Nationwide Uniform Scientific Evaluation of Flexible and Integrated Treatment Projects From 2022 Onwards (EVA64_2)

Technische Universität Dresden

Status: Enrolling

Conditions: Flexible and Integrated Treatment; Cross-sectoral Treatment; Cohort Studies; Evaluation Study; FIT; Psychiatry; Mental Health

Treatments: Other: FIT model project

Study type: Observational

Funder types: Other

Identifiers

NCT05855720

EVA64.2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

30,000 participants in 2 patient groups

Intervention Group (IG)

Description:

Patients being treated in FIT model project

Treatment:

Other: FIT model project

Control Group (CG)

Description:

Patients being treated in standard care (control hospitals)