BackgroundClose, 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/designA 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.DiscussionThe 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 registrationThis study was registered in the database “Health Services Research Germany” (trial number: VVfD_EVA64_15_003713).

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 Baum et al. Effectiveness of Global Treatment Budgetscontracts, 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.

Zusammenfassung Ziel der Studie Die angemessene und bedarfsgerechte Betreuung psychisch erkrankter Patienten stellt besondere Anforderungen an die psychiatrische Versorgung. §64b SGB V eröffnet die Möglichkeit, psychisch Erkrankte durch multiprofessionelle, behandlungsphasen- und sektorenübergreifende Modellvorhaben zu betreuen und neue Finanzierungsformen zu implementieren. Diese Modellprojekte werden seit 2015 in einer prospektiven und retrospektiven sekundärdatenbasierten kontrollierten Kohortenstudie (EVA64) evaluiert. Methode Im September 2016, und seitdem jährlich, erfolgte erstmalig die Datenbereitstellung aller an der Evaluation beteiligten gesetzlichen Krankenversicherungen (GKV) auf der Basis einer konsentierten Datensatzbeschreibung. Für die spätere Analyse sind die eindeutige Identifikation des Indexaufenthaltes und die Zuordnung zu Modell- oder Kontrollgruppe von Bedeutung. Die methodischen Herausforderungen der Datenbereitstellung durch die Dateneigner, das Einlesen, die formale und inhaltliche Prüfung sowie die anschließende Zusammenführung zu einem Auswertedatensatz werden ausführlich diskutiert und Fallstricke aufgezeigt. Ergebnisse Insgesamt wurden bislang Daten von 71 Krankenkassen berücksichtigt. In jeweils 20 Tabellen pro Kasse wurden Leistungsdaten zur vertragsärztlichen, ambulanten und stationären Versorgung im Krankenhaus (inkl. Psychiatrische Insti-tutsambulanzen [PIA]), Arznei- und Heilmittelversorgung sowie Arbeitsunfähigkeit übermittelt. Nicht alle Tabellen konnten von den Krankenkassen vollständig gefüllt werden. Zudem bedingen neue inhaltliche Aspekte u. a. die Anpassung der Datenselektion. Trotz mehrmaliger Datenlieferungen kann noch nicht von einem Routinevorgehen gesprochen werden. Schlussfolgerung Die kassenübergreifende Nutzung von Abrechnungsdaten zahlreicher GKVen im Rahmen einer Evaluationsstudie stellt eine große Herausforderung dar. Angesichts fehlender Richtwerte für Auffälligkeiten und Implausibilitäten war eine a-priori Festlegung von Prüfalgorithmen nur bedingt möglich; diese müssen vielmehr im Projektverlauf fortlaufend aktualisiert werden. Die resultierende individuelle Prüfung der Daten aller Krankenkassen gestaltet sich dadurch sehr aufwändig. Die ausführliche Dokumentation dieser Prüfprozesse und möglicher Fallstricke gibt Hilfestellung für zukünftige vergleichbare Studien.

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.

Zusammenfassung Ziel der Studie Es wird die Entwicklung voll- und teilstationärer Behandlungsdauer sowie der PIA-Kontakte von Modellvorhaben nach § 64b SGB V über einen Nachbeobachtungszeitraum von 3 Jahren untersucht. Methodik Patienten mit Referenzfall im ersten Modelljahr und einem Nachbeobachtungszeitraum von 3 Jahren wurden für 12 Modellvorhaben untersucht und mit gematchten Patienten der Regelversorgung verglichen. Ergebnisse Analysiert wurden 11 536 Patienten. Im ersten Jahr nach Referenzfall war die Anzahl vollstationärer Tage in fast allen Kliniken mit Modellvorhaben geringer und die Anzahl teilstationärer Tage höher im Vergleich zur Regelversorgung. Diese Effekte verstärkten sich in Modellkliniken mit Vorläufervertrag. Die PIA-Inanspruchnahme war zwischen Modellvorhaben unterschiedlich ausgeprägt. Schlussfolgerung Diese Analyse leistet einen Beitrag für evidenzgeleitete gesundheitspolitische Entscheidungen zur Eignung patientenzentrierter Versorgungskonzepte mit globalem Budget für die Regelversorgung.