Prevention of invasive ventilation (PRiVENT)-a prospective, mixed-methods interventional, multicentre study with a parallel comparison group: study protocol.

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).

Patient Safety and the COVID-19 Pandemic in Germany: A Repeated Population-Based Cross-Sectional Survey.

The coronavirus (COVID-19) has presented Germany with major challenges and has led to concerns about patient safety. We conducted an observational, population-based, nationwide, repeated cross-sectional survey on patient safety in Germany in 2019, 2020, and 2021. Each of the three samples consisted of 1000 randomly recruited adults. Self-reported data via computer-assisted telephone interviews were taken from TK Monitor of Patient Safety. Perceptions, experience, and knowledge relating to patient safety were assessed. The majority of respondents considered medical treatment to involve risks to patient safety. This proportion decreased during the pandemic. The majority also had a high degree of self-efficacy regarding the prevention of medical errors, whereby the percentage that felt well informed with regard to patient safety rose throughout the pandemic. The proportion of persons that suspected they had in the past experienced an error in their treatment remained steady at one third as well as the reported errors. In 2020, 65% of respondents thought health communication with service providers (e.g., extent and comprehensibility of information) remained unchanged during the pandemic, while 35% reported that medical appointments had been cancelled or postponed. This study is the first to assess patient safety from a general population perspective during the coronavirus pandemic in Germany. COVID-19 had a positive impact on perceived patient safety but no impact on suspected and reported errors. Self-efficacy with regard to medical error prevention steadily increased in the general population, and people considered themselves well informed.

Interprofessional weaning boards for invasively ventilated patients in intensive care units: Qualitative interview study with healthcare professionals in Germany.

Numbers of mechanically ventilated patients are increasing worldwide. Weaning Boards could support weaning from the ventilator by facilitating interprofessional consultations between Weaning Centers and nonpneumological intensive care units. This study, which is linked to the project Prevention of invasive Ventilation, aimed to explore the design and implementation of future Weaning Boards. Semistructured interviews were conducted with physicians, nurses, respiratory therapists, and physiotherapists of intensive care units and Weaning Centers in Baden-Wuerttemberg, Germany. Participants were asked to share their views on (a) required characteristics of Weaning Boards and (b) the current care of weaning patients in their wards. Qualitative data analysis included inductive and deductive steps referring to the Template for Intervention Description and Replication checklist and the Consolidated Framework for Implementation Research. The 14 interviewed healthcare professionals addressed characteristics of future Weaning Boards including (a) preconditions, (b) procedure, (c) interprofessional participants, (d) type of performance, and (d) time frame. Identified determinants for successful implementation were related to (a) individual characteristics of healthcare professionals, (b) ward characteristics, and (c) healthcare system characteristics. Weaning Boards could be a useful tool to advance knowledge sharing between professionals, improve education about weaning protocols, and support patient-oriented care. The implementation of Weaning Boards can be influenced by individual characteristics of participating professionals, difficulties in the interaction between professional groups, the present workplace culture, and the current coronavirus disease 2019 (COVID-19) pandemic.

Effects and Processes of an mHealth Intervention for the Management of Chronic Diseases: Prospective Observational Study.

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.

Building resilience in German primary care practices: a qualitative study.

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.

Resilience of the primary health care system - German primary care practitioners' perspectives during the early COVID-19 pandemic.

BACKGROUND: Primary care is a relevant pillar in managing not only individual, but also societal medical crises. The COVID-19 pandemic has demanded a rapid response from primary care with interventions in the health care system. The aim of this paper was to explore the responses of primary care practitioners (PCP) during the early COVID-19 pandemic and to analyze these with a view on the resilience of the primary health care system from the PCPs perspective. METHODS: Shortly after the first COVID-19 wave (July-October 2020) n = 39, semi-structured telephone interviews were conducted with PCP in practices and at Corona contact points (CCP) in Baden-Wuerttemberg (Germany). Qualitative content analysis was applied, and the evolved categories were related to in a framework for resilience. RESULTS: Primary care had an overall strong ability to adapt and show resilience, albeit with wide variance in speed and scope of the responses. When coping with uncertainty, the reasons given by PCPs in favor of opening a CCP mainly involved intrinsic motivation and self-initiative; the reasons against doing so were i.e. the lack of personal protective equipment, problems with space, and worries about organizational burden. A strong association existed between the establishment of a CCP and the use of resources (i.e. existing networks, personal protective equipment, exercising an office of professional political function). Our study predominantly found adaptive aspects for measures taken at medical practices and transformative aspects for setting up outpatient infection centers. PCPs played an important role in the coordination process (i.e. actively transferring knowledge, integration in crisis management teams, inclusion in regional strategic efforts) reaching a high level in the dimensions knowledge and legitimacy. The dimension interdependence repeatedly came into focus (i.e. working with stakeholders to open CCP, interacting among different types of primary care facilities, intersectoral interfaces). A need for regional capacity planning was visible at the time of the interviews. CONCLUSIONS: The results can be used for practical and research-based institutional and capacity planning, for developing resilience in primary care and for augmentation by perspectives from other stakeholders in the primary health care system.

Versorgungsbedarfe zu Long-COVID aus Sicht von Betroffenen und Hausärzt*innen – eine Mixed-Methods-Studie aus Baden-Württemberg Long COVID: care and support needs from the perspective of “long-haul” patients and primary care practitioners – a mixed-methods study from Baden-Wuerttemberg

Hintergrund Ansätze zur Bewältigung der medizinischen Versorgung von Long-COVID sind weltweit multidisziplinär und beziehen die Primärversorgung ein. Ziel der Studie war die Erhebung von Erfahrungen und Ideen zur Weiterentwicklung der medizinischen Versorgung bei Long-COVID auf Seiten von Patient*innen (PAT) und Hausärzt*innen (HÄ). Methoden Zwischen dritter und vierter Welle der COVID-19-Pandemie in Deutschland (Juli – September 2021) wurde eine Mixed-Methods-Erhebung mittels schriftlichem Fragebogen mit geschlossenen und offenen Fragen unter HÄ und PAT in zwei benachbarten Kreisen (Stadt- und Landkreis) in Baden-Württemberg durchgeführt. Auf Seiten der HÄ erfolgte eine papierbasierte, anonymisierte Vollerhebung, auf Seiten der symptomatischen Long-COVID-PAT eine anonymisierte Online-Fragebogenerhebung mit Bekanntmachung der Studie über mehrere Rekrutierungswege. Die Freitexte wurden mittels qualitativer Inhaltsanalyse, die quantitativen Ergebnisse vorwiegend deskriptiv ausgewertet. Ergebnisse Die Rückmeldungen von n = 72 HÄ (Rücklauf 12%) und n = 126 PAT zeigten in beiden Gruppen eine heterogene Bewertung mit Blick auf die Zufriedenheit mit der medizinischen Versorgung bei Long-COVID sowie die Wahrnehmung der Haltung gegenüber PAT und deren Erkrankung. Unsicherheit und der Umgang damit spielten in beiden Gruppen eine relevante Rolle. Das ärztliche Wissen wurde im Mittel mit 3,1 (Selbstbewertung HÄ) und 3,2 (PAT) auf einer fünfstufigen Likert-Skala (1 = „trifft nicht zu“;5 = „trifft zu“) eingeschätzt. Aus den Aussagen beider Gruppen ergab sich der Wunsch nach einem strukturierten Gesamtkonzept mit kompetenten Anlaufstellen und einer Koordination der medizinischen Versorgung bei Long-COVID. Schlussfolgerung Die Ergebnisse stützen ein interdisziplinäres, intersektorales und interprofessionelles gestuftes Versorgungskonzept für Long-COVID in Deutschland mit HÄ als ersten Ansprechpartner*innen, Einbezug von Spezialanlaufstellen und Wissenstransfer. Die Etablierung regionaler Netzwerke mit Verknüpfung der regionalen ambulanten Versorgungsstrukturen und dem universitären medizinischen Sektor erscheint hierfür sinnvoll und wichtig.

Mental health specialist video consultations for patients with somatic symptom disorder in primary care: protocol for a randomised feasibility trial (the VISION trial).

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.

Health providers' experiences with mental health specialist video consultations in primary care: a qualitative study nested within a randomised feasibility trial.

OBJECTIVE: Despite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers' experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care. METHODS: A qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data. RESULTS: Considering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients' improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier. CONCLUSIONS: MHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes). TRIAL REGISTRATION NUMBER: DRKS00015812; Results.

[Impact of the COVID-19 pandemic on outpatient physical therapy in Germany]. / Einfluss der COVID-19 Pandemie auf die ambulante Physiotherapie.

INTRODUCTION: Due to the COVID-19 pandemic, the German health system has faced major challenges since spring 2020. In addition to restrictions in the inpatient health care sector, the maintenance of outpatient care by health care providers has also been affected by the pandemic-related restrictions. Both a decline in treatment frequencies and temporary practice closures have been observed. The aim of the study was to survey the work and care situation in outpatient physiotherapy practices during the first wave of the pandemic. METHODS: An anonymous online survey including quantitative and qualitative items was conducted among physiotherapists in the outpatient sector in Germany between June 1 and August 31, 2020. The survey is part of the mixed-methods study "ArTheCo", which was conducted throughout Germany including outpatient therapists and patients in physiotherapy, speech therapy and occupational therapy. RESULTS: In total, 577 physiotherapists from all over Germany took part in the survey. During the first wave of the pandemic, the occupancy rate fell below 50% at 45% of the facilities. 15% of the facilities had to close temporarily. Short-time work was announced at 58% of the respondents' practices. This and the implementation of hygiene measures restricted the provision of physiotherapy. This mainly affected patients with a higher risk of a severe clinical course of disease, such as nursing home patients. Due to complex changes in practice organisation and patient care, many of the interviewees felt that their economic existence was threatened and also described a large physical and psychological burden. Existing dissatisfaction seemed to have increased by the pandemic. DISCUSSION: To maintain continuous physical therapy, a reorganisation of the reimbursement system as well as easily accessible, consistent and feasible action plans for practices are needed. In combination with threats to existence due to the pandemic and increasing skill shortage, the outpatient physiotherapeutic care also appears to be threatened beyond the pandemic. CONCLUSION: The current pandemic has highlighted long-standing challenges causing dissatisfaction and making the profession increasingly unattractive for some of the respondents. Political action to support physiotherapists needs to be initiated. This study indicates potential starting points.

Beliefs and practices among primary care physicians during the first wave of the COVID-19 pandemic in Baden-Wuerttemberg (Germany): an observational study.

BACKGROUND: During the first wave of the COVID-19 pandemic various ambulatory health care models (SARS-CoV-2 contact points: Subspecialised Primary Care Practices, Fever Clinics, and Special Places for Corona-Testing) were organised in a short period in Baden-Wuerttemberg, a region in Southern Germany. The aim of these SARS-CoV-2 contact points was to ensure medical treatment for patients with (suspected) and without SARS-CoV-2 infection. The present study aimed to assess the beliefs and practices of primary care physicians who either led a Subspecialised Primary Care Practice or a Primary Care Practice providing care as usual in Baden-Wuerttemberg during the first wave of the COVID-19 pandemic. METHODS: This cross-sectional study was based on a paper-based questionnaire in primary care physicians during the first wave of the pandemic. Participants were identified via the web page of the Association of Statutory Health Insurance Physicians Baden-Wuerttemberg. The questionnaire was distributed in June and July 2020. It measured knowledge, practices, self-efficacy and fears towards SARS-CoV-2, using newly developed questions. Data was descriptively analysed. RESULTS: One hundred fifty-five participants (92 leads of SARS-CoV-2 contact points/ 63 leads of primary care practices) completed the questionnaire. Out of 92 leads of SARS-CoV-2 contact points 74 stated to lead n Subspecialised Primary Care Practices. About half participants of both groups did not fear an own infection with the novel virus (between 50.8% and 62.2%), however about 75% feared financial loss. Knowledge was gained using various sources; main sources were the Association of Statutory Health Insurance Physicians (between 82.5% and 83.8%) and the German Society for Hygiene and Microbiology (RKI) (between 88.9% and 95.9%). Leads of Subspecialised Primary Care Practice felt more confident to perform anamnestic/diagnostic procedures (p < 0.001). The same was found for the confidence level regarding decision-making concerning the further treatment (p < 0.001). Several prevention measures to contain the spread of SARS-CoV-2 were adopted. Subspecialised Primary Care Practice had treated on average more patients with (suspected) COVID-19 (mean 408.12) than primary care practices (mean 83.8) (p < 0.001). CONCLUSION: The results of this study suggest that the Subspecialised Primary Care Practice that were implemented during the first wave of the SARS-CoV-2 pandemic contributed containment of the pandemic. Leads of Subspecialised Primary Care Practice indicated that physical separation of patients with potential SARS-CoV-2 infection was easier compared to those who continued working in their own practice. Additionally, leads of Subspecialised Primary Care Practice felt more confident in dealing with patients with SARS-CoV-2 infection. TRIAL REGISTRATION: The study has been prospectively registered at the German Clinical Trial Register (DRKS00022224).

[Primary Care Strategies and Cooperation During the First Phase of the COVID-19 Pandemic in Baden-Wuerttemberg, Germany]. / Primärärztliche Strategien und Zusammenarbeit während der ersten Phase der COVID-19-Pandemie in Baden-Württemberg, Deutschland.

OBJECTIVES: The aim of this study was to give an early snapshot of primary care strategies that were implemented to cope with the early period of the COVID-19 pandemic in Baden-Wuerttemberg (Germany). METHODS: In June 2020, all 271 outpatient SARS-CoV-2 contact points, established by the National Association of Statutory Health Insurance Physicians (16 centers for testing, 204 specialized family practices, 51 Outpatients Corona Centers), and a randomly generated sample of 400 primary care practices of Baden-Wuerttemberg were invited to take part in a paper-based questionnaire. The data were gathered anonymously and analysed descriptively. RESULTS: Out of those invited, n=63 (15.8%) primary care practices and n=92 (33.9%) SARS-CoV-2 contact points participated; 78.7% of the primary care practices cooperated with SARS-CoV-2 contact points (n=48). In all, 92.1% had implemented a compulsory registration by phone for patients with (suspected) COVID-19 (n=58) and 81% offered consultation exclusively by phone or video in case of a mild courses (n=51). The new outpatient SARS-CoV-2 contact points were established in collaboration with several stakeholders, mainly led by primary care physicians (n=76, 82.6%) and almost 50% of these were established in March 2020 (n=42, 48.3%). The most commonly reported method of registration was regulated mainly by primary care practices (n=88, 95.7%) and public health departments (n=74, 80.4%). In 92.4% (n=85) of cases, it was possible to register by phone. The consultation response was most commonly given in the form of oral information to the patient (n=65, 77.4%). Less then 50% of the SARS-CoV-2 contact points used standardized sheets for registration, documentation and consultation. The assessment of future primary care structures for (suspected) COVID-19 patients were heterogeneous. CONCLUSIONS: Effort, improvisation and collaboration were required for a successful and rapid implementation of measures for primary care during the initial period of the COVID-19 pandemic. Impulses for ongoing development of primary care strategies during a pandemic can be derived out of these results.

Implementation science in times of Covid-19.

The emergence of SARS-CoV-2/Covid-19 affects all of us and is associated with rapid and massive changes in healthcare and societies. As a response, a range of interventions for patients and populations have been implemented in health and preventive settings, or need to be implemented in the short and long term. Implementation science offers a multidisciplinary perspective and systematic approach for the design, evaluation and analysis of programmes and policies to enhance implementation. The emergence of Covid-19 provides an urgent need to develop new perspectives and approaches in implementation science, such as the addition of innovative and rigorous approaches to the collection, use and analysis of 'real-world' data. Above all, we hope that implementation scientists will focus on what they can contribute to manage Covid-19 and its consequences for people, healthcare and society.