NCT04727359

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)) (FIT64b) in the child and adolescent psychiatry at the University Hospital Tübingen (UKT). The central concern of this evaluation is to answer the question whether FIT64b models offer advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible treatment intensities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,037

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

November 17, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

January 15, 2021

Last Update Submit

August 19, 2025

Conditions

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). (Module A)

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

  • Health related quality of life

    The quality of life for patients will be measured using the KIDSCREEN-27 and compared between IG and CG. (Module B)

    cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline

Secondary Outcomes (16)

  • Duration of day care psychiatric treatment

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

  • Inpatient psychiatric length of stay

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

  • Day care psychiatric length of stay

    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

  • Inpatient hospital readmission

    first year after first full inpatient psychiatric discharge after recruitment

  • +11 more secondary outcomes

Study Arms (2)

FIT64b model project

Patients being treated in FIT64b model project at UKT

Other: FIT64b model project

Standard care

Patients being treated in standard care (control hospitals)

Interventions

FIT64b model project: The SHI funds AOK Baden-Württemberg and SVLFG (as an agricultural health insurance fund) 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 (FIT64b hospital, UKT). This contract encourages the model hospital an alternative treatment of their patients (with the above mentioned SHI fund), for example fewer inpatient and more outpatient treatment.

FIT64b model project

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Module A: anonymized data of the SHI fund AOK Baden-Württemberg, all patients being treated at the UKT or a control hospital between 01 January 2018 and 31 December 2021, claims data up to 31 December 2022 enabling an individual follow-up period of at least 12 months; Module B: all recruited patients being treated within 18-months recruitment phase starting in spring 2021 (and their custodians (e.g. parents or legal guardians) and siblings), in UKT and recruited control hospitals; Module C: C1: Semi-structured interviews: recruited parents (or legal guardians) of patients being treated within 18-months recruitment phase starting in spring 2021, only UKT, with recommendation for social service of the AOK Baden-Württemberg; C2: Focus group discussion: employees of UKT and social service

You may qualify if:

  • Module A
  • treatment in UKT or control hospital (both KJP) within recruitment phase
  • being insured with AOK Baden-Württemberg
  • Module B
  • at least 6 years of age
  • written consent of the children and adolescents plus written consent of the custodians
  • sufficient cognitive and linguistic ability to participate in the survey
  • Module C1 (semi-structured interviews)
  • sufficient knowledge of German as well as cognitive and linguistic abilities to participate in the interviews
  • written consent of the custodians to participate
  • recommendation for the social service of AOK Baden-Württemberg
  • Module C2 (focus group discussion) • several months of experience in working with the social service of the AOK Baden-Württemberg or the employees of the UKT within the framework of the FIT64b model project at the UKT

You may not qualify if:

  • Module A
  • less than one year follow-up data available
  • Module B
  • acute danger to self or others
  • Module C1 (semi-structured interviews) • none
  • Module C2 (focus group discussion)
  • little cooperation with employees of the respective other institution (UKT and social service, e.g. one-time participation in a case conference)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Related Publications (2)

  • 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: 27846670BACKGROUND
  • 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.

Study Officials

  • Anne Neumann, PhD

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 27, 2021

Study Start

November 17, 2021

Primary Completion

July 2, 2024

Study Completion

December 31, 2024

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations