[General practice care for patients with chronic non-cancer pain: A rapid review as part of the RELIEF project]. / Hausärztliche Versorgung von Patient:innen mit chronischen nicht-tumorbedingten Schmerzen: ein Rapid Review im Rahmen des RELIEF-Projekts.

INTRODUCTION: Approximately one fifth of the German population suffers from chronic pain, which is often associated with limitations in coping with everyday life, social isolation and psychological comorbidities such as anxiety and depression. The importance of a treatment approach that considers biological, psychological, and social factors (bio-psycho-social model) as well as non-drug interventions is emphasized in current guidelines, but presents challenges for primary care practices. To support the implementation of evidence-based best practice recommendations, the RELIEF project (Resource-oriented case management to implement recommendations for patients with chronic pain and frequent use of analgesics in general practices) aims to develop a case management program for the primary care of patients with chronic non-tumor pain. METHODS: Prior to intervention development, a rapid review was conducted to identify best practice recommendations for the care of patients with chronic non-tumor pain, barriers and strategies to their implementation, and gaps in care in current guidelines and literature. Selective searches of guidelines, PubMed, the Cochrane Library, bibliographies of relevant publications, and the gray literature focused on assessment and monitoring, education, promotion of self-care, and rational pharmacotherapy. RESULTS: Numerous recommendations on assessment and monitoring were identified, but only a few studies examined their feasibility in primary care practices. Guidelines contained few specific recommendations on content and format of patient education on chronic pain. Recommendations for non-drug self-care measures were mainly related to physical activity, relaxation techniques, behavioral therapy techniques and external applications. Especially for the area of physical activity, numerous barriers but also strategies for a successful implementation could be identified. DISCUSSION: In a potential primary care model for patients with chronic non-tumor pain, pain assessment should aim to identify patients who need support in implementing medication and non-medication interventions in the primary care setting and/or could benefit from specialized care. To implement recommendations for pain education, primary care physicians need educational materials in a variety of formats and levels of detail that ideally could be processed by patients at home and then get addressed in practices using simple key questions. Non-drug measures should be an explicit part of the treatment plan. CONCLUSION: Many of the identified recommendations for the treatment of patients with chronic non-tumor pain can also be considered relevant for the primary care setting. Specific guidelines and concepts for primary care physicians that include setting-specific characteristics at the physician, patient, and system levels would be desirable for a successful implementation of these recommendations.

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

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.

[Interprofessional weaning boards and weaning consults for long-term ventilated patients: A qualitative study of perceived potential for patient care]. / Interprofessionelle Weaning-Boards und Weaning-Konsile für Langzeitbeatmungspatient*innen: Eine qualitative Studie zum wahrgenommenen Potenzial für die Patientenversorgung.

BACKGROUND: The PRiVENT project aims to improve the care of invasively ventilated patients and to reduce the number of out-of-hospital long-term ventilated patients. PRiVENT offers intensive care units the opportunity to exchange information with experts from specialized weaning centers in interprofessional weaning boards and weaning consults and to exploit the full weaning potential of the patients. In the context of the accompanying process evaluation, the PRiVENT intervention components will be examined for sustainability, scalability and effectiveness, and the interprofessional collaboration between intensive care units and the responsible weaning centers will be investigated in order to identify potentials for the care of invasively managed patients. METHODS: In a qualitative cross-sectional study, semistructured, problem-oriented interviews were conducted with care providers of participating ICUs. The data were digitally recorded, pseudonymized and verbatim transcribed. Data analysis was based on Brown and Clarke's Thematic Analysis and the Consolidated Framework for Implementation Research. MAXQDA 2020 software was used to organize the data. RESULTS: Fourteen interviews were conducted with ICU care providers. The early transfer of patients to a weaning center and the integration of pulmonary expertise into routine care were identified as positively perceived potentials of the weaning boards and weaning consults. Especially in critically ill, multimorbid patients suffering from COVID-19, the expertise of the weaning centers was considered helpful. Due to heavy workloads, nurses were unable to participate in weaning boards and weaning consults. CONCLUSION: Interprofessional collaboration between weaning centers and ICUs in weaning boards and weaning consults can improve the care of invasively ventilated patients. Strategies to promote the involvement of nurses should be discussed and developed.

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.

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

BACKGROUND: 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.

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.

Exploring healthcare provider and patient perspectives on current outpatient care of venous leg ulcers and potential interventions to improve their treatment: a mixed methods study in the ulcus cruris care project.

BACKGROUND: The project "Ulcus Cruris Care" aims to improve primary care for patients with venous leg ulcer (VLU) in General Practitioner (GP) practices using a complex intervention comprised of educational components, standardized treatment recommendations, computer-assisted documentation, and case management by non-physician medical assistants (MAs). Prior to implementing and testing the intervention components in general practices, in-depth exploration of current outpatient treatment of VLU patients and relevant implementation determinants was pursued. METHODS: A mixed-methods study explored views of GPs, MAs, and patients regarding current VLU outpatient care and the planned intervention components to identify potential implementation determinants. Data were collected through semi-structured guide-based telephone interviews (n = 29) and a survey questionnaire (n = 28). Interviews were transcribed verbatim. Analysis was inductive initially and finalized in a deductive-inductive approach based on domains of the Theoretical Domains Framework to support structuring of relevant implementation determinants. Survey data were analyzed descriptively. RESULTS: Current VLU outpatient care was described as frequently tailored to individual wounds and gradient. In general, workload was shared by GPs (diagnostics, counselling) and MAs (wound care). All care providers were aware of compression therapy, yet not all of them considered it essential for VLU care. Standardized operating procedures and educational components including e-learning were considered supportive. Stronger involvement of non-physician assistants was seen as opportunity to optimize VLU care. Concerns were identified regarding integration of software-supported case management into daily practice routines and regarding potential limitations in decision-making autonomy when using standard operating procedures. CONCLUSIONS: Findings in this study emphasize a need for educational interventions addressing VLU care providers as well as patients, particularly with regards to compression therapy. The conception of the planned intervention appears to be adequate and a structured guideline-based case management might be a promising approach for optimization of VLU treatment.

Implementation fidelity in a multifaceted program to foster rational antibiotics use in primary care: an observational study.

BACKGROUND: The ARena study (Sustainable Reduction of Antimicrobial Resistance in German Ambulatory Care) is a three-arm, cluster randomized trial to evaluate a multifaceted implementation program in a German primary care setting. In the context of a prospective process evaluation conducted alongside ARena, this study aimed to document and explore fidelity of the implementation program. METHODS: This observational study is based on data generated in a three-wave survey of 312 participating physicians in the ARena program and attendance documentation. Measures concerned persistence of participation in the ARena program and adherence to intervention components (thematic quality circles, e-learning, basic expenditure reimbursements, additional bonus payments and a computerized decision support system). Participants' views on five domains of the implementation were also measured. Binary logistic and multiple linear regression analyses were used to explore which views on the implementation were associated with participants' adherence to quality circles and use of additional bonus compensation. RESULTS: The analysis of fidelity showed overall high persistence of participation in the intervention components across the three intervention arms (90,1%; 97,9%; 92,9%). 96.4% of planned quality circles were delivered to study participants and, across waves, 30.4% to 93% of practices participated; 56.1% of physicians attended the maximum of four quality circles. 84% of the practices (n = 158) with a minimum of one index patient received a performance-based additional bonus payment at least once. In total, bonus compensation was triggered for 51.8% of affected patients. Participation rate for e-learning (a prerequisite for reimbursement of project-related expenditure) covered 90.8% of practices across all intervention arms, with the highest rate in arm II (96.5%). Uptake of expenditure reimbursement was heterogeneous across study arms, with a mean rate of 86.5% (89.1% in arm I, 96.4% in arm II and 74.1% in arm III). Participants' views regarding participant responsiveness (OR = 2.298) 95% CI [1.598, 3.305] and Context (OR = 2.146) 95% CI [1.135, 4.055] affected additional bonus payment. Participants' views on participant responsiveness (Beta = 0.718) 95% CI [0.479, 0.957], Context (Beta = 0.323) 95% CI [0.055, 0.590] and Culture of shared decision-making (Beta = -0.334) 95% CI [-0.614, -0.053] affected quality circle attendance. CONCLUSION: This study showed an overall high fidelity to the implementation program. Participants' views on the implementation were associated with degree of intervention fidelity. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046.

[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.

Need for nursing care after laparoscopic and open colorectal cancer surgery: a claims data analysis in German primary care.

PURPOSE: Our study analyzes the influence of minimally invasive vs. open surgery on the postoperative need for nursing care in patients with colorectal carcinoma. Colorectal cancer is an age-related disease, and oncologic surgery is increasingly performed in elderly patients. Long-term effects of the procedural choice on patients' self-sufficiency and autonomy have not been scientifically addressed so far. METHODS: Multivariable logistic regression models based on claims data from a statutory health insurer (AOK, Baden-Württemberg, Germany) were applied to assess potential risk factors for assignment patients to a nursing care level, a German scale to categorize individual need for nursing care, at 12 and 36 months after colorectal cancer surgery. RESULTS: A total of 3996 patients were eligible to be included in the analysis. At 36 months postoperatively, 44 of 427 (10.3%) patients after minimally invasive colon cancer surgery and 231 of 1287 (17.9%) patients after open procedure were newly graded into a nursing care level (OR = 0.62, 95%CI = 0.44-0.90, p = 0.010). Thirty-four of 251 (13.5%) patients receiving minimally invasive rectal cancer surgery compared to 142 of 602 (23.6%) patients after open approach were newly assigned to a nursing care level (OR = 0.53, 95%CI = 0.34-0.81, p = 0.003). CONCLUSIONS: Laparoscopically assisted resection of colorectal cancer seems to be superior in preserving physical autonomy of elderly patients with colorectal cancer.

[Utilization and reporting of qualitative research methods in health services research in Germany: A scoping review on original research publications (2010-2019)]. / Anwendung und Darstellung qualitativer Methoden in der Versorgungsforschung in Deutschland: ein Scoping Review zu Primärstudien (2010­2019).

BACKGROUND: Qualitative research methods offer a unique perspective on health care services. However, little is known about the actual application of qualitative methods in health services research. Therefore, the aim of this study was to gain an overview of volume and variety of the use of qualitative research methods in health services research in Germany. METHODS: By means of a scoping review, a systematic literature search of the database PubMed was conducted in September 2020. We included (1) qualitative studies in (2) a health services setting (3) in Germany, (4) published in either German or English as (5) original research in a journal (6) between 2010 and 2019. After removing duplicates, tandem teams of researchers first performed a title and abstract screening, followed by a full text screening. Data was extracted by using a category grid considering research focus, study design and reporting. RESULTS: In total, 759 articles were included in the title and abstract screening. After applying the exclusion criteria, 97 articles were included in the data extraction. The studies investigating mainly subjective perspectives of different stakeholders, especially physicians and patients, covered 13 areas of health care. Interviews were the dominant form of data collection (n=64). Data analysis was mainly conducted using content analysis (n=65). CONCLUSION: A clear absolute increase in publications since the mid-2010s can be observed. At the same time, there has been a strong tendency towards certain methods being used for data collection and analysis. Compared to reporting standards and guidelines (e.g., COREQ), incomplete reporting of research methods has been noted. The results show that both an extension of the range of methods and the quality of reporting need to be discussed.

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.

Contextual factors influencing physicians' perception of antibiotic prescribing in primary care in Germany - a prospective observational study.

BACKGROUND: Antimicrobial resistance is a worldwide challenge for health services and systems alike. To reduce the overuse of antibiotics, multifaceted interventions are often used to achieve sustainable effects. It can be assumed that these effects are influenced by contextual factors. Embedded in the cluster randomized trial ARena (Sustainable reduction of antibiotic-induced antimicrobial resistance), the aim of this present study was to identify contextual factors associated with practitioners' perceptions of antibiotic prescribing in German primary health care. METHODS: In a prospective observational study, data were generated in a three-wave survey study between January 2018 and July 2019. Analysis was performed using logistic regression models. The outcome of interest was the physician perceived impact of participating in the ARena project on decision-making regarding antibiotic prescribing, the independent variables of interest included individual characteristics, intervention arm allocation, primary care network (PCN) environment and characteristics of the medical practice. RESULTS: Forty Six point eight percent (n = 126) of participants indicated to have perceived an impact on their decision-making regarding antibiotic prescribing by participating in the ARena project. Bivariate logistic regression analyses indicated that work experience (odds ratio (OR) 1.05, 95% confidence interval (CI) 1.006-1.103), PCN environment (OR 2.06, 95% CI 1.256-3.363), structural conditions (OR 1.66, 95% CI 1.161-2.371), environment of existing processes (OR 1.46, 95% CI 1.011-2.094), and externally defined general conditions (OR 1.57, 95% CI 1.035-2.378) were associated with physicians' perceived impact of participating in the ARena project on decision-making regarding antibiotic prescribing. In the multivariable logistic regression analysis, only work experience OR 1.05 (95% CI 1.001-1.104) continuously showed a significant influence. CONCLUSIONS: This study indicates that contextual factors at individual, practice, and system level influence physicians' perceptions of antibiotic prescribing. Longer work experience appeared to be a significant influencing factor to be considered in antimicrobial stewardship programs. TRIAL REGISTRATION: ISRCTN, ISRCTN58150046 (registered 13.09.2017).

Primary care disease management for venous leg ulceration-study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126).

BACKGROUND: Venous leg ulcers (VLU) have a prevalence of 1-2% in developed countries, and affected patients are severely and long-term impaired in daily activities, work, and social participation. Evidence-based outpatient treatment based on compression therapy is frequently not implemented. The "Ulcus Cruris Care" project was established to develop a disease management concept to improve outpatient treatment for patients with VLU in German primary care. For this purpose, a multifaceted intervention was conceived consisting of an online training for general practitioners and medical assistants, standardized treatment recommendations, e-learning and print-based information for patients, and a software support for case management. The main aims of the Ulcus Cruris Care intervention are to promote standardized treatment according to current scientific knowledge, to facilitate case management for VLU patients exerted by medical assistants, and to support patient education and participation in the treatment process. The UCC trial was designed to evaluate the effectiveness of the Ulcus Cruris Care intervention. METHODS: The UCC trial is a prospective cluster-randomized controlled multicenter trial. Fifty GP practices are intended to be recruited and randomized 1:1 to intervention or control arm. Patients with venous leg ulcers will be recruited by participating GP practices, to include a total of 63 patients in each arm. The primary outcome is time to ulcer healing. Secondary outcomes comprise number and sizes of ulcers, recurrence, pain intensity according to the visual analog scale, health-related quality of life according to EQ-5D-5L, depressiveness according to Patient Health Questionnaire (PHQ-9), patient satisfaction according to the Patient Assessment of Chronic Illness Care (PACIC-5A) query, and adherence to VLU treatment. The outcome analysis of the UCC trial is accompanied by a health economic analysis and a process evaluation. DISCUSSION: The UCC trial will evaluate whether the Ulcus Cruris Care intervention may lead to faster wound healing, higher health-related quality of life, and lower use of medical resources. If the intervention turns out to have a positive impact on assessed outcomes, comprehensive implementation in primary care may be considered. TRIAL REGISTRATION: The trial protocol (version 1 as of July 19, 2021) has been registered in the German Clinical Trials Register on August 30, 2021 ( DRKS00026126 ).

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. TRIAL REGISTRATION: Registration-ID DRKS00020344 (DRKS German Register of Clinical Trials.

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.

Primary care practice-based care management for chronically ill patients (PraCMan) in German healthcare: Outcome of a propensity-score matched cohort study.

BACKGROUND: Growing prevalence of chronic diseases is a rising challenge for healthcare systems. The Primary Care Practice-Based Care Management (PraCMan) programme is a comprehensive disease management intervention in primary care in Germany aiming to improve medical care and to reduce potentially avoidable hospitalisations for chronically ill patients. OBJECTIVES: This study aimed to assess the effect of PraCMan on hospitalisation rate and related costs. METHODS: A retrospective propensity-score matched cohort study was performed. Reimbursement data related to patients treated in general practices between 1st July 2013 and 31st December 2017 were supplied by a statutory health insurance company (AOK Baden-Wuerttemberg, Germany) to compare hospitalisation rate and direct healthcare costs between patients participating in the PraCMan intervention and propensity-score matched controls following usual care. Outcomes were determined for the one-year-periods before and 12 months after beginning of participation in the intervention. RESULTS: In total, 6148 patients participated in the PraCMan intervention during the observation period and were compared to a propensity-score matched control group of 6148 patients from a pool of 63,446 eligible patients. In the one-year period after the intervention, the per-patient hospitalisation rate was 8.3% lower in the intervention group compared to control (p = 0.0004). Per-patient hospitalisation costs were 9.4% lower in favour of the intervention group (p = 0.0002). CONCLUSION: This study showed that the PraCMan intervention may be associated with a lower rate of hospital admissions and hospitalisation costs than usual care. Further studies may assess long-term effects of PraCMan and its efficacy in preventing known complications of chronic diseases.