Clinical trial NCT04727359: Evaluation of a Flexible and Integrative Psychiatric Care Model in Child and Adolescent Psychiatry
Official title: [Wissenschaftliche Evaluation Modellvorhaben in Der Kinder- Und Jugendpsychiatrie (§ 64b SGB V) - Therapeutische Intensivbehandlung im Ambulanten Setting (TIBAS) am Universitätsklinikum Tübingen]
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health Care
Cross-sectoral Treatment
Flexible and Integrated Treatment
FIT64b
Child and Adolescent Psychiatry
Evaluation
Cohort Study
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Institute of Social Medicine and Health Systems Research, Medical Faculty, University Hospital Magdeburg
name: Scientific Institut for Health Economics and Health System Research (WIG2)
First posted: 2021-01-27
Enrollment: 300
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: 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

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.

Detailed description: The introduction of Section 64b of the German Social Code, Book V (SGB V) created the possibility of agreeing so-called FIT64b model projects for the further development of care for mentally ill people. The objective is to improve cross-sectoral care or optimize patient care. The statutory health insurance (SHI) funds AOK Baden-Württemberg and the SVLFG (as an agricultural health insurance fund) have developed a FIT64b model project in child and adolescent psychiatry (KJP) with the UKT, which will be tested for a total of eight years in the care region of Tübingen starting on 01 October 2017. The core of the model care is the Therapeutic Intensive Treatment in the Outpatient Setting (TIBAS, from the German abbreviation of "Therapeutische Intensivbehandlung im Ambulanten Setting").

The goal of this model care is to provide more cross-sectoral service delivery through more flexible treatment intensities. The creation of TIBAS as an intensive outpatient form of treatment is intended to enable earlier discharge from the full inpatient setting. Four TIBAS levels have been implemented, representing different treatment intensities and frequencies, which can be flexibly deployed according to patient needs. A person-centered case manager accompanies patients throughout the treatment period. If necessary, the patients, but especially the family members, are accompanied by the social service of the AOK Baden-Württemberg and supported with regard to stabilizing the overall care situation (psychosocial counseling and networking with other care structures, etc.). For patients fulfilling the diagnostic criteria for either anorexia nervosa or moderate depression, direct access to TIBAS is possible without prior hospitalization.

The aim of the evaluation is to examine the achievement of the objectives of the FIT64b model project on the basis of anonymized claims data and primary data to be collected and to assess the transferability of the care approach to standard care. The main goals of the model project are to shorten the duration of inpatient stays while intensifying outpatient forms of treatment, to reduce the cumulative psychiatric treatment duration and the emergency admission rate, to reduce the symptom burden, to accelerate the return to psychosocial living conditions and to increase the quality of life. Stabilization of the family's overall care situation will be used to sustain these improvements. Through qualitative research methods, the experiences with and the subjective benefit of the social service of the AOK Baden-Württemberg as well as the cooperation of this social service with the UKT will be examined in more detail. The costs of the FIT64b model care should not exceed those of the standard care or, at a maximum of the same costs, better results should be achieved with regard to the above-mentioned patient-related goals.

The effectiveness, costs, and cost-effectiveness of the FIT64b model hospital compared to standard care are examined. The study presented here is a controlled cohort study which utilizes claims data as well as primary data. It will employ quantitative analyses of anonymized SHI data (Module A), quantitative analyses of questionnaires (Module B), and qualitative analyses of semi-structured interviews and a focus group (Module C). The controlled design is based on the fact that information of patients from the intervention hospital, the UKT, is compared to information of comparable patients from structurally similar hospitals of child and adolescent psychiatry in the same federal state (Petzold et al, Gesundheitswesen 2019, 81(1):63-71).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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)

Primary outcomes:
measure: Duration of inpatient psychiatric treatment
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Health related quality of life
timeFrame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Secondary outcomes:
measure: Duration of day care psychiatric treatment
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Inpatient psychiatric length of stay
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Day care psychiatric length of stay
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Outpatient psychiatric treatment in the hospital
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Inpatient hospital readmission
timeFrame: first year after first full inpatient psychiatric discharge after recruitment
measure: Emergency admission rate
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Direct medical care costs
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Cost-effectiveness (direct medical costs)
timeFrame: one year prior to recruitment compared to first to fourth year after recruitment
measure: Symptom burden
timeFrame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
measure: Return to psychosocial relationships
timeFrame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
measure: Treatment satisfaction
timeFrame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
measure: Societal costs
timeFrame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
measure: Cost-effectiveness (societal costs)
timeFrame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
measure: Offer and effects of social service (qualitative data)
timeFrame: cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022
measure: Benefit social service (qualitative data)
timeFrame: cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022
measure: Cooperation (strengths and potentials for optimization) between UKT and social service employees (qualitative data)
timeFrame: cross-sectional, focus group discussion conducted between spring 2021 and summer 2022
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: Technische Universität Dresden
name: Anne Neumann, PhD
role: PRINCIPAL_INVESTIGATOR
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.
citation: 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.