Evaluation of a Flexible and Integrative Psychiatric Care Model in Child and Adolescent Psychiatry

Cohort Study Clinical Trial

— EVA_TIBAS  

Official title:

[Wissenschaftliche Evaluation Modellvorhaben in Der Kinder- Und Jugendpsychiatrie (§ 64b SGB V) - Therapeutische Intensivbehandlung im Ambulanten Setting (TIBAS) am Universitätsklinikum Tübingen]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04727359
• Other study ID #: EVA_TIBAS_01
• Status: Recruiting
• Start date: November 17, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Technische Universität Dresden
• Contact: Anne Neumann, PhD
• Phone: +49 351 458
• Email: anne.neumann[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Child and Adolescent Psychiatry
• Cohort Study
• Cross-sectoral Treatment
• Evaluation
• FIT64b
• Flexible and Integrated Treatment
• Mental Health Care

Intervention

Other:
• FIT64b model project
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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Tübingen	Tübingen

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	Institute of Social Medicine and Health Systems Research, Medical Faculty, University Hospital Magdeburg, Scientific Institut for Health Economics and Health System Research (WIG2)

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Duration of day care psychiatric treatment	Days with day care 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 day care stays. Day care stays that range outside the patient-specific follow-up time will be censored. The proportion of patients with at least one day care stay will be presented. Furthermore, the days of day care 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 day care 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
Secondary	Inpatient psychiatric length of stay	This outcome is similar to Outcome 1 with the difference that here it will be analyzed how long patients were treated in hospitals (only inpatient treatment), summed up over the time in hospital (i.e. only patients with hospital stays). (Module A)	one year prior to recruitment compared to first to fourth year after recruitment
Secondary	Day care psychiatric length of stay	This outcome is similar to Outcome 3 with the difference that here it will be analyzed how long patients were treated in hospitals (only day care treatment), summed up over the time in hospital (i.e. only patients with hospital stays). (Module A)	one year prior to recruitment compared to first to fourth year after recruitment
Secondary	Outpatient psychiatric treatment in the hospital	The number of days with a contact in the TIBAS care or the psychiatric outpatients departments (PIA) in the IG and CG will be recorded and compared. Since from 01.10.2017 the PIA care in the model project was merged into the TIBAS care and no separate PIA care took place in the IG from that date, here the TIBAS care will be considered as (intensive) outpatient treatment in the hospital and compared with the PIA care of the standard care. The annual and cumulative number of PIA contacts will be determined on the basis of the PIA documentation. (Module A)	one year prior to recruitment compared to first to fourth year after recruitment
Secondary	Inpatient hospital readmission	The proportion of persons with an inpatient stay who were readmitted as inpatients within one year after discharge from the hospital and the days between first inpatient discharge and second inpatient treatment will be examined. The follow-up period is determined on a patient-specific basis. For this purpose, the first discharge date from an inpatient stay in the reference hospital (IG or CG) after inclusion into the evaluation that allowed a one-year follow-up period will be taken as the basis. Readmission is given if the patient had a psychiatric diagnosis (ICD-10: Fx) as main diagnosis and was readmitted with a psychiatric diagnosis as main diagnosis within one year. (Module A)	first year after first full inpatient psychiatric discharge after recruitment
Secondary	Emergency admission rate	The proportion of inpatient cases with admission reason xxx7 (emergency admission) will be extracted. The proportion of patients with a psychiatric diagnosis and emergency admission will be analyzed in relation to all inpatient admissions with a psychiatric diagnosis at the reference hospital. (Module A)	one year prior to recruitment compared to first to fourth year after recruitment
Secondary	Direct medical care costs	The difference in the costs for the treatment of mental illnesses arising between IG and CG during the observation period taking a SHI-funds perspective will be analyzed. In addition, somatic costs will be estimated. For this purpose, the care costs of the following areas will be taken into account: costs of inpatient and day care, costs of TIBAS care, cost of outpatient care in hospitals, costs of SHI-accredited medical care, drug costs and remedies costs. (Module A)	one year prior to recruitment compared to first to fourth year after recruitment
Secondary	Cost-effectiveness (direct medical costs)	To compare the efficiency of the model project with standard care, a cost-effectiveness analysis will be performed taking a SHI-funds perspective. The incremental cost-effectiveness ratio will be determined using the primary outcome parameter cumulative duration of inpatient stays as the effect measure. (Module A)	one year prior to recruitment compared to first to fourth year after recruitment
Secondary	Symptom burden	The symptom burden will be measured using the Strengths and Difficulties Questionnaire (SDQ) and compared between IG and CG. (Module B)	cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Secondary	Return to psychosocial relationships	The return to psychosocial relationships will be measured using a self-developed questionnaire covering areas of friends, school, sports activities, hobbies, social integration and daily structure and compared between IG and CG. (Module B)	cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Secondary	Treatment satisfaction	Treatment satisfaction will be measured using the Treatment assessment questionnaire (FBB ("Fragebogen zur Beurteilung von Behandlungen")) and compared between IG and CG. (Module B)	cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Secondary	Societal costs	The costs of the treatment due to mental illnesses from a societal perspective will be estimated using an adapted questionnaire based on the Client Sociodemographic and Service Receipt Inventory (CSSRI) questionnaire. (Module B)	cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Secondary	Cost-effectiveness (societal costs)	Cost-effectiveness will be estimated comparing the results from the quality of life and the societal costs comparing IG and CG. (Module B)	cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Secondary	Offer and effects of social service (qualitative data)	Semi-structured interviews with families using a self-developed interview guide with open-ended questions will be used. (Module C)	cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022
Secondary	Benefit social service (qualitative data)	Semi-structured interviews with families using a self-developed interview guide with open-ended questions will be used. (Module C)	cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022
Secondary	Cooperation (strengths and potentials for optimization) between UKT and social service employees (qualitative data)	Self-developed open-ended questions in a focus group discussion will be used. (Module C)	cross-sectional, focus group discussion conducted between spring 2021 and summer 2022