Mental Health CareEVA_TIBASNCT04727359
Evaluation of a Flexible and Integrative Psychiatric Care Model in Child and Adolescent Psychiatry
An observational study of Mental Health Care and Cross-sectoral Treatment, run by Technische Universität Dresden at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health Care, Cross-sectoral Treatment, Flexible and Integrated Treatment
- What is being tested?
- FIT64b model project
- How many people
- 1,037 participants
- Where
- 1 siteGermany
- Study dates
- 17 Nov 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the 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).
- Conditions
- Mental Health Care, Cross-sectoral Treatment, Flexible and Integrated Treatment, FIT64b, Child and Adolescent Psychiatry, Evaluation
- Being tested
- FIT64b model project
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT64b model projectOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FIT64b model project | Patients being treated in FIT64b model project at UKT Receives: Other: FIT64b model project | |
| Standard care | Patients being treated in standard care (control hospitals) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Secondary outcomes (16)
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)
Measured: one year prior to recruitment compared to first to fourth year after recruitment
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)
Measured: one year prior to recruitment compared to first to fourth year after recruitment
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)
Measured: one year prior to recruitment compared to first to fourth year after recruitment
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)
Measured: one year prior to recruitment compared to first to fourth year after recruitment
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)
Measured: first year after first full inpatient psychiatric discharge after recruitment
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)
Measured: one year prior to recruitment compared to first to fourth year after recruitment
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)
Measured: one year prior to recruitment compared to first to fourth year after recruitment
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)
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Symptom burden
The symptom burden will be measured using the Strengths and Difficulties Questionnaire (SDQ) and compared between IG and CG. (Module B)
Measured: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
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)
Measured: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
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)
Measured: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
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)
Measured: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
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)
Measured: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
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)
Measured: cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022
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)
Measured: cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022
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)
Measured: cross-sectional, focus group discussion conducted between spring 2021 and summer 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start17 Nov 2021
- Primary completion2 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health CareStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Social Medicine and Health Systems Research, Medical Faculty, University Hospital Magdeburg, Scientific Institute for Health Economics and Health System Research
- Responsible party
- Principal investigator, Anne Neumann, Technische Universität Dresden
- Investigators
- Anne Neumann, PhD, Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727359
- Sponsor's protocol ID
- EVA_TIBAS_01
- Acronym
- EVA_TIBAS
- Status last verified
- Aug 2025
- First submitted
- 15 Jan 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27846670Neumann 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.
PubMed 34802427
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [Wissenschaftliche Evaluation Modellvorhaben in Der Kinder- Und Jugendpsychiatrie (§ 64b SGB V) - Therapeutische Intensivbehandlung im Ambulanten Setting (TIBAS) am Universitätsklinikum Tübingen]
- ClinicalTrials.gov ID
- NCT04727359
- Acronym / sponsor ID
- EVA_TIBAS / EVA_TIBAS_01
- Conditions
- Mental Health Care, Cross-sectoral Treatment, Flexible and Integrated Treatment, FIT64b, Child and Adolescent Psychiatry, Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,037 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Institute of Social Medicine and Health Systems Research, Medical Faculty, University Hospital Magdeburg, Scientific Institute for Health Economics and Health System Research
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIT64b model project | – | Other: FIT64b model projectPatients being treated in FIT64b model project at UKT |
| Standard care | – | –Patients being treated in standard care (control hospitals) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- Module A
- less than one year follow-up data available
- Module B
- acute danger to self or others
- Module C1 (semi-structured interviews) • none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIT64b model projectFIT64b 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. | Other | FIT64b model project |
Primary outcome
Duration of inpatient psychiatric treatment
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
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)
Health related quality of life
Time frame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
The quality of life for patients will be measured using the KIDSCREEN-27 and compared between IG and CG. (Module B)
16 secondary outcomes
Duration of day care psychiatric treatment
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Inpatient psychiatric length of stay
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Day care psychiatric length of stay
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Outpatient psychiatric treatment in the hospital
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Inpatient hospital readmission
Time frame: first year after first full inpatient psychiatric discharge after recruitment
Emergency admission rate
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Direct medical care costs
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Cost-effectiveness (direct medical costs)
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Symptom burden
Time frame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Return to psychosocial relationships
Time frame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Treatment satisfaction
Time frame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Societal costs
Time frame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Cost-effectiveness (societal costs)
Time frame: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline
Offer and effects of social service (qualitative data)
Time frame: cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022
Benefit social service (qualitative data)
Time frame: cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022
Cooperation (strengths and potentials for optimization) between UKT and social service employees (qualitative data)
Time frame: cross-sectional, focus group discussion conducted between spring 2021 and summer 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 27846670Petzold 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.
- Derived from this study: PubMed 34802427Neumann 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.
- Individual participant dataSharing planned: No
Related trials for Mental Health Care
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Bringing Health Home
Mental Disorders, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Neumann, PhD principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Care and Cross-sectoral Treatment, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of inpatient psychiatric treatment (time frame: one year prior to recruitment compared to first to fourth year after recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727359, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.