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Evaluation of a Flexible and Integrative Psychiatric Care Model at the Pfalzklinikum (EVA_Pfalz)

Observational Mental Health Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FIT contract with global treatment budget.
Who it may be relevant to
Registry conditions: Mental Health Care. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Wissenschaftliche Evaluation Des Modellvorhabens (§ 64b SGB V) am Pfalzklinikum (EVA_Pfalz)

Overview

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).

Interventions

  • Other FIT contract with global treatment budget
    Several SHI funds have established a contract (duration = at least eight year) with the model hospital for an alternative remuneration / financing of patients treated in the model hospital (FIT hospital, Pfalzklinikum). This contract encourages the model hospital an alternative treatment of their patients (insured with the involved SHI funds), for example fewer inpatient and more outpatient treatment. The contract is based on a global treatment budget (pre-defined fix budget for a specified numb

Primary outcome measures

  • Duration of inpatient psychiatric treatment [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Sick leave days [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
Secondary outcome measures (12)
  • Duration of day care psychiatric treatment [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Outpatient psychiatric treatment in the hospital [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Effects of special services [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Prevention of treatment discontinuation [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Inpatient hospital readmission [Time frame: first year after first full inpatient psychiatric discharge after recruitment]
  • Further disease- and care-related aspects: comorbidities [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Further disease- and care-related aspects: mortality [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Further disease- and care-related aspects: disease progression [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Further disease- and care-related aspects: guideline adherence [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Further disease- and care-related aspects: continuity of care [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Direct medical care costs [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]
  • Cost-effectiveness (direct medical costs) [Time frame: one year prior to recruitment compared to first to fourth year after recruitment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Center For Evidence-Based Healthcare, Technische Universität Dresden — Dresden

Publications

  • 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. PMID 23494246
  • 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. PMID 16224307
  • 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. PMID 27846670
  • 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. PMID 31962364
  • 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. PMID 29776348
  • 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. PMID 34802427

Identifiers

NCT: NCT05181982 · EVA_Pfalz

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗