Preference-Based Implementation of Video Consultations in Urban and Rural Regions in Outpatient Care in Germany: Protocol for a Mixed Methods Study.

BACKGROUND: Particularly in rural regions, factors such as lower physician density and long travel distances complicate adequate outpatient care. However, urban regions can also be affected by deficits in care, for example, long waiting times. One model of care intending to improve the situation is the implementation of video consultations. The study protocol presents the methodology of the research project titled "Preference-based implementation of the video consultation in urban and rural regions" funded by the German Federal Joint Committee (funding number 01VSF20011). OBJECTIVE: This study aims to identify existing barriers to the use of video consultation and the preferences of insured individuals and physicians as well as psychotherapists in order to optimize its design and thus increase acceptance and use of video consultations in urban and rural regions. METHODS: Built on a mixed methods approach, this study first assesses the status quo of video consultation use through claims data analysis and carries out a systematic literature review on barriers and promoting factors for the use of video consultations. Based on this preliminary work, focus groups are conducted in order to prepare surveys with insureds as well as physicians and psychotherapists in the second study phase. The central element of the survey is the implementation of discrete choice experiments to elicit relevant preferences of (potential) user groups and service providers. The summarized findings are discussed in a stakeholder workshop and translated into health policy recommendations. RESULTS: The methodological approach used in this study is the focus of this paper. The study is still ongoing and will continue until March 2024. The first study phase has already been completed, in which preliminary work has been done on potential applications and hurdles for the use of video consultations. Currently, the survey is being conducted and analyses are being prepared. CONCLUSIONS: This study is intended to develop a targeted strategy for health policy makers based on actual preferences and perceived obstacles to the use of video consultations. The results of this study will contribute to further user-oriented development of the implementation of video consultations in German statutory health insurance. Furthermore, the iterative and mixed methods approach used in this study protocol is also suitable for a variety of other research projects. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50932.

Determinants for participation in a prevention and early detection programme for children and adolescents in Germany: does social background play a role?

Early detection examinations and prevention are particularly important in childhood and adolescence, as certain diseases are already developing and health-related attitudes and behaviour patterns are formed and implemented. Despite the importance of screening and prevention, not all families use the available services and programmes. The aim of this study is to identify factors associated with participation in an early detection and prevention programme for children and adolescents, as well as factors associated with actual uptake of an examination. The analyses are based on questionnaire data of an online survey of participants and non-participants. Descriptive analyses and logistic regression models are conducted on a defined sample (n = 1,289). The results show that both groups differ with regard to several factors: age, chronic diseases, federal state, living space, number of siblings, country of birth, migration background, language spoken at home, mother's occupational status, household income, treatment duration, and trust in treating physician. Regression I shows that participation in the programme is significantly associated with higher age, language spoken at home, mother's occupational status and greater trust in the treating physician. The latter demonstrates the highest predictive power. Regression II indicates that the actual uptake of an examination among participants is significantly affected by age, federal state and father's occupational status. Overall, the results of this study show that social background partly plays a role in participation, but that factors such as trust in the treating physician also have a significant impact. For the future, further research on the factors influencing participation in screening and prevention services or programmes for children and adolescents is important in order to develop strategies to overcome existing barriers and thus reach groups that have not been reached yet. In this context, trust in the treating physician and his or her influence on decision-making should in particular be considered.

The effectiveness of additional screening examinations for children and adolescents in Germany: a longitudinal retrospective cohort study.

BACKGROUND: Continuous medical care is particularly important in childhood and adolescence. Since there are gaps in regular care in Germany, various health insurance providers offer to cover additional examinations (e.g., U10, U11, J2) to ensure ongoing paediatrician visits. However, the question arises as to whether these examinations are effective. Thus, the main objective of this study is to determine whether participation in the U10, U11 or J2 examinations leads to more frequent and earlier diagnosis and treatment of age-specific diseases. METHODS: The analyses are based on administrative claims data from a statutory health insurance fund. For each examination, an intervention group (IG) is formed and matched with a corresponding control group (CG). Descriptive analyses include proportion with diagnosis and treatment, average age of diagnosis and treatment initiation. Hypothesis testing is performed using methods appropriate to each. In addition, subgroup analyses and binominal logistic regression models are conducted. RESULTS: More diagnoses are detected in IG, irrespective of subgroups. Additionally, diagnoses are made slightly earlier on average in IG. In the total samples, more therapies are initiated in IG, and slightly earlier. Considering only diagnosed cases, more therapies are initiated in CG but continue to be started earlier in IG. Regression models show that participation in the examinations has the highest predictive power for detecting a diagnosis. The presence of a chronic disease and sex - male at the U10 and U11 and female at the J2 - are also significantly associated. The models further show that nationality, unemployment of parents and region also have a significant influence in some cases, whereas school-leaving qualification, vocational qualification and income of parents do not. Considering the initiation of treatment in overall samples, the models show similar results, but here the presence of a chronic illness has the highest predictive power. CONCLUSION: The results indicate that participation in the examinations leads to significantly more diagnoses and, in the overall samples, significantly more treatments. In addition, diagnoses were made somewhat earlier and therapies were initiated somewhat earlier. In the future, it would be useful to investigate the U10, U11 and J2 examinations over a longer time horizon to determine whether the statistically significant difference found is also clinically relevant, i.e., earlier diagnosis and initiation of therapy lead to prevention of manifestation or progression of the diagnosed diseases and to avoidance of secondary diseases. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00015280. Prospectively registered on 18 March 2019.

The detection and prevention of adverse drug events in nursing home and home care patients: Study protocol of a quasi-experimental study.

AIM: To estimate the cost-effectiveness of an intervention facilitating the early detection of adverse drug events through the means of health professional training and the application of a digital screening tool. DESIGN: Multi-centred non-randomized controlled trial from August 2018 to March 2020 including 65 nursing homes or home care providers. METHODS: We aim to estimate the effect of the intervention on the rate of adverse drug events as primary outcome through a quasi-experimental empirical study design. As secondary outcomes, we use hospital admissions and falls. All outcomes will be measured on patient-month level. Once the causal effect of the intervention is estimated, cost-effectiveness will be calculated. For cost-effectiveness, we include all patient costs observed by the German statutory health insurance. RESULTS: The results of this study will inform about the cost-effectiveness of the optimized drug supply intervention and provide evidence for potential reimbursement within the German statutory health insurance system.

Cost-effectiveness of noninvasive telemedical interventional management in patients with heart failure: health economic analysis of the TIM-HF2 trial.

BACKGROUND: Noninvasive remote patient management (RPM) in patients with heart failure (HF) has been shown to reduce the days lost due to unplanned cardiovascular hospital admissions and all-cause mortality in the Telemedical Interventional Management in Heart Failure II trial (TIM-HF2). The health economic implications of these findings are the focus of the present analyses from the payer perspective. METHODS AND RESULTS: A total of 1538 participants of the TIM-HF2 randomized controlled trial were assigned to the RPM and Usual Care group. Health claims data were available for 1450 patients (n = 715 RPM group, n = 735 Usual Care group), which represents 94.3% of the original TIM-HF2 patient population, were linked to primary data from the study documentation and evaluated in terms of the health care cost, total cost (accounting for intervention costs), costs per day alive and out of hospital (DAOH), and cost per quality-adjusted life year (QALY). The average health care costs per patient year amounted to € 14,412 (95% CI 13,284-15,539) in the RPM group and € 17,537 (95% CI 16,179-18,894) in the UC group. RPM led to cost savings of € 3125 per patient year (p = 0.001). After including the intervention costs, a cost saving of € 1758 per patient year remained (p = 0.048). CONCLUSION: The additional noninvasive telemedical interventional management in patients with HF was cost-effective compared to standard care alone, since such intervention was associated with overall cost savings and superior clinical effectiveness.

Second opinion programmes in Germany: a mixed-methods study protocol.

INTRODUCTION: Second opinion programmes aim to support the patients' decision-making process and to avoid treatments that are unnecessary from a medical perspective. The German second opinion directive, introduced in December 2018, constitutes a new legal framework in statutory health insurance for seeking second opinions for elective procedures and so far includes tonsillectomy, tonsillotomy, hysterectomy and shoulder arthroscopy. The directive mandates physicians who recommend one of the above-mentioned surgeries to inform their patients of their legal right to visit a certified second opinion provider. Since second opinion programmes are a fairly recent phenomenon in Germany, no comprehensive data are yet available on the degree of implementation, users, potential barriers and their effectiveness. We aim to examine the characteristics and the use of second opinion programmes as well as the needs and wishes from the perspective of (potential) users in Germany, with focus on the decision-making process, the patient-physician relationship and the motivation to seek a second opinion, as well as the role of health literacy. METHODS AND ANALYSIS: Six substudies will include the following stakeholders: (1 and 2) patients with one of the four surgery-indications covered by the directive, (3) patients who electively sought an online-based second opinion, (4) patients with oncological diseases, (5) the general population and (6) medical specialists. A mixed-methods approach will be used, including questionnaires, interviews and focus groups. The data will be evaluated using quantitative descriptive analysis and qualitative content analysis. The integration of the results will take place in the form of a triangulation protocol. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Brandenburg Medical School. The findings will be published in peer-reviewed journals and presented at scientific conferences.

Improving care coordination for patients with cardiac disease: Study protocol of the randomised controlled new healthcare programme (Cardiolotse).

INTRODUCTION: A lack of effective coordination and communication between ambulatory care physicians and hospitals, including the lack of follow-up care, poses a challenge to the recovery process of patients suffering from cardiac disease, often resulting in rehospitalisation and adverse outcomes. This innovative care programme aims to bridge the gap between ambulatory and hospital care. A key element of this programme is specifically trained care managers (Cardiolotse) who provide post-discharge support, access to additional resources and help the patient to navigate successfully through the healthcare system. MATERIAL AND METHODS: The study is set up as a prospective, randomised, controlled trial. Allocation to intervention group (support of care managers) and control group (usual care) follows an allocation ratio of 1:1 using block randomisation. Sample size calculations resulted in 1454patients per group after adjusting for potential non-compliance. All participants are surveyed at discharge, after 3 and 12 months. The primary outcome of the study is the 12-month rehospitalisation rate. Secondary outcomes include differences in length of hospital stay, mortality, quality-adjusted life years, costs and patient satisfaction. Statistical analysis and economic evaluation will be complemented by a process evaluation. DISCUSSION: The new healthcare programme is designed to support patients when leaving hospital with cardiac conditions by easing the transition between sectors through access to Cardiolotses and individualised care plans. We hypothesise that the programme reduces rehospitalisation and improves clinically relevant patient outcomes. TRIAL REGISTRATION: German Clinical Trial Register, DRKS00020424. Registered 2020-06-18, http://www.drks.de/DRKS00020424.

Evaluation of the pediatric-centered integrated care AOK Junior: protocol for a mixed-method study.

BACKGROUND: The "AOK-Junior" care program of the AOK Nordost (a German statutory health insurance) completes the primary care for children and adolescents (C&A) in the federal states of Berlin, Brandenburg and Mecklenburg-Vorpommern in Germany. The focus of this program is on prevention and early detection of illness on C&A. Furthermore, the aim is to maintain the health of C&A and to prevent, detect and treat illness on time. Elements of the program are not only the integrated care of C&A, but also, for example, weight reduction and additional medical checkups U10, U11 and J2. The evaluation of the complex intervention should provide information about the effectiveness of early disease detection and costs-effectiveness as well as of other parameters like satisfaction. METHODS: The evaluation is performed on the levels of structural-, process- and results-quality. The cost effectiveness is also assessed by means of a health economic evaluation. In addition to the collection of qualitative and quantitative primary data from participating and non-participating C&A and paediatricians, routine data from a statutory health insurance are used in the evaluation. Furthermore, a cross-sectional design is used to evaluate the structure and process quality. The effectiveness is evaluated in longitudinal section design on the basis of the secondary data. The quantitative surveys include net n = 1096 C&A and n = 340 pediatricians. For the focus groups, a sample of 72 to 96 parents as well as pediatricians will be sought by using the method of theoretical sampling. DISCUSSION: Around 560 pediatricians and 63,000 C&A currently participate in the AOK Nordost care program. The project provides information to what extent secondary preventive measures can lead to the early detection of diseases and on the associated cost-effectiveness. Furthermore, potentials and barriers of the program implementation are identified. The results of the evaluation study are expected not only to contribute to the further development of the care program, but also to derive recommendations for action. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00015280. Prospectively registered on 18 March 2019.

Decision modelling for economic evaluation of liver transplantation.

As the gap between a shortage of organs and the immense demand for liver grafts persists, every available donor liver needs to be optimized for utility, urgency and equity. To overcome this challenge, decision modelling might allow us to gather evidence from previous studies as well as compare the costs and consequences of alternative options. For public health policy and clinical intervention assessment, it is a potentially powerful tool. The most commonly used types of decision analytical models include decision trees, the Markov model, microsimulation, discrete event simulation and the system dynamic model. Analytic models could support decision makers in the field of liver transplantation when facing specific problems by synthesizing evidence, comprising all relevant options, generalizing results to other contexts, extending the time horizon and exploring the uncertainty. For modeling studies of economic evaluation for transplantation, understanding the current nature of the disease is crucial, as well as the selection of appropriate modelling techniques. The quality and availability of data is another key element for the selection and development of decision analytical models. In addition, good practice guidelines should be complied, which is important for standardization and comparability between economic outputs.

Prognostic factors for long-term survival after adult liver transplantation.

PURPOSE: Prognostic factors for survival ≥ 15 years and life years lost after liver transplantation are largely unknown. METHODS: One thousand six hundred thirty primary adult liver transplants between 1983 and 2014 were analyzed. Risk factors for survival were identified with multivariable Cox regression and subsequently tested for their relevance as prognostic factors for observed 15-year survival using multivariable logistic regression and c statistics. The difference of life expectancy between a matched national reference population and survival in patients with post-transplant survival ≥ 15 years was calculated. RESULTS: Survival of ≥ 15 years was observed in 361 patients (22%). Sixty-nine adults died after more than 15 years losing a median of 15 years of life expectancy. One of those patients lived longer while 292 patients still have the chance to survive longer than their normal life expectancy. The indication primary sclerosing cholangitis (PSC) and later eras of transplantation were identified as significant independent protective factors while recipient age > 36.8 years, graft loss due to initial non-function or thrombosis, the indications hepatocellular carcinoma (HCC), hepatitis-C-virus-related cirrhosis (HCV-cirrhosis) and all other indications, donor age > 53 years, the number of surgical complications, and operative durations > 4.5 h were identified as significant independent risk factors limiting survival. All of these factors except the duration of operation had also a significant independent influence on observed 15-year survival (AUROC = 0.739). CONCLUSIONS: Recipients can exceptionally live longer than their normal life expectancy. Older recipients and patients with the indications HCC, HCV-cirrhosis, or other indications except PSC, should be transplanted with younger donor organs.

Which strategies might improve local primary healthcare in Germany? An explorative study from a local government point of view.

BACKGROUND: Facing rising inequities and poorer accessibility of physicians in rural areas, new healthcare delivery structures are being considered to support local healthcare in German communities. To better understand perspectives on and attitudes towards different supplementary models, we examined attitudes among local politicians in the German federal state of Lower Saxony towards the suitability of supplementary care models. METHODS: As part of a cross-sectional study, we surveyed local politicians in Lower Saxony at the local authority and district levels (n = 449) by mail questionnaire. We asked for an assessment of four potential supplementary healthcare models at the local level: the use of trained medical assistants, patients' buses, mobile physicians' offices, and telemedicine. RESULTS: The response rate was 71.0% for mayors (n = 292) and 81.6% (n = 31) for county administrators. In summary, 72.4% of respondents supported the use of trained medical assistants, 48.9% voted for patients' buses, 22.0% for mobile physicians' offices, and 13.9% for telemedicine. Except for telemedicine, the politicians' approval of the supplementary models in rural areas was higher than in urban areas. The assessment regarding the suitability of each model was not significantly connected with indicators of a positively or negatively assessed local healthcare situation. The analyses showed that the use of trained medical assistants was associated with the positive effects of division of labor and potential to relieve physicians. In contrast, there was skepticism about technical support via telemedicine, mostly due to concerns about its unsuitability for elderly people and the potential lower quality of healthcare delivery. CONCLUSION: Local politicians widely accept the use of trained medical assistants, whereas the applicability of technical solutions such as telemedicine is perceived with skepticism. Therefore, the knowledge gap between evidence for and prejudices against telemedicine needs to be addressed more effectively. Reasons for the assessments of the presented models are more likely traceable to personal views than to assessments of the actual estimated local primary care situation.

Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany.

BACKGROUND: Infections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines. However, there is an ongoing discussion on high pharmaceutical prices. Our aim was to assess the long-term cost-effectiveness of treating hepatitis C genotype 1 patients with sofosbuvir/ledipasvir (SOF/LDV) treatment in Germany. MATERIAL AND METHODS: We used a Markov cohort model to simulate disease progression and assess cost-effectiveness. The model calculates lifetime costs and outcomes (quality-adjusted life years, QALYs) of SOF/LDV and other strategies. Patients were stratified by treatment status (treatment-naive and treatment-experienced) and absence/presence of cirrhosis. Different treatment strategies were compared to prior standard of care. Sensitivity analyses were performed to evaluate model robustness. RESULTS: Base-case analyses results show that in treatment-naive non-cirrhotic patients treatment with SOF/LDV dominates the prior standard of care (is more effective and less costly). In cirrhotic patients an incremental cost-effectiveness ratio (ICER) of 3,383 €/QALY was estimated. In treatment-experienced patients ICERs were 26,426 €/QALY and 1,397 €/QALY for treatment-naive and treatment-experienced patients, respectively. Robustness of results was confirmed in sensitivity analyses. CONCLUSIONS: Our analysis shows that treatment with SOF/LDV is cost-effective compared to prior standard of care in all patient groups considering international costs per QALY thresholds.

Would German physicians opt for pay-for-performance programs? A willingness-to-accept experiment in a large general practitioners' sample.

BACKGROUND: Implementing pay-for-performance (P4P) programs is a non-trivial task. As evaluation studies showed, P4P programs often failed to improve performance quality. A crucial element for the successful implementation of P4P is to gain acceptance with health care providers. OBJECTIVES: The aim of our study was to determine, if (and at what bonus rate) German general practitioners (GPs) would participate in a P4P program. We further examined differences between respondents who would participate in a P4P program (participants) versus respondents who would not participate (non-participants). METHODS: A mail survey was conducted among 2493 general practitioners (GPs) in Lower Saxony (with a response rate of 36.2%). The questionnaire addressed attitudes toward P4P and included a willingness to accept experiment concerning P4P implementation. RESULTS: The participation rate increased from 28% (at a bonus of 2.5%) to 50% (at a bonus of 20%). Participants showed better performance in target achievement and expected higher gains from P4P than non-participants. Major attitude differences were found in assessing feasibility of P4P, incentivizing performance and unintended consequences. The crucial factor for (not) accepting P4P might be the sense of (un)fairness of P4P. CONCLUSION: To convince GPs to participate in P4P, better evidence for the effectiveness of P4P is required. To address the concerns of GPs, future endeavors should be directed to tailoring P4P programs. Finally, program implementation must be well communicated and thoroughly discussed with health care providers.

Mothers and Fathers Both Matter: The Positive Influence of Parental Physical Activity Modelling on Children's Leisure-Time Physical Activity.

PURPOSE: To investigate associations between maternal and paternal sport participation, and children's leisure-time physical activity, and to explore differences by child gender. METHOD: The sample comprised 737 year five students (mean age: 11.0 ± 0.6 years, 52% male) recruited through the Fit for Pisa Project which was conducted in 2008 at 6 secondary schools in Goettingen, Germany. Maternal and paternal sport participation were assessed through child reports of mothers' and fathers' weekly participation in sport. Children's leisure-time physical activity was measured as minutes/week that children engaged in organized and nonorganized sport. Multiple linear regression was used to assess associations between maternal and paternal sport participation, and children's leisure-time physical activity. RESULTS: Both maternal and paternal sport participation were positively associated with children's leisure-time physical activity (maternal: b = 34.20, p < .001; paternal: b = 25.32, p < .05). When stratifying analyses by child gender, maternal sport participation remained significantly associated with leisure-time physical activity in girls (b = 60.64, p < .001). In contrast, paternal sport participation remained significantly associated with leisure-time physical activity in boys (b = 43.88, p < .01). CONCLUSION: Both maternal and paternal modeling positively influence children's leisure-time physical activity.

Do children's health resources differ according to preschool physical activity programmes and parental behaviour? A mixed methods study.

Preschool can have positive effects on the development of a healthy lifestyle. The present study analysed to what extent different conditions, structures and behavioural models in preschool and family-children's central social microsystems-can lead to differences in children's health resources. Using a cross-sectional mixed methods approach, contrast analyses of "preschools with systematic physical activity programmes" versus "preschools without physical activity programmes" were conducted to assess the extent to which children's physical activity, quality of life and social behaviour differ between preschools with systematic and preschools without physical activity programmes. Differences in children's physical activity according to parental behaviour were likewise assessed. Data on child-related outcomes and parent-related factors were collected via parent questionnaires and child interviews. A qualitative focused ethnographic study was performed to obtain deeper insight into the quantitative survey data. Two hundred and twenty seven (227) children were interviewed at 21 preschools with systematic physical activity programmes, and 190 at 25 preschools without physical activity programmes. There was no significant difference in children's physical activity levels between the two preschool types (p = 0.709). However, the qualitative data showed differences in the design and quality of programmes to promote children's physical activity. Data triangulation revealed a strong influence of parental behaviour. The triangulation of methods provided comprehensive insight into the nature and extent of physical activity programmes in preschools and made it possible to capture the associations between systematic physical activity promotion and children's health resources in a differential manner.