Medical App Treatment of Non-Specific Low Back Pain in the 12-month Cluster-Randomized Controlled Trial Rise-uP: Where Clinical Superiority Meets Cost Savings.

Purpose: Non-specific low back pain (NLBP) exerts a profound impact on global health and economics. In the era of Web 3.0, digital therapeutics offer the potential to improve NLBP management. The Rise-uP trial introduces a digitally anchored, general practitioner (GP)-focused back pain management approach with the Kaia back pain app as the key intervention. Here, we present the 12-months evaluation of the Rise-uP trial including clinical and economic outcomes, patient satisfaction and behavioral tracking analysis. Methods: The cluster-randomized controlled study (registration number: DRKS00015048) enrolled 1237 patients, with 930 receiving treatment according to the Rise-uP approach and 307 subjected to standard of care treatment. Assessments of pain, psychological state, functional capacity, and well-being (patient-reported outcome measures; PROMs) were collected at baseline, and at 3-, 6-, and 12-months follow-up intervals. Health insurance partners AOK, DAK, and BARMER provided individual healthcare cost data. An artificial intelligence (AI)-driven behavioral tracking analysis identified distinct app usage clusters that presented all with about the same clinical outcome. Patient satisfaction (patient-reported experience measures; PREMs) was captured at the end of the trial. Results: Intention-to-treat (ITT) analysis demonstrated that the Rise-uP group experienced significantly greater pain reduction at 12 months compared to the control group (IG: -46% vs CG: -24%; p < 0.001) with only the Rise-uP group achieving a pain reduction that was clinically meaningful. Improvements in all other PROMs were notably superior in patients of the Rise-uP group. The AI analysis of app usage discerned four usage clusters. Short- to long-term usage, all produced about the same level of pain reduction. Cost-effectiveness analysis indicated a substantial economic benefit for Rise-uP. Conclusion: The Rise-uP approach with a medical multimodal back pain app as the central element of digital treatment demonstrates both, clinical and economic superiority compared to standard of care in the management of NLBP.

Gender health gaps in guideline-based inpatient cardiovascular medical and nursing care and implementation strategies to reduce the gap (HeartGap): A mixed methods study protocol.

BACKGROUND: A growing body of evidence has demonstrated that a gender-sensitive approach to healthcare is needed in all areas of medicine. Although medical and nursing guidelines include gender-sensitive care (GSC+) recommendations, the level of implementation in health care practice is unknown. This study aims to examine the current level of implementation and acceptance of GSC+ among physicians and nurses and to identify potential gaps between guidelines and practice and barriers and facilitators of GSC+ implementation, taking the perceptions of all relevant stakeholders into account. The overarching aim is to develop holistic recommended actions to strengthen GSC+. METHODS: This study has a mixed methods triangulation design. The preparation phase consisting of a literature review and a two-part (qualitative and quantitative) data analysis will be conducted in the cardiology department of 9 pilot hospitals in Berlin, North Rhine-Westphalia, Lower Saxony, Rhineland-Palatinate, Germany. 18 focus groups with clinicians and nurses as well as interviews with experts in other relevant fields will be performed. In the national roll-out phase, a questionnaire survey will be conducted with hospital clinicians (n = 382), nurses (n = 386) and patients (n = 388). DISCUSSION: This study will provide comprehensive insights into the implementation and acceptance of GSC+ in cardiology from the perspective of doctors, nurses, patients, stakeholders and experts in relevant fields, such as policy and education. A focus will also be on the extent to which age or gender of health professionals, region and hospital type influence the implementation of GSC+. The identification of GSC+ implementation barriers and facilitators should help to improve the standard of care for cardiology patients of all genders. The outcomes from this study can be used to develop measures and recommended actions for the successful and sustainable implementation of gender-sensitive care. TRIAL REGISTRATION: The study is registered in the German Register of Clinical Studies (DRKS) under study number DRKS00031317.

Adolescents with type 1 diabetes' perspectives on digital health interventions to enhance health literacy: a qualitative study.

Introduction: Digital health intervention offers the potential to enhance health literacy, which is crucial for effective diabetes management, especially among adolescents. Diabetes is a major global public health issue, leading to devastating complications and increasing mortality rates. The incidence of type 1 diabetes mellitus (T1DM) is also on the rise, particularly among adolescents, necessitating multisectoral strategies to combat this disease. This study explores the perceptions of adolescents with T1DM in Germany regarding digital health interventions, with the aim of improving healthcare by addressing specific needs and guiding future research. Methodology: This study employed a qualitative approach using semi-structured individual interviews with adolescents with T1DM (n = 20) aged 14 to 18 years old in Germany to explore their perspectives on digital interventions for health literacy promotion. The study adopted content analysis according to Kuckartz et al. and the research followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist. Ethical considerations were paramount and data were rigorously analyzed using coding and iterative processes to ensure data quality and reliability. Results: The findings indicate that within three prominent domains, namely the utilization of digital health intervention for accessing and comprehending information, facilitating peer-to-peer interactions, and enhancing physician-patient communication and interaction, digital health interventions are either underutilized or insufficiently deployed. In addition, a notable observation is the apparent lack of patient-centered approaches for adolescents with T1DM in relation to digital health interventions and health literacy. Conclusion: In order to enhance the utilization of digital health interventions and enhance health literacy it is essential to focus on capacity building through a patient-centered approach, to promote digital health literacy, and foster the cultivation of a participatory culture. The outcomes of this study offer valuable insights that can inform practical applications, further research endeavors, and influence policymaking.

Why should stakeholders consider the effect of tensions in collaborative innovation in healthcare-lessons learned from surveying integrated care projects in Germany.

INTRODUCTION: The German Innovation Fund supports projects that aim to improve healthcare through integration and intersectoral collaboration. As is typical for collaborative innovation projects, partners often pursue different objectives, which can create tensions and affect outcomes. The study aims to explore the causes and effects of tensions in integrated care projects and how frameworks, processes, and management should be designed to deal with tensions and achieve their productive effects. METHODS: In an online survey we asked participants about the causes, effects, and management of tensions and their implications for integrated care projects (n = 58 completed questionnaires). We applied bivariate descriptive statistics to analyse the quantitative data. RESULTS: Tensions between stakeholders, caused by deep-seated differences and the design of the project frameworks, often affect the course and outcome of innovative integrated care projects. However, through appropriate conflict management and negotiation processes such tensions can be managed constructively and lead to better outcomes. DISCUSSION: Tension is usually seen as something unpleasant to be avoided and/or overcome. In fact, tensions can have positive effects, the importance of which remains little understood. Developing appropriate frameworks for managing and integrating different perspectives are key factors in unlocking the positive potential of tensions in integrated care projects.

Effectiveness of the Telemedical Lifestyle Intervention Program TeLIPro for Improvement of HbA1c in Type 2 Diabetes: A Randomized-Controlled Trial in a Real-Life Setting.

The effectiveness of the multimodal Telemedical Lifestyle Intervention Program (TeLIPro) was proven in the advanced stages of type 2 diabetes mellitus (T2DM). Since its therapeutic potential focusing on telemedical coaching without using a formula diet is unknown, we evaluated improvements in HbA1c, HbA1c normalisation rate, cardiometabolic risk factors, quality-of-life, and eating behaviour in real life. In this randomized-controlled trial, AOK Rhineland/Hamburg insured T2DM patients (n = 1163) were randomized (1:1) into two parallel groups, and 817 received the allocated intervention. In addition to routine care, all participants got scales, step counters, and access to an online portal. The TeLIPro group additionally received equipment for self-monitoring of blood glucose and telemedical coaching. Data were collected at baseline, after 6 and 12 months of intervention as well as after a 6-month follow-up. The primary endpoint after 12 months was (i) the estimated treatment difference (ETD) in HbA1c change and (ii) the HbA1c normalisation rate in those with diabetes duration < 5 years. The TeLIPro group demonstrated significantly stronger improvements in HbA1c (ETD -0.4% (-0.5; -0.2); p < 0.001), body weight, body-mass-index, quality-of-life, and eating behaviour, especially in T2DM patients with diabetes duration ≥ 5 years (ETD -0.5% (-0.7; -0.3); p < 0.001). The HbA1c normalisation rate did not significantly differ between groups (25% vs. 18%). Continuous addition of TeLIPro to routine care is effective in improving HbA1c and health-related lifestyle in T2DM patients with longer diabetes duration in real life.

Tensions between the Professions: How Integrated Care Can Benefit from Better Understanding and Managing Conflicting Perspectives and Demands.

In the transition from fragmented to integrated care, tensions are inevitable. Contradictions between the actors of the different professions involved can have negative but also positive effects on change processes in the healthcare system. This is especially true for integrated care, where collaboration among the workforce is pivotal. Therefore, efforts should not be made to avoid tensions from the outset, if this is at all possible, but to deal with them constructively. The attention of leading actors must be increased to recognize, analyse, and successfully manage tensions. The creative potential of tensions can be harnessed to successfully implement integrated care and engage the diverse workforce.

Design and implementation of ParkinsonAKTIV: an interventional study to evaluate the effectiveness of a novel online platform to guide quickcard-based treatment decisions.

INTRODUCTION: Patients with Parkinson's Disease (PD) require an all-encompassing and individualized care including pharmacological as well as non-pharmacological treatment approaches, such as physical therapy, occupational therapy and speech and swallowing therapy. ParkinsonAKTIV is an innovative, multidisciplinary, and comprehensive approach to guide this non-pharmacological PD treatment in northwestern Germany. Its online communication platform called JamesAKTIV has been developed to enhance and standardize PD healthcare professionals' communication. The implementation of ParkinsonAKTIV and JamesAKTIV is accompanied through a detailed process evaluation and to gather evidence on the impact on patient-related outcomes, such as health-related quality of life and healthcare costs for people with PD through an effectiveness evaluation. METHODS: The study design contains two parts: (1) first, a quantitative effectiveness evaluation is conducted utilizing a prospective quasi-experimental approach with a control group which examines PD patient's health-related quality of life and physician-assessed PD patient's health status (Unified Parkinson Disease Rating Scale). Moreover, a health economic evaluation of the ParkinsonAKTIV intervention is conducted using patient-reported outcomes and cost data as well as routine data from a statutory health insurance. (2) Second, a mixed-methods process evaluation among healthcare professionals, which examines the feasibility and potential barriers and facilitators of ParkinsonAKTIV for routine care, is performed. Quantitative results from a social network analysis and a survey among healthcare professionals will be triangulated with data from qualitative stakeholder interviews and focus group discussions. PERSPECTIVE: Findings are expected to provide evidence of an increase in quality of life of patients with PD, less severe PD symptoms, and a better ability to participate in activities of daily living. ParkinsonAKTIV has the potential of increasing PD patients' quality of care through sufficient and more tailored prescription of non-pharmacological therapies. It is anticipated that ParkinsonAKTIV will improve communication among health professionals. Results from the ParkinsonAKTIV study will provide first practice-oriented evidence and a roadmap for implementation of an online tool for a comprehensive, multidisciplinary care PD network for patients and their caregivers in routine care in Germany. Trial registration ClinicalTrials.gov: registration number NCT05251298 (retrospectively registered: https://clinicaltrials.gov/ct2/show/record/NCT05251298 ).

Impact of digital health interventions for adolescents with type 1 diabetes mellitus on health literacy: a systematic review.

BACKGROUND: Evidence shows that living with diabetes mellitus type 1 (T1DM) in adolescent age is particularly challenging and difficult to manage. A high level of health literacy is important to prevent and avoid debilitating complications. Despite the increasing prevalence and incidence of T1DM by adolescent and the large use of digital health interventions, little is known about the association between this use and health literacy. This systematic review provides an overview on the impact of digital health interventions for adolescents with type 1 diabetes on health literacy and derive recommendations for further research. METHODS: Electronic searches were performed in five databases in Medline (Medline, PubMed + via PubMed), The Cochrane Library, EMBASE (via Ovid), Web of Science and PsycINFO from 2011 to 2021. In addition, grey literature searches were conducted in Google Scholar, OAlster and Trip. Relevant studies that have been missed by electronic and hand-searching strategies were searched in the reference lists of all included studies. The review followed PRISMA guidelines. Two researchers independently screened abstracts for initial eligibility and applied the inclusion and exclusion criteria to the relevant full-text articles. Quality was assessed using the tools RoB2 Cochrane, ROBINS I, NOS (Newcastle-Ottawa Scale), CASP (Critical Appraisal Skills Programme) for primary studies and Amstar-2 for secondary studies. RESULTS: Out of 981 studies, 22 were included in the final review. Most primary studies included in this review were judged as moderate overall risk of bias or with some concerns and most of the secondary studies as critically low quality reviews. Our findings suggest that the interplay of health care providers (HCP) and patients through social media helps the management of the disease. This corroborates Bröder et al.' (2017) dimension of 'communication and interactions' in their concept of health literacy. CONCLUSIONS: For adolescents with T1DM, social media may be a specific and beneficial intervention for an improved communication and interaction with their HCP. Further research should investigate what specific form of social media suits best for which adolescents. TRIAL REGISTRATION: The study protocol was registered on the 15th of November 2021 on Prospero (reg. NR: CRD42021282199).

The effectiveness of low-dosed outpatient biopsychosocial interventions compared to active physical interventions on pain and disability in adults with nonspecific chronic low back pain: A systematic review with meta-analysis.

OBJECTIVE: To evaluate the effectiveness of low-dosed outpatient biopsychosocial interventions versus active physical interventions on pain intensity and disability in adults with nonspecific chronic low back pain. INTRODUCTION: Research has shown that primary care biopsychosocial interventions (PCBI) can reduce pain intensity and disability. While scattered studies support low-dosed (≤ 15 treatment hours) PCBI, no systematic review exists comparing the effectiveness of low-dosed PCBI treatment with traditional physical activity interventions in adults with nonspecific chronic low back pain (CLBP). INCLUSION CRITERIA: Randomized controlled trials that evaluate low-dosed PCBI compared to physical treatment with an active component such as exercise, physical activity or usual physiotherapy treatment for adult participants (18 years or older), who suffer from CLBP were included. Not recommended interventions that feature only passive therapies, spinal surgery or pharmacological treatment, and studies with inpatient multidisciplinary-based rehabilitation (MBR) were excluded. METHODS: Databases were searched from inception to December 31, 2021. Language was restricted to English or German. Keywords and derivatives of "chronic back pain", "exercise intervention", "cognitive-behavioral therapy", "primary care" and "randomized controlled trials" were used. Sources were CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Ovid Medline, Physiotherapy Evidence Database (PEDro), PubMed and Web of Science. Search was finished on March 08, 2022. Data appraisal, extraction and synthesis followed JBI guidance for systematic reviews of effectiveness. Risk of Bias was assessed using JBI 13-item checklist for randomized controlled trials. The GRADE approach for grading the certainty of evidence was followed. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO 2022 CRD42022302771. RESULTS: Eighteen RCTs were found eligible and 15 trials comprising a total of 1531 participants suffering from CLBP were entered in the meta-analyses. Risk of Bias was low. Overall evidence was moderate. Significant effects in favor of PCBI were found for pain intensity post-treatment (standardized mean difference (SMD) = -1.09, 95% confidence interval (CI) = -1.84 to -0.34, I2  = 97%, p = 0.004) as well as at short-term (SMD = -0.23, 95% CI = -0.39 to -0.08, I2  = 0%, p = 0.004), long term (SMD = -0.79, 95% CI = -1.42 to -0.17, I2  = 96%, p = 0.01) and very long-term (SMD = -1.13, 95% CI = -1.93 to -0.33, I2  = 94%, p = 0.005) follow-up. Significant effects in favor of PCBI for physical function were found post-treatment (SMD = -1.33, 95% CI = -2.17 to -0.49, I2  = 97%, p = 0.002) at short-term (SMD = -0.20, 95% CI = -0.36 to -0.04, I2  = 0%, p = 0.01) and at long-term follow-up (SMD = -1.17, 95% CI = -2.06 to -0.28, I2  = 98%, p = 0.01). The results were characterized by high heterogeneity due to different types (cognitive behavioral therapy, pain-neuroscience education, mindfulness, and motivation), delivery modes (individual and/or group), durations (3-12 weeks) and contact times (2-15 h) of PCBI. In sensitivity analysis outliers were removed to reduce heterogeneity. The results remained significant for pain intensity at short-term (SMD = -0.23, 95% CI = -0.39 to -0.08, I2  = 0%, p = 0.004) and long-term follow-up (SMD = -0.22, 95% CI = -0.41 to -0.03, I2  = 39%, p = 0.02). CONCLUSIONS: This meta-analysis suggests that low-dosed PCBI has favorable effects in terms of disability and pain intensity compared to active physical treatments alone. All conducted meta-analyses indicate that biopsychosocial interventions produce better outcomes than active physical treatment alone. Therefore, we strongly recommend decision makers and clinical practitioners to analyze how psychosocial elements can be introduced into outpatient (low-dosed) CLBP interventions.

What can healthcare systems learn from looking at tensions in innovation processes? A systematic literature review.

BACKGROUND: Until now, scholarship on innovation processes in healthcare systems lack an in-depth appreciation of tensions. Tensions often revolve around barriers and result from individual assessments and prioritizations that guide actions to eventually overcome these barriers. In order to develop a more differentiated understanding of tensions' role in healthcare innovation processes, this paper aims to shed light on the multifaceted ways in which tensions emerge, are being dealt with, and how they hinder or, at times, facilitate innovation processes. METHODS: A systematic review of published and grey literature was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline. The review involved searching three databases for original research articles and manually searching citations. Twenty-nine original full texts were identified, evaluated, and coded. These include papers on innovation in healthcare systems that investigated innovation-related organizational tensions. The findings were synthesized into different types of tensions in healthcare system innovation and the descriptions of the conflicting elements. We also analyzed the investigated innovations by type, process stages, and across different countries and healthcare systems. RESULTS: A total of forty-two tensions were identified and grouped into nine categories. Organizing tensions were predominant, followed by learning/belonging, performing, and performing/organizing tensions. Tensions most frequently occurred in the implementation phase and in the form of a dilemma. Included studies were conducted mainly in government-funded healthcare systems. CONCLUSION: Our data suggest that innovation processes in healthcare systems are impaired by conflicts between contradictory elements, working cultures, and convictions and the organizational and regulatory context. Since the majority of the tensions we collected in our study can be addressed, future policy-making and research should take advantage of this fact and develop strategies that significantly influence the successful management of tensions and thus improve the implementation of innovations.

The effectiveness of low-dosed outpatient biopsychosocial interventions compared to active physical interventions on pain and disability in adults with nonspecific chronic low back pain: A protocol for a systematic review with meta-analysis.

BACKGROUND: Best outpatient treatment of nonspecific chronic low back pain is high-dosed exercise that is maintained after therapy. Primary care biopsychosocial intervention (PCBI) is an outpatient multicomponent intervention that includes an active component (exercise, physical activity, or physiotherapy) and at least one psychological, social, or occupational component. Research has shown that PCBI can reduce pain intensity and disability. While scattered studies support low-dosed (<15 treatment hours) PCBI, there is no systematic review comparing the effectiveness of low-dosed PCBI treatment with traditional physical activity interventions in adults with nonspecific chronic low back pain (CLBP). INCLUSION CRITERIA: Randomised controlled trials that evaluate low-dosed outpatient biopsychosocial interventions compared to physical treatment with an active component such as exercise, physical activity or usual physiotherapy treatment for adult participants (18 years or older) who suffer from nonspecific CLBP will be included. METHODS: A comprehensive search of multiple databases will be used to find relevant studies. The databases will be searched from inception to December 2021, with English or German language restrictions imposed. Keywords and derivatives of "chronic back pain", "exercise intervention", "cognitive-behavioral therapy", "primary care" and "randomized controlled trials" will be used. Sources will include CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Ovid Medline, Physiotherapy Evidence Database (PEDro), PubMed and Web of Science. DISCUSSION: To our knowledge, this will be the first systematic review and meta-analysis of narrowly defined low- dosed PCBI across populations with nonspecific chronic low back pain. The objective of this review is to evaluate the effectiveness of low-dosed outpatient biopsychosocial interventions versus physical active interventions on pain intensity and disability in adults with CLBP. This study will provide evidence that could improve treatment options for patients with nonspecific CLBP. TRAIL REGISTRATION: Systematic review registration number: PROSPERO 2022 CRD42022302771. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022302771.

Cardiovascular risk factors, exercise capacity and health literacy in patients with chronic ischaemic heart disease and type 2 diabetes mellitus in Germany: Baseline characteristics of the Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes study.

BACKGROUND: Lifestyle interventions are a cornerstone in the treatment of chronic ischaemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM). This study aimed at identifying differences in clinical characteristics between categories of the common lifestyle intervention targets BMI, exercise capacity (peak V̇O2) and health literacy (HL). METHODS: Cross-sectional baseline characteristics of patients enrolled in the LeIKD trial (Clinicaltrials.gov NCT03835923) are presented in total, grouped by BMI, %-predicted peak V̇O2 and HL (HLS-EU-Q16), and compared to other clinical trials with similar populations. RESULTS: Among 499 patients (68.3±7.7 years; 16.2% female; HbA1c, 6.9±0.9%), baseline characteristics were similar to other trials and revealed insufficient treatment of several risk factors (LDL-C 92±34 mg/dl; BMI, 30.1±4.8 kg/m2; 69.6% with peak V̇O2<90% predicted). Patients with lower peak V̇O2 showed significantly higher (p < 0.05) CIHD and T2DM disease severity (HbA1c, CIHD symptoms, coronary artery bypass graft). Obese patients had a significantly higher prevalence of hypertension and higher triglyceride levels, whereas in patients with low HL both quality of life components (physical, mental) were significantly reduced. CONCLUSIONS: In patients with CIHD and T2DM, peak V̇O2, BMI and HL are important indicators of disease severity, risk factor burden and quality of life, which reinforces the relevance of lifestyle interventions.

App-based maintenance treatment for alcohol use disorder after acute inpatient treatment: Study protocol for a multicentre randomized controlled trial.

BACKGROUND: Alcohol use disorder, a prevalent and disabling mental health problem, is often characterized by a chronic disease course. While effective inpatient and aftercare treatment options exist, the transferal of treatment success into everyday life is challenging and many patients remain without further assistance. App-based interventions with human guidance have great potential to support individuals after inpatient treatment, yet evidence on their efficacy remains scarce. OBJECTIVES: To develop an app-based intervention with human guidance and evaluate its usability, efficacy, and cost-effectiveness. METHODS: Individuals with alcohol use disorder (DSM-5), aged 18 or higher, without history of schizophrenia, undergoing inpatient alcohol use disorder treatment (N = 356) were recruited in eight medical centres in Bavaria, Germany, between December 2019 and August 2021. Participants were randomized in a 1:1 ratio to either receive access to treatment as usual plus an app-based intervention with human guidance (intervention group) or access to treatment as usual plus app-based intervention after the active study phase (waitlist control/TAU group). Telephone-based assessments are conducted by diagnostic interviewers three and six weeks as well as three and six months after randomization. The primary outcome is the relapse risk during the six months after randomization assessed via the Timeline Follow-Back Interview. Secondary outcomes include intervention usage, uptake of aftercare treatments, AUD-related psychopathology, general psychopathology, and quality of life. DISCUSSION: This study will provide further insights into the use of app-based interventions with human guidance as maintenance treatment in individuals with AUD. If shown to be efficacious, the intervention may improve AUD treatment by assisting individuals in maintaining inpatient treatment success after returning into their home setting. Due to the ubiquitous use of smartphones, the intervention has the potential to become part of routine AUD care in Germany and countries with similar healthcare systems.

[10 Years Accountable Care Organizations in the USA: Impulses for Health Care Reform in Germany?] / 10 Jahre Accounable Care Organizations in den USA: Impulse für Reformen in Deutschland?

GOAL OF THE STUDY: An intent of the Patient Protection and Affordable Care Acts (ACA), also know as Obama Care, was to slow the expenditure growth in the public Medicare-System by shifting the accountability for health care outcomes and costs to the provider. For this purpose, provider were allowed to form networks, which would then take accountability for a defined population - Accountable Care Organizations (ACOs). Ten years after the introduction of ACOs, this paper looks at the impact of ACOs both on quality of care and costs of care to assess if ACOs can be a model of care delivery for Germany. METHODS: In a mixed-method approach, a rapid review was conducted in Health System Evidence and PubMed. This was supported with further papers identified using the snowballing-technique. After screening the abstracts, we included articles containing information on cost- and/or quality impact of US-Medicare-ACOs. The findings of the rapid review were challenged with 16 ACO-experts and stakeholder in the USA. RESULTS: In total, we included 60 publications which incorporated 6 reports that were either conducted directly by governmental institutions or ordered by them, along with 3 previous reviews. Among these, 31 contained information on costs of care, 18 contained information on quality of care and 11 had information on both aspects. The publications show that ACOs reduced costs of of care. Cost reductions were achieved compared to historic costs, to populations not cared for in ACOs, and counterfactuals. Quality of care stayed the same or improved. CONCLUSION: ACOs contributed to slowing the cost growth in US Medicare without compromising quality of care. Thus, a transferal of this model of care to Germany should be considered. However, various policies have led to ACOs failing to unleash their full potential. Against this background, and against the background of stark differences between US Medicare and the German health care system, a critical reflection of the necessary policies underlying ACOs-like structures in Germany, needs to be undertaken.

A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF.

BACKGROUND: The extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure. Early detection of deterioration in lung function and optimising adherence are therefore crucial in CF care. We implement a randomized controlled trial to evaluate efficacy of telemonitoring of adherence, lung function, and health condition in combination with behavior change interventions using innovative digital technologies. METHODS: This is a multi-centre, randomized, controlled, non-blinded trial aiming to include 402 patients ≥ 12 years-of-age with CF. A standard-of-care arm is compared to an arm receiving objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video-conferencing, a self-management app and professional telephone coaching. The duration of the intervention phase is 18 months. The primary endpoint is time to the first protocol-defined pulmonary exacerbation. Secondary outcome measures include number of and time between pulmonary exacerbations, adherence to inhalation therapy, changes in forced expiratory volume in 1 s from baseline, number of hospital admissions, and changes in health-related quality of life. CF-associated medical treatment and care, and health care related costs will be assessed by explorative analysis in both arms. DISCUSSION: This study offers the opportunity to evaluate the effect of adherence interventions using telemedicine capable devices on adherence and lung health, possibly paving the way for implementation of telemedicine in routine care for patients with CF. TRIAL REGISTRATION: This study has been registered with the German Clinical Trials Register (Identifier: DRKS00024642, date of registration 01 Mar 2021, URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00024642 ).

RubiN - continuous care in regional networks: a study protocol for a prospective controlled trial.

BACKGROUND: The health care situation of geriatric patients is often multifaceted, complex and often overlaps with social living conditions. Due to the lack of cross-sectoral and interprofessional health care geriatric patients often, receive insufficient care. Only a holistic view enables a comprehensive evaluation of the complex health risks, but also the potential to preserve the health of geriatric patients. The implementation of cross-sectoral, multi-professional case management could reduce the gaps in care, improve the autonomy of the geriatric patients in their own homes, and allow them to retain it as long as possible. The "RubiN" project examines the effects of multi-professional, cross-sectoral and assessment-based case management on the quality of the care of geriatric patients. The results of the study aim to show whether geriatric patients receive better care using case management than patients who receive standard health care. In addition, data on the effects of case management on practices of general practitioners (GP), the satisfaction with the care concept amongst the case managers, patients and relatives will be collected. Furthermore, a health economic analysis will be carried out. METHODS: The project is designed as a prospective controlled study and compares geriatric patients from practice networks in different regions in Germany. Inclusion criteria are: Age ≥ 70 years and care requirements from two different care complexes (identified with the screening instrument 'Angelina'-questionnaire). The intervention is the use of a geriatric case management, where health care is organised based on patient-specific care requirements. Five practice networks of physicians will implement the intervention (n = 3200 patients) and three practice networks will serve as the control group (n = 1200 patients). The primary endpoint is the ability to manage activities of daily living, measured using the Barthel Index. The patients in the intervention group receive geriatric case management and the patients in the control networks receive standard care ("care as usual"). The analysis of the primary data, which is pseudonymised, occurs according to the intention-to-treat principle. For this purpose, the endpoints will be analysed using a group comparison after 12 months. For the health economic analysis, secondary data from the statutory health insurance providers will be included in the analysis, in addition to the primary data. Data for the analysis of the effects the concept has on the GP practices as well as on the satisfaction of the project participants will be collected with questionnaires and interviews with experts. DISCUSSION: The implementation of cross-sectoral and interdisciplinary geriatric case management has been a topic of discussion for years, whereby positive effects have already been-shown. This planned study will be the first evaluation of the effect of case management for geriatric patients with a very large sample. In addition, the effects of case management on the GP practices and also on the relatives of the geriatric patients will be shown. It is intended that the study results pave the way for a widespread implementation of this concept. TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00016642 . Registered on 29 October 2019 - Retrospectively registered.

Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial.

INTRODUCTION: Guidelines recommend lifestyle intervention in chronic ischaemic heart disease (CIHD) and type 2 diabetes mellitus (T2DM). However, evidence from randomised controlled trials is scarce in patients with combined entities. METHODS AND ANALYSIS: The Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (LeIKD) trial is a prospective, multicentre study that will randomise (1:1) patients with CIHD (ICD-10: I20-I25) and T2DM (ICD-10: E11) from one health insurance company into a lifestyle intervention (LS) or usual care (UC). Active LS consists of an individual combined exercise programme of strength and endurance training and nutritional counselling with regular feedback for 6 months. Intervention is supported by telemedicine. Follow-up without individualised feedback will continue for 6 months. The study aims to investigate whether an individualised telemedical supported LS intervention is superior to UC in improving cardiovascular risk factors, physical activity, quality of life, health literacy, major cardiovascular events and health economics in patients with both CIHD and T2DM. Primary endpoint is the change in HbA1c from baseline to 6 months. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Technical University of Munich (registration number: 144/18-S) and at each study site. The study will be conducted according to the World Medical Association Declaration of Helsinki, and results will be published in articles and reports. It is funded by the Federal Joint Committee (www.innovationsfonds.g-ba.de), reference number 01NVF17015, which has no impact on data collection, analysis or interpretation. Dissemination is independent of the funding source. TRIAL REGISTRATION NUMBER: Clinical trials.gov identifier: NCT03835923. German registry for clinical studies (DRKS): DRKS00015140.

Parkinson Network Eastern Saxony (PANOS): Reaching Consensus for a Regional Intersectoral Integrated Care Concept for Patients with Parkinson's Disease in the Region of Eastern Saxony, Germany.

As integrated care is recognized as crucial to meet the challenges of chronic conditions such as Parkinson's disease (PD), integrated care networks have emerged internationally and throughout Germany. One of these networks is the Parkinson Network Eastern Saxony (PANOS). PANOS aims to deliver timely and equal care to PD patients with a collaborative intersectoral structured care pathway. Additional components encompass personalized case management, an electronic health record, and communicative and educative measures. To reach an intersectoral consensus of the future collaboration in PANOS, a structured consensus process was conducted in three sequential workshops. Community-based physicians, PD specialists, therapists, scientists and representatives of regulatory authorities and statutory health insurances were asked to rate core pathway-elements and supporting technological, personal and communicative measures. For the majority of core elements/planned measures, a consensus was reached, defined as an agreement by >75% of participants. Additionally, six representatives from all partners involved in the network-design independently assessed PANOS based on the Development Model for Integrated Care (DMIC), a validated model addressing the comprehensiveness and maturity of integrated care concepts. The results show that PANOS is currently in an early maturation state but has the potential to comprehensively represent the DMIC if all planned activities are implemented successfully. Despite the favorable high level of consensus regarding the PANOS concept and despite its potential to become a balanced integrated care concept according to the DMIC, its full implementation remains a considerable challenge.