Clinical trial NCT05181982: Evaluation of a Flexible and Integrative Psychiatric Care Model at the Pfalzklinikum (EVA_Pfalz)
Official title: Wissenschaftliche Evaluation Des Modellvorhabens (§ 64b SGB V) am Pfalzklinikum (EVA_Pfalz)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health Care
Keywords: Cross-sectoral Treatment
Flexible and Integrated Treatment
Global Treatment Budget
FIT
Psychiatry
Evaluation
Claims data
Cohort study
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: ISMG, Medical Faculty, Otto-von-Guericke University Magdeburg
name: Scientific Institute for Health Economics and Health System Research, Leipzig (WIG2)
First posted: 2022-01-10
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anonymized data of the participating SHI funds will be analyzed. This includes all patients being treated at the Pfalzklinikum or a control hospital between 01 January 2020 and 31 December 2023 using claims data up to 31 December 2024 enabling an individual follow-up period of at least 12 months.

Brief summary: This study is an evaluation of the flexible and integrative psychiatric care model (according to § 64b of the German Social Code Book V (SGB V)) (FIT) at the Pfalzklinikum. The central concern of this evaluation is to answer the question whether the FIT model offer advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible treatment intensities.

Detailed description: The introduction of Section 64b SGB V created the possibility of agreeing so-called FIT model projects for the further development of care for mentally ill people. The objective is to improve cross-sectoral care or optimize patient care. More than 20 statutory health insurance (SHI) funds have developed a FIT model project at the Pfalzklinikum in Germany targeting children, youth and adults. By now, this is the largest FIT project within Germany and the only one in the German Federal State Rheinland-Pfalz. There are more 22 FIT projects at German psychiatric hospitals by December 2021. This FIT project started on 01 January 2020 with an initial duration of eight years.

The goal of the contract is the implementation and further development of improved patient care within the framework of a global treatment budget. To optimize care, "Assertive Community Treatment (ACT)" was introduced as treatment in the patient's environment (home). ACT aims to strengthen patient care, especially in outreach treatment (home treatment), and gives treatment providers more flexibility to adapt the type, duration and intensity of treatment to the patient's needs. Furthermore, the model project aims at a continuous treatment and stabilization of the patients in consideration of their social and professional environment, the creation of a continuity of treatment, the increase of the acceptance of the patient-oriented, psychotherapeutic and sociotherapeutic interventions. Furthermore, the change in financing in the form of a global treatment budget should lead to a more effective use of financial resources.

In accordance with § 65 SGB V, all model projects under § 64b SGB V, must be scientifically evaluated by an independent expert (expert team). Eighteen of the 22 FIT projects are under evaluation with a similar study design elsewhere (Neumann et al., 2018), while for the evaluation of another FIT project a slightly adopted design with a multi-methods approach is used (Neumann et al., 2021). The aim of this evaluation is to examine the achievement of the objectives of the FIT model project based on anonymized claims data (March et al, 2020). The main goals of the model project are to shorten the duration of inpatient stays while intensifying day care and / or outpatient forms of treatment, decrease sick leave days, increase treatment continuity, reduce inpatient readmission rate and not to deteriorate further disease- and care-related aspects, such as disease progression or comorbidities. In addition, the total costs of the FIT model care should not exceed those of the standard care or, at a maximum of the same costs, better results should be achieved. However, it is expected that some costs will increase (e.g. outpatient care) while other costs will decrease (e.g. inpatient care) .

The effectiveness, costs, and cost-effectiveness of the FIT model hospital compared to standard care are to be examined. The study presented here is a controlled cohort study utilizing anonymous claims data. The controlled design is based on the fact that information of patients from the intervention hospital, the Pfalzklinikum, is compared to information of comparable patients from structurally similar psychiatric hospitals in the same federal state (Petzold et al, 2019).

Eligibility criteria: Inclusion Criteria:

* treatment at the Pfalzklinikum or control hospital after 01.01.2020 (date included) and before 31.12.2023 (date included) with one of the following diagnoses as main diagnosis (ICD-10: F00, F01, F02, F03, F07, F10, F20-29, F30-39, F43, F45, F40-48, F50, F60.31, F70-79, F84, F90-F98, B22 \& F02.8, G20.0 \& F02.3, G30.0 \& F00.0, G30.1 \& F00.1) at the department of psychiatry (FA 29xx), department of child and adolescent psychiatry (F30xx) or department of psychosomatic/psychotherapy (FA31xx)
* being insured with any of the participating SHI funds

Exclusion Criteria:

* less than one year follow-up data available
* non-permanent residence in Germany during observation period

Primary outcomes:
measure: Duration of inpatient psychiatric treatment
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Sick leave days
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
Secondary outcomes:
measure: Duration of day care psychiatric treatment
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Outpatient psychiatric treatment in the hospital
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Effects of special services
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Prevention of treatment discontinuation
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Inpatient hospital readmission
timeFrame: first year after first full inpatient psychiatric discharge after recruitment
measure: Further disease- and care-related aspects: comorbidities
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Further disease- and care-related aspects: mortality
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Further disease- and care-related aspects: disease progression
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Further disease- and care-related aspects: guideline adherence
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Further disease- and care-related aspects: continuity of care
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Direct medical care costs
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Cost-effectiveness (direct medical costs)
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Center For Evidence-Based Healthcare, Technische Universität Dresden
Study officials:
affiliation: Center For Evidence-Based Healthcare (ZEGV), Technische Universität Dresden, Germany
name: Anne Neumann, Dr.
role: STUDY_CHAIR
References:
citation: Grossimlinghaus I, Falkai P, Gaebel W, Janssen B, Reich-Erkelenz D, Wobrock T, Zielasek J. [Developmental process of DGPPN quality indicators]. Nervenarzt. 2013 Mar;84(3):350-65. doi: 10.1007/s00115-012-3705-4. German.
citation: Quan H, Sundararajan V, Halfon P, Fong A, Burnand B, Luthi JC, Saunders LD, Beck CA, Feasby TE, Ghali WA. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005 Nov;43(11):1130-9. doi: 10.1097/01.mlr.0000182534.19832.83.
citation: Petzold T, Neumann A, Seifert M, Kuster D, Pfennig A, Weiss J, Hackl D, Swart E, Schmitt J. [Identification of Control Hospitals for the Implementation of the Nationwide and Standardized Evaluation of Model Projects According to section sign 64b SGB V: Analysis of Data from Structured Quality Reports]. Gesundheitswesen. 2019 Jan;81(1):63-71. doi: 10.1055/s-0042-116436. Epub 2016 Nov 15. German.
citation: March S, Zimmermann L, Kubat D, Neumann A, Schmitt J, Baum F, Schoffer O, Arnold K, Seifert M, Kliemt R, Hackl D, Pfennig A, Swart E. [Methodological Challenges when Using Claims Data of more than 70 Statutory Health Insurances - A Progress Report from the EVA64 Study]. Gesundheitswesen. 2020 Mar;82(S 01):S4-S12. doi: 10.1055/a-1036-6364. Epub 2020 Jan 21. German.
citation: Neumann A, Swart E, Hackl D, Kliemt R, March S, Kuster D, Arnold K, Petzold T, Baum F, Seifert M, Weiss J, Pfennig A, Schmitt J. The influence of cross-sectoral treatment models on patients with mental disorders in Germany: study protocol of a nationwide long-term evaluation study (EVA64). BMC Psychiatry. 2018 May 18;18(1):139. doi: 10.1186/s12888-018-1721-z.
citation: Neumann A, Hense H, Baum F, Kliemt R, Seifert M, Harst L, Kubat D, Maicher B, Schrey C, Schmitt J, Pfennig A, Weinhold I, Swart E, Soltmann B. Evaluation of a flexible and integrative psychiatric care model in a department of child and adolescent psychiatry in Tubingen, Germany: study protocol (EVA_TIBAS). BMC Health Serv Res. 2021 Nov 22;21(1):1262. doi: 10.1186/s12913-021-07226-1.