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

NCT05855720 | Recruiting

• 1 other identifier: EVA64.2
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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

• Sick leave days

  The number of sick leave days due to any mental disorder will be counted.

  one year prior to recruitment compared to first to fourth year after recruitment

Secondary Outcomes (11)

• Duration of day care psychiatric treatment

  one year prior to recruitment compared to first to max year after recruitment

• Outpatient psychiatric treatment (within and outside the hospital)

  one year prior to recruitment compared to first to max year after recruitment

• Continuity of care

  one year prior to recruitment compared to first to max year after recruitment

• Inpatient hospital readmission

  one year prior to one year after first full inpatient psychiatric discharge after recruitment

• Discontinuation of contacts for severely mentally ill patients within the psychiatric care system

  one year prior to one year after recruitment

Study Arms (2)

Intervention Group (IG)

Patients being treated in FIT model project

Other: FIT model project

Control Group (CG)

Patients being treated in standard care (control hospitals)

Interventions

FIT model project OTHER

Several statutory health insurance (SHI) funds have established contracts with hospitals for an alternative remuneration / financing of patients treated in the hospital (FIT hospital). Some of those contracts already started in 2013 and were prolonged. Some FIT contracts will start freshly (until June 2026). These contracts encourage FIT hospitals to test alternative treatment options for their patients (insured with the involved SHI funds), for example fewer inpatient and more outpatient treatment.

Intervention Group (IG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• less than one year follow-up data available

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Institute of Social Medicine and Health Services Research, Medical Faculty, Otto-von-Guericke- University Magdeburg, Germany: collaborator
• WIG2 Scientific Institute for Health Economics and Health System Research Leipzig, Germany: collaborator

Study Sites (1)

Institute for Social Medicine and Health System Research (ISMG), Medical Faculty, Otto-von-Guericke-University Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Anne Neumann, PhD

CONTACT

+4 351 458; anne.neumann@ukdd.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 11, 2023
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 1, 2038
• Study Completion (Estimated): July 1, 2041
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)