Study protocol for the development, trial, and evaluation of a strategy for the implementation of qualification-oriented work organization in nursing homes.

BACKGROUND: Staffing ratios in nursing homes vary among the federal states of Germany, but there are no rational grounds for these variations. In a previous study, a new instrument for the standardized calculation of staffing requirements in nursing homes was developed (Algorithm 1.0). The development was based on a new empirical data collection method that derives actual and target values for the time and number of care interventions provided. Algorithm 1.0 found an increased requirement of 36% of staff in German nursing homes. Based on these results, the German legislature has commissioned a model program to trial and evaluate a complex intervention comprising increased staffing combined with strategies for organizational development. METHODS: The mixed-methods study consists of (i) developing a concept for restructuring the work organization, (ii) the application of this concept combined with increased staffing in 10 nursing homes (complex intervention), and the further development of the concept using a participatory and iterative formal evaluation process. The intervention consists of (a) quantitative measures of increased staffing based on a calculation using Algorithm 1.0 and (b) qualitative measures regarding organizational development. The intervention will be conducted over one year. The effects of the intervention on job satisfaction and quality of care will be evaluated in (iii) a comprehensive prospective, controlled summative evaluation. The results will be compared with ten matched nursing homes as a control group. Finally, (iv) prototypical concepts for qualification-oriented work organization, a strategy for the national rollout, and the further development of Algorithm 1.0 into Algorithm 2.0 will be derived. DISCUSSION: In Germany, there is an ongoing dynamic legislation process regarding further developing the long-term care sector. The study, which is the subject of the study protocol presented here, generates an evidence-based strategy for the staffing requirements for nursing homes. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the German Association of Nursing Science (Deutsche Gesellschaft für Pflegewissenschaft) on 02.08.2023 (amended on 20.09.2023). Research findings are disseminated through presentations at national and international conferences and publications in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: German Clinical Trails Register DRKS00031773 (Date of registration 09.11.2023).

Costs and its drivers for diabetes mellitus type 2 patients in France and Germany: a systematic review of economic studies.

BACKGROUND: Type 2 diabetes represents an increasingly critical challenge for health policy worldwide. It absorbs massive resources from both patients and national economies to sustain direct costs of the treatment of type 2 diabetes and its complications and indirect costs related to work loss and wages. More recently, there are innovations based on remote control and personalised programs that promise a more cost-effective diabetes management while reducing diabetes-related complications. In such a context, this work attempts to update cost analysis reviews on type 2 diabetes, focusing on France and Germany, in order to explore most significant cost drivers and cost-saving opportunities through innovations in diabetes care. Although both countries approach care delivery differently, France and Germany represent the primary European markets for diabetes technologies. METHODS: A systematic review of the literature listed in MEDLINE, Embase and EconLit has been carried out. It covered interventional, observational and modelling studies on expenditures for type 2 diabetes management in France or Germany published since 2012. Included articles were analysed for annual direct, associated and indirect costs of type 2 diabetes patients. An appraisal of study quality was performed. Results were summarised narratively. RESULTS: From 1260 records, the final sample was composed of 24 papers selected according to predefined inclusion/exclusion criteria. Both France and Germany revealed a predominant focus on direct costs. Comparability was limited due to different study populations and cost categories used. Indirect costs were only available in Germany. According to prior literature, reported cost drivers are hospitalisation, prescriptions, higher HbA1c and BMI, treatment with insulin and complications, all indicators of disease severity. The diversity of available data and included costs limits the results and may explain the differences found. CONCLUSIONS: Complication prevention and glycaemic control are widely recognized as the most effective ways to control diabetes treatment costs. The value propositions of self-based supports, such as hybrid closed-loop metabolic systems, already implemented in type 1 diabetes management, are the key points for further debates and policymaking, which should involve the perspectives of caregivers, patients and payers.

Health Technology Assessment of Public Health Interventions Published 2012 to 2016: An Analysis of Characteristics and Comparison of Methods.

OBJECTIVES: The aim of this study was to provide an overview of the methodological characteristics and compare the assessment methods applied in health technology assessments (HTAs) of public health interventions (PHIs). METHODS: We defined a PHI as a population-based intervention on health promotion or for primary prevention of chronic or nonchronic diseases. HTAs on PHIs were identified by systematically searching the Web pages of members of international HTA networks. We included only full HTA reports published between 2012 and 2016. Two reviewers extracted data on the methods used to assess effectiveness/safety, as well as on economic, social, cultural, ethical, and legal aspects using a-priori standardized tables. RESULTS: We included ten HTAs provided by four different organizations. Of these, all reports assessed the effectiveness of the interventions and conducted economic evaluations, seven investigated social/cultural aspects, and four each considered legal and ethical aspects, respectively. Some reports addressed applicability, context/setting, and intervention fidelity issues in different ways. We found that most HTAs adapted their methods to some extent, for example, by including nonrandomized studies, expanding the search strategy, involving stakeholders, or applying a framework to guide the HTA process. CONCLUSIONS: Our analysis provides a comprehensive overview of methods applied in HTAs on public health interventions. We found that a heterogeneous set of approaches is used to deal with the challenges of evaluating complex public health interventions.

Integrated care in German mental health services as benefit for relatives--a qualitative study.

BACKGROUND: As mental health services undergo the process of deinstitutionalization, this is resulting in a higher burden of care for relatives. Evidence suggests that interventions for carers have a beneficial impact on their psychological health. A reduction of responsibility for relatives is linked with a significantly improved outcome for the severely mentally ill. The aim of the study was to explore the relatives' experiences with severely mentally ill patients in different integrated care service providers. METHODS: Semi-structured focus groups and interviews were conducted with 24 relatives of patients receiving community based integrated care for severe mental illness. The collected data was transcribed and evaluated using qualitative content analysis. A deductive-inductive approach was used in generating thematic categories. RESULTS: Four main categories were found related to the structural aspects of the integrated care services and for the experiences of the relatives within these services. Relatives reported that the services offered significant relief and substantial support in daily life. In addition, relatives felt a reduced burden of carer responsibility and therefore that they were provided with more protection and stability. This resulted in a sense of encouragement and not feeling left alone to face challenges. CONCLUSION: Relatives are a critical resource for patients suffering from mental health problems and benefit from formal structures and interventions to support them in carer role. An important need is to ensure continuity of care for patients and the bridging of gaps concerning information and support needs for relatives when providing integrated mental health services in the community.

Interrupted Time Series for Assessing the Causality of Intervention Effects. Part 35 of a Series on Evaluating Scientific Publications.

BACKGROUND: The gold standard for evaluating interventions in medicine and health care is the randomized controlled trial (RCT). In practice, however, RCTs may be difficult to conduct because of high costs, ethical aspects, or practical considerations. This is particularly true of studies on the population level, e.g., for the evaluation of health policy measures. METHODS: We present a type of study design called the interrupted time series (ITS) and its critical interpretation, with several illustrative examples. This discussion is based on selected methodological publications. RESULTS: ITS are suitable for the assessment of interventions with a clear point of intervention (interruption). They are analyzed with the statistical methods of time-series analysis. One strength of ITS is that they can be used to estimate an immediate effect as well as a gradually developing effect. Under certain assumptions, the findings of an ITS analysis can be interpreted causally. The main assumption underlying an ITS is that the trend after the intervention would have been exactly the same as the trend before the intervention if the intervention had not taken place and all other conditions had remained unchanged. A further assumption is that there should be no differences in the pre- versus postintervention phases in the subjects or other entities being tested (e.g., hospitals) that might affect the measured endpoints (e.g., differences in mean age affecting measured mortality). Moreover, the intervention periods must be properly distinct from one another in order to prevent biased effect estimates. The robustness of the assumptions should also be checked with sensitivity analyses. CONCLUSION: As long as all sources of bias have been avoided and the findings are both plausible and robust, the effects revealed by ITS can be interpreted as causal. ITS may serve as an alternative method for evaluating intervention effects when an RCT cannot be performed.

ATME-Needs, requirements and cross-sectoral patient journeys of patients with out-of-hospital mechanical ventilation and intensive care in outpatient settings: study protocol for an observational study.

INTRODUCTION: An increasing number of tracheotomised and/or ventilated patients with high-cost out-of-hospital intensive care needs and, at the same time, a decreasing number of healthcare professionals inevitably lead to challenges in the care of this patient population. In addition, little is known about this population, their health restrictions, needs, patient journeys, care structures and processes. The project 'Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients' (ATME) aims to analyse these aspects and explore current care structures to inform further development of care in line with patients' needs and requirements. METHODS AND ANALYSIS: Qualitative and quantitative methods will be used. In preparation of a semistandardised survey, exploratory interviews will be conducted with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) (n=15), nursing care providers (n=30), outpatient medical centres, as well as outpatient medical, medical technology and therapeutic care providers (n=35). Three semistandardised survey questionnaires for TVPOI (n=2,000) will be developed and conducted with nursing care facilities (n=250) and outpatient medical centres for mechanical ventilation (n=25). Content analyses will be conducted for qualitative data; survey data will be analysed descriptively. In addition, healthcare claims data will be analysed descriptively to provide information on patient journeys. Three result workshops and one consensus conference will be carried out with representatives of the relevant target groups to analyse the suitability of care structures and to develop recommendations for action to improve TVPOI. ETHICS AND DISSEMINATION: The ATME study received a positive vote from the Ethics Committee of the Osnabrück University of Applied Sciences and is registered in 'Deutsches Register Klinischer Studien (DRKS)' (registration number: DRKS00030891). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (the Innovation Committee of the Federal Joint Committee) on their website.

What contributes to good patient outcomes in the home treatment of the severely mentally ill: study protocol of a multi-centre analysis.

BACKGROUND: While evidence is available that home treatment could be effective for treating severe mental illness, there is a lack of evidence on what exactly makes home treatment effective. The study presented here aims to develop recommendations for structures and processes in home treatment that are necessary for its effectiveness. METHODS/DESIGN: 14 provider networks of home treatment for severe mental illness will be analyzed and compared according to their structures, processes and patient-related outcomes. Data will be drawn from health care claims data, routine assessments of psychosocial functioning, and from questionnaires on structures and processes. The primary outcome will be psychosocial functioning; secondary outcomes, quality of life and days spent in hospital. The relation between structures and processes on one hand side and outcomes on the other side will be identified by multilevel analysis. In addition, focus groups with patients, relatives and network staff will be held to add further insight into relevant processes. All networks will receive individual quality reports, providing them with feedback on the results of this research and benchmarking them against the average. Based on this research, recommendations for processes and structures of home treatment will be developed. DISCUSSION: The research will use longitudinal data on outcomes routinely assessed since 2009 and claims data. Routine data is also used for the assessment of structures and processes. By way of additional questionnaires developed in discussion with providers, further relevant factors can be included. The approach of this study becomes more comprehensive by conducting focus groups with patients, relatives and providers and by having the chance to evaluate the results with the networks by providing feedback of results. Several factors such as outcomes related to regional availability of hospital beds or size of networks might limit this study.

[What is a public health intervention? Results of a Delphi process in German-speaking countries]. / Was wird unter einer Public-Health-Intervention verstanden? Ergebnisse eines Delphi-Prozesses im deutschsprachigen Raum.

BACKGROUND: Internationally, a variety of definitions for public health interventions (PHI) exist. In the German-speaking countries, however, a definition is still outstanding. Therefore, the aim of this study was to derive consensus criteria for the definition of PHI from the expert perspective of science and practice. METHODS: A Delphi survey with two online rounds was conducted from December 2022 to February 2023. Six criteria were formulated by a working group and posed for consensus: 1) the intention of the intervention, 2) potential conflicts of interest of the initiators of the intervention, 3) primary vs. secondary/tertiary prevention, 4) costs, 5) targeting, and 6) the reach of the intervention. In both Delphi rounds, experts from academia and practice were recruited through relevant networks and associations throughout the German-speaking world. The judgments were asked about standardized rating scales with the possibility of open justification. RESULTS: In the first Delphi round, n = 52 and in the second round n = 43 experts from research, care and administration/management in health care participated. Consensus was reached on four of the six criteria after the second Delphi round: the intention of the intervention, possible conflicts of interest of the initiators of the intervention, primary vs. secondary/tertiary prevention, and the scope of the intervention. From the perspective of the experts interviewed, these are the criteria that distinguish PHI. DISCUSSION AND CONCLUSION: Based on the consensus criteria, PHI can be defined more concretely. Thus, the results contribute to a better inter- and transdisciplinary understanding. Ideally, the criteria will make it easier to assign interventions to the public health sector in the future, even if a precise examination will be necessary in individual cases, among other things because the experts disagreed on the criteria of costs and how to address the target group.

The German Fast Track Toward Reimbursement of Digital Health Applications (DiGA): Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes.

BACKGROUND: Digital health applications (DiGA) supporting the management of diabetes are among the most commonly available digital health technologies. However, transparent quality assurance of DiGA and clinical proof of a positive healthcare effect is often missing, which creates skepticism of some stakeholders regarding the usage and reimbursement of these applications. METHODS: This article reviews the recently established fast-track integration of DiGA in the German reimbursement market, with emphasis on the current impact for manufacturers, healthcare providers, and people with diabetes. The German DiGA fast track is contextualised with corresponding initiatives in Europe. RESULTS: The option of a provisional prescription and reimbursement of DiGA while proving a positive healthcare effect in parallel may expedite the adoption of DiGA in Germany and beyond. However, hurdles for a permanent prescription and reimbursement of DiGA are high and only one of 12 that have achieved this status specifically addresses people with diabetes. CONCLUSION: The DiGA fast track needs to be further enhanced to cope with remaining skepticism and contribute even more to a value-based diabetes care.

Artificial Pancreas Systems for People With Type 2 Diabetes: Conception and Design of the European CLOSE Project.

In the last 10 years tremendous progress has been made in the development of artificial pancreas (AP) systems for people with type 1 diabetes (T1D). The pan-European consortium CLOSE (Automated Glu cose Contro l at H ome for People with Chronic Disea se) is aiming to develop integrated AP solutions (APplus) tailored to the needs of people with type 2 diabetes (T2D). APplus comprises a product and service package complementing the AP system by obligatory training as well as home visits and telemedical consultations on demand. Outcome predictors and performance indicators shall help to identify people who could benefit most from AP usage and facilitate the measurement of AP impact in diabetes care. In a first step CLOSE will establish a scalable APplus model case working at the interface between patients, homecare service providers, and payers in France. CLOSE will then scale up APplus by pursuing geographic distribution, targeting additional audiences, and enhancing AP functionalities and interconnectedness. By being part of the European Institute of Innovation and Technology (EIT) Health public-private partnership, CLOSE is committed to the EIT "knowledge triangle" pursuing the integrated advancement of technology, education, and business creation. Putting stakeholders, education, and impact into the center of APplus advancement is considered key for achieving wide AP use in T2D care.

Working atmosphere, job satisfaction and individual characteristics of community mental health professionals in integrated care.

Working requirements of community mental healthcare professionals in integrated care are complex. There is a lack of research concerning the relation of job satisfaction, working atmosphere and individual characteristics. For the current study, a survey evaluating job satisfaction and working atmosphere of mental healthcare professionals in integrated care was performed. About 321 community mental healthcare professionals were included in the survey; the response rate was 59.5%. The professional background of community mental healthcare professionals included nursing, social work and psychology. Community mental healthcare professionals reported the highest satisfaction with colleagues and the lowest satisfaction with income. Moreover, it could be shown that more responsibility, more recognition and more variety in job tasks lead to an increase of overall job satisfaction. Healthcare for mentally ill patients in the community setting is complex and requires well-structured care with appropriate responsibilities within the team. A co-operative relationship among colleagues as well as clearly defined responsibilities seem to be the key for the job satisfaction of community mental healthcare professionals in integrated care.

["The Crutch is in the corner  " - Experience of Mental Ill People with Cross-Sectoral Care in Integrated Care - A Qualitative Study]. / "Die Krücke steht in der Ecke  " ­ Erfahrungen psychisch kranker Menschen in einem Versorgungsmodell der ambulanten sektorenübergreifenden vernetzten Versorgung.

The aim of the qualitative study was the evaluation of experiences with integrated care especially with the care in network "NetzWerk psychische Gesundheit" (NWpG) from the perspective of mental ill patients. The patients were recruited from the NWpG. Focus groups were conducted in five of these networks and analyzed with qualitative content analysis. 40 mental ill patients participated on the focus groups. Overall, they were very positive about their care in such a network. Especially, aspects like need orientation, 24/7 telephone hotline, involvements of relatives as well as outreach care has been experienced as a support for their own care. The health care in NWpG seems to be important for an independent existence and presents relevant components for an autonomous life.

Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods-study protocol.

BACKGROUND: Conducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues. The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs. METHODS: We will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way. DISCUSSION: Our analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs.

[Studies to Evaluate Outpatient Mental Health Services: Are Patients' Priorities Considered?] / Studien zur Evaluation ambulanter psychiatrischer Versorgung: Werden die Prioritäten psychisch kranker Menschen berücksichtigt?

Objective: To evaluate whether outcome measures in studies to evaluate outpatient mental health services reflect patients' priorities. Methods: Two systematic literature reviews were conducted to identify, 1) patients' priorities and 2) outcome measures that are used for evaluating outpatient mental health care. 3) The findings from the literature review for patients' priorities were contrasted with the findings from the literature review for outcome measures. Results: 19 patients' priorities and 48 outcome measures were identified. Only eight priorities were directly assessed by an outcome measure in evaluations of outpatient mental health care. Conclusion: The majority of studies that evaluate outpatient mental health care do not consider patients' priorities as an outcome.

Development of indicators for a nationwide cross-sectoral quality assurance procedure for mental health care of patients with schizophrenia, schizotypal and delusional disorders in Germany.

PURPOSE: This paper describes the development of quality indicators for an external statutory and cross-sectoral quality assurance (QA) procedure in the context of the German health care system for adult patients suffering from schizophrenia, schizotypal and delusional disorders (F20-F29). METHODS: Indicators were developed by a modified RAND/UCLA Appropriateness Method with 1) the compilation of an indicator register based on a systematic literature search and analyses of health care claims data, 2) the selection of indicators by an expert panel that rated them for relevance and for feasibility regarding implementation. Indicators rated positive for both relevance and feasibility formed the final indicator set. RESULTS: 847 indicators were identified by different searches. Out of these, 56 were selected for the indicator register. During the formal consensus process the expert panel recommended another 45 indicators so that a total of 101 indicators needed to be considered by the panel. Of these, 27 indicators rated both relevant and feasible were included in the final set of indicators: this set included 4 indicators addressing structures, 19 indicators addressing processes and 4 indicators addressing outcomes. 17 indicators of the set will be reported by hospitals and 8 by psychiatric outpatient facilities. Two indicators considered to be cross-sectoral will be reported by both sectors. DISCUSSION: F20-F29 and its treatment show some specific features which so far have not been addressed by any procedure within the statutory QA program of the German health care system. These features include: Schizophrenia and related disorders a) are potentially chronic conditions, b) are mainly treated in outpatient settings, c) require a multi-professional treatment approach and d) are treated regionally in catchment areas. These specific features in combination with the peculiarities of some legal, political and organizational characteristics of the German health care system and its statutory QA program have strongly influenced the development of indicators. The result was a seemingly "imbalanced" set of indicators with a greater number of indicators for inpatient than for outpatient care despite the fact that clinical reality is otherwise. CONCLUSIONS: The circumstances of the German health care system that restricted the development of this cross-sectoral QA procedure addressing care for F20-F29 are also most likely to emerge with the development of cross-sectoral QA procedures for other (potentially) chronic conditions that are mainly treated in the outpatient setting by multi-professional teams or by networks of different providers. In order to be able to develop a QA procedure that mirrors the reality of service provision for (potentially) chronic diseases such as F20-F29 we need to explore further current and new data sources, diminish sectoral borders, and implement health care responsibility on the level of catchment areas.