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Background: In recent years, health systems worldwide have been confronted with several crises such as natural disasters or the COVID-19 pandemic, that affected lives and health of many people. In light of waves of infections and heat, climate change is considered to be the biggest health threat of the 21st century. Strengthening individual and organizational crisis resilience in healthcare settings thus becomes a crucial factor in maintaining care quality and protecting vulnerable patients during such crises. The RESILARE project therefore aimed to develop and evaluate quality indicators that support primary care practices in preparing for and adapting to crisis-related challenges., Methods: In a three-phased process, indicator development was based on systematic literature research and qualitative data, a two-stage expert panel process, and pilot testing in a maximum of n = 35 ambulatory practices during an outreach visit. Practice-individual indicator-related status and benchmarking information were provided via feedback reports to complete the audit and feedback program. A mixed-methods process evaluation used semistructured interviews with participating General practitioners and nonphysician health professionals to explore support and challenges for the implementation of the derived set of quality indicators. Two online surveys were conducted to evaluate all indicators and the two-part feedback report. Qualitative data were analyzed inductively using a thematic analysis approach. Survey data were analyzed descriptively., Results: A total of n = 32 indicators covered four domains: (1) individual resilience, (2) crisis prevention, (3) organizational resilience, and (4) climate resilience. N = 34 practices participated in the piloting and the process evaluation. Participants generally attributed a high relevance to the domains, and considered the indicator set suitable for implementation into existing quality management systems. Planning and implementation of measures that strengthen crisis resilience in practices were triggered or intensified by piloting the indicators and by the two-part feedback report. The identified challenges involved the volume of indicators and practice-individual implementation of renewable energy sources on rented premises. Participants expressed their desire for peer exchange regarding proven concepts for crisis resilience., (© 2024. The Author(s).)

Medical guidelines recommend actively addressing patients' information needs regarding complementary and integrative healthcare (CIH). Within the CCC-Integrativ study, an interprofessional counseling program on CIH was developed and implemented at four comprehensive cancer centers (CCCs) in Germany. As part of the process evaluation, this study examines cancer patients' experiences with interprofessional CIH counseling sessions conducted by a physician and a nurse. Forty problem-centered interviews were conducted using a semi-structured interview guide. All interviews were audio-recorded, transcribed verbatim, and analyzed using deductive-inductive content analysis based on Kuckartz and Rädiker's approach. Findings revealed that most participants had prior experience with CIH approaches and were burdened by physiological and psychological symptoms. Counseling sessions focused on cancer- and treatment-related symptoms and appropriate CIH recommendations (e.g., herbal poultice against anxieties and acupressure against nausea). Participants appreciated the mutual exchange and integration of perspectives from different healthcare professions within the interprofessional approach. They noted that the counseling team comprehensively addressed their healthcare and CIH information needs. Suggestions for improvement included the specificity of the CIH recommendations. As the participants only received counseling and no CIH treatments, information about reputable CIH providers was particularly important to many seeking advice. Patients with cancer receiving tailored CIH counseling from two healthcare professionals experienced benefits in CIH counseling for symptom management. The interprofessional teams offered a comprehensive perspective on patients' needs, proposing personalized recommendations for symptom control. These insights may foster collaboration between healthcare professionals interested in CIH counseling, enabling them to expand and consolidate their counseling services., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: To evaluate whether an integrated mental health video consultation approach (PROVIDE model) can improve symptoms compared with usual care in adults with depression and anxiety disorders attending primary care., Design: Assessor masked, multicentre, randomised controlled trial (PROVIDE-C)., Setting: In 29 primary care practices in Germany, working remotely online from one trial hub., Participants: 376 adults (18-81 years) who presented to their general practitioner (GP) with depression or anxiety, or both., Intervention: Participants were randomised (1:1) to receive the PROVIDE model (n=187) or usual care (n=189). Usual care was provided by GPs through interventions such as brief counselling and psychotropic medication prescriptions and may or may not have included referrals to mental health specialists. The PROVIDE model comprised transdiagnostic treatment provided through five real-time video sessions between the patient at the primary care practice and a mental health specialist at an offsite location., Main Outcome Measures: The primary outcome was the absolute change in the mean severity of depressive and anxiety symptoms measured using the patient health questionnaire anxiety and depression scale (PHQ-ADS) at six months, in the intention-to-treat population. Secondary outcomes, measured at six and 12 months, included PHQ-ADS subscores, psychological distress related to somatic symptoms, recovery, health related quality of life, quality and patient centredness of chronic illness care, and adverse events., Results: Between 24 March 2020 and 23 November 2021, 376 patients were randomised into treatment groups. Mean age was 45 years (standard deviation (SD) 14), 63% of the participants were female, and mean PHQ-ADS-score was 26 points (SD 7.6). Compared with usual care, the PROVIDE intervention led to improvements in severity of depressive and anxiety symptom (adjusted mean change difference in the PHQ-ADS score -2.4 points (95% confidence interval -4.5 to -0.4), P=0.02) at six months. The effects were sustained at 12 months (-2.9 (-5.0 to -0.7), P<0.01). No serious adverse events were reported in either group., Conclusions: Through relatively low intensity treatment, the PROVIDE model led to a decrease in depressive and anxiety symptoms with small effects in the short and long term. Depression and anxiety disorders are prevalent and therefore the small effect might cumulatively impact on population health in this population., Trial Registration: ClinicalTrials.gov NCT04316572., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/and declare: funding from German Federal Ministry of Education and Research (BMBF) (grant no. 01GY16129); no financial relationships with any funding from organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have affected the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Symptoms of somatic symptom disorder (SSD) are one of the most common reasons for consultations in primary care. However, specialized psychological services are mostly unavailable. This pilot trial aimed to determine the feasibility, acceptability, and safety of the integrated mental health video consultations VISION model for patients with SSD in primary care., Methods: We conducted a parallel group, randomized controlled pilot trial involving fifty-one patients with SSD from ten primary care practices in Germany, who we randomized to the VISION model or enhanced treatment-as-usual (eTAU). The VISION model comprised five video consultations which featured diagnostic clarification, psychoeducation (acknowledging and legitimizing of symptoms), and brief psychological therapy. eTAU included training primary care practice teams on the DSM-5 concept of SSD and on current guideline recommendations for its treatment in primary care. We assessed feasibility as the primary outcome at 6-months, measuring efficiency of recruitment, intervention acceptability, and safety., Results: Recruitment was efficient reflected in an overall recruitment yield (number randomized per number screened) of 55% (51/92) and a consent rate (number randomized per number eligible) of 94% (51/54). Acceptability of the intervention was high with 98% (123/125) of the video consultations conducted as planned. No serious adverse events were reported in either group., Conclusion: An integrated mental health video consultations VISION model for patients with SSD presenting to primary care is feasible, acceptable, and safe. Potential clinical effectiveness of the model should be evaluated in confirmatory trial implementing the multifaceted approach tailored to the individual patient with SSD directly into primary care practice., Trial Registration: The trial protocol was registered at German Clinical Trials Register (number: DRKS00026075, https://www.drks.de)., Competing Interests: Declaration of competing interest None., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In comparison to the general population, prison inmates are at a higher risk for drug abuse and psychiatric, as well as infectious, diseases. Although intramural health care has to be equivalent to extramural services, prison inmates have less access to primary and secondary care. Furthermore, not every prison is constantly staffed with a physician. Since transportation to the nearest extramural medical facility is often resource-intensive, video consultations may offer cost-effective health care for prison inmates., Objective: This study aims to quantify the need for referrals to secondary care services and hospital admissions when video consultations with family physicians and psychiatrists are offered in prison., Methods: In 5 German prisons, a mixed methods evaluation study was conducted to assess feasibility, acceptance, and reasons for conducting video consultations with family physicians and psychiatrists. This analysis uses quantitative data from these consultations (June 2018 to February 2019) in addition to data from a sixth prison added in January 2019 focusing on referral and admission rates, as well as reasons for encounters., Results: At the initiation of the project, 2499 prisoners were detained in the 6 prisons. A total of 435 video consultations were conducted by 12 physicians (3 female and 7 male family physicians, and 2 male psychiatrists during the study period). The majority were scheduled consultations (341/435, 78%). In 68% (n=294) of all encounters, the patient was asked to consult a physician again if symptoms persisted or got worse. In 26% (n=115), a follow-up appointment with either the video consultant or prison physician was scheduled. A referral to other specialties, most often psychiatry, was necessary in 4% (n=17) of the cases. Only in 2% (n=8) of the consultations, a hospital admission was needed. Usually, hospital admissions were the result of unscheduled consultations, and the videoconferencing system was the method of communication in 88% (n=7) of these cases, while 12% (n=1) were carried out over the phone. Reasons for admissions were severe abdominal pain, hypotension, unstable angina or suspected myocardial infarction, or a suspected schizophrenic episode., Conclusions: Most scheduled and unscheduled consultations did not require subsequent patient transport to external health care providers. Using telemedicine services allowed a prompt patient-physician encounter with the possibility to refer patients to other specialties or to admit them to a hospital if necessary., (©Katharina Schmalstieg-Bahr, Miriam Giovanna Colombo, Roland Koch, Joachim Szecsenyi, Friedrich Völker, Eva Elisabeth Blozik, Martin Scherer. Originally published in the Interactive Journal of Medical Research (https://www.i-jmr.org/), 28.06.2024.)

Background: A structural reform of the German psychotherapy guideline in 2017 was intended to facilitate access to outpatient guideline psychotherapy. In the present study, we evaluate the effects of this reform in particular for patients with a comorbidity of mental disorders and chronic physical conditions (cMP)., Methods: Pre-post analyses of the two primary endpoints "percentage of mentally ill persons who have made an initial contact with a psychotherapist" and "waiting time for guideline psychotherapy" were carried out employing population-based and weighted routine statutory health insurance data from the German BARMER. The secondary endpoints included evaluations from the patients' perspective, based on a representative survey of patients in psychotherapy, and an overview of the health care situation based on data from the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) (study registration number: DRKS00020344)., Results: From 2015 to 2018, the percentage of mentally ill persons who had made an initial contact with a psychotherapist rose moderately, from 3.7% (95% confidence interval, [3.6; 3.7]) to 3.9% [3.8; 3.9] among persons with cMP and from 7.3% [7.2; 7.4] to 7.6% [7.5; 7.7] among those with mental disorders but without any chronic physical condition (MnoP). The new structural elements were integrated into patient care. The interval of time between the initial contact and the beginning of guideline psychotherapy became longer in both groups, from a mean of 80.6 [79.4; 81.8] to 114.8 [113.4; 116.2] days among persons with complex disease and from 80.2 [79.2; 81.3] to 109.6 [108.4; 111.0] days among persons with non-complex disease; most patients considered the waiting time. Approximately 8% of the patients who sought psychotherapy reported that they had not obtained access to a psychotherapist., Conclusion: Neither in general nor for patients with cMP did the introduction of the structural reform appreciably lower the access barriers to psychotherapy. Further steps are needed so that outpatient care can meet the needs of all patients and particularly those with cMP.

Background: PRiVENT (PRevention of invasive VENTilation) is an evaluation of a bundle of interventions aimed at the prevention of long-term invasive mechanical ventilation. One of these elements is an e-learning course for healthcare professionals to improve weaning expertise. The aim of our analysis is to examine the implementation of the course in cooperating intensive care units., Methods: The course has been developed through a peer review process by pulmonary and critical care physicians in collaboration with respiratory therapists, supported by health services researchers and a professional e-learning agency. The e-learning platform "weLearn" was made available online to participating healthcare professionals. Feedback on the e-learning programme was obtained and discussed in quality circles (QCs). We measured the acceptance and use of the programme through access statistics., Results: The e-learning course "Joint Prevention of Long-Term Ventilation" consists of 7 separate modules with practice-oriented training units as well as a cross-module area and corresponding interactive case studies. Users can receive 23 CME (continuing medical education) credits. The platform was released on July 1, 2021. By June 28, 2023, 214 users from 33 clinics had registered. Most users (77-98%) completed the modules, thus performing well in the test, where 90-100% passed. In the QCs, the users commended the structure and practical relevance of the programme, as well as the opportunity to earn CME credits., Conclusion: Especially for medical staff in intensive care units, where continuous training is often a challenge during shift work, e-learning is a useful supplement to existing medical training., Trial Registration: The PRiVENT study is registered at ClinicalTrials.gov (NCT05260853) on 02/03/2022., (© 2024. The Author(s).)

Background: The increasing number of requests for help for acutely ill patients and their management is a major problem in the health systems of many countries, but especially in Germany. Rescue coordination centers and ambulances in Germany are increasingly overloaded. As a result, rides as a part of rescue operations have been increasing in length for years, yet a relevant proportion of these operations represent low-acuity calls (LACs). The basic objective of this pilot study is the quantitative analysis of the potential misuse of requests to the rescue control center. Indications for alternative treatment options and how to handle these treatment options in nonacute, non-life-threatening health conditions, such as minor injuries or minor infectious diseases, will be assessed. The identification of these LACs is vital in order to prevent health care resources in emergency medical care becoming inadequate., Objective: The overarching goal of this study is to determine the percentage of unnecessary rescue missions on site and subsequently to obtain an impression of the paramedics' assessment of alternative treatment options or alternative methods of rescue transportation., Methods: This will be an exploratory, noninterventional, cross-sectional study with a quantitative approach. The study is multicentric, with 21 ambulances in 12 different locations. The data for this study were collected via a questionnaire, newly developed for this study, for rescue personnel. Additionally, secondary data from the responsible control center will be linked and processed in an initial descriptive analysis. This descriptive analysis will form the basis for a subsequent variance analysis., Results: Data collection started as projected on September 18, 2023, and was ongoing until end of November 2023. We expect the documentation of several thousand rescue operations. We expect the following study results: (1) many unnecessary rescue operations, (2) immediate on-site assessment of correct care and treatment, and (3) patients' reasons for calling a rescue coordination center., Conclusions: To our knowledge, this is the first observational study in which acute rescue operations are recorded on site. The focus of this study is on the trained paramedics' assessment of whether rescue operations are necessary or not. Additionally, alternative treatments, such as out-of-hours care service or primary care service, are shown for each individual case. The study also intends to cover the question of which factors are relevant and statistically significantly connected to the misuse of ambulances., Trial Registration: German Register for Clinical Studies (Deutsches Register für Klinische Studien) DRKS00032510; https://drks.de/search/en/trial/DRKS00032510., International Registered Report Identifier (irrid): DERR1-10.2196/54002., (©Lara Maria Nau, Gunter Laux, Attila Altiner, Joachim Szecsenyi, Rüdiger Leutgeb. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.04.2024.)

Background: Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback., Methods: The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at ClinicalTrials.gov (NCT03988985) and is complete., Findings: Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by -4·15 (95% CI -4·99 to -3·30) in the no feedback group, -4·19 (-5·04 to -3·33) in the GP feedback group, and -4·91 (-5·76 to -4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was -0·77 (-1·60 to 0·07, d=-0·16) and when comparing with the GP-only feedback group was -0·73 (-1·56 to 0·11, d=-0·15). No increase in suicidality was observed as an adverse event in either group., Interpretation: Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups., Funding: German Innovation Fund., Translation: For the German translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests BL reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the European Commission Horizon 2020 Framework Programme, the European Joint Programme for Rare Diseases, the Ministry of Science, Research and Equality of the Free and Hanseatic City of Hamburg, Germany, and the Foundation Psychosomatics of Spinal Diseases, Stuttgart, Germany. He has received remuneration for several scientific book articles from various book publishers and as a committee member from Aarhus University, Denmark. He received travel expenses from the European Association of Psychosomatic Medicine (EAPM) and accommodation and meals from the Societatea de Medicina Biopsyhosociala, Romania, for a presentation at the EAPM Academy at the Conferința Națională de Psihosomatică (Cluj-Napoca, Romania; October, 2023). He was a board member of the EAPM (unpaid) until 2022. MS reports research funding (no personal honoraria) from the German Innovation Committee at the Joint Federal Committee. He is President of the German College of General Practitioners. GM reports research funding (no personal honoraria) from the German Innovation Committee at the Joint Federal Committee. She has received remuneration for a book chapter from Elsevier and for a lecture from the Forum Palliativmedizin. ME reports research funding (no personal honoraria) from the German Innovation Committee at the Joint Federal Committee and the Deutsche Alzheimer Gesellschaft e.V. Selbsthilfe Demenz. She has received remuneration for a scholarly book chapter from Elsevier. AS reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, and the German Innovation Committee at the Joint Federal Committee. He has received remuneration for a scholarly book chapter from Elsevier. KL reports research funding (no personal honoraria) from the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, and the Technische Universität München, TUM School of Medicine and the Bavarian Ministry for Science and Art, Munich, Germany. CA reports research funding (no personal honoraria) from the German Federal Ministry of Education and Research. SJ reports research funding (no personal honouraria) from the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the German Federal Ministry of Health, and the AOK Statutory Health Insurance Baden-Württemberg. She has received remuneration for a scholarly book chapter from Thieme and as a member of the Data and Safety Monitoring Board for a study carried out at the Department of Naturopathy (Charité, Berlin, Germany). She is a member of an expert council on health and care of the German Federal Ministry of Health. SZ is President-elect of the International College of Psychosomatic Medicine. He is a member of the editorial board of The Lancet Psychiatry. SS reports research funding (no personal honouraria) from the Central Institute of the Association of Statutory Health Insurance Physicians in Germany (Zentralinstitut für die kassenärztliche Versorgung). He has received remuneration for a book chapter from Thieme. KB-F reports research funding (no personal honoraria) from the German Research Foundation and the German Federal Ministry of Education and Research. CN reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the Ministry of Science and Art Baden-Württemberg (Germany), the German Federal Ministry of Health, and the Köhler Research Fund (Germany). He has received remuneration for several scientific book articles from various book publishers. MH reports research funding (no personal honoraria) from the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, and the DAK Gesundheit (Germany; health insurance fund). He has received remuneration for several scientific book articles from various book publishers and consulting fees from the Agency for Quality in Medicine (Berlin, Germany). He has received honoraria for lectures and presentations from the Techniker Krankenkasse (Germany), the Kanton Basel CH, the Polish Institute for Evidence-based Medicine, the Klinik Münsterlingen, and the University of Lübeck (Germany). He has received payment for expert testimony from the Institute of Regional Health Research, University of Southern Denmark. As a member of the Executive Board, he has received congress fees and travel expenses to the 22nd Congress of Health Services Research 2023 from the German Network of Health Services Research, and he has received travel costs from the German Cancer Society to attend their meeting. He was Chief Executive of the German Network for Health Services Research (unpaid), Past President of the German Society of Medical Psychology (unpaid), and previous President of the International Shared Decision Making Society (unpaid). JG reports research funding (no personal honoraria) from the German Research Foundation and the German Federal Ministry of Education and Research. He has received remuneration for a scholarly book from Elsevier. He has received honoraria for lectures and presentations from Lundbeck, Janssen-Ciag, and Boehringer. H-HK reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the European Commission Horizon 2020 Framework Programme, the European Union, and the Zentralinstitut für die kassenärztliche Versorgung (Germany). AF reports research funding (no personal honoraria) from the German Research Foundation and the German Innovation Committee at the Joint Federal Committee. EV reports research funding (no personal honoraria) from the German Research Foundation and the German Innovation Committee at the Joint Federal Committee. AZ reports research funding (no personal honoraria) from the German Research Foundation and the German Innovation Committee at the Joint Federal Committee. ML is an employee of Oviva, Germany. SK reports research funding (no personal honoraria) from the German Research Foundation and the German Federal Ministry of Education and Research. All other authors report no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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., Competing Interests: Joachim Szecsenyi ist Gründer des aQUA Institutes. Franziska Trudzinski gibt folgende Interessenkonfilkte an: 1. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Novartis, CSL Behring, Streamed up RG Gesellschaft für Information und Organisation mbH. 2. Participation on a Data Safety Monitoring Board or Advisory Board: CSL Behring, GlaxoSmithKline., (Thieme. All rights reserved.)

Background: Digital health applications (DiGA) supporting the management of diabetes are among the most commonly available digital health technologies. However, transparent quality assurance of DiGA and clinical proof of a positive healthcare effect is often missing, which creates skepticism of some stakeholders regarding the usage and reimbursement of these applications., Methods: This article reviews the recently established fast-track integration of DiGA in the German reimbursement market, with emphasis on the current impact for manufacturers, healthcare providers, and people with diabetes. The German DiGA fast track is contextualised with corresponding initiatives in Europe., Results: The option of a provisional prescription and reimbursement of DiGA while proving a positive healthcare effect in parallel may expedite the adoption of DiGA in Germany and beyond. However, hurdles for a permanent prescription and reimbursement of DiGA are high and only one of 12 that have achieved this status specifically addresses people with diabetes., Conclusion: The DiGA fast track needs to be further enhanced to cope with remaining skepticism and contribute even more to a value-based diabetes care., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: F.S. and T.A.D. are full-time employees of Profil Institut für Stoffwechselforschung GmbH. L.H. is a shareholder of Profil Institut für Stoffwechselforschung GmbH. F.S. is a member of the EIT Health Supervisory Board. J.-M.B. and N.G. are full-time employees of the EIT Health e.V. and the EIT Health Colocation Center Germany–Switzerland, respectively. F.S., T.A.-D., C.S., J.S., M.J., and D.M.-W. are part of the EIT Health-funded RealWorld4Clinic consortium.

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., (© 2024. The Author(s).)

Background: Long-term invasive mechanical ventilation (IMV) is a major burden for those affected and causes high costs for the health care system. Early risk assessment is a prerequisite for the best possible support of high-risk patients during the weaning process. We aimed to identify risk factors for long-term IMV within 96 h (h) after the onset of IMV., Methods: The analysis was based on data from one of Germany's largest statutory health insurance funds; patients who received IMV ≥ 96 h and were admitted in January 2015 at the earliest and discharged in December 2017 at the latest were analysed. OPS and ICD codes of IMV patients were considered, including the 365 days before intubation and 30 days after discharge. Long-term IMV was defined as evidence of invasive home mechanical ventilation (HMV), IMV ≥ 500 h, or readmission with (re)prolonged ventilation., Results: In the analysis of 7758 hospitalisations, criteria for long-term IMV were met in 38.3% of cases, of which 13.9% had evidence of HMV, 73.1% received IMV ≥ 500 h and/or 40.3% were re-hospitalised with IMV. Several independent risk factors were identified (p < 0.005 each), including pre-diagnoses such as pneumothorax (OR 2.10), acute pancreatitis (OR 2.64), eating disorders (OR 1.99) or rheumatic mitral valve disease (OR 1.89). Among ICU admissions, previous dependence on an aspirator or respirator (OR 5.13), and previous tracheostomy (OR 2.17) were particularly important, while neurosurgery (OR 2.61), early tracheostomy (OR 3.97) and treatment for severe respiratory failure such as positioning treatment (OR 2.31) and extracorporeal lung support (OR 1.80) were relevant procedures in the first 96 h after intubation., Conclusion: This comprehensive analysis of health claims has identified several risk factors for the risk of long-term ventilation. In addition to the known clinical risks, the information obtained may help to identify patients at risk at an early stage. Trial registration The PRiVENT study was retrospectively registered at ClinicalTrials.gov (NCT05260853). Registered at March 2, 2022., (© 2024. The Author(s).)

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.

Background: The concept of Care Assistant in General Practice (VERAH) was developed in order to integrate non-medical staff more strongly into primary care and thus to meet the increasing demand for care and the simultaneous shortage of medical staff. VERAHs are increasingly responsible for software-supported case management and are thus confronted with new tasks. The aim of this study was therefore to explore the role of the VERAH in primary care practices., Methods: The present study is a qualitative secondary data analysis; the data collection took place within the projects VESPEERA and TelePraCMan. Twenty individual interviews and two focus group meetings were conducted with a total of 30 physicians, VERAHs and medical assistants from primary care. The data were analysed qualitatively according to Emerson. Contextual and socio-demographic data were collected with an accompanying questionnaire., Results: The VERAHs of all primary care practices from which interview partners participated performed tasks within software-supported case management. Concerning the role of the VERAH, three themes were identified in the interviews: a) concrete tasks of the VERAH in software-supported case management within the practice team, b) relevance of software-supported case management within the activities of the VERAHS and c) relationship between VERAHs and patients., Conclusion: Taking over tasks in software-supported case management can contribute to strengthening and expanding the role of the VERAH. In the future, more attention should be paid to a clear description of the new role, and the conditions of the VERAHs' task fulfilment should be considered., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Introduction: Multidisciplinary and multispecialty approaches with central integration of primary care, individualized long-term rehabilitative care, and multidisciplinary care pathways are recommended by international consortia to face the challenges of care of long COVID. Two regional long COVID networks-Rhein-Neckar (RN) and Ludwigsburg (LU) have emerged as ad hoc examples of best practice in Southern Germany. The aim of the community case study is to provide first insights into the experiences of the networks., Methods: The exploratory observational study was conducted between April and June 2023, focusing on an observation period of just under 24 months and using a document analysis supported by MAXQDA and SWOT analysis with ambulatory health care professionals in two online group discussions., Results: The document analysis revealed that both networks have defined network participants who have agreed on common goals and patient pathways and have established ways of communicating, organizing, and collaborating. Both networks agreed on a primary care-based, multidisciplinary and multispecialty approach. The main differences in realization emerged in LU as a focus on the ambulatory setting and very concrete application to individual patients, while RN showed a focus on an intersectoral character with participation of the specialized university hospital sector, knowledge transfer and a supra-regional approach with the involvement of the meso and macro level. The SWOT analysis ( n  = 14 participants, n  = 6 male, 7 physicians (4 disciplines), 7 therapists (5 professions)) showed strengths such as resulting collaboration, contribution to knowledge transfer, and improvement of care for individual patients. As barriers, e.g., lack of reimbursement, high efforts of care, and persistent motivation gaps became apparent. Potentials mentioned were, e.g., transferability to other diseases such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, promotion of addressing a "difficult topic" and promotion of intersectoral care concepts; risks mentioned were, e.g., limited network resources and negative effects on the development of other structures., Conclusion: Resulting implications for practice and research address a call to policy makers and funders to support further research to find out what generalizable results regarding usefulness, effectiveness, and efficiency including transferability to other post-infectious diseases can be derived., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Stengel, Gölz, Kolb, Tarbet, Völler, Koetsenruijter, Szecsenyi and Merle.)

Objective: The VISION intervention is a manualized short-term treatment for people with somatic symptom disorder, integrated into the primary care and delivered by psychotherapists via video consultations. As an innovative technology-based approach, the intervention was most recently piloted in a randomized feasibility trial. During the qualitative accompanying study presented here, the intervention was evaluated and optimised from the user perspective of patients who participated in the feasibility study., Methods: We interviewed a total of N=10 patients included in the intervention group in three semi structured focus group discussions focusing on how they (1) assess the intervention in terms of acceptance and individual benefit and (2) which adjustments are necessary from the user perspective for further optimization of the intervention. We performed a qualitative content analysis using MAXQDA Plus 2022., Results: Respondents reported initial reservations on their part regarding care via video consultation. After a brief period of habituation, the intervention was universally accepted. Main suggestions for improvement included a stronger focus on supporting patients find follow-up psychotherapy (if indicated) more flexible settings (e. g., location of video consultation), and a stronger integration of treatment into primary care., Discussion and Conclusion: The study provides systematically elaborated comprehensive findings on participants' practical experiences with the intervention. The model is appropriate for treating people with somatic symptom disorder. Before implementation, important suggestions for improvement should be thoroughly considered with continued patient and public involvement., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

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.

Background: Multiple studies indicate that residents in family medicine (FM) are exposed to considerable stress and are particularly affected by burnout syndrome. Aim of the study was to specify the effects of a so-called "compact intervention" (i.e., a short intervention) in self-care on FM residents., Methods: The authors performed a concurrent and independent mixed-methods study with FM residents on the KWBW Verbundweiterbildung PLUS © program. FM residents could voluntarily take part in a two-day seminar including 270 min on self-care, which can be regarded as a compact intervention. Study participants completed a questionnaire before (T1) and ten to twelve weeks after the course (T2), with subsequent recruitment to interview. The main outcomes of the quantitative part were to evaluate (I) self-rated change of cognition and (II) change in behavior. The qualitative outcomes were all possible effects of the compact intervention on participants´ competencies as well as all sorts of induced behavioral changes., Results: From a total of n = 307 residents, n = 287 FM residents (intervention group: n = 212; control group: n = 75) participated in the study. At T2, 111 post-intervention questionnaires were completed. 56% rated the intervention to be helpful for their well-being (n = 63/111). At T2, there was a significant increase in those willing to act in comparison to T1 (p = .01): 36% (n = 40/111) had changed their behavior and half of the study participants had passed on competencies to others (n = 56/111). From the intervention group, n = 17 participants additionally gave an interview. FM residents favored a trustful learning atmosphere, an interactive teaching concept and practical exercises. They described an encouraging stimulus to act and specified behavioral changes., Conclusions: A compact intervention in self-care could increase well-being, foster competencies and induce behavioral changes, if implemented into a training program with sufficient group cohesiveness. Further studies are required to specify long-term-results., (© 2023. The Author(s).)

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.

Background: fall-risk-increasing drugs (FRIDs) are a ubiquitous issue, especially for older patients. As part of a German guideline for pharmacotherapy, from 2019, a new quality indicator for this patient group was developed to measure the percentage of patients receiving FRIDs., Methods: patients, aged at least 65 years in 2020, insured by the Allgemeine OrtsKrankenkasse statutory health insurance (Allgemeine Ortskrankenkasse, Baden-Wuerttemberg, Germany) with a particular general practitioner (GP) were observed from 1 January to 31 December 2020 cross-sectionally. The intervention group received GP-centred health care. Within GP-centred health care, GPs have the role of gatekeepers for patients within the health system and are-in contrast to regular care GPs in addition to other commitments-obliged to regularly attend training sessions on appropriate pharmacotherapy. The control group received regular GP care. For both groups, we measured the percentage of patients receiving FRIDs as well as the occurrence of (fall-related) fractures as the main outcomes. To test our hypotheses, we performed multivariable regression modelling., Results: a total of 634,317 patients were eligible for analysis. Within the intervention group (n = 422,364), we could observe a significantly reduced odds ratio (OR) for obtaining a FRID (OR = 0.842, confidence interval [CI]: [0.826, 0.859], P < 0.0001) in comparison to the control group (n = 211,953). Moreover, we could observe a significantly reduced chance for (fall-related) fractures in the intervention group (OR: 0.932, CI: [0.889, 0.975], P = 0.0071)., Conclusions: the findings point in the direction that the health care providers' awareness of the potential danger of FRIDs for older patients is higher in the GP-centred care group., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Educational interventions for patients with venous leg ulceration (VLU) may promote adherence and self-management, however, their effect on wound healing is unclear. A systematic literature search was performed and randomised controlled trials with a focus on educational interventions were included. Wound healing was analysed by assessing wound healing rate, ulcer size, and the PUSH Score. Additional outcomes comprised pain, quality of life, and functional ability. The study protocol for this work is registered at PROSPERO 2020 (ID: CRD42021286152). Nine studies were included in this meta-analysis. The odds ratio for wound healing was 1.91 (95% CI, 0.99-3.67, P = .053) in favour of educational interventions compared to usual care. Ulcer size reduction was higher (MD: -7.22; 95% CI, -11.91 to -2.53, P = .003) in patients following educational interventions. Included studies also showed significant effects on pain, quality of life, and functional analysis, though no quantitative synthesis was feasible. The overall risk of bias showed some concerns. Educational interventions aim to actively involve patients in their treatment, thereby appearing to be able to have a positive impact on wound healing within 12 weeks. Consequently, integrating educational approaches to routine wound care may be a promising strategy to improve treatment of VLU., (© 2022 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.)

Background: Older adults with multimorbidity represent a growing segment of the population. Metrics to assess quality, safety and effectiveness of care can support policy makers and healthcare providers in addressing patient needs. However, there is a lack of valid measures of quality of care for this population. In the MULTIqual project, 24 general practitioner (GP)-reported and 14 patient-reported quality indicators for the healthcare of older adults with multimorbidity were developed in Germany in a systematic approach. This study aimed to select, validate and pilot core sets of these indicators., Methods: In a cross-sectional observational study, we collected data in general practices (n = 35) and patients aged 65 years and older with three or more chronic conditions (n = 346). One-dimensional core sets for both perspectives were selected by stepwise backward selection based on corrected item-total correlations. We established structural validity, discriminative capacity, feasibility and patient-professional agreement for the selected indicators. Multilevel multivariable linear regression models adjusted for random effects at practice level were calculated to examine construct validity., Results: Twelve GP-reported and seven patient-reported indicators were selected, with item-total correlations ranging from 0.332 to 0.576. Fulfilment rates ranged from 24.6 to 89.0%. Between 0 and 12.7% of the values were missing. Seventeen indicators had agreement rates between patients and professionals of 24.1% to 75.9% and one had 90.7% positive and 5.1% negative agreement. Patients who were born abroad (- 1.04, 95% CI =  - 2.00/ - 0.08, p = 0.033) and had higher health-related quality of life (- 1.37, 95% CI =  - 2.39/ - 0.36, p = 0.008), fewer contacts with their GP (0.14, 95% CI = 0.04/0.23, p = 0.007) and lower willingness to use their GPs as coordinators of their care (0.13, 95% CI = 0.06/0.20, p < 0.001) were more likely to have lower GP-reported healthcare quality scores. Patients who had fewer GP contacts (0.12, 95% CI = 0.04/0.20, p = 0.002) and were less willing to use their GP to coordinate their care (0.16, 95% CI = 0.10/0.21, p < 0.001) were more likely to have lower patient-reported healthcare quality scores., Conclusions: The quality indicator core sets are the first brief measurement tools specifically designed to assess quality of care for patients with multimorbidity. The indicators can facilitate implementation of treatment standards and offer viable alternatives to the current practice of combining disease-related metrics with poor applicability to patients with multimorbidity., (© 2023. The Author(s).)

Background: Invasive mechanical ventilation (IMV) is a standard therapy for intensive care patients with respiratory failure. With increasing population age and multimorbidity, the number of patients who cannot be weaned from IMV increases, resulting in impaired quality of life and high costs. In addition, human resources are tied up in the care of these patients., Methods: The PRiVENT intervention is a prospective, mixed-methods interventional, multicentre study with a parallel comparison group selected from insurance claims data of the health insurer Allgemeine Ortskrankenkasse Baden-Württemberg (AOK-BW) conducted in Baden-Württemberg, Germany, over 24 months. Four weaning centres supervise 40 intensive care units (ICUs), that are responsible for patient recruitment. The primary outcome, successful weaning from IMV, will be evaluated using a mixed logistic regression model. Secondary outcomes will be evaluated using mixed regression models., Discussion: The overall objective of the PRiVENT project is the evaluation of strategies to prevent long-term IMV. Additional objectives aim to improve weaning expertise in and cooperation with the adjacent Intensive Care Units., Trial Registration: This study is registered at ClinicalTrials.gov (NCT05260853)., (© 2023. The Author(s).)

Background: Post-acute sequelae after COVID-19 are still associated with knowledge gaps and uncertainties at the end of 2022, e.g., prevalence, pathogenesis, treatment, and long-term outcomes, and pose challenges for health providers in medical management. The aim of this study was to contribute to the understanding of the multi-faceted condition of long-/ post-COVID. It was designed to evaluate whether a prior SARS-CoV-2 infection during the first COVID-19 wave in Germany increases the rate of disease, as measured via a record of insurance data on diagnoses, symptoms, and treatment, in the subsequent 12 months compared with matched control groups without recorded SARS-CoV-2 infection., Method: 50 outcome variables at disease, symptom and treatment levels (14 main categories and 36 sub-categories; new diagnoses) were defined from health insurance data. Logistic regression was carried out for two groups of patients tested positive in a PCR test in March/April 2020 for SARS-CoV-2, compared to the respective risk-adjusted (age, administrative region, 1:5 propensity-score matching), contemporaneous control group without prior documented SARS-CoV-2 infection (CG): First, individuals with outpatient treatment of acute COVID-19, indicating a not severe course (COV-OUT), and second, individuals with inpatient treatment of acute COVID-19, indicating a severe course (COV-IN) were compared with their respective control group., Results: The mortality rate in COV-OUT ( n  = 32,378) and COV-IN ( n  = 5,998) groups is higher compared to their control groups with odds ratio (OR) 1.5 [95%CI (1.3, 1.6)] and 1.7 [95%CI (1.5, 1.8)] respectively. Both groups were more likely to have experienced at least one outcome compared to their CG [OR = 1.4, 95%CI (1.4, 1.4)]; OR = 2.5, 95%CI [2.4, 2.6]). 42/37 (COV-IN/COV-OUT) outcome variables showed increased ORs. COV-OUT: Loss of taste and smell [OR = 5.8, 95%CI (5.1, 6.6)], interstitial respiratory diseases [OR = 2.8, 95%CI (2.0, 4.1)] and breathing disorders [OR = 3.2, 95%CI (2.2, 4.7)] showed the highest ORs. COV-IN: Interstitial respiratory diseases [OR = 12.2, 95%CI (8.5, 17.5)], oxygen therapy [OR = 8.1, 95%CI (6.4, 10.2)] and pulmonary embolism/anticoagulation [OR = 5.9, 95%CI (4.4, 7.9)] were the most pronounced., Conclusion: Following a SARS-CoV-2 infection during the first wave of the COVID-19 pandemic in Germany, 8.4 [COV-OUT, 95%CI (7.7, 9.1)] respectively 25.5 [COV-IN, 95%CI (23.6, 27.4)] percentage points more subjects showed at least one new diagnosis/symptom/treatment compared to their matched CG (COV-OUT: 44.9%, CG: 36.5%; COV-IN: 72.0%, CG: 46.5%). Because the symptoms and diagnoses are so varied, interdisciplinary and interprofessional cooperation among those providing management is necessary., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Müller, Stengel, Roesler, Schillinger, Dräther, Günster, Tillmanns, Erhart, Szecsenyi and Merle.)

Background: Integrated mental health care models that provide rapid access to video consultations with mental health specialists for primary care patients are a promising short-term, low-threshold treatment option and may reduce waiting times for specialist care. This qualitative study, nested within a randomized feasibility trial, aimed to explore participants' views on this type of care model, its influence on the lived experience of patients, and barriers and facilitators for its delivery., Methods: In five primary care practices, 50 adults with depression and/or anxiety were randomly assigned to either an integrated care model (maximum of five video consultations with a mental health specialist) or usual care (primary care or another treatment option). Prior to obtaining the trial results, interviews were held with participants who had received video consultations. Interviews were transcribed and analysed thematically., Results: Twenty of the 23 patients who received video consultations participated in the interviews. Patients engaged well with the care model and reported positive effects on their most pressing needs, while denying safety concerns. Generally, they perceived the usability of video consultations as high, and temporary connectivity failures were not considered a substantial barrier. We identified two key mechanisms of impacts on the patients' lived experience: fast access to specialist mental healthcare and the emerging rapport with the specialist. In particular, patients with no prior mental healthcare experience indicated that familiarity with the primary practice and their physician as a gatekeeper were important facilitators of proactive treatment., Conclusions: From the patients' perspective, mental health care models integrating video consultations with mental health specialists into primary care are linked to positive lived experiences. Our findings imply that primary care physicians should promote their role as gatekeepers to (1) actively engage patients, (2) apply integrated care models to provide a familiar and safe environment for conducting mental health care video consultations, and (3) be able to regularly assess whether certain patients need in-person services. Scaling up such models may be worthwhile in real-world service settings, where primary care physicians are faced with high workloads and limited specialist services., Trial Registration: DRKS00015812., (© 2023. The Author(s).)

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., (© 2022. The Author(s).)

Introduction: The VESPEERA programme is a multifaceted programme to enhance information transfer between general practice and hospital across the process of hospital admission, stay and discharge. It was implemented in 7 hospitals and 72 general practices in Southern Germany. Uptake was heterogeneous and overall low. A process evaluation aimed at identifying factors associated with the implementation of the VESPEERA programme., Methods: This was a qualitative study using semi-structured interviews in a purposeful sample of health workers in hospitals and general practices in the VESPEERA programme. Qualitative framework analysis using the Consolidated Framework for Implementation Research was performed and revealed the topic of previous and new routines to be protruding. Inductive content analysis was used for in-depth examination of stages in the process of staying in a previous or falling into a new routines., Results: Thirty-six interviews were conducted with 17 participants from general practices and 19 participants from hospitals. The interviewees were in different stages of the implementation process at the time of the interviews. Four stages were identified: Stage 1,'Previous routine and tension for change', describes the situation in which VESPEERA was to be implemented and the factors leading to the decision to participate. In stage 2,'Adoption of the VESPEERA programme', factors that influenced whether individuals decided to employ the innovation are relevant. Stage 3 comprises 'Determinants for falling into and staying in the new VESPEERA-routine' relates to actual implementation and finally, in stage 4, the participants reflect on the success of the implementation., Conclusions: The individuals and organisations participating in the VESPEERA programme were in different stages of a process from the previous to the new routine, which were characterised by different determinants of implementation. In all stages, organisational factors were main determinants of implementation, but different factors emerged in different implementation stages. A low distinction between decision-making power and executive, as well as available resources, were beneficial for the implementation of the innovation., Trial Registration: DRKS00015183 on DRKS / Universal Trial Number (UTN): U1111-1218-0992., (© 2022. The Author(s).)

Background: Most COVID-19 patients with severe symptoms are treated in hospitals. General practices are responsible for assessing most ambulatory patients. However, they face several challenges managing COVID-19 patients, and those with non-COVID-19 conditions. In April of 2020, we designed a software tool for the structured surveillance of high-risk home-quarantined COVID-19 patients in general practice (CovidCare) including several telephone monitorings, in order to support general practices and early identification of severe courses. This study presents the qualitative results of a mixed-methods process evaluation study on CovidCare., Methods: In a qualitative process evaluation study conducted between March and May 2021, we explored the perspectives of seven general practitioners (GPs) and twelve VERAHs (medical care assistants with special training) on CovidCare using semi-structured interviews based on the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance). We used deductive qualitative content analysis employing the RE-AIM framework to assess the utilisation and implementation of CovidCare., Results: Overall, most health care professionals were satisfied with CovidCare. They highlighted 1) a good orientation for the management of COVID-19 patients, especially due to a high level of uncertainty at the beginning of the pandemic, 2) the possibility to gain new knowledge, and 3) the structured data collection as facilitators for the implementation of CovidCare. Moreover, CovidCare reduced the workload for GPs while some VERAHs perceived a higher workload as they were responsible for large parts of the CovidCare management. However, CovidCare positively affected the VERAHs' job satisfaction as most patients provided positive feedback and felt less anxious about coping with their disease. Previous experience with the software and an easy integration into daily practice were considered to be crucial utilisation drivers. Time and personnel resources were identified as major barriers. To further improve CovidCare, participants suggested a less comprehensive version of CovidCare, the expansion of inclusion criteria as well as an app for the patients' self-management., Conclusion: The COVID-19 surveillance and care tool for COVID-19 patients with increased risk was perceived as useful by GPs and VERAHs. Supportive remote health care tools such as CovidCare are a viable means to maintain comprehensive and continuous health care during a pandemic and may strengthen the primary care system., Trial Registration: German Clinical Trials Register DRKS00022054 ; date of registration: 02/06/2020., (© 2022. The Author(s).)

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., (© 2022. The Author(s).)

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., (© 2022. The Author(s).)

Background and Objectives: Providing health care for older adults with multimorbidity is often complex, challenging, and prone to fragmentation. Although clinical decision making should take into account treatment interactions, individual burden, and resources, current approaches to assessing quality of care mostly rely on indicators for single conditions. The aim of this project was to develop a set of generic quality indicators for the management of patients aged 65 and older with multimorbidity that can be used in both health care research and clinical practice., Research Design and Methods: Based on the findings of a systematic literature review and eight focus groups with patients with multimorbidity and their family members, we developed candidate indicators. Identified aspects of quality were mapped to core domains of health care to obtain a guiding framework for quality-of-care assessment. Using nominal group technique, indicators were rated by a multidisciplinary expert panel (n = 23) following standardized criteria., Results: We derived 47 candidate quality indicators from the literature and 4 additional indicators from the results of the focus groups. The expert panel selected a set of 25 indicators, which can be assigned to the levels of patient factors, patient-provider communication, and context and organizational structures of the conceptual framework., Discussion and Implications: We developed a comprehensive indicator set for the management of multimorbidity that can help to highlight areas with potential for improving the quality of care and support application of multimorbidity guidelines. Furthermore, this study may serve as a blueprint for participatory designs in the development of quality indicators., (© The Author(s) 2022. Published by Oxford University Press on behalf of The Gerontological Society of America.)

Background: In recent years, healthcare has faced many different crises around the world such as HIV-, Ebola- or H1N1-outbrakes, opioid addiction, natural disasters and terrorism attacks). In particular, the current pandemic of Covid-19 has challenged the resilience of health systems. In many healthcare systems, primary care practices play a crucial role in the management of crises as they are often the first point of contact and main health care provider for patients. Therefore, this study explored which situations are perceived as crises by primary care practice teams and potential strategies for crisis management., Methods: A qualitative observational study was conducted. Data were collected in interviews and focus groups with experts from primary care practices and stakeholders focusing on primary care practices in Germany such as physicians, medical assistants, practice managers, quality managers, hygiene managers and institutions on health system level (politics, research and health insurance). All interviews and focus groups were audio-recorded and transcribed verbatim. A qualitative content analysis was performed using a rapid qualitative analysis approach first, followed by a thematic analysis., Results: Two focus groups and 26 interviews including 40 participating experts were conducted. Many different situations were perceived as crises, varying from issues in the practice organization to problems on health system level and international disasters. Distinct aspects associated with the perception of a crisis situation by interviewees were the presence of emotional reactions, a need for organizational changes and a lack of necessary resources. A broad spectrum of possible strategies was discussed that could help to cope with or even prevent the emergence of an actual crisis. In particular, strengthening communication within practice teams and resilience among employees was perceived to be fundamental for improving responses to crises or preventing them., Conclusions: The study provides perspectives of primary health care workers on crises in health, that could inform health policy regarding prevention and management of future crises in primary care facilities., (© 2022. The Author(s).)

Introduction: In 2017, in Germany, a structural reform of the outpatient psychotherapy guideline took place, aiming to reduce waiting times, to facilitate flexible low-threshold access (eg, general reachability by phone) and to lower access barriers for specific patient groups. The reform included new service elements, such as the implementation of additional psychotherapeutic consultations, acute short-term psychotherapeutic interventions and relapse prophylaxis as well as the promotion of group therapies, the facilitation of psychotherapists' availability, and the installation of appointment service centres. The ES-RiP project aims to thoroughly evaluate the effects of the reform with a special focus on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs) compared with patients with a mental disorder but no long-term physical condition (MnoP). The project aims to evaluate (a) the extent to which the reform goals were achieved in the large group of patients with cMPs compared with MnoP, (b) the barriers that might hinder the implementation of the new guideline and (c) the procedures required for further developing and improving outpatient psychotherapy., Methods and Analysis: A mixed-methods design (quantitative, qualitative) along with a multilevel approach (patients, service providers, payers) triangulating several data sources (primary and secondary data) will be applied to evaluate the reform from different perspectives., Ethics and Dissemination: Ethical approval was obtained from the coordinating committee as well as one local ethics committee, Justus Liebig University Giessen and Marburg - Faculty of Medicine (approval number: AZ 107/20) and Heidelberg (approval number: S-466/2020). The results of this study will be disseminated through expert panels, conference presentations and publications in peer-reviewed journals., Trial Registration Number: DRKS00020344., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Mobile health (mHealth) interventions for self-management are a promising way to meet the needs of patients with chronic diseases in primary care practices. Therefore, an mHealth intervention, TelePraCMan, was developed and evaluated for patients with type 2 diabetes mellitus, chronic obstructive pulmonary disease, high blood pressure, or heart failure in a German primary care setting. TelePraCMan entails a symptom diary, an appointment manager, a manager to document goals, and a warning system. The app should foster the self-management of participating patients., Objective: We aimed to examine the effects of TelePraCMan on patient activation and quality of life and explored the underlying contextual factors, impacts, and degree of implementation., Methods: In a prospective observational study design, we collected data by using interviews and written questionnaires from participating patients (intervention and control groups) and primary care workers (physicians and practice assistants). The primary outcomes of interest were patient-reported quality of life (12-Item Short Form Survey) and patient activation (patient activation measure). The quantitative analysis focused on differences between patients in the intervention and control groups, as well as before (T0) and after (T1) the intervention. Interviews were analyzed by using qualitative content analysis via MAXQDA (VERBI GmbH)., Results: At baseline, 25 patients and 24 primary care workers completed the questionnaire, and 18 patients and 21 primary care workers completed the follow-up survey. The patients were predominantly male and, on average, aged 64 (SD 11) years (T0). The primary care workers were mostly female (62%) and, on average, aged 47 (SD 10) years (T0). No differences were observed in the outcomes before and after the intervention or between the intervention and control groups. In the additional interviews, 4 patients and 11 primary care workers were included. The interviewees perceived that the intervention was useful for some patients. However, contextual factors and problems with implementation activities negatively affected the use of the app with patients. The main reasons for the low participation were the COVID-19 pandemic and the target group, which seemed to have less interest in mHealth; the interviewees attributed this to the older age of patients. However, the respondents felt that the app would be better accepted in 5 or 10 years., Conclusions: Although the TelePraCMan app was rated as very good and important by the participants, few patients used it. The digital intervention was hardly implemented and had limited impact in the current setting of German primary care., Trial Registration: German Clinical Trials Register DRKS00017320; https://tinyurl.com/4uwrzu85., (©Amanda Breckner, Nicola Litke, Linda Göbl, Lars Wiezorreck, Antje Miksch, Joachim Szecsenyi, Michel Wensing, Aline Weis. Originally published in JMIR Formative Research (https://formative.jmir.org), 25.08.2022.)

Objectives: This study aimed to explore the association between patient activation and patients' experience of care among an elderly multimorbid population in Germany., Design: Cross-sectional study., Setting: Primary care practices in two German settings., Participants: 346 patients with 3 or more chronic conditions aged 65 years and over from 36 primary care practices., Outcome Measures: Patient activation was measured with the patient activation measure (PAM). To assess patient experiences with primary care, a set of questions concerning domains of primary care were included. Multilevel regression analyses were performed to examine which domains of care were associated with patient activation., Results: Out of 1243 invited patients, a total of 346 took part in the study (participation rate 27.8 %). Mean PAM score was 76.1. Across all patients, 3.8% achieved PAM level 1, 7.5% level 2, 27.2% level 3% and 60.7% level 4. PAM scores suggest a highly activated patient group. In the regression analysis, three out ten domains of patients' experiences showed an association with patient activation. The domains 'being involved in decision as much as desired' (B=-8.56, p=0.012) and 'receiving a self-management plan' (B=6.51, p=0.051) were associated with higher patient activation scores. Patients with an up-to-date medication plan had lower patient activation scores (B=-12.01, p=0.041)., Conclusion: Specific domains of primary care were found to be associated with patient activation. To enhance patient activation, primary care physicians may increase involvement of patients in decisions. Future research should examine the causality of these associations., Trial Registration Number: DRKS00015718., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The approaches to cope with the challenges of providing medical care to patients with symptoms of long COVID are multidisciplinary and involve primary care worldwide. The aim of this study was to explore the experiences and ideas for continued development of medical care of long COVID from the patients' (PAT) and primary care practitioners' (PCP) perspective., Methods: Between the third and fourth COVID-19 wave in Germany (July to September 2021), a mixed methods study was conducted by inviting patients and PCPs in two neighboring districts (urban and rural) in Baden-Wuerttemberg to a paper-based questionnaire with both closed and open questions. On the part of the PCPs a written, anonymized, complete survey was conducted, on the part of symptomatic COVID long-haulers an anonymized online survey with announcement of the study by multiple recruiting processes. Qualitative content analysis was applied to free text entries. The quantitative results were analyzed mainly descriptively., Results: The responses of n = 72 PCPs (response rate 12%) and n = 126 PAT showed a heterogeneous assessment regarding the satisfaction with medical care for long COVID as well as the perception of the attitude towards patients and their disease in both groups. Uncertainty and dealing with it played a relevant role in both groups as well. The professional medical knowledge was assessed by 3,1 (self-assessment PCPs) and 3,2 (PAT) on average using a five-point Likert scale (1 = not applicable; 5 = applicable). The request for a structured overall concept with competent contact points and coordination of medical care for long COVID patients emerged out of the statements of both groups., Conclusion: The results support an interdisciplinary, intersectoral and interprofessional stepped-care concept for long COVID in Germany with PCPs as the first contact persons, integration of specialized contact points and knowledge transfer. Therefore, it appears to be both reasonable and appropriate to establish regional networks with links between regional outpatient medical care structures and the university medical sector., (Copyright © 2022. Published by Elsevier GmbH.)

Objectives: We aimed to assess general practice (GP) trainees' self-perception of surgical competencies and to explore longitudinal effects of a compact intervention., Design: We performed a mixed-methods study including a before and after comparison in the intervention group (IG), a comparison of attendees and non-attendees (control group (CG)) and a qualitative evaluation of the intervention. Competencies were self-assessed through surveys. Semi-structured interviews were performed after 9 months., Setting: In 2019, a 2-day voluntary seminar focussing on minor surgery/injuries was offered on 13 occasions by educators from KWBW Verbundweiterbildung plus ( Competence Centre for Postgraduate Medical Education Baden-Württemberg )., Participants: All enrolled GP trainees were offered participation. GP trainees who did not attend a seminar (non-attendees) were recruited for CG after the 13th intervention., Intervention: Attendees took part in an interactive, GP-oriented short course incorporating 270 min of focused minor surgery/injuries training (compact intervention) on the second day of the 2-day seminar., Results: 326 GP trainees (IG: n=257; CG: n=69) participated in the study. 17 attendees were interviewed. CG had more often experienced a surgical rotation (p=0.03) and reported higher interest in performing minor surgery in future practice (p=0.03). GP trainees self-rated their all-round competency in minor surgery as average (IG: 3.0±1.0, CG: 3.2±0.9, IG:CG p=0.06). After the intervention, attendees felt that surgical skills should be a core component of GP vocational training (p=0.05). After 9 months, attendees remembered a variety of content and valued the interactive, case-oriented, peer-to-peer approach in a mixed learning group. Some attendees reported they had started to overcome competency gaps in minor surgery., Conclusions: A compact intervention in minor surgery provides an 'intense' stimulus which could foster positive attitudes towards minor surgery and promote longitudinal personal development of related competencies in GP trainees, including those with little interest in surgery. Such measures appear crucial to support individual progress of GP trainees to provide comprehensive primary care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To describe the prevalence of complexity factors in the medication regimens of community-dwelling patients with more than five drugs and to evaluate the relevance of these factors for individual patients., Methods: Data were derived from the HIOPP-6 trial, a controlled study conducted in 9 general practices which evaluated an electronic tool to detect and reduce complexity of drug treatment. The prevalence of complexity factors was based on the results of the automated analysis of 139 patients' medication data. The relevance assessment was based on the patients' rating of each factor in an interview (48 patients included for analysis)., Results: A median of 5 (range 0-21) complexity factors per medication regimen were detected and at least one factor was observed in 131 of 139 patients. Almost half of these patients found no complexity factor in their medication regimen relevant., Conclusion: In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves. When assessing complexity of medication regimens, one should especially consider factors that are both particularly frequent and often challenging for patients, such as use of inhalers or tablet splitting., Trial Registration: The HIOPP-6 trial was registered retrospectively on May 17, 2021, in the German Clinical Trials register under DRKS-ID DRKS00025257., (© 2022. The Author(s).)

Background: A complex drug treatment might pose a barrier to safe and reliable drug administration for patients. Therefore, a novel tool automatically analyzes structured medication data for factors possibly contributing to complexity and subsequently personalizes the results by evaluating the relevance of each identified factor for the patient by means of key questions. Hence, tailor-made optimization measures can be proposed., Methods: In this controlled, prospective, exploratory trial the tool was evaluated with nine general practitioners (GP) in three study groups: In the two intervention groups the tool was applied in a version with (G I&#95;with ) and a version without (G I&#95;without ) integrated key questions for the personalization of the analysis, while the control group (G C ) did not use any tools (routine care). Four to eight weeks after application of the tool, the benefits of the optimization measures to reduce or mitigate complexity of drug treatment were evaluated from the patient perspective., Results: A total of 126 patients regularly using more than five drugs could be included for analysis. GP suggested 117 optimization measures in G I&#95;with , 83 in G I&#95;without , and 2 in G C . Patients in G I&#95;with were more likely to rate an optimization measure as helpful than patients in G I&#95;without (IRR: 3.5; 95% CI: 1.2-10.3). Thereby, the number of optimization measures recommended by the GP had no significant influence (P = 0.167)., Conclusions: The study suggests that an automated analysis considering patient perspectives results in more helpful optimization measures than an automated analysis alone - a result which should be further assessed in confirmatory studies., Trial Registration: The trial was registered retrospectively at the German Clinical Trials register under DRKS-ID DRKS00025257 (17/05/2021)., (© 2022. The Author(s).)

Non-governmental organisations (NGOs) regularly report data on their work with uninsured migrants (UM) within a (so-called) parallel health care system. The role and involvement of public authorities therein have yet been underrepresented in research. Our aim was to gain a better understanding of public authorities' role in the parallel health care system and their view of the health situation of UM. We conducted qualitative semi-structured interviews with 12 experts recruited by purposive sampling from local public health authorities (LPHAs), state-level public health authorities (SPHAs), and social services offices (SSO) in nine cities, recorded, transcribed, and subjected the data to qualitative content analysis. LPHAs are more often directly involved in providing medical services, while SSOs and SPHAs function as gatekeepers for access to social benefits, including health insurance, and in grant-funded projects. NGOs keep substituting for the lack of access to regular health care from public institutions, but even in settings with extended services, public authorities and NGOs have not been able to provide sufficient care through the parallel health care system: Experts report gaps in the provision of health care with respect to the depth and height of coverage, due to the fragmentation of services and (ostensible) resource scarcity. Our study highlights the necessity for universal access to regular health care to overcome the fragmentation of services and improve access to needed health care for UM in Germany.

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., (©Martina Kamradt, Regina Poß-Doering, Joachim Szecsenyi. Originally published in JMIR Formative Research (https://formative.jmir.org), 18.05.2022.)

Background: Conducting a process evaluation is essential to understand how health interventions work in different healthcare settings. Particularly in the case of complex interventions, it is important to find out whether the intervention could be carried out as planned and which factors had a beneficial or hindering effect on its implementation. The aim of this study is to present the detailed protocol of the process evaluation embedded in the controlled implementation study CCC-Integrativ aiming to implement an interprofessional counselling program for cancer patients on complementary and integrative health care (CIH)., Methods: This mixed methods study will draw upon the "Consolidated Framework for Implementation Research" (CFIR) combined with the concept of "intervention fidelity" to evaluate the quality of the interprofessional counselling sessions, to explore the perspective of the directly and indirectly involved healthcare staff, as well as to analyze the perceptions and experiences of the patients. The qualitative evaluation phase consists of analyzing audio-recorded counselling sessions, as well as individual and group interviews with the involved persons. The quantitative evaluation phase applies questionnaires which are distributed before (T0), at the beginning (T1), in the middle (T2) and at the end (T3) of the intervention delivery., Discussion: This protocol provides an example of how a process evaluation can be conducted parallel to a main study investigating and implementing a complex intervention. The results of this mixed methods research will make it possible to identify strengths and weaknesses of the team-based intervention, and to target more specifically the key factors and structures required to implement healthcare structures to meet patients' unmet needs in the context of CIH. To our knowledge, this study is the first applying the CFIR framework in the context of interprofessional CIH counselling, and its results are expected to provide comprehensive and multidisciplinary management of cancer patients with complex supportive healthcare needs., Competing Interests: The authors have declared that no competing interests exist.

Introduction: General practitioners (GP) report increasing difficulties in referring patients with somatic symptom disorder (SSD) in specialised psychosocial care. Barriers are structural conditions of the respective healthcare system and patients' reservations against receiving specialised psychosocial care. As patients with SSD often predominantly assume somatic influencing factors for the development and maintenance of their somatic complaints, close collaboration between the GP and mental health specialist (MHS) seems particularly important. Integrating internet-based video consultations by remotely located MHS and primary care can improve effective treatment of patients with SSD by overcoming structural barriers and provide low-threshold and timely care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing MHS video consultations in primary care practices., Methods and Analysis: Fifty primary care patients with SSD will be individually randomised in two groups receiving either enhanced treatment as usual as provided by their GP (control group) or two versus five video consultations conducted by an MHS additionally to enhanced treatment as usual. The video consultations focus on (a) diagnostic clarification, (b) the development of a biopsychosocial disorder model, and (c) development of a treatment plan against the background of a stepped-care algorithm based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters., Ethics and Dissemination: This trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-620/2021). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial., Trial Registration Number: DRKS00026075., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Due to individual care needs, the provision of care to patients with two or more chronic diseases (multimorbidity) is described as complex. In addition, the number of chronically ill people is increasing, due in part to demographic changes which pose a challenge, especially for outpatient primary care. In order to fulfil patients' needs and to promote self-management as a central care element of chronically ill patients, the use of eHealth applications increases. TelePraCMan will be developed as one of these applications and includes a symptom-based electronic diary, which will be implemented in the established German disease management programme 'PraCMan'. This study is conducted as a part of the TelePraCMan project and aims to detect the needs of potential end users (physicians, medical assistants, patients)., Methods: In the TelePraCMan development phase, an explorative cross-sectional study was conducted with potential end users of the TelePraCMan app (patients, physicians and medical assistants). For this purpose, a written survey was conducted in Baden-Wurttemberg between April 2019 and March 2020. The survey covered smartphone usage behaviour, technology affinity using the standardised questionnaire TA-EG, support network for technical questions and sociodemographic data., Results: A total of n=202 patients (n=98), physicians (n=58) and medical assistants (n=43) participated in the survey. Concerning smartphone use, 78.2 % of the participants stated that the function used most frequently was writing short messages. Health apps were the least used function (9.6 %). Furthermore, patients (12.6 %) use health apps more often than medical assistants (10.3%) and doctors (4.4 %). Participants aged 50 and younger were found to have a higher affinity for technology (mean=3.20, SD=0.51) than participants over 50 years of age (mean=2.98, SD=0.67). Older, multimorbid respondents had a particularly low affinity for technology (mean=2.52, SD=0.69). 10.9 % of the over-fifties and 12.5 % of the multimorbid persons felt able to fix any technical problems on their own without help. Multimorbid participants over the age of 50 were observed to prefer personal support over internet-based support., Discussion: On average, multimorbid respondents in the age group over 50 have a lower affinity for technology than respondents aged under 50 without multimorbidity. The most frequent negative attitude towards electronic devices is also found among patients over 50 years of age, who are expected to be the main target group of the TelePraCMan app. These findings can be used to derive requirements for the design and development of functions of the app, as well as accompanying measures, such as intuitive and simple user interface, a telephone hotline to support users, close consultation with users on the planned functions, and more., Conclusion: Based on this survey, we were able to determine the needs of the future target group of the TelePraCMan app. This is seen as a starting point for the development of an implementation strategy and the pilot testing of the app in primary care., (Copyright © 2022. Published by Elsevier GmbH.)

Background: Self-efficacy is decisive for the quality of life of elderly, multimorbid persons. It may be possible to strengthenpatients' self-efficacy can be strengthened by the targeted reinforcement of individual spirituality, social activity, and self-care.This hypothesis was tested with the aid of a complex intervention., Methods: A non-blinded, exploratory, cluster-randomized, controlled trial was carried out, with primary care practices as therandomization unit (registration number DRKS00015696). The patients included were at least 70 years of age, had at least threechronic diseases, were taking at least three medications, and were participating in a disease management program. In theintervention group, primary care physicians took a spiritual history, and medical assistants advised the patients on the use ofhome remedies (e.g., tea, application of heat/cold) and on regionally available programs for the elderly. The primary endpoint-health-related self-efficacy, measured using the SES6G scale-and further, secondary endpoints were evaluated withmultistep regression analyses., Results: Data from 297 patients treated in 24 primary care practices were evaluated. The analysis of the primary endpointindicated no effect (mean difference between study arms 0.30 points, 95% confidence interval [-0.21; 0.81], d = 0.14, p = 0.25).Subgroup analysis revealed the following situation for the secondary endpoint "mental well-being" (SF-12 subscale): patientswho had already been using home remedies before the trial began experienced a marked improvement (a difference of 7.3points on a scale from 0 to 100; d = 0.77, p < 0.001). This was also the case for patients who stated that spirituality played amajor role in their lives (a difference of 6.2 points on a scale from 0 to 100; d = 0.65; p = 0.002)., Conclusion: The main hypothesis concerning health-related self-efficacy was not confirmed. The results of the analysis ofsecondary parameters indicate that some subgroups of patients can benefit from the interventional approach.

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 )., (© 2022. The Author(s).)