Clinical trial NCT05855720: Nationwide Uniform Scientific Evaluation of Flexible and Integrated Treatment Projects From 2022 Onwards
Official title: Bundesweit Einheitliche Wissenschaftliche Evaluation Von Modellvorhaben Nach § 64b SGB V ab 2022
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health
Cross-sectoral Treatment
Flexible and Integrated Treatment
FIT
Psychiatry
Evaluation Study
Cohort Studies
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Institute of Social Medicine and Health Services Research, Medical Faculty, Otto-von-Guericke- University Magdeburg, Germany
name: WIG2 Scientific Institute for Health Economics and Health System Research Leipzig, Germany
First posted: 2023-05-11
Enrollment: 30000
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, all patients being treated in any of the participating FIT hospitals (within FIT model period) or a control hospital within recruitment period

Brief summary: This study is an evaluation of flexible and integrated psychiatric care models (according to § 64b of the German Social Code Book V (SGB V)) (FIT) including new FIT projects starting after 2022 and the prolongation of any of 19 already established FIT projects (mainly at German psychiatric hospitals). The central concern of this evaluation is to answer the question whether FIT care offers advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible psychiatric treatment intensities. However, FIT program structures depend on the individual situation and organization of the FIT hospital together with the participating statutory health insurance (SHI) funds.

Detailed description: The introduction of Section 64b of the German Social Code, Book V (SGB V) created the possibility of agreeing so-called FIT (flexible and integrated treatment) model projects for the further development of care for mentally ill people in Germany. The objective is to improve cross-sectoral care or optimize patient care. More than 20 FIT projects have been established at German psychiatric hospitals since 2013. Some FIT projects were prolonged after eight years (max. 15 years in sum). New FIT projects are planned.

In accordance with § 65 SGB V, all FIT projects under § 64b SGB V, must be scientifically evaluated by an independent expert. The aim of this evaluation is to examine the achievement of the objectives of the FIT model projects based on anonymized claims data.

The effectiveness, costs, and cost-effectiveness of the FIT model hospital care compared to standard care are to be examined. FIT projects include those starting before 2022 and being prolonged and those FIT projects starting between 2022 and June 2026. 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 intervention hospitals (any FIT design) is compared to information of comparable patients from structurally similar psychiatric hospitals in the same federal state (Petzold et al, Gesundheitswesen 2019, 81(1):63-71).

Eligibility criteria: Inclusion Criteria:

* treatment in any of the participating hospitals or control hospitals within recruitment phase (number of hospitals will be fix until June 2026)
* being insured with any of the participating SHI funds

Exclusion Criteria:

* less than one year follow-up data available

Primary outcomes:
measure: Duration of inpatient psychiatric treatment
timeFrame: one year prior to recruitment compared to first to max year after recruitment. Max year = latest possible year for maximal observation period depending on the length of FIT project
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 max year after recruitment
measure: Outpatient psychiatric treatment (within and outside the hospital)
timeFrame: one year prior to recruitment compared to first to max year after recruitment
measure: Continuity of care
timeFrame: one year prior to recruitment compared to first to max year after recruitment
measure: Inpatient hospital readmission
timeFrame: one year prior to one year after first full inpatient psychiatric discharge after recruitment
measure: Discontinuation of contacts for severely mentally ill patients within the psychiatric care system
timeFrame: one year prior to one year after recruitment
measure: Hopping
timeFrame: one year prior to recruitment compared to first to max year after recruitment
measure: Comorbidities
timeFrame: one year prior to recruitment compared to first to max year after recruitment
measure: Mortality
timeFrame: event time analysis
measure: Disease progression
timeFrame: event time analysis
measure: Direct medical care costs
timeFrame: one year prior to recruitment compared to first to max year after recruitment
measure: Cost-effectiveness (direct medical costs)
timeFrame: one year prior to recruitment compared to first to max year after recruitment
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Institute for Social Medicine and Health System Research (ISMG), Medical Faculty, Otto-von-Guericke-University Magdeburg
Study officials:
References:
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.