Cohort Study Clinical Trial
— EVA_TIBASOfficial title:
[Wissenschaftliche Evaluation Modellvorhaben in Der Kinder- Und Jugendpsychiatrie (§ 64b SGB V) - Therapeutische Intensivbehandlung im Ambulanten Setting (TIBAS) am Universitätsklinikum Tübingen]
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.
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) |
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Tübingen | Tübingen |
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) |
Germany,
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
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 |
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