Understanding health care pathways of patients with sepsis: protocol of a mixed-methods analysis of health care utilization, experiences, and needs of patients with and after sepsis.

BACKGROUND: Sepsis is associated with about 20% of deaths worldwide. It often presents with non-specific initial symptoms, making its emergency treatment an interdisciplinary and cross-sectoral challenge. Three in four sepsis survivors suffers from new cognitive, psychological, or physical sequelae for which specific treatment concepts are scarce. The AVENIR project aims to improve the understanding of patient pathways, and subjective care experiences and needs along the entire healthcare pathway before, with and after sepsis. Based on this, concrete recommendations for the organization of care and patient information materials will be developed with close patient participation. METHODS: Mixed-methods study including (1) analysis of anonymized nationwide health claims data from Germany, (2) linkage of health claims data with patient care reports (PCR) of emergency medical services from study regions in two federal states within Germany, and (3) qualitative exploration of the patient, relative, and care provider perspective on sepsis care. In (1), we analyze inpatient and outpatient health care utilization until 30 days pre-sepsis; clinical sepsis care including intra- and inter-hospital transfers; and rehabilitation, inpatient and outpatient aftercare of sepsis survivors as well as costs for health care utilization until 24 months post-sepsis. We attempt to identify survivor classes with similar health care utilization by Latent Class Analyses. In (2), PCR are linked with health claims data to establish a comprehensive database outlining care pathways for sepsis patients from pre-hospital to follow-up. We investigate e.g., whether correct initial assessment is associated with acute (e.g., same-day lethality) and long-term (e.g., new need for care, long-term mortality) outcomes of patients. We compare the performance of sepsis-specific screening tools such as qSOFA, NEWS-2 or PRESEP in the pre-clinical setting. In (3), semi-structured interviews as well as synchronous and asynchronous online focus groups are conducted and analyzed using qualitative content analyses techniques. DISCUSSION: The results of the AVENIR study will contribute to a deeper understanding of sepsis care pathways in Germany. They may serve as a base for improvements and innovations in sepsis care, that in the long-term can contribute to reduce the personal, medical, and societal burden of sepsis and its sepsis sequelae. TRIAL REGISTRATION: Registered at German Clinical Trial Register (ID: DRKS00031302, date of registration: 5th May 2023).

Association between hospital onset of infection and outcomes in sepsis patients - A propensity score matched cohort study based on health claims data in Germany.

BACKGROUND: Hospital-acquired infections are a common source of sepsis. Hospital onset of sepsis was found to be associated with higher acute mortality and hospital costs, yet its impact on long-term patient-relevant outcomes and costs is unknown. OBJECTIVE: We aimed to assess the association between sepsis origin and acute and long-term outcomes based on a nationwide population-based cohort of sepsis patients in Germany. METHODS: This retrospective cohort study used nationwide health claims data from 23 million health insurance beneficiaries. Sepsis patients with hospital-acquired infections (HAI) were identified by ICD-10-codes in a cohort of adult patients with hospital-treated sepsis between 2013 and 2014. Cases without these ICD-10-codes were considered as sepsis cases with community-acquired infection (CAI) and were matched with HAI sepsis patients by propensity score matching. Outcomes included in-hospital/12-month mortality and costs, as well as readmissions and nursing care dependency until 12 months postsepsis. RESULTS: We matched 33,110 HAI sepsis patients with 28,614 CAI sepsis patients and 22,234 HAI sepsis hospital survivors with 19,364 CAI sepsis hospital survivors. HAI sepsis patients had a higher hospital mortality than CAI sepsis patients (32.8% vs. 25.4%, RR 1.3, p < .001). Similarly, 12-months postacute mortality was higher (37.2% vs. 30.1%, RR=1.2, p < .001). Hospital and 12-month health care costs were 178% and 22% higher in HAI patients than in CAI patients, respectively. Twelve months postsepsis, HAI sepsis survivors were more often newly dependent on nursing care (33.4% vs. 24.0%, RR=1.4, p < .001) and experienced 5% more hospital readmissions (mean number of readmissions: 2.1 vs. 2.0, p < .001). CONCLUSIONS: HAI sepsis patients face an increased risk of adverse outcomes both during the acute sepsis episode and in the long-term. Measures to prevent HAI and its progression into sepsis may be an opportunity to mitigate the burden of long-term impairments and costs of sepsis, e.g., by early detection of HAI progressing into sepsis, particularly in normal wards; adequate sepsis management and adherence to sepsis bundles in hospital-acquired sepsis; and an improved infection prevention and control.

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

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

[Once vaccinated, always vaccinated? A claims data analysis on repeated influenza vaccinations among individuals aged ≥ 60 years]. / Einmal geimpft, immer geimpft? Routinedatenanalyse zur wiederholten Influenzaimpfung von ≥ 60-Jährigen.

BACKGROUND: The Standing Committee on Vaccination recommends the seasonal influenza vaccination as a standard vaccination for individuals aged ≥ 60 years and as an indication vaccination independent of age. Empirical data on repeated vaccination are not available for Germany. The aim of this study was therefore to investigate the frequency and influencing factors of repeated vaccinations. METHODS: We conducted a longitudinal retrospective observational study with claims data from ≥ 60­year-olds insured with the statutory health insurance AOK Plus in Thuringia between 2012 and 2018. The number of seasons with influenza vaccination was described and the association with various individual characteristics was analysed in a regression model. RESULTS: Included were 103,163 individuals with at least one influenza vaccination in the 2014/2015 season, of whom 75.3% had been vaccinated in ≥ 6 of 7 seasons. We found repeated vaccinations more frequently among nursing home residents (rate ratio (RR) 1.27), individuals with increased health risk due to underlying diseases (RR 1.21) and higher age groups (vs. 60-69 years: RR 1.17-1.25). With each additional year of participating in a disease management program, the number of vaccinations increased (RR 1.03). Women (RR 0.91), individuals with nursing care level 1 (vs. no nursing care level: RR 0.90) and people with a comorbidity (vs. no comorbidity: RR 0.97) were less likely to receive repeated vaccinations. DISCUSSION: A large proportion of individuals aged ≥ 60 years who have been vaccinated against influenza once is likely to repeatedly receive vaccinations. In accordance with vaccination recommendations, nursing home residents and in particular individuals with an increased health risk are vaccinated repeatedly. General practitioners play a central role: non-acute patient contacts should be used to offer vaccinations, especially to women and individuals in need of care who are living at home.

[Utilization of palliative care at the end of life in Germany: temporal trend (2016-2019) and regional variability]. / Inanspruchnahme von Palliativversorgung am Lebensende in Deutschland: zeitlicher Verlauf (2016­2019) und regionale Variabilität.

BACKGROUND: In Germany, palliative care (PC) is provided on a homecare, inpatient, general, and specialized basis. Since little is currently known about the temporal course and regional differences in the forms of care, the present study was aimed to investigate this. METHOD: In a retrospective routine data study with 417,405 BARMER-insured persons who died between 2016 and 2019, we determined the utilization rates of primary PC (PPC), specially qualified and coordinated palliative homecare (PPC+), specialized palliative homecare (SPHC), inpatient PC, and hospice care on the basis of services billed at least once in the last year of life. We calculated time trends and regional variability and controlled for needs-related patient characteristics and access-related county of community characteristics. RESULTS: From 2016 to 2019, total PC increased from 33.8 to 36.2%, SPHC from 13.3 to 16.0% (max: Rhineland-Palatinate), and inpatient PC from 8.9 to 9.9% (max: Thuringia). PPC decreased from 25.8 to 23.9% (min: Brandenburg) and PPC+ came in at 4.4% (max: Saarland) in 2019. Hospice care remained constant at 3.4%. Regional variability in utilization rates remained high, increased for PPC and inpatient PC from 2016 to 2019, and decreased for SPHC and hospice care. The regional differences were also evident after adjustment. CONCLUSION: Increasingly more SPHC, less PPC, and high regional variability, which cannot be explained by demand- or access-related characteristics, indicate that the use of PC forms is oriented less to demand than to regionally available care capacities. In view of the growing need for palliative care due to demographic factors and decreasing personnel resources, this development must be viewed critically.

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

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

[DNVF Memorandum: Health Services Research in the Last Year of Life]. / DNVF-Memorandum Versorgungsforschung im letzten Lebensjahr.

This memorandum outlines current issues concerning health services research on seriously ill and dying people in the last year of their lives as well as support available for their relatives. Patients in the last phase of life can belong to different disease groups, they may have special characteristics (e. g., people with cognitive and complex impairments, economic disadvantage or migration background) and be in certain phases of life (e. g., parents of minor children, (old) age). The need for a designated memorandum on health services research in the last year of life results from the special situation of those affected and from the special features of health services in this phase of life. With reference to these special features, this memorandum describes methodological and ethical specifics as well as current issues in health services research and how these can be adequately addressed using quantitative, qualitative and mixed methods. It has been developed by the palliative medicine section of the German Network for Health Services Research (DNVF) according to the guidelines for DNVF memoranda.

[Emergency situations and emergency department visits in nursing homes-a scoping review about circumstances and healthcare interventions]. / Notfallsituationen und Krankenhauszuweisungen in Pflegeeinrichtungen ­ ein Scoping-Review zu Begleitumständen und versorgungsrelevanten Maßnahmen.

BACKGROUND: Nursing home residents are more likely to be hospitalized as non-institutionalized peers. A large number of emergency medical services (EMS) and emergency department visits are classified as potentially avoidable. OBJECTIVES: To identify circumstances that increase the number of emergency situations in nursing homes and approaches to reduce hospital admissions in order to illustrate the complexity and opportunities for action. MATERIALS AND METHODS: Scoping review with analysis of current original and peer-reviewed papers (2015-2020) in PubMed, CINAHL, and hand-search databases. RESULTS: From 2486 identified studies, 302 studies were included. Injuries, fractures, cardiovascular, respiratory, and infectious diseases are the most frequent diagnostic groups that have been retrospectively recorded. Different aspects could be identified as circumstances inducing emergency department visits: resident-related (e.g., multimorbidity, lack of volition, and advance directives), facility-related (e.g., staff turnover, uncertainties), physician-related (lack of accessibility, challenging access to specialists), and system-related circumstances (e.g., limited possibilities for diagnostics and treatment in facilities). Multiple approaches to reduce emergency department visits are being explored. CONCLUSIONS: A variety of circumstances influence the course of action in emergency situations in nursing facilities. Therefore, interventions to reduce emergency department visits address, among other things, strengthening the competence of nursing staff, interprofessional communication, and systemic approaches. A comprehensive understanding of the complex processes of care is essential for developing and implementing effective interventions.

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

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

Psychological interventions for posttraumatic stress disorder involving primary care physicians: systematic review and Meta-analysis of randomized controlled trials.

BACKGROUND: Evidence-based psychological interventions for posttraumatic stress disorder (PTSD) are available in specialized settings, but adequate care in primary care is often lacking. The aim of this systematic review was to determine the effectiveness of psychological interventions for PTSD involving primary care physicians (PCPs) and to characterize these interventions as well as their providers. METHOD: A systematic review and meta-analyses of randomized controlled trials (RCTs). Primary outcome were symptoms of PTSD. RESULTS: Four RCTs with a total of 774 patients suffering from PTSD symptoms were included, all applying cognitive behavioural based interventions. Three studies with psychological interventions being conducted by case managers were pooled in a meta-analysis. Interventions were not effective in the short term (0-6 months; SMD, - 0.1; 95% CI, - 0.24-0.04; I2 = 0%). Only two studies contributed to the meta-analysis for long term (12-18 months) outcomes yielding a small effect (SMD, - 0.23; 95% CI, - 0.38- -0.08; I2 = 0%). CONCLUSIONS: Psychological interventions for PTSD in primary care settings may be effective in the long term but number and quality of included studies was limited so the results should be interpreted with caution.

[Date of Service Provision and Date of Payment in Claims Data: Dealing with Time Differences]. / Leistungs- und Abrechnungsdatum in GKV-Routinedaten: Umgang mit zeitlichen Abweichungen.

AIM: The paper quantifies discrepancies between date of payment and date of service provision when doing analyses in relation to date of death and also in relation to the end of a calendar year. In analyses of this type, time differences between service provision and payment can lead to both under- and overestimation of service use. We aim to capture these phenomena in claims data from different sectors (primary care, medication prescription, prescription of remedies and medical aids, hospital care). METHOD: We have used pre-structured claims data from a scientific data warehouse of a large German statutory health insurance covering people that died in 2016. We investigated the discrepancies in time between date of service provision and date of payment for different outpatient and inpatient services based on data from 2015 to 2017. An exact date (dd/mm/yyyy) was only available for data covering prescriptions of remedies and medical aids. Data covering medication prescriptions were only exact to the month of payment (mm/yyyy), whereas data covering outpatient physician care were only exact to the quarter of payment (q/yyyy). RESULTS: For both outpatient physician care and hospital care, less than 1% had a payment date after the date of death. The share is considerably higher (28-31%) for prescriptions of remedies and medical aids. The majority of payments occurred within 3 months after death (93% for prescriptions of remedies and medical aids, 67% for primary care services). Less than 1% of outpatient physician care and about 18% of remedies had been paid after the end of the calender year 2015. Here too, the majority of payments were made within the first 3 months of 2016 (100% of prescriptions of remedies and medical aids, 65% of primary care services). CONCLUSIONS: Discrepancies in time between date of service provision and date of payment pose a challenge and are a potential source of under-/overestimation of health service utilization when doing analyses in relation to date of death or the end of a calendar year. This needs to be taken into account when requesting the data, but also in preparing and analysing them. The primary recommendation is to ensure that services with a payment date after death are included explicitly.

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

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

Multidisciplinary intervention to improve medication safety in nursing home residents: protocol of a cluster randomised controlled trial (HIOPP-3-iTBX study).

BACKGROUND: Medication safety is an important health issue for nursing home residents (NHR). They usually experience polypharmacy and often take potentially inappropriate medications (PIM) and antipsychotics. This, coupled with a frail health state, makes NHR particularly vulnerable to adverse drug events (ADE). The value of systematic medication reviews and interprofessional co-operation for improving medication quality in NHR has been recognized. Yet the evidence of a positive effect on NHR' health and wellbeing is inconclusive at this stage. This study investigates the effects of pharmacists' medication reviews linked with measures to strengthen interprofessional co-operation on NHR' medication quality, health status and health care use. METHODS: Pragmatic cluster randomised controlled trial in nursing homes in four regions of Germany. A total of 760 NHR will be recruited. Inclusion: NHR aged 65 years and over with an estimated life expectancy of at least six months. Intervention with four elements: i) introduction of a pharmacist's medication review combined with a communication pathway to the prescribing general practitioners (GPs) and nursing home staff, ii) facilitation of change in the interprofessional cooperation, iii) educational training and iv) a "toolbox" to facilitate implementation in daily practice. ANALYSIS: primary outcome - proportion of residents receiving PIM and ≥ 2 antipsychotics at six months follow-up. Secondary outcomes - cognitive function, falls, quality of life, medical emergency contacts, hospital admissions, and health care costs. DISCUSSION: The trial assesses the effects of a structured interprofessional medication management for NHR in Germany. It follows the participatory action research approach and closely involves the three professional groups (nursing staff, GPs, pharmacists) engaged in the medication management. A handbook based on the experiences of the trial in nursing homes will be produced for a rollout into routine practice in Germany. TRIAL REGISTRATION: Registered in the German register of clinical studies (DRKS, study ID DRKS00013588 , primary register) and in the WHO International Clinical Trials Registry Platform (secondary register), both on 25th January 2018.

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

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

Increasing influenza and pneumococcal vaccine uptake in the elderly: study protocol for the multi-methods prospective intervention study Vaccination60.

BACKGROUND: Influenza and pneumococcal vaccination can prevent disease and potentially life-threatening complications like sepsis. Elderly people have an increased risk of severe disease and therefore constitute a major target group for vaccination. To increase vaccination coverage, targeted interventions are needed that take theory-based specific determinants of vaccination behaviour into account. Moreover, message and campaign design should consider specific age-related characteristics (e.g., information processing, media use). The aim of this study is (i) to identify the specific informational and interventional needs of this risk group, (ii) to design and implement a targeted intervention aiming to decrease vaccine hesitancy, increase vaccine uptake and decrease the health and economic burden due to the respective diseases, and (iii) to measure the effect of this evidence-informed intervention on various levels. METHODS: Prospective, multi-methods intervention study targeting individuals aged ≥60 years in a model region in Germany (federal state of Thuringia, 500,000 inhabitants ≥60 years old). The development of the intervention follows theory-based and evidence-informed principles: Data from a cross-sectional representative study provide insights into specific determinants of the target group's vaccination behaviour. Additionally, media use is analysed to identify adequate communication channels for specific subgroups. In pilot studies, the intervention materials are adapted to the specific cognitive requirements of the target group. For development and implementation of the intervention, an interdisciplinary and trans-sectoral approach is used, including psychology, communication science, design, medical science, epidemiology and various public health players. The intervention will be implemented in autumn and winter 2017/18 and 2018/19 and adjusted in between. Evaluation of the intervention includes: awareness, use and recall of intervention materials, effects on changes in determinants of vaccination behaviour, self-reported vaccine uptake, and vaccination coverage in the intervention area (primary outcomes), as well as disease incidences (secondary outcomes) and the economic burden of influenza, pneumonia, invasive pneumococcal disease and sepsis for the healthcare system (tertiary outcomes). DISCUSSION: The data will add to the body of evidence on the effectiveness of evidence-informed vaccination campaign development as well as on the clinical and economic effects of pneumococcal and influenza vaccination. The effect of the intervention will teach valuable lessons about the principles of campaign development and evaluation, and can motivate a subsequent nationwide intervention. TRIAL REGISTRATION: DRKS00012653 . Registered 24.11.2017. Retrospectively registered.

German general practitioners' self-reported management of patients with chronic depression.

BACKGROUND: Patients with chronic depression (persisting symptoms for ≥2 years) are a clinically relevant group with extensive (co)morbidity, high functional impairment and associated costs in primary care. The General Practitioner (GP) is the main health professional attending to these patients. The aim of this study was to examine the GPs' perception on managing patients with chronic depression. METHODS: We performed an explorative cross-sectional study with a systematic sample of GPs in central Germany. Source of data was a written questionnaire (46 items). Descriptive analysis was carried out. RESULTS: Two hundred twenty (out of 1000; 22%) GPs participated. 93% of the GPs distinguish between care for patients with chronic depression and acute depressive episode. 92% would recommend psychotherapeutic co-treatment to the chronically depressed patient. 52% of GPs would favour a general restraint on antidepressants (ADs) in older chronically depressed patients (≥ 75 years) whereas 40% suggest long-term pharmacotherapy. If severe physical comorbidity is present GPs would be restrictive in prescribing ADs (65%) or would urgently refer to specialist psychiatric services (40%). In case of a comorbid anxiety disorder 66% of the GPs would suggest a combined psycho- und pharmacotherapy. If a substance use disorder coexists 84% would prefer urgent referrals to specialist services. CONCLUSIONS: Participating GPs report awareness towards chronic depression in their patients. Physical and mental comorbidity seem to play an important role in GPs' treatment decisions.

Effect of a Primary Care Management Intervention on Mental Health-Related Quality of Life Among Survivors of Sepsis: A Randomized Clinical Trial.

IMPORTANCE: Survivors of sepsis face long-term sequelae that diminish health-related quality of life and result in increased care needs in the primary care setting, such as medication, physiotherapy, or mental health care. OBJECTIVE: To examine if a primary care-based intervention improves mental health-related quality of life. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted between February 2011 and December 2014, enrolling 291 patients 18 years or older who survived sepsis (including septic shock), recruited from 9 intensive care units (ICUs) across Germany. INTERVENTIONS: Participants were randomized to usual care (n = 143) or to a 12-month intervention (n = 148). Usual care was provided by their primary care physician (PCP) and included periodic contacts, referrals to specialists, and prescription of medication, other treatment, or both. The intervention additionally included PCP and patient training, case management provided by trained nurses, and clinical decision support for PCPs by consulting physicians. MAIN OUTCOMES AND MEASURES: The primary outcome was change in mental health-related quality of life between ICU discharge and 6 months after ICU discharge using the Mental Component Summary (MCS) of the 36-Item Short-Form Health Survey (SF-36 [range, 0-100; higher ratings indicate lower impairment; minimal clinically important difference, 5 score points]). RESULTS: The mean age of the 291 patients was 61.6 years (SD, 14.4); 66.2% (n = 192) were men, and 84.4% (n = 244) required mechanical ventilation during their ICU stay (median duration of ventilation, 12 days [range, 0-134]). At 6 and 12 months after ICU discharge, 75.3% (n = 219 [112 intervention, 107 control]) and 69.4% (n = 202 [107 intervention, 95 control]), respectively, completed follow-up. Overall mortality was 13.7% at 6 months (40 deaths [21 intervention, 19 control]) and 18.2% at 12 months (53 deaths [27 intervention, 26 control]). Among patients in the intervention group, 104 (70.3%) received the intervention at high levels of integrity. There was no significant difference in change of mean MCS scores (intervention group mean at baseline, 49.1; at 6 months, 52.9; change, 3.79 score points [95% CI, 1.05 to 6.54] vs control group mean at baseline, 49.3; at 6 months, 51.0; change, 1.64 score points [95% CI, -1.22 to 4.51]; mean treatment effect, 2.15 [95% CI, -1.79 to 6.09]; P = .28). CONCLUSIONS AND RELEVANCE: Among survivors of sepsis and septic shock, the use of a primary care-focused team-based intervention, compared with usual care, did not improve mental health-related quality of life 6 months after ICU discharge. Further research is needed to determine if modified approaches to primary care management may be more effective. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN61744782.

Rehabilitation interventions for postintensive care syndrome: a systematic review.

OBJECTIVE: An increasing number of ICU patients survive and develop mental, cognitive, or physical impairments. Various interventions support recovery from this postintensive care syndrome. Physicians in charge of post-ICU patients need to know which interventions are effective. DATA SOURCES: Systematic literature search in databases (MEDLINE, EMBASE, Cochrane CENTRAL, PsycInfo, CINAHL; 1991-2012), reference lists, and hand search. STUDY SELECTION: We included comparative studies of rehabilitation interventions in adult post-ICU patients if they considered health-related quality of life, frequency/severity of postintensive care syndrome symptoms, functional recovery, need for care, autonomy in activities of daily living, mortality, or hospital readmissions. DATA EXTRACTION: Two reviewers extracted data and assessed risk of bias independently. DATA SYNTHESIS: From 4,761 publications, 18 studies with 2,510 patients were included. Studies addressed 20 outcomes, using 45 measures, covering inpatient (n = 4 trials), outpatient (n = 9), and mixed (n = 5) healthcare settings. Eight controlled trials with moderate to high quality were considered for evaluation of effectiveness. They investigated inpatient geriatric rehabilitation, ICU follow-up clinic, outpatient rehabilitation, disease management, and ICU diaries. Five of these trials assessed posttraumatic stress disorder, with four trials showing positive effects: first, ICU diaries reduced new-onset posttraumatic stress disorder (5% vs 13%, p = 0.02) after 3 months and second showed a lower mean Impact of Event Scale-Revised score (21.0 vs 32.1, p = 0.03) after 12 months. Third, aftercare by ICU follow-up clinic reduced Impact of Event Scale for women (20 vs 31; p < 0.01). Fourth, a self-help manual led to fewer patients scoring high in the Impact of Event Scale after 8 weeks (p = 0.026) but not after 6 months. For none of the other outcomes did more than one study report positive impacts. CONCLUSION: Interventions which have substantial effects in post-ICU patients are rare. Positive effects were seen for ICU-diary interventions for posttraumatic stress disorder. More interventions for the growing number of ICU survivors are needed.

Utilization and quality of palliative care in patients with hematological and solid cancers: a population-based study.

BACKGROUND: Palliative care (PC) contributes to improved end-of-life care for patients with hematologic malignancies (HM) and solid tumors (ST) by addressing physical and psychological symptoms and spiritual needs. Research on PC in HM vs. ST patients is fragmented and suggests less use. METHODS: We analyzed claims data of all deceased members of a large German health insurance provider for the year before death. First, we analyzed the frequency and the beginning of different types of PC and compared patients with HM vs. ST. Second, we analyzed the adjusted impact of PC use on several end-of-life quality outcomes in patients with HM vs. ST. We performed simple and multiple (logistic) regression analysis, adjusted for relevant covariates, and standardized for age and sex. RESULTS: Of the 222,493 deceased cancer patients from 2016 to 2020, we included 209,321 in the first analysis and 165,020 in the second analysis. Patients with HM vs. ST received PC less often (40.4 vs. 55.6%) and later (34 vs. 50 days before death). PC use significantly improved all six quality indicators for good end-of-life care. HM patients had worse rates in five of the six indicators compared with ST patients. Interaction terms revealed that patients with ST derived greater benefit from PC in five of six quality indicators than those with HM. CONCLUSION: The data highlight the need to integrate PC more often, earlier, and more effectively into the care of patients with HM.

Cost-effectiveness of depression case management in small practices.

BACKGROUND: Case management undertaken by healthcare assistants in small primary care practices is effective in improving depression symptoms and adherence in patients with major depression. AIMS: To evaluate the cost-effectiveness of depression case management by healthcare assistants in small primary care practices. METHOD: Cost-effectiveness analysis on the basis of a pragmatic randomised controlled trial (2005-2008): practice-based healthcare assistants in 74 practices provided case management to 562 patients with major depression over 1 year. Our primary outcome was the incremental cost-effectiveness ratio (ICER) calculated as the ratio of differences in mean costs and mean number of quality-adjusted life-years (QALYs). Our secondary outcome was the mean depression-free days (DFDs) between the intervention and control group at 24-month follow-up. The study was registered at the International Standard Randomised Controlled Trial Number Registry: ISRCTN66386086. RESULTS: Intervention v. control group: no significant difference in QALYs; significantly more DFDs (mean: 373 v. 311, P<0.01); no significant difference in mean direct healthcare costs (€4495 v. €3506, P = 0.16); considerably lower mean indirect costs (€5228 v. €7539, P = 0.06), resulting in lower total costs (€9723 v. €11 045, P = 0.41). The point estimate for the cost-utility ratio was €38 429 per QALY gained if only direct costs were considered, and 'dominance' of the intervention if total costs were considered. Yet, regardless of decision makers' willingness to pay per QALY, the probability of the intervention being cost-effective was never above 90%. CONCLUSIONS: In small primary care practices, 1 year of case management did not increase the number of QALYs but it did increase the number of DFDs. The intervention was likely to be cost-effective.