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Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05181982
Study type Observational
Source Technische Universität Dresden
Status Not yet recruiting
Start date September 2022
Completion date July 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04727359 - Evaluation of a Flexible and Integrative Psychiatric Care Model in Child and Adolescent Psychiatry