Cost-effectiveness of a specialist palliative care nurse-patient consultation followed by an interprofessional case conference for patients with non-oncological palliative care needs: results of the KOPAL trial.

BACKGROUND: Worldwide, progressive chronic, non-malignant diseases are highly prevalent. Especially with increasing age, they are characterised by high hospitalisation rates and high healthcare costs. Improved interprofessional collaboration between general practitioners (GPs) and specialist palliative home care (SPHC) teams might reduce hospitalisation while improving symptoms and quality of life, or preventing them from deterioration. The aim of this study was to examine the cost-effectiveness of a newly developed intervention in patients with advanced chronic, non-malignant diseases consisting of a structured palliative care nurse-patient consultation followed by an interprofessional telephone case conference. METHODS: The analysis was based on data from 172 participants of the KOPAL multi-centre, cluster randomised controlled trial. Patients with advanced congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), or dementia were randomised into intervention group (IG) and control group (CG, usual care). Cost-effectiveness was examined over 48 weeks from a societal and healthcare payer's perspective. Effects were quantified as quality-adjusted life years (QALYs, EQ-5D-5L). Incremental cost-effectiveness ratios were calculated and cost-effectiveness acceptability curves were constructed. RESULTS: Baseline imbalances in costs and effects could be observed between IG and CG. After adjusting for these imbalances and compared to the CG, mean costs in the IG were non-significantly higher from a societal and lower from a payer's perspective. On the effect side, the IG had marginally lower mean QALYs. The results were characterized by high statistical uncertainty, indicated by large confidence intervals for the cost and effect differences between groups and probabilities of cost-effectiveness between 18% and 65%, depending on the perspective and willingness-to-pay. CONCLUSIONS: Based on the results of this study, the cost-effectiveness of the KOPAL intervention was uncertain. The results highlighted (methodological) challenges of economic evaluations in patients with chronic, non-malignant diseases related to sample size, heterogeneity of participants, and the way the intervention effectiveness is typically captured in economic evaluations.

[A regional comparison of outcomes quality and costs of general and specialized palliative care in Germany: a claims data analysis]. / Ergebnisqualität und Kosten der allgemeinen und spezialisierten Palliativversorgung in Deutschland im regionalen Vergleich: eine GKV-Routinedatenstudie.

BACKGROUND: The main framework conditions for palliative care are set at the regional level. The scope of the forms of care used (outpatient, inpatient, general, specialized) varies widely. What is the quality of outcomes achieved by the palliative care provided on a federal states level? What are the associated costs of care? METHOD: Retrospective observational study using BARMER claims data from 145,372 individuals who died between 2016 and 2019 and had palliative care in the last year of life. Regional comparison with regard to the following outcomes: proportion of palliative care patients who died in the hospital, potentially burdensome care in the last 30 days of life (ambulance calls, [intensive care] hospitalizations, chemotherapy, feeding tubes, parenteral nutrition), total cost of care (last three months), cost of palliative care (last year), and cost-effectiveness ratios. Calculation of patient/resident characteristic adjusted rates, costs, and ratios. RESULTS: Federal states vary significantly with respect to the outcomes (also adjusted) of palliative care. Palliative care costs vary widely, most strongly for specialized outpatient palliative care (SAPV). Across all indicators and the cost-effectiveness ratio of total cost of care to at-home deaths, Westphalia-Lippe shows favorable results. CONCLUSION: Regions with better quality and more favorable cost (ratios) can provide guidance for other regions. The extent to which the new federal SAPV agreement can incorporate the empirical findings should be reviewed. Patient-relevant outcome parameters should be given greater weight than parameters aiming at structures of care.

Analysing the administration of an intermediate level of outpatient palliative care in Germany and developing recommendations for improvement (Polite): A study protocol for a mixed-methods study.

BACKGROUND: To date, there has been no systematic research on the intermediate level service (level 2) in outpatient palliative care that was introduced in Germany in 2017. Accordingly, the Polite research project aims at: (1) investigating the current state of level 2 palliative care and (2) developing recommendations for its optimisation. METHODS: The multi-perspective, observational study will follow a mixed-methods approach across two study phases. In phase 1a, quantitative routinely collected data from a statutory general local health insurance provider will be used to identify patients who received level 2 or other outpatient palliative care in the years 2017-2019. In phase 1b, a questionnaire will be sent to all registered general practitioners (GPs) in Lower Saxony to collect information on the number and characteristics of physicians offering level 2 palliative care. In phase 1c, a quantitative, standardised online questionnaire for teams providing specialised outpatient palliative care will be administered to assess the interfaces of level 2 palliative care. In phase 2a, the results from phases 1a-c will be discussed in an expert workshop with the aim of developing ideas to adapt and optimise level 2 outpatient palliative care. Finally, in phase 2b, the empirically derived recommendations from phases 1 and 2a will be agreed upon via a multi-round Delphi survey involving experts with sufficient influence to promote the project results and recommendations nationally. DISCUSSION: The results of the project will facilitate the optimisation of outpatient palliative care, as well as its administration, nationwide. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien) (Registration N° DRKS00024785); date of registration: 06th May 2021) and is searchable under the International Clinical Trials Registry Platform Search Portal of the World Health Organization, under the German Clinical Trials Register number.

Quality indicators for the evaluation of end-of-life care in Germany - a retrospective cross-sectional analysis of statutory health insurance data.

BACKGROUND: The provision and quality of end-of-life care (EoLC) in Germany is inconsistent. Therefore, an evaluation of current EoLC based on quality indicators is needed. This study aims to evaluate EoLC in Germany on the basis of quality indicators pertaining to curative overtreatment, palliative undertreatment and delayed palliative care (PC). Results were compared with previous findings. METHODS: Data from a statutory health insurance provider (AOK Lower Saxony) pertaining to deceased members in the years 2016 and 2017 were used to evaluate EoLC. The main indicators were: chemotherapy for cancer patients in the last month of life, first-time percutaneous endoscopic gastrostomy (PEG) for patients with dementia in the last 3 months of life, number of hospitalisations and days spent in inpatient treatment in the last 6 months of life, and provision of generalist and specialist outpatient PC in the last year of life. Data were analysed descriptively. RESULTS: Data for 64,275 deceased members (54.3% female; 35.1% cancer patients) were analysed. With respect to curative overtreatment, 10.4% of the deceased with cancer underwent chemotherapy in the last month and 0.9% with dementia had a new PEG insertion in the last 3 months of life. The mean number of hospitalisations and inpatient treatment days per deceased member was 1.6 and 16.5, respectively, in the last 6 months of life. Concerning palliative undertreatment, generalist outpatient PC was provided for 28.0% and specialist outpatient PC was provided for 9.0% of the deceased. Regarding indicators for delayed PC, the median onset of generalist and specialist outpatient PC was 47.0 and 24.0 days before death, respectively. CONCLUSION: Compared to data from 2010 to 2014, the data analysed in the present study suggest an ongoing curative overtreatment in terms of chemotherapy and hospitalisation, a reduction in new PEG insertions and an increase in specialist PC. The number of patients receiving generalist PC remained low, with delayed onset. Greater awareness of generalist PC and the early integration of PC are recommended. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register ( DRKS00015108 ; 22 January 2019).

Systematic identification of critically ill and dying patients in primary care using the German version of the Supportive and Palliative Care Indicators Tool (SPICT-DE).

Objective: The systematic identification of patients who are at risk of deteriorating and dying is the prerequisite for the provision of palliative care (PC). This study aimed to investigate the feasibility and practicability of the German version of the Supportive and Palliative Care Indicators Tool (SPICT-DE) for the systematic identification of these patients in general practice. Methods: In the beginning of 2017, twelve general practitioners (GPs; female n=6) were invited to take part in the study. GPs were asked to apply the SPICT-DE in everyday practice over a period of two months in patients with chronic progressive diseases. Six months after initial assessment, a follow-up survey revealed how the clinical situation of the initially identified patients had changed and which PC actions had been initiated by GPs. In addition, GPs gave feedback on the practicability of SPICT-DE in daily routine. Results: 10 of the 12 GPs (female n=5, median age 46 years, range 38-68) participated in both the two-month assessment period and the follow-up survey. A total of 79 patients (female n=40, median age 79 years, range 44-94) was assessed with the SPICT-DE. Main diagnoses were predominately of cardio-vascular (n=28) or oncological (n=26) origin. Follow-up after six months showed that 38 patients (48%) went through at least one crisis during the course of disease and almost one third (n=26) had died. The majority of GPs (n=7) considered the SPICT-DE to be practical in daily routine and helpful in identifying patients who might benefit from PC. Seven GPs indicated that they would use the SPICT-DE as part of everyday practice. Conclusions: The SPICT-DE seems to be a practical tool supporting the systematic identification of critically ill and dying patients in general practice.

[Primary palliative care provision by general practitioners: Development of strategies to improve structural, legal and financial framework conditions]. / Allgemeine Palliativversorgung in der hausärztlichen Praxis: Entwicklung von Strategien zur Verbesserung struktureller, rechtlicher und finanzieller Rahmenbedingungen.

INTRODUCTION: General practitioners (GPs) make a major contribution to outpatient palliative care (AAPV). In 2013, new fee rates for AAPV were included in the uniform assessment standard, which strengthens the financial framework conditions for outpatient palliative care by GPs. The aim of the ALLPRAX project is to improve the framework conditions for AAPV. This contribution focusses on ideas for changing structural, legal, and financial framework conditions for an optimised AAPV. METHODS: In April 2018, 28 healthcare professionals (10 GPs, 3 medical assistants, 3 hospital doctors, and 12 representatives of the nursing professions) from hospice and palliative care providers in Lower Saxony were invited to participate in nine group discussions at Hannover Medical School. During these group discussions, inhibitory factors for AAPV and possible solutions were discussed. The analysis of the group discussions was carried out using a summarizing content analysis according to Mayring. RESULTS: In order to optimise palliative care by GPs in Germany, it is proposed that a) additional palliative care specialists for care coordination and round-the-clock availability for patients and relatives in GP practices should be provided (structural solution), b) nursing staff should be permitted to prescribe aids (legal solution), and c) higher remuneration for medical consultations should be provided (financial solution). These approaches could increase feasibility in day-to-day practice and create incentives for caregivers to provide more high-quality general outpatient palliative care. DISCUSSION: The described high expenditure in general outpatient palliative care, which is hardly inferior to specialised outpatient palliative care from the caregivers' point of view, is not reflected accordingly, neither structurally nor financially. CONCLUSION: In order to optimise general outpatient palliative care, structural, legal and financial framework conditions need to be correspondingly adapted.

Primary palliative Care in General Practice - study protocol of a three-stage mixed-methods organizational health services research study.

BACKGROUND: The focus of this project is on improving the provision of primary palliative care (PC) by general practitioners (GPs). While approximately 10-15% of the incurable, seriously ill or dying people will be in need of specialist PC, the vast majority can be adequately treated within generalist care. The strengthening of the GP's role in PC, as well as ensuring close collaboration between specialist PC services and GPs have been identified as top priorities for the improvement of PC in Germany. Despite healthcare policy actions, diverse obstacles still exist to successful implementation of primary PC on a structural, process, and economic level. Therefore, this project aims at addressing barriers and facilitators to primary PC delivery in general practice in Germany. METHODS: The study follows a three-step approach; first, it aims at systematically analyzing barriers and facilitators to primary PC provision by GPs. Second, based on these outcomes, a tailored intervention package will be developed to enhance the provision of primary PC by GPs. Third, the intervention package will be implemented and evaluated in practice. The expected outcome will be an evidence-based model for successful implementation of primary PC delivery tailored to the German healthcare system, followed by a strategic action plan on how to improve current practice both on a local level and nationally. DISCUSSION: The first step of the project has been partly completed at the time of writing. The chosen methodologies of four sub-projects within this first step have opened up different advantages and disadvantages for the data collection. In sum of all sub-projects, the different methodologies and target groups contributed valuable information to the systematic analysis of barriers and facilitators to primary PC provision by GPs. TRIAL REGISTRATION: The study (BMBF-FK 01 GY 1610) was retrospectively registered at the German Clinical Trials Register (Deutsches Register Klinischer Studien) (Registration N° DRKS00011821 ; date of registration: December 04th 2017) and at the German Register of health care research (Versorgungsforschung Deutschland - Datenbank) (Registration N° VfD_ALLPRAX_16_003817 ; date of registration: March 30th 2017).

A geriatric assessment in general practice: prevalence, location, impact and doctor-patient perceptions of pain.

BACKGROUND: To investigate what a geriatric assessment in general practice adds towards previous findings of prevalence, location, impact and the dyadic doctor-patient perception of pain in this age group. METHODS: Cross-sectional study. Consecutive patients aged 70 and over underwent a comprehensive geriatric assessment in general practice that included a basic pain assessment (severity, sites and impact). Patients with pain and their doctors then independently rated its importance. Pain was correlated with further findings from the assessment, such as overall health, physical impairments, everyday function, falls, mood, health related lifestyle, social circumstances, using bivariate and multivariate statistics. Patient-doctor agreement on the importance of pain was calculated using kappa statistics. RESULTS: 219 out of 297 patients (73.7 %) reported pain at any location. Pain was generally located at multiple sites. It was most often present at the knee (33.9%), the lumbar spine (33.5%) as well as the hip (13.8%) and correlated with specific impairments such as restrictions of daily living (knee) or sleep problems (spine). Patients with pain and their physicians poorly agreed on the importance of the pain problem. CONCLUSIONS: A basic pain assessment can identify older patients with pain in general practice. It has resulted in a high prevalence exceeding that determined by encounters in consultations. It has been shown that a geriatric assessment provides an opportunity to address pain in a way that is adapted to older patients' needs - addressing all sites, its specific impact on life, and the patients' perceived importance of pain. Since there is little doctor-patient agreement, this seems a valuable strategy to optimize concrete treatment decisions and patient centered care. TRIAL REGISTRATION: This study is registered in the German Clinical Trial Register ( DRKS00000792 ).

Living with and dying from advanced heart failure: understanding the needs of older patients at the end of life.

BACKGROUND: Heart failure (HF) is a life-limiting illness and patients with advanced heart failure often suffer from severe physical and psychosocial symptoms. Particularly in older patients, HF often occurs in conjunction with other chronic diseases, resulting in complex co-morbidity. This study aims to understand how old and very old patients with advanced HF perceive their disease and to identify their medical, psychosocial and information needs, focusing on the last phase of life. METHODS: Qualitative longitudinal interview study with old and very old patients (≥70 years) with severe HF (NYHA III-IV). Interviews were conducted at three-month intervals over a period of up to 18 months and were analysed using qualitative methods in relation to Grounded Theory. RESULTS: A total of 95 qualitative interviews with 25 patients were conducted and analysed. The following key categories were developed: (1a) dealing with advanced heart failure and ageing, (1b) dealing with end of life; (2a) perceptions regarding care, and (2b) interpersonal relations. Overall, our data show that older patients do not experience HF as a life-limiting disease. Functional restrictions and changed conditions leading to problems in daily life activities were often their prime concerns. The needs and priorities of older HF patients vary depending on their disease status and individual preferences. Pain resulting in reduced quality of life is an example of a major symptom requiring treatment. Many older HF patients lack sufficient knowledge about their condition and its prognosis, particularly concerning emergency situations and end of life issues, and many expressed a wish for open discussions. From the patients' perspective, there is a need for improvement in interaction with health care professionals, and limits in treatment and medical care are not openly discussed. CONCLUSION: Old and very old patients with advanced HF often do not acknowledge the seriousness and severity of the disease. Their communication with physicians predominantly focuses on curative treatment. Therefore, aspects such as self-management of the disease, dealing with emergency situations and end-of-life issues should be addressed more prominently. An advanced care planning (ACP) programme for heart disease in older people could be an option to improve patient-centred care.

End of life care for frail older patients in family practice (ELFOP)--protocol of a longitudinal qualitative study on needs, appropriateness and utilisation of services.

BACKGROUND: Frail elderly people represent a major patient group in family practice. Little is known about the patients' needs, and how their needs evolve over time with increasing frailty towards the end of life. This study will address end-of-life care needs, service utilisation, and experiences of frail elderly patients and their informal caregivers, with regard to family practice. This paper aims to introduce the research protocol. METHODS/DESIGN: The study uses a multiple perspective approach qualitative design. The first study part consists of serial six-monthly in-depth interviews with 30 community-dwelling elderly patients (≥70 years) with moderate to severe frailty and their key informal caregivers, over a period of 18 months. Additionally, semi-structured interviews with the patients' family physician will be conducted. The serial interviews will be analysed with grounded theory and narrative approaches. Special attention will be paid to the comparison of distinct views of the patients', informal caregivers', and family physicians' as well as on chronological aspects. In the second study part, five focus groups with experts in family medicine, geriatrics, palliative medicine, and nursing will be conducted. Finally, the implications for family practice and health care policy will be discussed in an expert workshop. DISCUSSION: To our knowledge, this is the first prospective, longitudinal qualitative study on the needs of elderly patients with advanced frailty towards the end of life in German family practice, which integrates the perspectives of patients, informal caregivers, family physicians and other health professionals. The study will contribute to the understanding of the clinical, psychosocial and information needs of patients and their caregivers, and of respective changes of experiences and needs along the illness/frailty trajectory including the last phase of life. It will provide an empirical basis for improving patient-centred care for this increasingly relevant target group.

'Who is going to explain it to me so that I understand?' Health care needs and experiences of older patients with advanced heart failure.

Heart failure is a leading cause of death and can result in significant palliative care needs. The aim of this study was to explore the needs of older patients with advanced heart failure, and their experiences with health care delivery in Germany. Qualitative interviews were carried out with 12 patients (6 men, 6 women; age 73-94 years; heart failure in an advanced stage according to the New York Heart Association Functional Classification) recruited in two geriatric hospitals. The interviews were analyzed by a qualitative descriptive approach. The main categories derived from the patient interviews were: understanding of illness and prognosis, health care services and social life. The patients expressed the need for better information and communication regarding illness and prognosis, and the desire for more respectful treatment by health care providers. Heart failure was not recognized as a potentially life-limiting disease, and the patients had no experience with palliative care services. The study emphasizes the need for improving communication with patients with advanced heart failure. To achieve this, strengthening the palliative care approach in all relevant services that deliver care for these patients and introducing advanced care planning appear to be promising strategies.

Palliative care in urgent need of recognition and development in general practice: the example of Germany.

BACKGROUND: Specialist palliative care is being increasingly recognised and developed to improve end-of-life care in many developed countries. However, only a small proportion of the total number of patients with incurable, progressive diseases actually has direct contact with specialist palliative care practitioners. Using the German situation as an example, the main purpose of this paper is to argue that the emphasis on specialist palliative care services without a similar encouragement of primary palliative care will deliver a constrained service. DISCUSSION: For the vast majority of people with incurable, progressive diseases, good palliative care delivered by General Practitioners and community nurses, with access to specialist support when needed, is the optimal response. In Germany, specialist palliative care in the community was established in the 2007 health care reforms. However actual and potential delivery of palliative care by general practitioners and community based nurses has been sorely neglected. The time-consuming care of palliative patients and their families is currently far from accurately reflected in German, indeed most European primary care payment systems. However, it is not just a question of adequate financial compensation but also of the recognition of the fundamental value of this intense form of holistic family medicine. SUMMARY: It is imperative palliative care carried out by community nurses and general practitioners is better recognised by health professionals, health insurers, government and the scientific community as a central part of the delivery of health care for people in the last phase of life. Health systems should be arranged so that this critical role of general practice and primary care is intentionally fostered. Palliative care carried out by generalists needs an identity at an academic and practical level, developing in concert with specialist palliative care.

The federal government commissioner for patient issues in Germany: initial analysis of the user inquiries.

BACKGROUND: The political objective in many countries worldwide is to give better consideration to the interests of patients within the health system. The establishment of a federal government commissioner for the issues of patients in the health system in Germany in 2004 is part of these endeavours. The structure and field of activities of this institution has been unique so far. This study investigates for the first time the inquiries the commissioner receives from the public. METHODS: A 33% sampling (n = 850) of the written inquiries (correspondence and e-mails) addressed to the commissioner in the first six months of the year 2005 (n = 2580) was investigated. In a procedure comprising combined qualitative and quantitative levels, the material was thematically encoded and the inquiries allocated to the resulting categories (multiple nominations). The results are presented in descriptive form and investigated especially with respect to sex and age-specific differences. The interdependences between the categorized criteria are analysed. RESULTS: The inquirers are equally spread out amongst the sexes (49% women, 51% men). Older persons outweigh the younger (69% over 60 years). In most cases the issues take the form of claims (72%, n = 609). In every fifth inquiry (n = 168) the personal financial burden for health services is considered as being too high; about equally high (n = 159) is the proportion of persons who criticize the communication with health professionals, especially hospitals and doctors' surgeries. Every third who mentions a medical practice uses terms such as "uncertainty" and "anxiety". It is conspicuous that men more often than women write that they feel unfairly treated in the health system (62% vs. 38%, p < 0.05). CONCLUSION: Predominantly older persons seek the assistance of the federal government commissioner for patient issues. Considerable uncertainty and anxiety with respect to services and charges within the system of the German health insurances become evident. It is not possible from the data to draw conclusions concerning the impact of the commissioner's work on the health system. Nor do we gain any knowledge about the usefulness of the service for the individual. Therefore, evaluation of the political impact and the user satisfaction should follow.

[High need for improvement and many open questions in health care for palliative patients]. / Hoher Entwicklungsbedarf und viele offene Fragen bei der Versorgung von Palliativpatienten.

The health care for patients with incurable, advanced diseases is increasingly attended to in Germany. Among other things, this is enforced by the debate on euthanasia and by the criticism of the inadequate structure of services and processes of care. The palliative care approach refers to cancer as well as to non-cancer patients; due to demographic changes, it becomes more and more important for an increasing number of old and very old patients with particular complex needs (e. g., caused by multimorbidity, dementia and chronic pain). Therefore, the need for improving palliative care is immense. However, the statements on the current situation and the recommendations for improvement are based only slightly on valid scientific data. This article (written from the perspective of health services research) provides an overview on the topic with particular respect to the structure of specialized palliative care services (such as palliative care teams and palliative care units) and to the political framework. Open questions on diverse levels are picked out as a central theme, and the need for interdisciplinary, application-oriented research is pointed out.