselling sessions. Data collection is conducted throughout validated questionnaires administered at three intervals: before counselling (t0), directly after counselling (t1), and at a 6-week follow-up (t2). The primary outcomes will be health knowledge and healthy behaviours relating to LRFFs during pregnancy. A process evaluation will examine the processes, used resources, and future implementations through additional quantitative questions and qualitative interviews and focus groups. DISCUSSION: Based on this study, an implementation strategy for future conduction of lifestyle consultation during pregnancy could be developed with the aim of reducing pre- and post-mortem mobility and mortality. TRIAL REGISTRATION: The German Clinical Trials Register DRKS00027804. Registered on 2022/01/12.

Optimizing Antibiotic Prescribing for Acute Respiratory Tract Infections in German Primary Care: Results of the Regional Intervention Study CHANGE-3 and the Nested cRCT.

Within primary care, acute respiratory tract infections (ARTIs) are the most common reason for prescribing antibiotics. The aim of the CHANGE-3 study was to investigate how antibiotic prescribing for non-complicated ARTIs can be reduced to a reasonable level. The trial was conducted as a prospective study consisting of a regional public awareness intervention in two regions of Germany and a nested cluster randomised controlled trial (cRCT) of a complex implementation strategy. The study involved 114 primary care practices and comprised an intervention period of six winter months for the nested cRCT and two times six winter months for the regional intervention. The primary outcome was the percentage of antibiotic prescribing for ARTIs between baseline and the two following winter seasons. The regression analysis confirmed a general trend toward the restrained use of antibiotics in German primary care. This trend was found in both groups of the cRCT without significant differences between groups. At the same time, antibiotic prescribing was higher in routine care (with the public campaign only) than in both groups of the cRCT. With regard to secondary outcomes, in the nested cRCT, the prescribing of quinolones was reduced, and the proportion of guideline-recommended antibiotics increased.

[Acute respiratory tract infections and antibiotic prescriptions: What are patients' expectations?] / Akute Atemwegsinfekte und Antibiotikaverordnungen: Welche Erwartungen haben Patient*innen?

INTRODUCTION: The use of antibiotics in human medicine is partly responsible for the global increase in antibiotic resistance. Significant reductions in antibiotic prescribing were realised through educational campaigns, communication training and prescribing feedback. Based on data from the cluster-randomised CHANGE-3 trial, the present analysis focuses on the question of patient expectations for an antibiotic in acute respiratory infections. METHODS: 106 of 114 General Practitioner (GP) practices in Baden-Württemberg and Mecklenburg-Western Pomerania took part in the study. 4736 patients who visited the practices with acute respiratory infections from October 2018 to May 2019 filled out a questionnaire after the doctor's consultation. The analysis was descriptive. RESULTS: 16.7 % of patients with acute respiratory infections reported receiving antibiotics from their GP. 13.3 % of patients had hoped for an antibiotic and 5.5 % stated that they had asked their GP for an antibiotic prescription. The lowest prescription rate for antibiotics was reported by patients who had received a diagnosis of influenza from their GP. With specific diagnoses differentiated from uncomplicated respiratory tract infection, an increase in both the number of antibiotics hoped for and the number of antibiotics prescribed was observed. DISCUSSION: Patients still receive antibiotics more often than they actually hope for. On the part of GPs, prescriptions may still be written because of perceived pressure from patients, but this is not reflected in patient expectations. In addition to dealing openly with patients' expectations, strengthening patients' health literacy, mindful doctor-patient communication and offered opportunities for re-presentation in the case of specific diagnoses could further reduce the perceived pressure on GPs.

[Acute respiratory tract infections and antibiotic prescriptions: What are patients' expectations?] / Akute Atemwegsinfekte und Antibiotika-Verordnungen: Welche Erwartungen haben Patient*innen?

INTRODUCTION: The use of antibiotics in human medicine is partly responsible for the global increase in antibiotic resistance. Significant reductions in antibiotic prescribing were realised through educational campaigns, communication training and prescribing feedback. Based on data from the cluster-randomised CHANGE-3 trial, the present analysis focuses on the question of patient expectations for an antibiotic in acute respiratory infections. METHODS: 106 of 114 General Practitioner (GP) practices in Baden-Württemberg and Mecklenburg-Western Pomerania took part in the study. 4736 patients who visited the practices with acute respiratory infections from October 2018 to May 2019 filled out a questionnaire after the doctor's consultation. The analysis was descriptive. RESULTS: 16.7 % of patients with acute respiratory infections reported receiving antibiotics from their GP. 13.3 % of patients had hoped for an antibiotic and 5.5 % stated that they had asked their GP for an antibiotic prescription. The lowest prescription rate for antibiotics was reported by patients who had received a diagnosis of influenza from their GP. With specific diagnoses differentiated from uncomplicated respiratory tract infection, an increase in both the number of antibiotics hoped for and the number of antibiotics prescribed was observed. DISCUSSION: Patients still receive antibiotics more often than they actually hope for. On the part of GPs, prescriptions may still be written because of perceived pressure from patients, but this is not reflected in patient expectations. In addition to dealing openly with patients' expectations, strengthening patients' health literacy, mindful doctor-patient communication and offered opportunities for re-presentation in the case of specific diagnoses could further reduce the perceived pressure on GPs.

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

BACKGROUND: Development 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. OBJECTIVE: This study explores physician perspectives on providing and using real-world care data for the development of AI-based solutions in health care in Germany. METHODS: As 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. RESULTS: Interviews (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. CONCLUSIONS: The 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.

Assessing Reduction of Antibiotic Prescribing for Acute, Non-Complicated Infections in Primary Care in Germany: Multi-Step Outcome Evaluation in the Cluster-Randomized Trial ARena.

The three-armed cluster-randomized trial ARena (sustainable reduction of antibiotic-induced antimicrobial resistance) aimed to foster appropriate antibiotic use and reduce overprescribing in German ambulatory care to counter antibiotic resistance. Multi-faceted interventions targeted primary care physicians, teams and patients. This study examined the effectiveness of the implementation program. ARena was conducted in 14 primary care networks with 196 practices. All arms received data-based feedback on antibiotics prescribing and quality circles. Arms II and III received different add-on components each. Primary outcome examined is the prescribing rate for systemic antibiotics for cases with non-complicated acute infections (upper respiratory tract, bronchitis, sinusitis, tonsillitis, otitis media). Secondary outcomes refer to the prescribing of quinolones and guideline-recommended antibiotics. Based on pseudonymized quarterly claims data, mixed logistic regression models examined pre-post intervention antibiotic prescribing rate changes and compared to matched standard care. A significant rate reduction (arm I 11.7%; arm II 9.9%; arm III 12.7%) and significantly lower prescribing rates were observed for all arms (20.1%, 18.9% and 23.6%) compared to matched standard care (29.4%). Fluoroquinolone prescribing was reduced in all intervention arms and rates for recommended substances generally increased. No significant post-interventional difference between intervention arms was detected. Findings indicate implementation program impact compared to standard care.

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.

Fostering Appropriate Antibiotic Use in a Complex Intervention: Mixed-Methods Process Evaluation Alongside the Cluster-Randomized Trial ARena.

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.

Applying Digital Information Delivery to Convert Habits of Antibiotic Use in Primary Care in Germany: Mixed-Methods Study.

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.

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

BACKGROUND: Primary care networks in Germany are formalized regional collaborations of physicians and other healthcare providers. Common goals are optimized healthcare processes and services for patients, enhanced communication, agency for professional concerns and strengthened economic power. In the ARena study (Sustainable reduction of antibiotic-induced antimicrobial resistance), 14 primary care networks in two federal German states aimed to promote appropriate antibiotics use for acute non-complicated infections by fostering awareness and understanding. Factors related to the role of primary care networks were to be identified. METHODS: For this study, audio-recorded telephone interviews were conducted with physicians, non-physician health professionals and stakeholder representatives. Pseudonymized verbatim transcripts were coded using thematic analysis. In-depth analysis was based on the inductive categories 'social support', 'social learning', 'social normative pressures' and 'social contagion' to reflect social influence processes. Data generated through a survey with physicians and non-physician health professionals were analyzed descriptively to foster understanding of the networks' potential impact on antibiotic prescribing. RESULTS: Social influence processes proved to be relevant regarding knowledge transfer, manifestation of best-practice care and self-reflection. Peer communication was seen as a great asset, the main reason for membership and affirmative for own perspectives. All interviewed physicians (n = 27) considered their network to be a strong support factor for daily routines, introduction of new routines, and continuity of care. They utilized network-offered training programs focusing on best practice guideline-oriented use of antibiotics and considered their networks supportive in dealing with patient expectations. A shared attitude combined with ARena intervention components facilitated reflective management of antibiotic prescribing. Non-physician health professionals (n = 11) also valued network peer exchange. They assumed their employers joined networks to offer improved and continuous care. Stakeholders (n = 7) expected networks and their members to be drivers for care optimization. CONCLUSION: Primary care networks play a crucial role in providing a platform for professional peer exchange, social support and reassurance. With regards to their impact on antibiotic prescribing for acute non-complicated infections, networks seem to facilitate and amplify quality improvement programs by providing a platform for refreshing awareness, knowledge and self-reflection among care providers. They are well suited to promote a rational use of antibiotics. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046. Registered 24 August 2017.

The complex phenomenon of dysrational antibiotics prescribing decisions in German primary healthcare: a qualitative interview study using dual process theory.

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.

Correction: Care management intervention to strengthen self-care of multimorbid patients with type 2 diabetes in a German primary care network: A randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pone.0214056.].

Care management intervention to strengthen self-care of multimorbid patients with type 2 diabetes in a German primary care network: A randomized controlled trial.

PURPOSE: This study aimed to assess the effectiveness of a care management intervention in improving self-management behavior in multimorbid patients with type 2 diabetes; care was delivered by medical assistants in the context of a primary care network (PCN) in Germany. METHODS: This study is an 18-month, multi-center, two-armed, open-label, patient-randomized parallel-group superiority trial (ISRCTN 83908315). The intervention group received the care management intervention in addition to the usual care. The control group received usual care only. The primary outcome was the change in self-care behavior at month 9 compared to baseline. The self-care behavior was measured with the German version of the Summary of Diabetes Self-Care Activities Measure (SDSCA-G). A multilevel regression analysis was applied. RESULTS: We assigned 495 patients to intervention (n = 252) and control (n = 243). At baseline, the mean age was 68 ±11 years, 47.8% of the patients were female and the mean HbA1c was 7.1±1.2%. The primary analysis showed no statistically significant effect, but a positive trend was observed (p = 0.206; 95%-CI = -0.084; 0.384). The descriptive analysis revealed a significantly increased sum score of the SDSCA-G in the intervention group over time (P = 0.012) but not in the control group (p = 0.1973). CONCLUSION: The sum score for self-care behavior markedly improved in the intervention group over time. However, the results of our primary analysis showed no statistically significant effect. Possible reasons are the high baseline performance in our sample and the low intervention fidelity. The implementation of this care management intervention in PCNs has the potential to improve self-care behavior of multimorbid patients with type 2 diabetes.

Meeting the needs of multimorbid patients with Type 2 diabetes mellitus - A randomized controlled trial to assess the impact of a care management intervention aiming to improve self-care.

AIMS: This study explored the impact of a care management intervention aiming to improve self-care behavior in multimorbid individuals with Type 2 diabetes mellitus on health-related quality of life (HRQoL). METHODS: A patient-level randomized parallel-group superiority trial with 32 primary care practice teams, 11 care managers and 495 patients was conducted. The intervention was delivered as add-on to an already implemented disease management program and embedded in a network of primary care practices. Hierarchical linear modeling was used to analyze impacts of the care management approach on HRQoL. RESULTS: Small improvements of HRQoL in the intervention arm were found after nine months (r = 0.024; 95%CI = [0.000, 0.047]). However, compared to standard care no significant differences of HRQoL changes were observed (r = 0.022; 95%CI = [-0.011, 0.054]). Subgroup analyses showed effects for female participants favoring the intervention arm (r = 0.059; 95%CI = [0.010, 0.108]). No significant differences between intervention and control arm for several other subgroups were observed, including subgroups defined by comorbidities. CONCLUSION: Additional care management did not influence HRQoL over and above standard disease management. Improving diabetes patients' self-care behavior in the context of structured disease management programs may be difficult to achieve. Women might benefit from additional care management, but this finding needs to be confirmed in future research.

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.

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.

Complexity of care and strategies of self-management in patients with colorectal cancer.

PURPOSE: Given the inherent complexity of cancer care, in which personal, social, and clinical aspects accumulate and interact over time, self-management support need to become more comprehensive. This study has the following two aims: 1) to analyze and describe the complexity of individual patient situations and 2) to analyze and describe already established self-management strategies of patients to handle this complexity. METHODS: A qualitative study was conducted. Ten focus groups were performed collecting perspectives of the following three user groups: patients with colorectal cancer (n=12) and representatives from support groups (n=2), physicians (n=17), and other health care professionals (HCPs; n=16). Data were analyzed using qualitative content analysis. RESULTS: The results showed that cancer patients are struggling with the complexity of their individual situations characterized by the 1) "complexity of disease", 2) "complexity of care", and 3) "complexity of treatment-related data". To deal with these multifaceted situations, patients have established several individual strategies. These strategies are "proactive demanding" (eg, to get support and guidance or a meaningful dialog with the doctor), "proactive behavior" (eg, preparation of visits), and "proactive data management" (eg, in terms of merging treatment-related data and to disseminate these to their health care providers). CONCLUSION: Patients with colorectal cancer have to handle a high complexity of individual situations within treatment and care of their disease. Private and social challenges have a culminating effect. This complexity increases as patients experience a longer duration of treatment and follow-up as patients have to handle a significantly higher amount of data over time. Self-management support should focus more on the individual complexity in a patient's life. This includes assisting patients with strategies that have already been established by themselves (like preparation of visits).

Reflection of illness and strategies for handling advanced lung cancer - a qualitative analysis in patients and their relatives.

BACKGROUND: Lung cancer patients are often diagnosed in an advanced stage of disease. In a situation of palliative treatment, both patients and their relatives experience existential burden. Evidence suggests that multi-professional teams should deal with them as dyads. However, little is known about differences in their individual situation. The purpose of this study is to explore and compare reflections that arise out of the context of diagnosis and to compare how patients and their relatives try to handle advanced lung cancer. METHODS: Data was collected by qualitative interviews. A total of 18 participants, 9 patients diagnosed with advanced lung cancer (ICD- 10 C-34, stage IV) starting or receiving palliative treatment and 9 relatives were interviewed. Data was interpreted using qualitative content analysis. RESULTS: Reflection aspects were "thoughts about the cause", "meaning of belief" and "experience of inequity". Patients often experienced the diagnosis as inequity and were more receptive for believing in treatment success. The main strategies found were "repression", "positive attitude", "strong focus on the present" and "adjustment of life terms". Patient and relative dyads used the same strategies, but with different emphasis. That life time is limited was more frequently realized by relatives than by patients. CONCLUSION: While strategies used by relatives are similar to those of patients', they are less reflective and more pragmatic in terms of handling daily life and organizing care. The interviewed patients were mostly not able to takeover these tasks. To strong was their belief in treatment success, their repression of the future and the focus on the present. This implicates, that in terms of end-of-life care, relatives are important to reach patients who are often not receptive to this topic.

Health-Related Quality of Life in Primary Care: Which Aspects Matter in Multimorbid Patients with Type 2 Diabetes Mellitus in a Community Setting?

BACKGROUND AND OBJECTIVE: Knowledge about predictors of health-related quality of life for multimorbid patients with type 2 diabetes mellitus in primary care could help to improve quality and patient-centeredness of care in this specific group of patients. Thus, the aim of this study was to investigate the impact of several patient characteristics on health-related quality of life of multimorbid patients with type 2 diabetes mellitus in a community setting. RESEARCH DESIGN AND METHODS: A cross-sectional study with 32 primary care practice teams in Mannheim, Germany, and randomly selected multimorbid patients with type 2 diabetes mellitus (N = 495) was conducted. In order to analyze associations of various patient characteristics with health-related quality of life (EQ-5D index) a multilevel analysis was applied. RESULTS: After excluding patients with missing data, the cohort consisted of 404 eligible patients. The final multilevel model highlighted six out of 14 explanatory patient variables which were significantly associated with health-related quality of life: female gender (r = -0.0494; p = .0261), school education of nine years or less (r = -0.0609; p = .0006), (physical) mobility restrictions (r = -0.1074; p = .0003), presence of chronic pain (r = -0.0916; p = .0004), diabetes-related distress (r = -0.0133; p < .0001), and BMI (r = -0.0047; p = .0045). CONCLUSION: The findings of this study suggest that increased diabetes-related distress, chronic pain, restrictions in (physical) mobility, female gender, as well as lower education and, increased BMI have a noteworthy impact on health-related quality of life in multimorbid patients with type 2 diabetes mellitus seen in primary care practices in a community setting. The highlighted aspects should gain much more attention when treating multimorbid patients with type 2 diabetes mellitus.

Strengthening Interprofessional Requirements Engineering Through Action Sheets: A Pilot Study.

BACKGROUND: The importance of information and communication technology for healthcare is steadily growing. Newly developed tools are addressing different user groups: physicians, other health care professionals, social workers, patients, and family members. Since often many different actors with different expertise and perspectives are involved in the development process it can be a challenge to integrate the user-reported requirements of those heterogeneous user groups. Nevertheless, the understanding and consideration of user requirements is the prerequisite of building a feasible technical solution. In the course of the presented project it proved to be difficult to gain clear action steps and priorities for the development process out of the primary requirements compilation. Even if a regular exchange between involved teams took place there was a lack of a common language. OBJECTIVE: The objective of this paper is to show how the already existing requirements catalog was subdivided into specific, prioritized, and coherent working packages and the cooperation of multiple interprofessional teams within one development project was reorganized at the same time. In the case presented, the manner of cooperation was reorganized and a new instrument called an Action Sheet was implemented. This paper introduces the newly developed methodology which was meant to smooth the development of a user-centered software product and to restructure interprofessional cooperation. METHODS: There were 10 focus groups in which views of patients with colorectal cancer, physicians, and other health care professionals were collected in order to create a requirements catalog for developing a personal electronic health record. Data were audio- and videotaped, transcribed verbatim, and thematically analyzed. Afterwards, the requirements catalog was reorganized in the form of Action Sheets which supported the interprofessional cooperation referring to the development process of a personal electronic health record for the Rhine-Neckar region. RESULTS: In order to improve the interprofessional cooperation the idea arose to align the requirements arising from the implementation project with the method of software development applied by the technical development team. This was realized by restructuring the original requirements set in a standardized way and under continuous adjustment between both teams. As a result not only the way of displaying the user demands but also of interprofessional cooperation was steered in a new direction. CONCLUSIONS: User demands must be taken into account from the very beginning of the development process, but it is not always obvious how to bring them together with IT knowhow and knowledge of the contextual factors of the health care system. Action Sheets seem to be an effective tool for making the software development process more tangible and convertible for all connected disciplines. Furthermore, the working method turned out to support interprofessional ideas exchange.