Changes in patient care through flexible and integrated treatment programs in German psychiatric hospitals: meta-analyses based on a series of controlled claims-based cohort studies.

BACKGROUND: Global treatment budgets, i.e. predefined budgets for patients treated in hospital independent of the setting within the hospital, together with flexible and integrated treatment (FIT) have been introduced in some German psychiatric hospitals since 2013. We investigated pooled changes in inpatient, day-care, outpatient treatment, and continuity of care for patients with mental disorders in 12 FIT-hospitals. METHODS: We conducted a series of 12 controlled cohort studies regarding FIT hospitals using anonymized patient claims data from more than 70 German statutory health insurance funds. Each study compared one FIT-hospital to matched patients from equivalent non-FIT-hospitals (routine care). We included only those patients without treatment in the respective hospital within two years prior to first hospital treatment (either FIT or routine care). We contrasted results between the year prior to with the first and second year after patient's first treatment (treatment continuity: only group comparison) using multivariate multi-level models. To approximate the difference-in-difference effect in the meta-analysis, we used the interaction terms group (FIT hospital vs. routine care) x time (year before vs. first or second patient year after study inclusion) in the Poisson models. RESULTS: The 12 studies included 36,069 patients with 2,358 patients from a Department of child and adolescent psychiatry. The pooled effect revealed a 5.1 days lower increase in inpatient treatment in FIT-hospitals during the first patient year compared to routine care. Results were statistically significant for adult care FIT-hospitals but not for child and adolescent FIT-hospitals. Utilization of day-care treatment increased more in most FIT-hospitals during the first year, while outpatient contacts increased in some and decreased in others. The odds of treatment continuity increased by 1.4 in FIT-hospitals compared to non-FIT-hospitals. CONCLUSIONS: Global treatment budgets lead to the intended changes in mental health care in the majority of FIT-hospitals compared to routine care in this large real-world evidence study from Germany. For child and adolescent psychiatry, more evidence is needed to draw firm conclusions. TRIAL REGISTRATION: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).

Agreement between self-reports and statutory health insurance claims data on healthcare utilization in patients with mental disorders.

BACKGROUND: Data on resource use are frequently required for healthcare assessments. Studies on healthcare utilization (HCU) in individuals with mental disorders have analyzed both self-reports and administrative data. Source of data may affect the quality of analysis and compromise the accuracy of results. We sought to ascertain the degree of agreement between self-reports and statutory health insurance (SHI) fund claims data from patients with mental disorders. METHODS: Claims data from six German SHI and self-reports were obtained along with a cost-effectiveness analysis performed as a part of a controlled prospective multicenter cohort study conducted in 18 psychiatric hospitals in Germany (PsychCare), including patients with pre-defined psychiatric disorders. Self-reports were collected using the German adaption of the Client Sociodemographic and Service Receipt Inventory (CSSRI) questionnaire with a 6-month recall period. Data linkage was performed using a unique pseudonymized identifier. Missing responses were coded as non-use for all analyses. HCU was calculated for inpatient and outpatient care, day-care services, home treatment, and pharmaceuticals. Concordance was measured using Cohen's Kappa (κ) and intraclass correlation coefficient (ICC). Regression approaches were used to investigate the effect of independent variables on the agreements. RESULTS: In total 274 participants (mean age 47.8 [SD = 14.2] years; 47.08% women) were included in the analysis. No significant differences were observed between the linked and unlinked patients in terms of baseline characteristics. Total agreements values were 63.9% (κ = 0.03; PABAK = 0.28) for outpatient contacts, 69.3% (κ = 0.25; PABAK = 0.39) for medication use, 81.0% (κ = 0.56; PABAK = 0.62) for inpatient days and 86.1% (κ = 0.67; PABAK = 0.72) for day-care services. There was varied quantitative agreement between data sources, with the poorest agreement for outpatient care (ICC [95% CI] = 0.22 [0.10-0.33]) and the best for psychiatric day-care services (ICC [95% CI] = 0.72 [0.66-0.78]). Marital status and time since first treatment positively affected the chance of agreement on utilization of outpatient services. CONCLUSIONS: Although there were high levels of absolute agreement, the measures of concordance between administrative records and self-reports were generally minimal to moderate. Healthcare investigations should consider using linked or at least different data sources to estimate HCU for specific utilization areas, where unbiased information can be expected. TRIAL REGISTRATION: This study was part of the multi-center controlled PsychCare trial (German Clinical Trials Register No. DRKS00022535; Date of registration: 2020-10-02).

Evaluation of a flexible and integrative psychiatric care model in a department of child and adolescent psychiatry in Tübingen, Germany: study protocol (EVA_TIBAS).

BACKGROUND: Model projects for flexible and integrated treatment (FIT) in Germany aim at advancing the quality of care for people with mental disorders. A new FIT model project was established in 2017 at the Department of child and adolescent psychiatry (KJP) of the University Hospital Tübingen (Universitätsklinikum Tübingen, UKT). The study design of EVA_TIBAS presented here describes the evaluation of the FIT model project at the KJP of the UKT. This evaluation aims at quantifying the anticipated FIT model project changes, which are to improve patients' cross-sectoral care at the same maximum cost as standard care. METHODS: EVA_TIBAS is a controlled cohort study using a mix of quantitative and qualitative methods. The FIT evaluation consists of three modules. In Module A, anonymized claims data of a statutory health insurance fund will be used to compare outcomes (duration of inpatient and day care psychiatric treatment, inpatient and day care psychiatric length of stay, outpatient psychiatric treatment in hospital, inpatient hospital readmission, emergency admission rate, direct medical costs) of patients treated in the model hospital with patients treated in structurally comparable control hospitals (estimated sample size = ca. 600 patients). In Module B, patient-reported outcomes (health related quality of life, symptom burden, return to psychosocial relationships (e.g. school, friends, hobbies), treatment satisfaction, societal costs) will be assessed quantitatively using validated questionnaires for the model and two control hospitals (estimated sample size = ca. 300 patients). A subsequent health economic evaluation will be based on cost-effectiveness analyses from both the insurance fund's and the societal perspective. In Module C, about 30 semi-structured interviews will examine the quality of offer, effects and benefits of the service offered by the social service of the AOK Baden-Württemberg (for stabilizing the overall situation of care in the family) in the model hospital. A focus group discussion will address the quality of cooperation between employees of the university hospital and the social services. DISCUSSION: The results of this evaluation will be used to inform policy makers whether this FIT model project or aspects of it should be implemented into standard care. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov PRS (ID: NCT04727359 , date: 27 January 2021).

[Methodological Challenges when Using Claims Data of more than 70 Statutory Health Insurances - A Progress Report from the EVA64 Study]. / Methodische Herausforderungen bei der Nutzung von Daten von mehr als 70 gesetzlichen Krankenkassen ­ Ein Werkstattbericht aus der EVA64-Studie.

AIM OF THE STUDY: The adequate and need-based medical care of mentally ill patients places special demands on psychiatric care. The §64b Social Code Book (SGB) V enables mentoring mentally ill people through multiprofessional, cross-sectoral model projects across the treatment phase and implementing new forms of financing. These model projects have been evaluated in a prospective and retrospective claims data-based controlled cohort study (EVA64) since 2015. METHODS: In September 2016 and since then annually, the data transfer of all statutory health insurance funds (SHI) involved in this evaluation took place for the first time on the basis of a consented data set description. For later analysis, the clear identification of the index hospital admission and the assignment to the model or control group are important. The methodological challenges of data provision by the data owner, the formal and content-related data preparation as well as the subsequent establishing of an evaluation data set are discussed in detail. RESULTS: So far, data from 71 SHI has been taken into account. In each case 20 tables with claims data from outpatient and inpatient care (including psychiatric institute outpatient departments [PIA]), drug and medical supplies as well as data from incapacity to work and personal data of the insurees. Not all tables could be filled completely by the SHIs. In addition, updates of the study designs require the adaptation of the data selection process. Even though data sets have been delievered regularly the data preparation process is still not routine. CONCLUSION: The scientific use of claims data of numerous SHIs in the context of an evaluation study represents a great challenge. In the absence of reference values for abnormalities and implausibilities, an a priori determination of test algorithms was limited; instead they had to be updated every year. The individual examination of the data of all health insurance companies remains very complex. The detailed documentation of these algorithms provides support for future comparable studies.

The influence of cross-sectoral treatment models on patients with mental disorders in Germany: study protocol of a nationwide long-term evaluation study (EVA64).

BACKGROUND: Close, continuous and efficient collaboration between different professions and sectors of care is necessary to provide patient-centered care for individuals with mental disorders. The lack of structured collaboration between in- and outpatient care constitutes a limitation of the German health care system. Since 2012, a new law in Germany (§64b Social code book (SGB) V) has enabled the establishment of cross-sectoral and patient-centered treatment models in psychiatry. Such model projects follow a capitation budget, i.e. a total per patient budget of inpatient and outpatient care in psychiatric clinics. Providers are able to choose the treatment form and adapt the treatment to the needs of the patients. The present study (EVA64) will investigate the effectiveness, costs and efficiency of almost all model projects established in Germany between 2013 and 2016. METHODS/DESIGN: A health insurance data-based controlled cohort study is used. Data from up to 89 statutory health insurance (SHI) funds, i.e. 79% of all SHI funds in Germany (May 2017), on inpatient and outpatient care, pharmaceutical and non-pharmaceutical treatments and sick leave for a period of 7 years will be analyzed. All patients insured by any of the participating SHI funds and treated in one of the model hospitals for any of 16 pre-defined mental disorders will be compared with patients in routine care. Sick leave (primary outcome), utilization of inpatient care (primary outcome), utilization of outpatient care, continuity of contacts in (psychiatric) care, physician and hospital hopping, re-admission rate, comorbidity, mortality, disease progression, and guideline adherence will be analyzed. Cost and effectivity of model and routine care will be estimated using cost-effectiveness analyses. Up to 10 control hospitals for each of the 18 model hospitals will be selected according to a pre-defined algorithm. DISCUSSION: The evaluation of complex interventions is an important main task of health services research and constitutes the basis of evidence-guided advancement in health care. The study will yield important new evidence to guide the future provision of routine care for mentally ill patients in Germany and possibly beyond. TRIAL REGISTRATION: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713 ).

Health-related quality of life among patients with treated alcohol use disorders, schizophreniform disorders or affective disorders and the influence of flexible and integrative psychiatric care models in Germany (PsychCare).

Introduction: Flexible and integrated treatment options (FIT) have been established in German psychiatric hospitals to enhance continuous and patient-centered treatment for patients with mental disorders. We hypothesized that patients with experience in FIT treatment showed higher health-related quality of life (HRQoL) and comparable symptom severity compared with patients treated as usual (TAU). Further, we expected that some sub-dimensions of HRQoL determined HRQoL results clearer than others, while certain factors influenced HRQoL and symptom severity stronger in the FIT compared to the TAU group. In addition, we hypothesized that HRQoL is correlated with symptom severity. Methods: We undertook a controlled, prospective, multicenter cohort study (PsychCare) conducted in 18 psychiatric hospitals in Germany, using the questionnaires Quality of Well Being Self-Administered (QWB-SA) (HRQoL) and Symptom-Checklist-K-9 (SCL-K-9) (symptom severity) at recruitment (measurement I) and 15 months later (measurement II). We assessed overall HRQoL (measured in health utility weights (HUW) and symptom severity score for patients from FIT and TAU treatment. We investigated the QWB-SA dimensions and separated the results by diagnosis. We used beta regressions to estimate the effect of multiple co-variates on both outcomes. To investigate the correlation between HRQoL and symptom severity, we used Pearson correlation. Results: During measurement I, 1,150 patients were recruited; while 359 patients participated during measurement II. FIT patients reported higher HUWs at measurement I compared to TAU patients (0.530 vs. 0.481, p = 0.003) and comparable HUWs at measurement II (0.581 vs. 0.586, p = 0.584). Symptom severity was comparable between both groups (I: 21.4 vs. 21.1, p = 0.936; II: 18.8 vs. 19.8, p = 0.122). We found lowest HRQoL and highest symptom severity in participants with affective disorders. HRQoL increased and symptom severity decreased over time in both groups. The QWB-SA dimension acute and chronic symptoms was associated with highest detriments in HRQoL. We identified risk/protective factors that were associated with lower quality of life and higher symptom severity in both groups. We confirmed that HRQoL was negatively associated with symptom severity. Discussion: Health-related quality of life (during hospital treatment) was higher among patients treated in FIT hospitals compared to patients in routine care, while symptom severity was comparable between both groups.

Lengths of inpatient stay and sick leave of patients with mental diseases: disorder-specific effects of flexible and integrated treatment programs in Germany.

Mental disorders pose a worldwide growing public health burden. One of the major challenges for healthcare systems remains to respond to the need of patients with mental disorders for continuous and flexible treatment. The EVA64 study evaluates novel programs of flexible and integrative treatment (FIT) in hospitals. This manuscript presents results from the evaluation of FIT hospitals in comparison to hospitals from regular routine care. In addition to data from adult patients, we also present data from affiliated child and adolescent psychiatric wards employing FIT programs. Using comprehensive claims data, primary outcomes are the utilization of inpatient care and sick leave for a priori defined clusters of mental disorders. We stratify between patients already under treatment (ongoing treatment) and patients with incident treatment cases (initial treatment) at the point of inclusion in the study. In the initial treatment group, we found a significant reduction in the length of inpatient stay of 4.1 days in FIT hospitals compared to routine care. While patients with mood affective disorders (-1.8 days) and patients with neurotic, stress-related, and somatoform disorders (-3.6 days) showed an even stronger effect of the reduction of inpatient lengths of stay, the effect was significantly weaker in patients with mental and behavioral disorders due to use of alcohol (+3.3 days). Regarding the duration of sick leave, we found no significant treatment effect of FIT programs compared to routine care. In the ongoing treatment group of adult patients, we found a significantly lower utilization of inpatient treatment by 1.3 days as well as a shorter duration of sick leave by 4.3 days in FIT hospitals compared to routine care. In the cohort of children and adolescent patients, we also did not observe a significant treatment effect in either the initial treatment group or the ongoing treatment group. Registration: this study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).

[Reduction of Days in Inpatient Care in Psychiatric Hospitals with Flexible and Integrated Treatment for Patient-Centered Care with a Global Budget - Results with Three-Year Follow-up from the Evaluation Study EVA64]. / Verringerung vollstationärer Behandlungstage in psychiatrischen Kliniken mit Modellvorhaben zur patientenzentrierten Versorgung mit globalem Budget (§â€Š64b SGB V).

OBJECTIVE: This analysis describes the development of the duration of inpatient and daycare treatment as well as contacts in outpatient PIA in hospitals with flexible and integrated treatment (FIT) over a three-year follow-up period. METHODS: Patients with treatment in the first year after FIT-onset and a follow-up period of three years were examined for 12 FIT-hospitals and compared with matched patients from hospitals providing routine care. RESULTS: 11,536 patients were analyzed. In the year after first treatment, the number of inpatient days was lower in almost all FIT-hospitals compared to routine care. On the other hand, the number of daycare treatment days was mostly higher than in routine care. FIT hospitals with a pre-existing FIT-like structure showed stronger effects. PIA utilization differed between FIT-hospitals. CONCLUSION: This analysis supports evidence-based health policy decisions on the adoption of patient-centered global budget care concepts.

Multiperspective and Multimethod Evaluation of Flexible and Integrative Psychiatric Care Models in Germany: Study Protocol of a Prospective, Controlled Multicenter Observational Study (PsychCare).

Background: New cross-sectoral mental health care models have been initiated in Germany to overcome the fragmentation of the German health care system. Starting in 2013, flexible and integrative psychiatric care model projects according to §64b SGB V German Social Law (FIT64b) have been implemented. The study "PsychCare" combines quantitative and qualitative primary data with routine health insurance data for the evaluation of these models. Effects, costs and cost-effectiveness from the perspectives of patients, relatives and care providers are compared with standard care. Additionally, quality indicators for a modern, flexible and integrated care are developed. This article describes the rationale, design and methods of the project. Methods: "PsychCare" is built on a multiperspective and multimethod design. A controlled prospective multicenter cohort study is conducted with three data collection points (baseline assessment, follow-up after 9 and 15 months). A total of 18 hospitals (10 FIT64b model and 8 matched control hospitals) have consecutively recruited in- and outpatients with pre-specified common and/or severe psychiatric disorders. Primary endpoints are differences in change of health-related quality of life and treatment satisfaction. Sociodemographic and service receipt data of the primary data collection are linked with routine health insurance data. A cost-effectiveness analysis, a mixed method, participatory process evaluation by means of qualitative surveys and the development of quality indicators are further elements of "PsychCare." Discussion and Practical Implications: The results based on data from different methodological approaches will provide essential conclusions for the improvement of hospital based mental health care in Germany. This should result in the identification of key FIT64b elements that can be efficiently implemented into standard care in Germany and re-structure the care strongly aligned to patient needs. Clinical Trial Registration: German Clinical Trial Register, identifier DRKS 00022535.

Effectiveness of Global Treatment Budgets for Patients With Mental Disorders-Claims Data Based Meta-Analysis of 13 Controlled Studies From Germany.

Background: Individuals with mental disorders need continuous and efficient collaboration between different sectors of care. In 2012, a new law in Germany enabled the implementation of novel budgets in psychiatry (flexible and integrated treatment = FIT). Hospitals implementing FIT programs have been evaluated in controlled cohort studies. We present first results based on a meta-analysis from 13 FIT hospitals. Methods/Design: We undertook a series of claims-data-based controlled cohort studies. Data from over 70 statutory health insurance (SHI) funds in Germany were analyzed. All patients insured by any of the participating SHI funds and treated in one of the FIT hospitals for any of 16 predefined mental disorders were compared with matched control patients from routine care. The patient collective was subdivided into hospital-new and hospital-known patients. Analyses included utilization of inpatient care, day care, outpatient PIA (psychiatrische Institutsambulanz) care, outpatient care with established practitioners, and durations of sick leave. Individual treatment effects of the 13 FIT hospitals were pooled in a random-effects meta-analysis. Meta-regression analysis was used to explore potential reasons for heterogeneity in model effectiveness. Results: The meta-analysis revealed a significant reduction by over 5 days of inpatient care in hospital-new patients in FIT hospitals compared to control hospitals. This effect was stronger among FIT hospitals with a preexisting FIT-like environment. There was no overall significant effect regarding sick leave between the two groups. Further meta-regression for hospital-new patients revealed a significantly reduced duration of sick leave by almost 13 days for patients in FIT hospitals with a preexisting FIT-like contract compared to FIT hospitals without such a contract. Conclusions: This study suggests positive effects of FIT programs for patients with mental disorders pointing toward a shorter duration of inpatient treatment. Furthermore, contracts already existent prior to initialization of FIT programs appear to have facilitated the transition into the new treatment environment. For FIT hospitals without such contracts, supposedly there is a certain implementation phase for effects to be apparent. The results should still be interpreted with caution as this manuscript only covers the first year of the 5 year evaluation period in 13 of 18 FIT hospitals. Clinical Trial Registration: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).