Triggers of intensive care patients with palliative care needs from nurses' perspective: a mixed methods study.

PURPOSE: Triggers have been developed internationally to identify intensive care patients with palliative care needs. Due to their work, nurses are close to the patient and their perspective should therefore be included. In this study, potential triggers were first identified and then a questionnaire was developed to analyse their acceptance among German intensive care nurses. METHODS: For the qualitative part of this mixed methods study, focus groups were conducted with intensive care nurses from different disciplines (surgery, neurosurgery, internal medicine), which were selected by convenience. Data were analysed using the "content-structuring content analysis" according to Kuckartz. For the quantitative study part, the thus identified triggers formed the basis for questionnaire items. The questionnaire was tested for comprehensibility in cognitive pretests and for feasibility in a pilot survey. RESULTS: In the qualitative part six focus groups were conducted at four university hospitals. From the data four main categories (prognosis, interprofessional cooperation, relatives, patients) with three to 15 subcategories each could be identified. The nurses described situations requiring palliative care consults that related to the severity of the disease, the therapeutic course, communication within the team and between team and patient/relatives, and typical characteristics of patients and relatives. In addition, a professional conflict between nurses and physicians emerged. The questionnaire, which was developed after six cognitive interviews, consists of 32 items plus one open question. The pilot had a response rate of 76.7% (23/30), whereby 30 triggers were accepted with an agreement of ≥ 50%. CONCLUSION: Intensive care nurses see various triggers, with interprofessional collaboration and the patient's prognosis playing a major role. The questionnaire can be used for further surveys, e.g. interprofessional triggers could be developed.

Consensus definition of advance care planning in dementia: A 33-country Delphi study.

INTRODUCTION: Existing advance care planning (ACP) definitional frameworks apply to individuals with decision-making capacity. We aimed to conceptualize ACP for dementia in terms of its definition and issues that deserve particular attention. METHODS: Delphi study with phases: (A) adaptation of a generic ACP framework by a task force of the European Association for Palliative Care (EAPC); (B) four online surveys by 107 experts from 33 countries, September 2021 to June 2022; (C) approval by the EAPC board. RESULTS: ACP in dementia was defined as a communication process adapted to the person's capacity, which includes, and is continued with, family if available. We identified pragmatic boundaries regarding participation and time (i.e., current or end-of-life care). Three interrelated issues that deserve particular attention were capacity, family, and engagement and communication. DISCUSSION: A communication and relationship-centered definitional framework of ACP in dementia evolved through international consensus supporting inclusiveness of persons with dementia and their family. HIGHLIGHTS: This article offers a consensus definitional framework of advance care planning in dementia. The definition covers all stages of capacity and includes family caregivers. Particularly important are (1) capacity, (2) family, (3) engagement, and communication. Fluctuating capacity was visualized in relation to roles and engaging stakeholders.

[Ensuring Future Primary Care from a Municipal Perspective]. / Die zukünftige Sicherstellung der hausärztlichen Versorgung aus kommunaler Perspektive.

BACKGROUND: In view of the continuing shortage of general practitioners, ensuring access to (primary) medical care close to home is also becoming increasingly important for local authorities. The aim of the present study was to analyse the current and future provision of primary care from the viewpoint of the municipalities in North Rhine-Westphalia (NRW). From the results, it should be possible to derive future health policy design of a needs-based primary care close to home. METHODS: In an online survey in spring 2023, we surveyed the mayors or representatives of health departments of all 427 municipalities (396 cities and communities, 31 districts) in NRW in cooperation with the NRW Association of Cities and Municipalities, the NRW Association of Counties and the NRW Association of Cities. The items of the questionnaire (n=28) were developed on the basis of two other surveys on medical care in Lower Saxony and Baden-Württemberg, each with a municipal policy target group. They were tested in repeated pretests. RESULTS: In total, 192 municipalities participated in the survey (response rate: 45.0%). The majority of the municipalities (86.6%) considered the local provision of primary care to be (rather) not ensured within the next 10 years. The municipalities expressed the wish for more opportunities to exert their own influence (79.5% yes or rather yes), but nevertheless considered a stronger commitment, especially of the Associations of Statutory Health Insurance Physicians (85.4%), as well as an intensification of assumption of responsibility by the federal states (72.4%) to be necessary for ensuring primary care. CONCLUSION: The survey shows that municipalities are quite aware of the problem of future deficits in the supply of general practitioners at the local level. The results also indicate that, in view of increasing supply shortfalls, the municipalities see obligations for the Associations of Statutory Health Insurance Physicians and the federal states to take responsibility and to exert greater political pressure in the future. The municipal perspective is an essential building block in considerations of how primary care can be ensured in the future. The responsible stakeholders should therefore involve the municipal level in the planning and measures to secure primary care more closely than in the past.

[Primary Care Inequalities to the Disadvantage of the Population of Socially Deprived Urban Areas: A Case Study of Essen, Germany]. / Primärärztliche Versorgungsungleichheiten zu Ungunsten der Bevölkerung sozial benachteiligter Stadtgebiete ­ eine Fallanalyse am Beispiel der Stadt Essen.

Background As a large city in the middle of a metropolitan area, the city of Essen is characterized by strong social segregation and a north-south divide in the social status of its population. The conventional demand planning does not take such strong disparities within a planning unit into account. The present study aims to analyze the distribution of primary care structures using the example of two large urban areas within the city of Essen and to identify perspectives for strengthening primary care in disadvantaged urban areas. Methods First, a secondary data analysis was carried out at the district level and the study area Essen North (258,790 residents), consisting of 19 districts, was defined on the basis of two inclusion criteria - 1. location of the district north of the A40 freeway and 2. a mean subsistence rate>17.20 percent (average value of the city of Essen). Subsequently the study area was compared with the rest of the city (332,242 residents) with regard to the indicators a) social status, and b) available general practioners and pediatricians. The data of the selected indicators is based on the social reporting of the city of Essen and the "Online Practice Search" (Online-Praxissuche) of the Association of Statutory Health Insurance Physicians North Rhine. The resulting database (last update: 10/20212) was then evaluated at the district level and the primary care situation of the two urban areas was compared. Results The results revealed a significantly lower primary care coverage in the socially disadvantaged study area Essen North by about 25 percent for general practioners and by almost half for pediatricians. Thus, higher social disadvantage was associated with poorer access to primary care close to home, especially for children and adolescents. Conclusion The distribution of primary care providers in the city of Essen increases the risk of contributing to the manifestation of geographic disparities and health inequalities. The existing planning system in particular is not suitable for addressing the threatening or already existing undersupply of primary health care to the population in disadvantaged urban districts.

General practitioners' attitudes towards patients with poorly controlled type 2 diabetes: a qualitative study.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) with poor glycaemic control can represent a challenge from the perspective of the general practitioner (GP). Apart from patient-sided factors, the understanding of GPs' attitudes may provide ideas for improved management in these patients. The aim of this study is to reveal attitudes of GPs towards T2DM patients with poor metabolic control. METHODS: Qualitative research in German general practice; 20 GPs, randomly chosen from participants of a larger study; in-depth narrative interviews, audio-recorded and transcribed; inductive coding and categorisation in a multi-professional team; abstraction of major themes in terms of attitudinal responses. RESULTS: 1) Orientation on laboratory parameters: GPs see it as their medical responsibility to achieve targets, which instil a sense of security. 2) Resignation: GPs believe their efforts are in vain and see their role as being undermined. 3) Devaluation of the patient: GPs blame the "non-compliance" of the patients and experience care as a series of conflicts. 4) Fixed role structure: The expert GP on the one hand, the ignorant patient on the other. 5) Solidarity with the patient: GPs appreciate a doctor-patient relationship in terms of partnership. CONCLUSIONS: The conflict GPs experience between their sense of duty and feelings of futility may lead to perceptions such as personal defeat and insecurity. GPs (and patients) may benefit from adjusting the patient-doctor relationship with regard to shared definitions of realistic and authentic goals.

[Advance Care Planning and its Relevance for Emergency and Intensive Care Medicine]. / Behandlung im Voraus planen ­ Bedeutung für die Intensiv- und Notfallmedizin.

Like in other countries, advance care planning (ACP) is currently being implemented in Germany as a new concept to realise valid and effective advance directives. This concept comprises processes to explore and document individual preferences for future treatment, and to honour them at a time when the person is incapacitated. ACP aims to ensure that patients will be treated according to their preferences when they are no longer capable due to acute health crises or chronic diseases. This paper gives an overview of the concept of ACP with a focus on relevant issues for emergency and intensive care medicine.

Advance directives and power of attorney for health care in the oldest-old - results of the AgeQualiDe study.

BACKGROUND: Completion of advance directives (ADs) and power of attorney (POA) documents may protect a person's autonomy in future health care situations when the individual lacks decisional capacity. As such situations become naturally much more common in old age, we specifically aimed at providing information on (i) the frequency of ADs/POA in oldest-old individuals and (ii) factors associated with having completed ADs/POA. METHODS: We analyzed data of oldest-old primary care patients (85+ years; including community-dwelling and institutionalized individuals) within the German AgeQualiDe study. Patients were initially recruited via their general practitioners (GPs). We calculated frequencies of ADs and POA for health care with 95% confidence intervals (CI) and used multivariable logistic regression analysis to evaluate the association between having ADs and POA and participants' socio-demographic, cognitive, functional, and health-related characteristics. RESULTS: Among 868 GP patients participating in AgeQualiDe (response = 90.9%), n = 161 had dementia and n = 3 were too exhausted/ill to answer the questions. Out of the remaining 704 (81.1%) dementia-free patients (mean age = 88.7 years; SD = 3.0), 69.0% (95%-CI = 65.6-72.4) stated to having ADs and 64.6% (95%-CI = 61.1-68.2) to having a POA for health care. Individual characteristics did not explain much of the variability of the presence/absence of ADs and POA (regression models: Nagelkerke's R2 = 0.034/0.051). The most frequently stated reasons for not having ADs were that the older adults trust their relatives or physicians to make the right decisions for them when necessary (stated by 59.4% and 44.8% of those without ADs). Among the older adults with ADs, the majority had received assistance in its preparation (79.0%), most frequently from their children/grandchildren (38.3%). Children/grandchildren were also the most frequently stated group of designated persons (76.7%) for those with a POA for health care. CONCLUSIONS: Our findings suggest a high dissemination of ADs and POA for health care in the oldest-old in Germany. Some adults without ADs/POA perhaps would have completed advance care documents, if they had had received more information and support. When planning programs to offer advanced care planning to the oldest old, it might be helpful to respond to these specific needs, and also to be sensitive to attitudinal differences in this target group.

Does facilitated Advance Care Planning reduce the costs of care near the end of life? Systematic review and ethical considerations.

BACKGROUND: While there is increasing evidence that Advance Care Planning has the potential to strengthen patient autonomy and improve quality of care near the end of life, it remains unclear whether it could also reduce net costs of care. AIM: This study aims to describe the cost implications of Advance Care Planning programmes and discusses ethical conflicts arising in this context. DESIGN: We conducted a systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. DATA SOURCES: We systematically searched the databases PubMed, NHS EED, EURONHEED, Cochrane Library and EconLit. We included empirical studies (no limitation to study type) that investigated the cost implications of Advance Care Planning programmes involving professionally facilitated end-of-life discussions. RESULTS AND DISCUSSION: Seven studies met our inclusion criteria. Four of them used a randomised controlled design, one used a before-after design and two were observational studies. Six studies found reductions in costs of care ranging from USD1041 to USD64,827 per patient, depending on the study period and the cost measurement. One study detected no differences in costs. Studies varied considerably regarding the Advance Care Planning intervention, patient selection and costs measured which may explain some of the variations in findings. NORMATIVE APPRAISAL: Looking at the impact of Advance Care Planning on costs raises delicate ethical issues. Given the increasing pressure to reduce expenditures, there may be concerns that cost considerations could unduly influence the sensitive communication process, thus jeopardising patient autonomy. Safeguards are proposed to reduce these risks. CONCLUSION: The limited data indicate net cost savings may be realised with Advance Care Planning. Methodologically robust trials with clearly defined Advance Care Planning interventions are needed to make the costs and returns of Advance Care Planning transparent.

From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial.

BACKGROUND: Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk (CVR) rather than by blood pressure levels alone. However, this paradigm change has not yet arrived in German General Practice. We have evaluated the effect of an educational outreach visit with general practitioners (GPs), encouraging them to consider CVR in treatment decisions for patients with hypertension. METHODS: Prospective cluster-randomised trial comprising 3443 patients with known hypertension treated by 87 GPs. Practices were randomly assigned to complex (A) or simple (B) intervention. Both groups received a guideline by mail; group A also received complex peer intervention promoting the concept of global CVR. Clinical data were collected at baseline and 6-9 months after intervention. Main outcome was improvement of calculated CVR in the predefined subpopulation of patients with a high CVR (10-year mortality ≥5%), but no manifest cardiovascular disease. RESULTS: Adjusted for baseline the follow-up CVR were 13.1% (95% CI 12.6%-13.6%) (A) and 12.6% (95% CI 12.2%-13.1%) (B) with a group difference (A vs. B) of 0.5% (-0.2%-1.1%), p = 0.179. The group difference was -0.05% in patients of GPs familiar with global CVR and 1.1% in patients of GPs not familiar with with global CVR. However, this effect modification was not significant (p = 0.165). Pooled over groups, the absolute CVR reduction from baseline was 1.0%, p < 0.001. The ICC was 0.026 (p = 0.002). Hypertension control (BP <140/90 mmHg) improved in the same subpopulation from 38.1 to 45.9% in the complex intervention group, and from 35.6 to 46.5% in the simple intervention group, with adjusted follow-up control rates of 46.7% (95% CI 40.4%-53.1%) (A) and 46.9% (95% CI 40.3%-53.5% (B) and an adjusted odds ratio (A vs B) of 0.99 (95% CI 0.68-1.45), p = 0.966. CONCLUSIONS: Our complex educational intervention, including a clinical outreach visit, had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention. TRIAL REGISTRATION: ISRCTN44478543 .

Future policy and research for advance care planning in dementia: consensus recommendations from an international Delphi panel of the European Association for Palliative Care.

Advance care planning (ACP) is increasingly recognised in the global agenda for dementia care. The European Association for Palliative Care (EAPC) Taskforce on ACP in Dementia aimed to provide recommendations for policy initiatives and future research. We conducted a four-round Delphi study with a 33-country panel of 107 experts between September, 2021, and June, 2022, that was approved by the EAPC Board. Consensus was achieved on 11 recommendations concerning the regulation of advance directives, equity of access, and dementia-inclusive approaches and conversations to express patients' values. Identified research gaps included the need for an evidence-based dementia-specific practice model that optimises engagement and communication with people with fluctuating and impaired capacity and their families to support decision making, while also empowering people to adjust their decisions if their goals or preferences change over time. Policy gaps included insufficient health services frameworks for dementia-inclusive practice. The results highlight the need for more evidence and policy development that support inclusive ACP practice models.

Management of low back pain in general practice - is it of acceptable quality: an observational study among 25 general practices in South Tyrol (Italy).

BACKGROUND: There are several guidelines dealing with the management of low back pain (LBP), but only few studies on the quality of care provided within General Practices as judged against those guidelines.The objective of this study is to analyse the management of LBP in Italian General Practice and compare it with guideline recommendations. METHODS: In this observational study, all patients visiting their General Practitioners (GPs) for treatment of LBP within a 8-week period were monitored for at least four weeks with regard to symptoms and diagnostic and therapeutic interventions. Management of LBP was judged by pre-defined quality indicators based on guideline recommendations. RESULTS: Twenty-five of 114 eligible GPs participated in the study, representing a total of 43,012 registered patients. Of the 475 patients complaining of LBP and monitored for four weeks, 55.8% were diagnosed as having acute lumbar pain, 13.5% chronic lumbar pain, 17.1% acute sciatica, and 12.6% chronic sciatica; 76.0% underwent no technical investigations, 21.7% underwent x-rays, 5.5% MRI and 4% CT scans; 20.4% were referred to secondary care; 93.3% of all patients received some medication. In those receiving a medication, in 88.3% it was an NSAID, in 6.3% Paracetamol, in 10.4% Paracetamol combined with Codeine, and in 9% a muscle relaxants. When physiotherapy was prescribed (17,1%), it was mostly massage. Hardly more than 50% of GPs (partially) followed locally established guidelines, while the remainder seemed not to follow guidelines at all. CONCLUSIONS: Our study reveals gross deviations of GP management of LBP from current guidelines and points to two different types of deviators: those who partially follow guidelines, and those who do not follow them at all. Further research should evaluate whether these two types of deviation are best addressed by different foci of education, i.e. on knowledge versus attitudes, respectively.

Advance Care Planning in Germany.

Advance Care Planning (ACP) defined as a comprehensive concept requiring a cultural change following implementation at the individual, institutional and regional level in order to achieve care consistency with care preferences when individuals are incapable of participating in critical decisions was first implemented in two regional projects (LIMITS and beizeiten begleiten, North Rhine Westphalia) in Germany in the 2000s. Based on the positive evaluation of beizeiten begleiten, legislation of 2015 (§ 132g, Social Code Book V) allows nursing homes and care homes for persons with disabilities to offer qualified ACP facilitation covered by the statutory health insurance. However, trainers for ACP facilitators need no specific qualification, and the training program for ACP facilitators is only broadly defined, which resulted in great heterogeneity of ACP facilitator qualifications. Furthermore, neither the institutional nor the regional implementation are sufficiently considered in this legislation, i.e. essential components of a successful implementation of ACP are missing. Nevertheless, a growing number of initiatives, research projects and a professional national society for ACP, engage in approaches to advance institutional and regional implementation, and to offer ACP to other target groups beyond the legal framework.

Predictors of patients' acceptance of video consultation in general practice during the coronavirus disease 2019 pandemic applying the unified theory of acceptance and use of technology model.

Background: The coronavirus disease 2019 pandemic has led to an increase in remote consultations in health care. This study aimed to assess the acceptance of video consultation as an alternative to face-to-face in-office visits in general practice (GP) and to investigate its drivers and barriers. Methods: A cross-sectional study was conducted in Germany during the coronavirus disease 2019 pandemic from December 2020 to April 2021. Participants were recruited among patients in 16 GP surgeries. Assessed were sociodemographic and medical data as well as information and communications technology related data. Acceptance of video consultation and its predictors were determined using a modified questionnaire based on a short version of the renowned unified theory of acceptance and use of technology model. Results: In total, 371 participants were included in the data analysis. Acceptance of video consultation was moderate. A hierarchical regression revealed acceptance was significantly predicted by the PHQ-2, taking no regular medication, computer proficiency, knowledge about digital health care solutions, no prior use of video consultation, and the unified theory of acceptance and use of technology predictors performance expectancy, effort expectancy, and social influence. The extended unified theory of acceptance and use of technology model explained significantly more variance than the restricted unified theory of acceptance and use of technology model in acceptance of video consultation. Conclusions: In this study computer proficiency, existing knowledge about digital health care solutions and depressive symptoms functioned as drivers to acceptance, no prior use of video consultation could be identified as a potential barrier. Patients with regular medication have been particularly receptive to video consultation. The study confirmed the validity of the unified theory of acceptance and use of technology model in determining acceptance of video consultation. Considering that there is growing demand and acceptance for different approaches to engage with health care providers, additional steps should be taken to establish video consultation as a genuine alternative.

[Physician assistants as a future model in primary care: Experiences, needs, potentials and barriers]. / Physician Assistants als Zukunftsmodell in der hausärztlichen Versorgung ­ Erfahrungen, Bedarfe, Potenziale und Hürden.

INTRODUCTION: In the coming decades, demographic change will dramatically increase health care needs, especially for general practitioners (GPs). However, there is a shortage of young primary care physicians, with signs of (impending) underuse already becoming apparent in rural and structurally weak areas. Innovative care concepts are needed to counteract this development and ensure the future of primary care. In addition to medical assistants (MFA), academically trained physician assistants (PAs) could be considered for more demanding delegation tasks and be involved in direct patient care under the responsibility of a physician in the practice team. In England, the Netherlands and the USA, PAs have been a part of the health care systems for many years. RESEARCH QUESTIONS: 1) What are the potentials for delegation/possibilities for PAs working in primary care practices in contrast to medical assistants? 2) What structural requirements are necessary to regularly integrate PAs in primary care practices? METHODS: After preliminary interviews with PA experts and primary care researchers and practitioners (n=29), four expert interviews (n=4) with GPs and PAs were performed in a case analysis in order to elicit experiences with PAs in family practice. Based on this, three focus groups were conducted with GPs and practice staff (n=15) to discuss the extent, the need and the willingness to delegate physician services to PAs, as well as existing barriers. After transcription, analyses were performed using qualitative content analysis according to Mayring. RESULTS: The participants acknowledged the potential to reduce physician workloads and showed a high willingness to delegate tasks. Practical examples suggest that a clearly defined delegation of medical tasks to PAs, e.g. participation in infection consultations, is possible after only a few weeks working in family practices. Thus, the cooperation between GPs, PAs and medical assistants can be successful. Uncertainties exist regarding the legal possibilities and limits of delegation as well as the current and future financial reimbursement of PAs. DISCUSSION: The legal and financial framework for the utilization of PAs in ambulatory care should be reliably clarified as well as transparently communicated so that the considerable potentials of delegating tasks to academically trained staff, e.g. PAs, especially in the GP sector, can be exploited in the future. CONCLUSION: Participation of PAs in the GP team could be key to overcoming the often threatening or already existing under-provision of medical care in structurally weak regions.

Tiza-Titre increase and enhanced immunity through an adjuvanted, recombinant herpes zoster subunit vaccine in patients with liver cirrhosis and post-liver transplantation: a study protocol for a prospective cohort study.

INTRODUCTION: Shingrix, an effective adjuvanted, recombinant herpes zoster vaccine (RZV), has been available since 2018. Immunocompromised patients are known to be predisposed to vaccine failure. In-vitro testing of immunological surrogates of vaccine protection could be instrumental for monitoring vaccination success. So far, no test procedure is available for vaccine responses to RZV that could be used on a routine basis. METHODS AND ANALYSIS: This is a single-centre, three-arm, parallel, longitudinal cohort study aspiring to recruit a total of 308 patients (103 with a liver cirrhosis Child A/B, 103 after liver transplantation (both ≥50 years), 102 immunocompetent patients (60-70 years)). Blood samples will be taken at seven data collection points to determine varicella zoster virus (VZV) and glycoprotein E (gE)-specific IgG and T cell responses. The primary study outcome is to measure and compare responses after vaccination with RZV depending on the type and degree of immunosuppression using gE-specific antibody detection assays. As a secondary outcome, first, the gE-specific CD4+ T cell response of the three cohorts will be compared and, second, the gE-VZV antibody levels will be compared with the severity of possible vaccination reactions. The tertiary outcome is a potential association between VZV immune responses and clinical protection against shingles. ETHICS AND DISSEMINATION: Ethical approval was issued on 07/11/2022 by the Ethics Committee Essen, Germany (number 22-10805-BO). Findings will be published in peer-reviewed open-access journals and presented at local, national and international conferences. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (number DRKS00030683).

cfDNA as a surrogate marker for COVID-19 severity in patients with influenza-like symptoms with and without SARS-CoV-2 infections in general practice: a study protocol for a prospective cohort study.

INTRODUCTION: The clinical course of patients with a SARS-CoV-2 (COVID-19) infection varies widely, from symptom-free to severe courses that can lead to death. Laboratory values of SARS-CoV-2 patients such as lymphocyte counts or C-reactive protein (CRP) do not allow a prediction of the actual course of the disease. To identify a possible predictive marker for the differentiation and prognosis of illness with influenza-like symptoms with and without SARS-CoV-2 infections in general practice, we will analyse the concentrations of cell-free DNA (cfDNA) levels, laboratory and clinical parameters, temperature, oxygen saturation, breathing rate and concomitant symptoms in patients with flu-like symptoms with and without a SARS-CoV-2 infection. METHODS AND ANALYSIS: This is a single-centre, two-arm, parallel longitudinal cohort study with a total of 44 patients. 22 patients with flu-like symptoms without a SARS-CoV-2 infection and 22 patients with flu-like symptoms with a SARS-CoV-2 infection will be recruited. The primary objective is to compare cfDNA levels in ambulatory patients in general practice with flu-like symptoms with SARS-CoV-2 infection with those with influenza like symptoms without a SARS-CoV-2 infection during the disease (day 7 and day 14). The secondary objective is to determine whether there is a correlation between cfDNA concentrations on the one hand, and laboratory and clinical parameters on the other hand. cfDNA, differential blood count, high-sensitive CRP and erythrocyte sedimentation rate will be measured in blood samples, concomitant symptoms will be surveyed via a self-assessment questionnaire, and oxygen saturation, breathing rate and examination of the lungs will be reported by treating physicians. ETHICS AND DISSEMINATION: Ethical approval was issued on 1 March 2021 by the Ethics Committee Essen under the number 21-9916-BO. Findings will be published in peer-reviewed open-access journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER: DRKS00024722.

Work-Related Intervention Needs of Medical Assistants and How to Potentially Address Them according to Supervising General Practitioners: A Qualitative Study.

Work stress is common among health care professionals and this observation also holds true for general practitioners (GPs) and their medical assistance staff in Germany. Therefore, prior studies have examined the work-related intervention needs of medical assistants (MAs). We sought to explore potential interventions that may help to address these needs according to GPs' views. Between December 2018 and April 2019 GPs were recruited via physician networks and through personal visits in general practices. Information on the nature and prevalence of 20 work-related intervention needs of MAs was presented to GPs. GPs then participated in a qualitative interview to reflect on the MAs' needs. Qualitative content analysis according to Mayring was carried out using MAXQDA. A total of 21 GPs participated and perceived many of the needs as justified. The least understanding was expressed for requests of MA related to occupational aspects that were already known prior to hiring. The responsibility to address needs was often assigned to the German health policy. GPs expressed though that they considered addressing the need for better leadership style as their own responsibility as supervisors. Furthermore, professional training was discussed as one opportunity to raise the recognition and remuneration of MAs. Measures to address the work-related intervention needs of MAs and to thereby improve the working conditions of MAs were discussed with GPs.

Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial).

BACKGROUND: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. METHODS: This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. DISCUSSION: This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.

A complex regional intervention to implement advance care planning in one town's nursing homes: Protocol of a controlled inter-regional study.

BACKGROUND: Advance Care Planning (ACP) is an emerging strategy to ensure that well-reflected, meaningful and clearly documented treatment preferences are available and respected when critical decisions about life-sustaining treatment need to be made for patients unable to consent. In Germany, recent legislation confirms that advance directives (AD) have to be followed if they apply to the medical situation, but implementation of ACP has not yet been described. METHODS/DESIGN: In a longitudinal controlled study, we compare 1 intervention region (4 nursing homes [n/hs], altogether 421 residents) with 2 control regions (10 n/hs, altogether 985 residents). Inclusion went from 01.02.09 to 30.06.09, observation lasted until 30.06.10. Primary endpoint is the prevalence of ADs at follow-up, 17 (12) months after the first (last) possible inclusion. Secondary endpoints compare relevance and validity of ADs, process quality, the rate of life-sustaining interventions and, in deceased residents, location of death and intensity of treatment before death. The regional multifaceted intervention on the basis of the US program Respecting Choices® comprises training of n/h staff as facilitators, training of General Practitioners, education of hospital and ambulance staff, and development of eligible tools, including Physician Orders for Life-Sustaining Treatment in case of Emergency (POLST-E). Participation data: Of 1406 residents reported to live in the 14 n/hs plus an estimated turnover of 176 residents until the last possible inclusion date, 645 (41%) were willing to participate. Response rates were 38% in the intervention region and 42% in the control region. Non-responder analysis shows an equal distribution of sex and age but a bias towards dependency on nursing care in the responder group. Outcome analysis of this study will become available in the course of 2011. DISCUSSION: Implementing an ACP program for the n/hs and related health care providers of a region requires a complex community intervention with the effect of nothing less than a cultural shift in this health care sector. This study is to our knowledge the first to develop a strategy for regional implementation of ACP, and to evaluate its feasibility in a controlled design.