Evaluation of a Flexible and Integrative Psychiatric Care Model at the Pfalzklinikum (EVA_Pfalz)

NCT05181982 | Recruiting

• 1 other identifier: EVA_Pfalz
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Care

Keywords

Cross-sectoral Treatment; Flexible and Integrated Treatment; Global Treatment Budget; FIT; Psychiatry; Evaluation; Claims data; Cohort study

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 fourth year after recruitment

• Sick leave days

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

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

Secondary Outcomes (12)

• Duration of day care psychiatric treatment

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

• Outpatient psychiatric treatment in the hospital

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

• Effects of special services

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

• Prevention of treatment discontinuation

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

• Inpatient hospital readmission

  first year after first full inpatient psychiatric discharge after recruitment

Study Arms (2)

Intervention Group

Patients being treated at the FIT hospital (Pfalzklinikum) between January 2020 and December 2023

Other: FIT contract with global treatment budget

Control group

Patients being treated in standard care (control hospitals) in the German federal state Rheinland-Pfalz

Interventions

FIT contract with global treatment budget OTHER

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).

Intervention Group

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 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.

You may qualify if:

• treatment at the Pfalzklinikum or control hospital after 01.01.2020 (date included) and before 31.12.2023 (date included) with one of the following diagnoses as main diagnosis (ICD-10: F00, F01, F02, F03, F07, F10, F20-29, F30-39, F43, F45, F40-48, F50, F60.31, F70-79, F84, F90-F98, B22 \& F02.8, G20.0 \& F02.3, G30.0 \& F00.0, G30.1 \& F00.1) at the department of psychiatry (FA 29xx), department of child and adolescent psychiatry (F30xx) or department of psychosomatic/psychotherapy (FA31xx)
• being insured with any of the participating SHI funds

You may not qualify if:

• less than one year follow-up data available
• non-permanent residence in Germany during observation period

Sponsors & Collaborators

• Technische Universität Dresden: lead
• ISMG, Medical Faculty, Otto-von-Guericke University Magdeburg: collaborator
• Scientific Institute for Health Economics and Health System Research, Leipzig (WIG2): collaborator

Study Sites (1)

Center For Evidence-Based Healthcare, Technische Universität Dresden

Dresden, Germany

RECRUITING

Related Publications (6)

• Grossimlinghaus I, Falkai P, Gaebel W, Janssen B, Reich-Erkelenz D, Wobrock T, Zielasek J. [Developmental process of DGPPN quality indicators]. Nervenarzt. 2013 Mar;84(3):350-65. doi: 10.1007/s00115-012-3705-4. German.

  PMID: 23494246 BACKGROUND

• Quan H, Sundararajan V, Halfon P, Fong A, Burnand B, Luthi JC, Saunders LD, Beck CA, Feasby TE, Ghali WA. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005 Nov;43(11):1130-9. doi: 10.1097/01.mlr.0000182534.19832.83.

  PMID: 16224307 BACKGROUND

• 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

• March S, Zimmermann L, Kubat D, Neumann A, Schmitt J, Baum F, Schoffer O, Arnold K, Seifert M, Kliemt R, Hackl D, Pfennig A, Swart E. [Methodological Challenges when Using Claims Data of more than 70 Statutory Health Insurances - A Progress Report from the EVA64 Study]. Gesundheitswesen. 2020 Mar;82(S 01):S4-S12. doi: 10.1055/a-1036-6364. Epub 2020 Jan 21. German.

  PMID: 31962364 BACKGROUND

• Neumann A, Swart E, Hackl D, Kliemt R, March S, Kuster D, Arnold K, Petzold T, Baum F, Seifert M, Weiss J, Pfennig A, Schmitt J. The influence of cross-sectoral treatment models on patients with mental disorders in Germany: study protocol of a nationwide long-term evaluation study (EVA64). BMC Psychiatry. 2018 May 18;18(1):139. doi: 10.1186/s12888-018-1721-z.

  PMID: 29776348 BACKGROUND

• Neumann A, Hense H, Baum F, Kliemt R, Seifert M, Harst L, Kubat D, Maicher B, Schrey C, Schmitt J, Pfennig A, Weinhold I, Swart E, Soltmann B. Evaluation of a flexible and integrative psychiatric care model in a department of child and adolescent psychiatry in Tubingen, Germany: study protocol (EVA_TIBAS). BMC Health Serv Res. 2021 Nov 22;21(1):1262. doi: 10.1186/s12913-021-07226-1.

  PMID: 34802427 BACKGROUND

Study Officials

• Anne Neumann, Dr.

  Center For Evidence-Based Healthcare (ZEGV), Technische Universität Dresden, Germany

  STUDY CHAIR

Central Study Contacts

Anne Neumann, Dr.

CONTACT

+49 (0)351 458 5634; Anne.Neumann@uniklinikum-dresden.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Head of Mental Health Services Research, PhD

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: September 30, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

DE (1)