Evaluating palliative care case conferences in primary care for patients with advanced non-malignant chronic conditions: a cluster-randomised controlled trial (KOPAL).

BACKGROUND: Patients with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and dementia are underrepresented in specialist palliative home care (SPHC). However, the complexity of their conditions requires collaboration between general practitioners (GPs) and SPHC teams and timely integration into SPHC to effectively meet their needs. OBJECTIVE: To facilitate joint palliative care planning and the timely transfer of patients with advanced chronic non-malignant conditions to SPHC. METHODS: A two-arm, unblinded, cluster-randomised controlled trial. 49 GP practices in northern Germany were randomised using web-based block randomisation. We included patients with advanced CHF, COPD and/or dementia. The KOPAL intervention consisted of a SPHC nurse-patient consultation followed by an interprofessional telephone case conference between SPHC team and GP. The primary outcome was the number of hospital admissions 48 weeks after baseline. Secondary analyses examined the effects on health-related quality of life and self-rated health status, as measured by the EuroQol 5D scale. RESULTS: A total of 172 patients were included in the analyses. 80.4% of GP practices had worked with SHPC before, most of them exclusively for cancer patients. At baseline, patients reported a mean EQ-VAS of 48.4, a mean quality of life index (EQ-5D-5L) of 0.63 and an average of 0.80 hospital admissions in the previous year. The intervention did not significantly reduce hospital admissions (incidence rate ratio = 0.79, 95%CI: [0.49, 1.26], P = 0.31) or the number of days spent in hospital (incidence rate ratio = 0.65, 95%CI: [0.28, 1.49], P = 0.29). There was also no significant effect on quality of life (∆ = -0.02, 95%CI: [-0.09, 0.05], P = 0.53) or self-rated health (∆ = -2.48, 95%CI: [-9.95, 4.99], P = 0.51). CONCLUSIONS: The study did not show the hypothesised effect on hospitalisations and health-related quality of life. Future research should focus on refining this approach, with particular emphasis on optimising the timing of case conferences and implementing discussed changes to treatment plans, to improve collaboration between GPs and SPHC teams.

Ethisch begründet entscheiden in der Intensivmedizin.

The process recommendations of the Ethics Section of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) for ethically based decision-making in intensive care medicine are intended to create the framework for a structured procedure for seriously ill patients in intensive care. The processes require appropriate structures, e.g., for effective communication within the treatment team, with patients and relatives, legal representatives, as well as the availability of palliative medical expertise, ethical advisory committees and integrated psychosocial and spiritual care services. If the necessary competences and structures are not available in a facility, they can be consulted externally or by telemedicine if necessary. The present recommendations are based on an expert consensus and are not the result of a systematic review or a meta-analysis.

Symptom and problem clusters in German specialist palliative home care - a factor analysis of non-oncological and oncological patients' symptom burden.

BACKGROUND: Specialist palliative home care (SPHC) aims to maintain and improve patients' quality of life in the community setting. Symptom burden may differ between oncological and non-oncological patients. However, little is known about diagnosis-related differences of SPHC patients. This study aims to describe the prevalence of physical symptom burden and psychosocial problems of adult patients in SPHC, and to evaluate diagnosis-related symptom clusters. METHODS: Secondary analysis of data from a prospective, cross-sectional, multi-centre study on complexity of patients, registered at the German Register for Clinical Studies (DRKS trial registration number: DRKS00020517, 12/10/2020). Descriptive statistics on physical symptom burden and psychosocial problems at the beginning of care episodes. Exploratory and confirmatory factor analyses to identify symptom and problem clusters. RESULTS: Seven hundred seventy-eight episodes from nine SPHC teams were included, average age was 75 years, mean duration of episode 18.6 days (SD 19.4). 212/778 (27.2%) had a non-oncological diagnosis. Main burden in non-oncological episodes was due to poor mobility (194/211; 91.9%) with significant diagnosis-related differences (χ² = 8.145, df = 1, p = .004; oncological: 472/562; 84.0%), and due to weakness (522/565; 92.4%) in oncological episodes. Two symptom clusters (psychosocial and physical) for non-oncological and three clusters (psychosocial, physical and communicational/practical) for oncological groups were identified. More patients in the non-oncological group compared to the oncological group showed at least one symptom cluster (83/212; 39.2% vs. 172/566; 30.4%). CONCLUSION: Patients with non-oncological diseases had shorter episode durations and were more affected by symptom clusters, whereas patients with oncological diseases showed an additional communicational/practical cluster. Our findings indicate the high relevance of care planning as an important part of SPHC to facilitate anticipatory symptom control in both groups.

Structural characteristics and contractual terms of specialist palliative homecare in Germany.

BACKGROUND: Multi-professional specialist palliative homecare (SPHC) teams care for palliative patients with complex symptoms. In Germany, the SPHC directive regulates care provision, but model contracts for each federal state are heterogeneous regarding staff requirements, cooperation with other healthcare providers, and financial reimbursement. The structural characteristics of SPHC teams also vary. AIM: We provide a structured overview of the existing model contracts, as well as a nationwide assessment of SPHC teams and their structural characteristics. Furthermore, we explore whether these characteristics serve to find specifc patterns of SPHC team models, based on empirical data. METHODS: This study is part of the multi-methods research project "SAVOIR", funded by the German Innovations Fund. Most model contracts are publicly available. Structural characteristics (e.g. number, professions, and affiliations of team members, and external cooperation) were assessed via an online database ("Wegweiser Hospiz- und Palliativversorgung") based on voluntary information obtained from SPHC teams. All the data were updated by phone during the assessment process. Data were descriptively analysed regarding staff, cooperation requirements, and reimbursement schemes, while latent class analysis (LCA) was used to identify structural team models. RESULTS: Model contracts have heterogeneous contract partners and terms related to staff requirements (number and qualifications) and cooperation with other services. Fourteen reimbursement schemes were available, all combining different payment models. Of the 283 SPHC teams, 196 provided structural characteristics. Teams reported between one and 298 members (mean: 30.3, median: 18), mainly nurses and physicians, while 37.8% had a psychosocial professional as a team member. Most teams were composed of nurses and physicians employed in different settings; for example, staff was employed by the team, in private practices/nursing services, or in hospitals. Latent class analysis identified four structural team models, based on the team size, team members' affiliation, and care organisation. CONCLUSION: Both the contractual terms and teams' structural characteristics vary substantially, and this must be considered when analysing patient data from SPHC. The identified patterns of team models can form a starting point from which to analyse different forms of care provision and their impact on care quality.

Symptom relief, prognostic factors, and outcome in patients receiving urgent radiation therapy for superior vena cava syndrome : A single-center retrospective analysis of 21 years' practice.

PURPOSE: Superior vena cava syndrome (SVCS) often results from external vessel compression due to tumor growth. Urgent symptom-guided radiotherapy (RT) remains a major treatment approach in histologically proven, rapidly progressive disease. Despite several publications, recent data concerning symptom relief and oncological outcome as well as potential confounders in treatment response are still scarce. METHODS: We performed a retrospective single-center analysis of patients receiving urgent RT between 2000 and 2021 at the University Medical Center Göttingen. Symptom relief was evaluated by CTCAE score during the RT course. Effects of variables on symptom relief were assessed by logistic regression. The impact of parameters on overall survival (OS) was evaluated using Kaplan-Meier plot along with the log-rank test and by Cox regression analyses. Statistically significant (p-value < 0.05) confounders were tested in multivariable analyses. RESULTS: A total of 79 patients were included. Symptom relief was achieved in 68.4%. Mean OS was 59 days, 7.6% (n = 6) of patients showed long-term survival (> 2 years). Applied RT dose > 39 Gy, clinical target volume (CTV) size < 387 ml, concomitant chemotherapy, and completion of the prescribed RT course were found to be statistically significant for OS; applied RT dose and completion of the prescribed RT course were found to be statistically significant for symptom relief. CONCLUSION: Symptom relief by urgent RT for SVCS was achieved in the majority of patients. RT dose and completion of the RT course were documented as predictors for OS and symptom relief, CTV < 387 ml and concomitant chemotherapy were predictive for OS.

COMPANION: development of a patient-centred complexity and casemix classification for adult palliative care patients based on needs and resource use - a protocol for a cross-sectional multi-centre study.

BACKGROUND: A casemix classification based on patients' needs can serve to better describe the patient group in palliative care and thus help to develop adequate future care structures and enable national benchmarking and quality control. However, in Germany, there is no such an evidence-based system to differentiate the complexity of patients' needs in palliative care. Therefore, the study aims to develop a patient-oriented, nationally applicable complexity and casemix classification for adult palliative care patients in Germany. METHODS: COMPANION is a mixed-methods study with data derived from three subprojects. Subproject 1: Prospective, cross-sectional multi-centre study collecting data on patients' needs which reflect the complexity of the respective patient situation, as well as data on resources that are required to meet these needs in specialist palliative care units, palliative care advisory teams, and specialist palliative home care. Subproject 2: Qualitative study including the development of a literature-based preliminary list of characteristics, expert interviews, and a focus group to develop a taxonomy for specialist palliative care models. Subproject 3: Multi-centre costing study based on resource data from subproject 1 and data of study centres. Data and results from the three subprojects will inform each other and form the basis for the development of the casemix classification. Ultimately, the casemix classification will be developed by applying Classification and Regression Tree (CART) analyses using patient and complexity data from subproject 1 and patient-related cost data from subproject 3. DISCUSSION: This is the first multi-centre costing study that integrates the structure and process characteristics of different palliative care settings in Germany with individual patient care. The mixed methods design and variety of included data allow for the development of a casemix classification that reflect on the complexity of the research subject. The consecutive inclusion of all patients cared for in participating study centres within the time of data collection allows for a comprehensive description of palliative care patients and their needs. A limiting factor is that data will be collected at least partly during the COVID-19 pandemic and potential impact of the pandemic on health care and the research topic cannot be excluded. TRIAL REGISTRATION: German Register for Clinical Studies trial registration number: DRKS00020517 .

["Creativity and a Mindset Shift were Essential." Impact of the COVID-19 Pandemic on Specialized Palliative Home: A Nationwide Online Survey]. / "Es waren Kreativität und Umdenken erforderlich." Auswirkungen der COVID-19 Pandemie auf die spezialisierte ambulante Palliativversorgung (SAPV). Eine bundesweite Onlinebefragung.

Objectives The aim of this study was to explore the impact of the COVID-19 pandemic and the efforts taken to contain it on specialized palliative homecare (SPHC) practice from the perspective of SPHC team leaders.Methods In this cross-sectional study, an online questionnaire with quantitative and qualitative questions was developed and used, focusing on the experience of SAPV in the first and second wave of the COVID-19 pandemic in Germany. In a structured recruitment process, all German SPHC teams (n=357) were invited to participate. Results From 10/10/2020 to 07/01/2021, 154 SPHC teams participated (response rate 43%). They described clear effects of the COVID-19 pandemic on their activities. Despite pandemic-related problems with staff availability (78.5%), patient care was ensured without major problems. The number of patients to be cared for remained stable for most teams, was increasing for some, and decreasing only for a few. A central factor was the switch from direct contact with patients and their relatives to telephone contact. Additional complicating factors were the general avoidance of contacts, compliance with hygiene regulations for necessary personal contacts, and pandemic-related uncertainties and fears, both among the team itself and among relatives and patients. The procurement of protective equipment was a challenge during the first wave. Problems in collaboration with network partners (e. g., nursing homes and volunteer hospice services) had decreased over the course of the pandemic, but were greater than before in all areas. Many measures to cope with the pandemic challenges were implemented, others were assessed as useful but not implemented, and others as not useful or feasible. Conclusions SPHC teams report that despite the need to adapt many processes to the pandemic situation, they have managed to maintain patient care, although under more difficult conditions.

[Health Care Planning for the Final Phase of Life - an Advance Care Planning Concept in Germany]. / Behandlung im Voraus Planen ­ ein «Advance Care Planning¼-Konzept für Deutschland.

Health Care Planning for the Final Phase of Life - an Advance Care Planning Concept in Germany Abstract. The international concept of Advance Care Planning (ACP) is a systematic and qualified communication process for people who want to talk about possible disease scenarios and their wishes for medical, nursing, psychosocial and spiritual care, and treatment for those scenarios, in the presence of their relatives and therapists. In Germany, section 132 g on health care planning for the last phase of life was stipulated in the Social Security Code Book (Sozialgesetzbuch) V as an insurance benefit of statutory health insurance funds (Gesetzliche Krankenversicherung) for certain patient groups, which reflects the ACP concept. An ACP concept that is geared towards the structures of the healthcare system in Germany has become known nationwide as "Behandlung im Voraus Planen" (BVP). As part of the BVP conversations, the individual wishes for future medical, nursing, and psychosocial treatments are recorded and discussed according to the principle of shared decision-making with residents of senior citizens' facilities or with disabled people in cantres for integration assistance. These wishes can be recorded in detail in a document such as an advance directive. Specially trained persons from the medical and non-medical professional groups - such as nurses, social workers, curative educator therapists - can hold these BVP conversations. For this purpose, further training which follows a predefined core curriculum of the GKV-Spitzenverband must be successfully completed.

Supportive care needs and service use during palliative care in family caregivers of patients with advanced cancer: a prospective longitudinal study.

PURPOSE: This study aimed to investigate the supportive care needs of family caregivers (FCs) of advanced cancer patients and their support service use at the beginning of specialist inpatient palliative care (SIPC), near the patient's death, and during bereavement. METHODS: FCs reported their needs using the Family Inventory of Needs (FIN), along with their utilization of psychosocial and bereavement support services at the beginning (N = 232) and 6-9 months after SIPC (N = 160). RESULTS: At the beginning of SIPC, mean of 16.9 of 20 needs were reported to be highly important, and 12.2 were reported to be met. At the time of the patient's death, 16.8 needs were highly important, and 13.8 were met. At both time points, the highest ranked need was related to information about changes in the patient's condition (100% vs. 99%), and the most frequently unmet need was related to feeling hope (73% vs. 71%). Multivariate linear regression analysis revealed a low education level to be consistently related to a greater number of highly important needs. Higher satisfaction with care and better social support was related to a greater number of met needs. Twenty-five percent of FCs had accessed at least one psychosocial support service prior to SIPC, and 30% had done so during bereavement. Among non-users of support services, > 75% indicated sufficient informal support as a barrier to service use. CONCLUSIONS: The findings offer a useful guide for adequately addressing FCs' needs in an effort to optimize FC support. However, only a subgroup of the FCs used support services. Better information and provision of tailored services might improve FCs' situations in the future.

Effectiveness of two types of palliative home care in cancer and non-cancer patients: A retrospective population-based study using claims data.

BACKGROUND: Comparative effectiveness of different types of palliative homecare is sparsely researched internationally-despite its potential to inform necessary decisions in palliative care infrastructure development. In Germany, specialized palliative homecare delivered by multi-professional teams has increased in recent years and factors beyond medical need seem to drive its involvement and affect the application of primary palliative care, delivered by general practitioners who are supported by nursing services. AIM: To compare effectiveness of primary palliative care and specialized palliative homecare in reducing potentially aggressive interventions at the end-of-life in cancer and non-cancer. DESIGN: Retrospective population-based study with claims data from 95,962 deceased adults in Germany in 2016 using multivariable regression analyses. SETTINGS/PARTICIPANTS: Patients having received primary palliative care or specialized palliative homecare (alone or in addition to primary palliative care), for at least 14 days before death, differentiating between cancer and non-cancer patients. RESULTS: Rates of potentially aggressive interventions in most indicators were higher in primary palliative care than in specialized palliative homecare (p < 0.01), in both cancer and non-cancer patients: death in hospital (odds ratio (OR) 4.541), hospital care (OR 2.720), intensive care treatment (OR 6.749), chemotherapy (OR 2.173), and application of a percutaneous endoscopic gastrostomy (OR 4.476), but not for parenteral nutrition (OR 0.477). CONCLUSION: Specialized palliative homecare is more strongly associated with reduction of potentially aggressive interventions than primary palliative care in the last days of life. Future research should identify elements of specialized palliative homecare applicable for more effective primary palliative care, too. German Clinical Trials Register (DRKS00014730).

Adaptation of the Australian Palliative Care Phase concept to the German palliative care context: a mixed-methods approach using cognitive interviews and cross-sectional data.

BACKGROUND: Palliative care phases (stable, unstable, deteriorating, terminal and bereavement) are routinely used in Australia and the UK to describe the clinical situation of patients and their families and to evaluate the associated care plan. In addition, it serves as a benchmark developed by the Australian Palliative Care Outcome Collaboration (PCOC) and is used nationwide for comparisons between services. In Germany, the concept is not used consistently due to various translations. Furthermore, there is no nationwide systematic approach to routinely assess clinical outcomes in palliative care. The study aims to develop a German version of the palliative care phase definitions by adapting them culturally, and to examine the inter-rater reliability of the adjusted definitions with healthcare professionals. METHODS: Mixed-methods approach: Cognitive interview study using 'think aloud' and verbal probing techniques and a consecutive multi-center cross-sectional study with two clinicians independently assigning the phase definitions. Interviewees/participants were selected through convenience and purposive sampling in specialist palliative care inpatient units, advisory and community services and in three specialist palliative care units with doctors, nursing staff and allied health professionals. RESULTS: Fifteen interviews were conducted. Identified difficulties were: Some translated terms were 1) not self-explanatory (e.g. 'family/carer' or 'care plan') and (2) too limited to the medical dimension neglecting the holistic approach of palliative care. (3) Problems of comprehension regarding the concept in general occurred, e.g. in differentiating between the 'unstable' and 'deteriorating' phase. Inter-rater reliability was moderate (kappa = 0.44; 95% CI = 0.39-0.52). The assignment of the phase 'deteriorating' has caused the most difficulties. CONCLUSION: Overall, the adapted palliative care phases are suitable to use in the German specialist palliative care setting. However, the concept of the phases is not self-explanatory. To implement it nationwide for outcome measurement/benchmarking, it requires further education, on-the-job training and experience as well as the involvement of healthcare professionals in implementation process. For the use of international concepts in different healthcare systems, a deeper discussion and cultural adaptation is necessary besides the formal translation.

[Integration of palliative care into acute care medicine]. / Integration der Palliativmedizin in die Akutmedizin.

Palliative care is aimed at patients with incurable oncological and non-oncological diseases and their relatives with the aim of maintaining or improving their quality of life. In order to integrate palliative care into acute care medicine, palliative care training and continuing education for medical and nursing staff is recommended. Appropriate screening tools and standard operating procedures should be implemented to identify and address palliative care needs in emergency situations. For palliative care, established specialist palliative care services can be called upon for advice and/or cotreatment. Symptom control, treatment of malignant wounds, difficult ethical decision-making, and communication difficulties with patients, their legal representatives or relatives are the tasks of palliative care experts.

[Palliative care at the end of life in Germany : Utilization and regional distribution]. / Palliativversorgung am Lebensende in Deutschland : Inanspruchnahme und regionale Verteilung.

BACKGROUND: Palliative care supply increased in Germany in recent years. But how many people use which forms of palliative care and how does this differ between regions? METHOD: Retrospective cohort study with claims data from insured persons who died in 2016: Based on services billed at least once in the last six months of life, we determined the use of primary palliative care (PPC), specialized palliative homecare (SPHC), as well as inpatient palliative and hospice care, using regional billing codes for PPC and SPHC services for the first time. RESULTS: Of the 95,962 deceased in the study population, 32.7% received palliative care nationwide, with variations from 26.4% in Bremen to 40.8% in Bavaria. PPC services were billed at 24.4% (16.9% in Brandenburg to 34.1% in Bavaria). SPHC services received 13.1% (6.3% in Rhineland-Palatinate to 18.9% in Brandenburg and 22.9% in Westphalia-Lippe with different SPHC practices). Inpatient palliative care was received by 8.1% (6.7% in Schleswig-Holstein/Hesse to 13.0% in Thuringia); 3.3% (1.6% in Bremen to 5.6% in Berlin) with hospice services. CONCLUSION: SPHC is used more frequently than previously reported, while PPC is declining. Utilization seems to be based less on objective needs than on region-specific framework conditions. Besides needs criteria, further development of palliative care should be oriented more towards outcomes and relevant framework conditions.

[Palliative Care in Intensive Care Units]. / Palliativmedizin meets Intensivmedizin.

Palliative care is becoming increasingly important in intensive care units. The main goal of palliative treatment is to improve quality of life in patients with critical and life-threatening conditions when curative therapies can no longer be achieved. Treatment is not limited to end-of-life care, but also includes relief of distressing symptoms such as pain, nausea, vomiting, dyspnea, delirium or anxiety, as well as communication with patients and their families. Defining patient-centred goals of care together with patients, relatives and intensive care staff supports shared decision-making. Aspects of palliative care can be integrated in the ICU in different ways. The "integrative model" presumes that all patients with critical illness may benefit from palliative care principles and interventions practiced by the ICU team. The "consultative model" involves palliative care consultants in the care of ICU patients with palliative care need that may be identified using trigger criteria. This article gives an overview on different aspects of palliative care in intensive care units and provides practical advice for the implementation of palliative care in the ICU.

Ethical challenges in primary care: a focus group study with general practitioners, nurses and informal caregivers.

BACKGROUND: General practitioners (GPs), nurses and informal caregivers are often jointly involved in healthcare situations in which ethical issues play an important role. OBJECTIVES: To describe ethical problems from the perspective of these three groups and to investigate whether there is a common experience of ethical issues in primary care. METHODS: We conducted six focus groups with general practitioners, nurses and informal caregivers in Germany. We asked the participants to describe at least one experience of ethical problem in detail and documented the findings by an illustration software that visualized and structured the discussion. We used thematic analysis to identify ethical problems and to develop categories of ethical issues. RESULTS: Problems reported barely overlapped. GPs had to do mainly with uncertainty about the scope and limits of their responsibility for patients. Nurses were concerned about bureaucratic and other barriers to professional care and about dual loyalty if they had to consider the conflicting interests of patients and family members. They often felt powerless and unable to act according to their professional standards. Informal caregivers reported problems that resulted from role strain and being both a family member and a caregiver. GPs, nurses and informal caregivers sometimes perceived the other parties as a source of ethical problems. CONCLUSIONS: All parties may benefit from ethics support services, a rarity in German primary care so far. Furthermore, nurses' self-confidence towards GPs, demanding patients and family members has to be strengthened. Informal caregivers, the most vulnerable group, need more attendance and tailored support.

"An odyssey without receiving proper care" - experts' views on palliative care provision for patients with migration background in Germany.

BACKGROUND: Migrants seem to be underrepresented in palliative care in Germany. Access barriers and challenges in care remain unclear. We aimed to provide a comprehensive insight into palliative care for migrants, using expert interviews. METHODS: Interviews with experts on palliative and general health care for migrants were audiotaped and transcribed. Data analysis followed a qualitative content analysis method for expert interviews proposed by Meuser and Nagel. RESULTS: In total, 13 experts from various fields (palliative and hospice care, other care, research and training) were interviewed. Experts identified access barriers on the health care system and the patient level as well as the sociopolitical level. Services don't address migrants, who may use parallel structures. Patients may distrust the health care system, be oriented towards their home country and expect the family to care for them. In care, poor adaptation and inflexibility of health care services regarding needs of migrant patients because of scarce resources, patients' preferences which may contradict professionals' values, and communication both on the verbal and nonverbal level were identified as the main challenges. Conflicts between patients, families and professionals are at risk to be interpreted exclusively as cultural conflicts. Palliative care providers should use skilled interpreters instead of family interpreters or unskilled staff members, and focus on training cultural competence. Furthermore, intercultural teams could enhance palliative care provision for migrants. CONCLUSIONS: Though needs and wishes of migrant patients are often found to be similar to those of non-migrant patients, there are migration-specific aspects that can influence care provision at the end of life. Migration should be regarded as a biographical experience that has a severe and ongoing impact on the life of an individual and their family. Language barriers have to be considered, especially regarding patients' right to informed decision making. The reimbursement of interpreters in health care remains an open question.

Psychological burden in family caregivers of patients with advanced cancer at initiation of specialist inpatient palliative care.

BACKGROUND: This study prospectively evaluated distress, depressive and anxiety symptoms as well as associated factors in family caregivers (FC) of advanced cancer patients at initiation of specialist inpatient palliative care. METHODS: Within 72 h after the patient's first admission, FCs were asked to complete German versions of the Distress Thermometer, Generalized Anxiety Disorder 7-item scale (GAD-7), Patient Health Questionnaire depression module 9-item scale (PHQ-9) for outcome measure. Multivariate logistic regression analyses were used to identify associated factors. RESULTS: In 232 FCs (62% spouses/partners), mean level of distress was 7.9 (SD 1.8; range, 2-10) with 95% presenting clinically relevant distress levels. Most frequent problems were sadness (91%), sorrows (90%), anxiety (78%), exhaustion (77%) and sleep disturbances (73%). Prevalence rates of moderate to severe anxiety and depressive symptoms were 47 and 39%, respectively. Only 25% of FCs had used at least one source of support previously. In multivariate regression analysis, being female (OR 2.525), spouse/partner (OR 2.714), exhaustion (OR 10.267), and worse palliative care outcome ratings (OR 1.084) increased the likelihood for moderate to severe anxiety symptom levels. Being female (OR 3.302), low socio-economic status (OR 6.772), prior patient care other than home-based care (OR 0.399), exhaustion (OR 3.068), sleep disturbances (OR 4.183), and worse palliative care outcome ratings (OR 1.100) were associated with moderate to severe depressive symptom levels. CONCLUSIONS: FCs of patients presenting with indication for specialist palliative care suffer from high distress and relevant depressive and anxiety symptoms, indicating the high need of psychological support not only for patients, but also their FCs. Several socio-demographic and care-related risk-factors influence mental burden of FCs and should be in professional caregivers' focus in daily clinical practice.

Study protocol for a multi-methods study: SAVOIR - evaluation of specialized outpatient palliative care (SAPV) in Germany: outcomes, interactions, regional differences.

BACKGROUND: Since 2007, the German statutory health insurance covers Specialized Outpatient Palliative Care (SAPV). SAPV offers team-based home care for patients with advanced and progressive disease, complex symptoms and life expectancy limited to days, weeks or months. The introduction of SAPV is ruled by a directive (SAPV directive). Within this regulation, SAPV delivery models can and do differ regarding team structures, financing models, cooperation with other care professionals and processes of care. The research project SAVOIR is funded by G-BA's German Innovations Fund to evaluate the implementation of the SAPV directive. METHODS: The processes, content and quality of SAPV will be evaluated from the perspectives of patients, SAPV teams, general practitioners and other care givers and payers. The influence of different contracts, team and network structures and regional and geographic settings on processes and results including patient-reported outcomes will be analyzed in five subprojects: [1] structural characteristics of SAPV and their impact on patient care, [2] quality of care from the perspective of patients, [3] quality of care from the perspective of SAPV teams, hospices, ambulatory nursing services, nursing homes and other care givers, content and extent of care from [4] the perspective of General Practitioners and [5] from the perspective of payers. The evaluation will be based on different types of data: team and organizational structures, treatment data based on routine documentation with electronic medical record systems, prospective assessment of patient-reported outcomes in a sample of SAPV teams, qualitative interviews with other stakeholders like nursing and hospice services, a survey in general practitioners and a retrospective analysis of claims data of all SAPV patients, covered by the health insurance fund BARMER in 2016. DISCUSSION: Data analysis will allow identification of variables, associated with quality of SAPV. Based on these findings, the SAVOIR study group will develop recommendations for the Federal Joint Committee for a revision of the SAPV directive. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013949 (retrospectively registered, 14.03.2018), DRKS00014726 (14.05.2018), DRKS00014730 (30.05.2018). Subproject 3 is an interview study with professional caregivers and therefore not registered in DRKS as a clinical study.

Team members perspectives on conflicts in clinical ethics committees.

BACKGROUND: Clinical ethics committees have been broadly implemented in university hospitals, general hospitals and nursing homes. To ensure the quality of ethics consultations, evaluation should be mandatory. RESEARCH QUESTION/AIM: The aim of this article is to evaluate the perspectives of all people involved and the process of implementation on the wards. RESEARCH DESIGN AND PARTICIPANTS: The data were collected in two steps: by means of non-participating observation of four ethics case consultations and by open-guided interviews with 28 participants. Data analysis was performed according to grounded theory. ETHICAL CONSIDERATIONS: The study received approval from the local Ethics Commission (registration no.: 32/11/10). FINDINGS: 'Communication problems' and 'hierarchical team conflicts' proved to be the main aspects that led to ethics consultation, involving two factors: unresolvable differences arise in the context of team conflicts on the ward and unresolvable differences prevent a solution being found. Hierarchical asymmetries, which are common in the medical field, support this vicious circle. Based on this, minor or major disagreements regarding clinical decisions might be seen as ethical conflicts. The expectation on the clinical ethics committee is to solve this (communication) problem, but the participants experienced that hierarchy is maintained by the clinical ethics committee members. DISCUSSION: The asymmetrical structures of the clinical ethics committee reflect the institutional hierarchical nature. They endure, despite the fact that the clinical ethics committee should be able to detect and overcome them. Disagreements among care givers are described as one of the most difficult ethically relevant situations and should be recognised by the clinical ethics committee. On the contrary, discussion of team conflicts and clinical ethical issues should not be combined, since the first is a mandate for team supervision. CONCLUSION: To avoid dominance by physicians and an excessively factual character of the presentation, the case or conflict could be presented by both physicians and nurses, a strategy that strengthens the interpersonal and emotional aspects and also integrates both professional perspectives.

Integration of oncology and palliative care: a Lancet Oncology Commission.

Full integration of oncology and palliative care relies on the specific knowledge and skills of two modes of care: the tumour-directed approach, the main focus of which is on treating the disease; and the host-directed approach, which focuses on the patient with the disease. This Commission addresses how to combine these two paradigms to achieve the best outcome of patient care. Randomised clinical trials on integration of oncology and palliative care point to health gains: improved survival and symptom control, less anxiety and depression, reduced use of futile chemotherapy at the end of life, improved family satisfaction and quality of life, and improved use of health-care resources. Early delivery of patient-directed care by specialist palliative care teams alongside tumour-directed treatment promotes patient-centred care. Systematic assessment and use of patient-reported outcomes and active patient involvement in the decisions about cancer care result in better symptom control, improved physical and mental health, and better use of health-care resources. The absence of international agreements on the content and standards of the organisation, education, and research of palliative care in oncology are major barriers to successful integration. Other barriers include the common misconception that palliative care is end-of-life care only, stigmatisation of death and dying, and insufficient infrastructure and funding. The absence of established priorities might also hinder integration more widely. This Commission proposes the use of standardised care pathways and multidisciplinary teams to promote integration of oncology and palliative care, and calls for changes at the system level to coordinate the activities of professionals, and for the development and implementation of new and improved education programmes, with the overall goal of improving patient care. Integration raises new research questions, all of which contribute to improved clinical care. When and how should palliative care be delivered? What is the optimal model for integrated care? What is the biological and clinical effect of living with advanced cancer for years after diagnosis? Successful integration must challenge the dualistic perspective of either the tumour or the host, and instead focus on a merged approach that places the patient's perspective at the centre. To succeed, integration must be anchored by management and policy makers at all levels of health care, followed by adequate resource allocation, a willingness to prioritise goals and needs, and sustained enthusiasm to help generate support for better integration. This integrated model must be reflected in international and national cancer plans, and be followed by developments of new care models, education and research programmes, all of which should be adapted to the specific cultural contexts within which they are situated. Patient-centred care should be an integrated part of oncology care independent of patient prognosis and treatment intention. To achieve this goal it must be based on changes in professional cultures and priorities in health care.