An observational study in Mental Health Care, sponsored by Technische Universität Dresden. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Technische Universität Dresden · Observational
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.
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).
Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients being treated at the FIT hospital (Pfalzklinikum) between January 2020 and December 2023
Other: FIT contract with global treatment budget
Patients being treated in standard care (control hospitals) in the German federal state Rheinland-Pfalz
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 number of patients independent from the setting of treatment in the hospital).
Duration of inpatient psychiatric treatment
Days with inpatient stays of each included patient will be marked within the patient-individual follow-up period. A billing matrix defining the type of charge and describing the count will be used to mark days with inpatient stays. Inpatient stays that range outside the patient-specific follow-up time will be censored. The proportion of patients with at least one inpatient stay will be presented. Furthermore, the days of inpatient stays per patient will be added, including the stay that led to inclusion in the evaluation. The classification into inpatient and day care is based on the corresponding charges. If inpatient and day care cases are billed on one day in one hospital, this day will be counted as an inpatient day. It will be analyzed how long patients were treated in hospitals (here only inpatient stays), summed over the entire observation period for each case (all patients).
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Sick leave days
The number of sick leave days due to any mental disorder among employed persons will be counted.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Duration of day care psychiatric treatment
Days with day care stays of each included patient will be marked within the patient-individual follow-up period. A billing matrix defining the type of charge and describing the count will be used to mark days with day care stays. Day care stays that range outside the patient-specific follow-up time will be censored. The proportion of patients with at least one day care stay will be presented. Furthermore, the days of day care stays per patient will be added, including the stay that led to inclusion in the evaluation. The classification into inpatient and day care is based on the corresponding charges. If inpatient and day care cases are billed on one day in one hospital, this day will be counted as an inpatient day. It will be analyzed how long patients were treated in hospitals (here only day care stays), summed over the entire observation period for each case (all patients).
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Outpatient psychiatric treatment in the hospital
The number of days with a contact in the psychiatric outpatients departments (PIA) in the IG and CG will be recorded and compared. The annual and cumulative number of PIA contacts will be determined on the basis of the PIA documentation.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Effects of special services
Patients with ACT treatment in the IG will be described in more detail in regard to readmission rate and total costs. Sub-analyses regarding the influence of special services will be conducted and a joint conclusion will be drawn on the effects of special services.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Prevention of treatment discontinuation
The number of patients with contact to the outpatient section within 30 and 90 days after hospital discharge, the frequency of severely mentally ill patients with no contact to the psychiatric care system within 180 days and the percentage of patients with more than three different service providers within the same care sector will be investigated.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Inpatient hospital readmission
The proportion of persons with an inpatient stay who were readmitted as inpatients within one year after discharge from the hospital and the days between first inpatient discharge and second inpatient treatment will be examined. The follow-up period is determined on a patient-specific basis. For this purpose, the first discharge date from an inpatient stay in the reference hospital (IG or CG) after inclusion into the evaluation that allowed a one-year follow-up period will be taken as the basis. Readmission is given if the patient had a psychiatric diagnosis (ICD-10: Fx) as main diagnosis and was readmitted with a psychiatric diagnosis as main diagnosis within one year.
Time frame: first year after first full inpatient psychiatric discharge after recruitment
Further disease- and care-related aspects: comorbidities
The number of comorbidities will be determined for each patient within the follow-up period and compared between IG and CG. Comorbidities are defined based on the diagnoses of the Elixhauser Score, the diagnosis groups are added unweighted in the context of this analysis.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: mortality
The proportion of individuals who die within a defined period of time after inclusion in the evaluation will be analyzed and compared.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: disease progression
The proportion of patient who transition from F32.0 or F32.1 (mild/moderate depressive episode) to F32.2 or F32.3 (severe depressive episode) or from F32 (depressive episode) to F33 (recurrent depressive disorder) or from no addictive disorder (F10-F19) to any additive disorder (F10-F19) will be recorded and compared.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: guideline adherence
Quality indicators for alcohol dependence, dementia, depression and schizophrenia according to Großimlinghaus et al (2013) which can be mapped with claims data will be examined.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: continuity of care
It will be analyzed how many cases had at least one contact with the outpatient sector after hospital discharge. A distinction will be made between the outpatient sector in the hospital (PIA) and the outpatient sector outside the hospital (contracted medical sector). In addition, the area of continuity of treatment in the "psychiatric sector" (PIA, physician for psychiatry or child and adolescent psychiatry or psychotherapist) will be summarized.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Direct medical care costs
The difference in the costs for the treatment of mental illnesses arising between IG and CG during the observation period will be analyzed. In addition, somatic costs will be estimated. For this purpose, the care costs of the following areas will be taken into account: costs of inpatient and day care, cost of outpatient care in hospitals, costs of SHI-accredited medical care, drug costs and remedies costs.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Cost-effectiveness (direct medical costs)
To compare the efficiency of the model project with standard care, a cost-effectiveness analysis will be performed taking a SHI-funds perspective. The incremental cost-effectiveness ratio will be determined using the primary outcome parameter cumulative duration of inpatient stays as the effect measure.
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Ran from Sep 2022 to primary completion in Sep 2025, 36 months.
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