Mental Health CareEVA_PfalzNCT05181982
Evaluation of a Flexible and Integrative Psychiatric Care Model at the Pfalzklinikum (EVA_Pfalz)
An observational study of Mental Health Care, 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)) (FIT) at the Pfalzklinikum. The central concern of this evaluation is to answer the question whether the FIT model offer advantages over standard care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health Care
- What is being tested?
- FIT contract with global treatment budget
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- 30 Sep 2022to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Anonymized data of the participating SHI funds will be analyzed. This includes all patients being treated at the Pfalzklinikum or a control hospital between 01 January 2020 and 31 December 2023 using claims data up to 31 December 2024 enabling an individual follow-up period of at least 12 months.
Who may be able to join
- treatment at the Pfalzklinikum or control hospital after 01.01.2020 (date included) and before 31.12.2023 (date included) with one of the following diagnoses as main diagnosis (ICD-10: F00, F01, F02, F03, F07, F10, F20-29, F30-39, F43, F45, F40-48, F50, F60.31, F70-79, F84, F90-F98, B22 \& F02.8, G20.0 \& F02.3, G30.0 \& F00.0, G30.1 \& F00.1) at the department of psychiatry (FA 29xx), department of child and adolescent psychiatry (F30xx) or department of psychosomatic/psychotherapy (FA31xx)
- being insured with any of the participating SHI funds
Who cannot join
- less than one year follow-up data available
- non-permanent residence in Germany during observation period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Center For Evidence-Based Healthcare, Technische Universität Dresden
Dresden
Anne Neumann, Dr., Anne.Neumann@uniklinikum-dresden.de
About this study
Official title: Wissenschaftliche Evaluation Des Modellvorhabens (§ 64b SGB V) am Pfalzklinikum (EVA_Pfalz)
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)) (FIT) at the Pfalzklinikum. The central concern of this evaluation is to answer the question whether the FIT model 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 SGB V created the possibility of agreeing so-called FIT model projects for the further development of care for mentally ill people. The objective is to improve cross-sectoral care or optimize patient care. More than 20 statutory health insurance (SHI) funds have developed a FIT model project at the Pfalzklinikum in Germany targeting children, youth and adults. By now, this is the largest FIT project within Germany and the only one in the German Federal State Rheinland-Pfalz. There are more 22 FIT projects at German psychiatric hospitals by December 2021. This FIT project started on 01 January 2020 with an initial duration of eight years.
The goal of the contract is the implementation and further development of improved patient care within the framework of a global treatment budget. To optimize care, "Assertive Community Treatment (ACT)" was introduced as treatment in the patient's environment (home). ACT aims to strengthen patient care, especially in outreach treatment (home treatment), and gives treatment providers more flexibility to adapt the type, duration and intensity of treatment to the patient's needs. Furthermore, the model project aims at a continuous treatment and stabilization of the patients in consideration of their social and professional environment, the creation of a continuity of treatment, the increase of the acceptance of the patient-oriented, psychotherapeutic and sociotherapeutic interventions. Furthermore, the change in financing in the form of a global treatment budget should lead to a more effective use of financial resources.
In accordance with § 65 SGB V, all model projects under § 64b SGB V, must be scientifically evaluated by an independent expert (expert team). Eighteen of the 22 FIT projects are under evaluation with a similar study design elsewhere (Neumann et al., 2018), while for the evaluation of another FIT project a slightly adopted design with a multi-methods approach is used (Neumann et al., 2021). The aim of this evaluation is to examine the achievement of the objectives of the FIT model project based on anonymized claims data (March et al, 2020). The main goals of the model project are to shorten the duration of inpatient stays while intensifying day care and / or outpatient forms of treatment, decrease sick leave days, increase treatment continuity, reduce inpatient readmission rate and not to deteriorate further disease- and care-related aspects, such as disease progression or comorbidities. In addition, the total costs of the FIT model care should not exceed those of the standard care or, at a maximum of the same costs, better results should be achieved. However, it is expected that some costs will increase (e.g. outpatient care) while other costs will decrease (e.g. inpatient care) .
The effectiveness, costs, and cost-effectiveness of the FIT model hospital compared to standard care are to be examined. The study presented here is a controlled cohort study utilizing anonymous claims data. The controlled design is based on the fact that information of patients from the intervention hospital, the Pfalzklinikum, is compared to information of comparable patients from structurally similar psychiatric hospitals in the same federal state (Petzold et al, 2019).
- Conditions
- Mental Health Care
- Being tested
- FIT contract with global treatment budget
- Keywords
- Cross-sectoral Treatment, Flexible and Integrated Treatment, Global Treatment Budget, FIT, Psychiatry, Evaluation, Claims data, Cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT contract with global treatment budgetOther
Several SHI funds 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 (FIT hospital, Pfalzklinikum). This contract encourages the model hospital an alternative treatment of their patients (insured with the involved SHI funds), for example fewer inpatient and more outpatient treatment. The contract is based on a global treatment budget (pre-defined fix budget for a specified number of patients independent from the setting of treatment in the hospital).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Patients being treated at the FIT hospital (Pfalzklinikum) between January 2020 and December 2023 Receives: Other: FIT contract with global treatment budget | |
| Control group | Patients being treated in standard care (control hospitals) in the German federal state Rheinland-Pfalz |
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).
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Sick leave days
The number of sick leave days due to any mental disorder among employed persons will be counted.
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Secondary outcomes (12)
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).
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 psychiatric outpatients departments (PIA) in the IG and CG will be recorded and compared. The annual and cumulative number of PIA contacts will be determined on the basis of the PIA documentation.
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Effects of special services
Patients with ACT treatment in the IG will be described in more detail in regard to readmission rate and total costs. Sub-analyses regarding the influence of special services will be conducted and a joint conclusion will be drawn on the effects of special services.
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Prevention of treatment discontinuation
The number of patients with contact to the outpatient section within 30 and 90 days after hospital discharge, the frequency of severely mentally ill patients with no contact to the psychiatric care system within 180 days and the percentage of patients with more than three different service providers within the same care sector will be investigated.
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.
Measured: first year after first full inpatient psychiatric discharge after recruitment
Further disease- and care-related aspects: comorbidities
The number of comorbidities will be determined for each patient within the follow-up period and compared between IG and CG. Comorbidities are defined based on the diagnoses of the Elixhauser Score, the diagnosis groups are added unweighted in the context of this analysis.
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: mortality
The proportion of individuals who die within a defined period of time after inclusion in the evaluation will be analyzed and compared.
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: disease progression
The proportion of patient who transition from F32.0 or F32.1 (mild/moderate depressive episode) to F32.2 or F32.3 (severe depressive episode) or from F32 (depressive episode) to F33 (recurrent depressive disorder) or from no addictive disorder (F10-F19) to any additive disorder (F10-F19) will be recorded and compared.
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: guideline adherence
Quality indicators for alcohol dependence, dementia, depression and schizophrenia according to Großimlinghaus et al (2013) which can be mapped with claims data will be examined.
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: continuity of care
It will be analyzed how many cases had at least one contact with the outpatient sector after hospital discharge. A distinction will be made between the outpatient sector in the hospital (PIA) and the outpatient sector outside the hospital (contracted medical sector). In addition, the area of continuity of treatment in the "psychiatric sector" (PIA, physician for psychiatry or child and adolescent psychiatry or psychotherapist) will be summarized.
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 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, cost of outpatient care in hospitals, costs of SHI-accredited medical care, drug costs and remedies costs.
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.
Measured: one year prior to recruitment compared to first to fourth year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start30 Sep 2022
- Primary completion30 Sep 2025
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- ISMG, Medical Faculty, Otto-von-Guericke University Magdeburg, Scientific Institute for Health Economics and Health System Research
- Responsible party
- Principal investigator, Anne Neumann, Technische Universität Dresden
- Investigators
- Anne Neumann, Dr., Study chair, Center For Evidence-Based Healthcare (ZEGV), Technische Universität Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181982
- Sponsor's protocol ID
- EVA_Pfalz
- Acronym
- EVA_Pfalz
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2021
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grossimlinghaus I, Falkai P, Gaebel W, Janssen B, Reich-Erkelenz D, Wobrock T, Zielasek J. [Developmental process of DGPPN quality indicators]. Nervenarzt. 2013 Mar;84(3):350-65. doi: 10.1007/s00115-012-3705-4. German.
PubMed 23494246Quan H, Sundararajan V, Halfon P, Fong A, Burnand B, Luthi JC, Saunders LD, Beck CA, Feasby TE, Ghali WA. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005 Nov;43(11):1130-9. doi: 10.1097/01.mlr.0000182534.19832.83.
PubMed 16224307Petzold 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 27846670March S, Zimmermann L, Kubat D, Neumann A, Schmitt J, Baum F, Schoffer O, Arnold K, Seifert M, Kliemt R, Hackl D, Pfennig A, Swart E. [Methodological Challenges when Using Claims Data of more than 70 Statutory Health Insurances - A Progress Report from the EVA64 Study]. Gesundheitswesen. 2020 Mar;82(S 01):S4-S12. doi: 10.1055/a-1036-6364. Epub 2020 Jan 21. German.
PubMed 31962364Neumann A, Swart E, Hackl D, Kliemt R, March S, Kuster D, Arnold K, Petzold T, Baum F, Seifert M, Weiss J, Pfennig A, Schmitt J. The influence of cross-sectoral treatment models on patients with mental disorders in Germany: study protocol of a nationwide long-term evaluation study (EVA64). BMC Psychiatry. 2018 May 18;18(1):139. doi: 10.1186/s12888-018-1721-z.
PubMed 29776348Neumann 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wissenschaftliche Evaluation Des Modellvorhabens (§ 64b SGB V) am Pfalzklinikum (EVA_Pfalz)
- ClinicalTrials.gov ID
- NCT05181982
- Acronym / sponsor ID
- EVA_Pfalz / EVA_Pfalz
- Conditions
- Mental Health Care
- Keywords
- Cross-sectoral Treatment, Flexible and Integrated Treatment, Global Treatment Budget, FIT, Psychiatry, Evaluation, Claims data, Cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- ISMG, Medical Faculty, Otto-von-Guericke University Magdeburg, Scientific Institute for Health Economics and Health System Research
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Jan 2022 (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)) (FIT) at the Pfalzklinikum. The central concern of this evaluation is to answer the question whether the FIT model 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 SGB V created the possibility of agreeing so-called FIT model projects for the further development of care for mentally ill people. The objective is to improve cross-sectoral care or optimize patient care. More than 20 statutory health insurance (SHI) funds have developed a FIT model project at the Pfalzklinikum in Germany targeting children, youth and adults. By now, this is the largest FIT project within Germany and the only one in the German Federal State Rheinland-Pfalz. There are more 22 FIT projects at German psychiatric hospitals by December 2021. This FIT project started on 01 January 2020 with an initial duration of eight years.
The goal of the contract is the implementation and further development of improved patient care within the framework of a global treatment budget. To optimize care, "Assertive Community Treatment (ACT)" was introduced as treatment in the patient's environment (home). ACT aims to strengthen patient care, especially in outreach treatment (home treatment), and gives treatment providers more flexibility to adapt the type, duration and intensity of treatment to the patient's needs. Furthermore, the model project aims at a continuous treatment and stabilization of the patients in consideration of their social and professional environment, the creation of a continuity of treatment, the increase of the acceptance of the patient-oriented, psychotherapeutic and sociotherapeutic interventions. Furthermore, the change in financing in the form of a global treatment budget should lead to a more effective use of financial resources.
In accordance with § 65 SGB V, all model projects under § 64b SGB V, must be scientifically evaluated by an independent expert (expert team). Eighteen of the 22 FIT projects are under evaluation with a similar study design elsewhere (Neumann et al., 2018), while for the evaluation of another FIT project a slightly adopted design with a multi-methods approach is used (Neumann et al., 2021). The aim of this evaluation is to examine the achievement of the objectives of the FIT model project based on anonymized claims data (March et al, 2020). The main goals of the model project are to shorten the duration of inpatient stays while intensifying day care and / or outpatient forms of treatment, decrease sick leave days, increase treatment continuity, reduce inpatient readmission rate and not to deteriorate further disease- and care-related aspects, such as disease progression or comorbidities. In addition, the total costs of the FIT model care should not exceed those of the standard care or, at a maximum of the same costs, better results should be achieved. However, it is expected that some costs will increase (e.g. outpatient care) while other costs will decrease (e.g. inpatient care) .
The effectiveness, costs, and cost-effectiveness of the FIT model hospital compared to standard care are to be examined. The study presented here is a controlled cohort study utilizing anonymous claims data. The controlled design is based on the fact that information of patients from the intervention hospital, the Pfalzklinikum, is compared to information of comparable patients from structurally similar psychiatric hospitals in the same federal state (Petzold et al, 2019).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: FIT contract with global treatment budgetPatients being treated at the FIT hospital (Pfalzklinikum) between January 2020 and December 2023 |
| Control group | – | –Patients being treated in standard care (control hospitals) in the German federal state Rheinland-Pfalz |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anonymized data of the participating SHI funds will be analyzed. This includes all patients being treated at the Pfalzklinikum or a control hospital between 01 January 2020 and 31 December 2023 using claims data up to 31 December 2024 enabling an individual follow-up period of at least 12 months.
Key inclusion criteria (2 listed)
- treatment at the Pfalzklinikum or control hospital after 01.01.2020 (date included) and before 31.12.2023 (date included) with one of the following diagnoses as main diagnosis (ICD-10: F00, F01, F02, F03, F07, F10, F20-29, F30-39, F43, F45, F40-48, F50, F60.31, F70-79, F84, F90-F98, B22 \& F02.8, G20.0 \& F02.3, G30.0 \& F00.0, G30.1 \& F00.1) at the department of psychiatry (FA 29xx), department of child and adolescent psychiatry (F30xx) or department of psychosomatic/psychotherapy (FA31xx)
- being insured with any of the participating SHI funds
Key exclusion criteria (2 listed)
- less than one year follow-up data available
- non-permanent residence in Germany during observation period
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 |
|---|---|---|
| FIT contract with global treatment budgetSeveral SHI funds 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 (FIT hospital, Pfalzklinikum). This contract encourages the model hospital an alternative treatment of their patients (insured with the involved SHI funds), for example fewer inpatient and more outpatient treatment. The contract is based on a global treatment budget (pre-defined fix budget for a specified number of patients independent from the setting of treatment in the hospital). | Other | Intervention Group |
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).
Sick leave days
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
The number of sick leave days due to any mental disorder among employed persons will be counted.
12 secondary outcomes
Duration of day care psychiatric treatment
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
Effects of special services
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Prevention of treatment discontinuation
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
Further disease- and care-related aspects: comorbidities
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: mortality
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: disease progression
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: guideline adherence
Time frame: one year prior to recruitment compared to first to fourth year after recruitment
Further disease- and care-related aspects: continuity of care
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 23494246Grossimlinghaus I, Falkai P, Gaebel W, Janssen B, Reich-Erkelenz D, Wobrock T, Zielasek J. [Developmental process of DGPPN quality indicators]. Nervenarzt. 2013 Mar;84(3):350-65. doi: 10.1007/s00115-012-3705-4. German.
- Background: PubMed 16224307Quan H, Sundararajan V, Halfon P, Fong A, Burnand B, Luthi JC, Saunders LD, Beck CA, Feasby TE, Ghali WA. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005 Nov;43(11):1130-9. doi: 10.1097/01.mlr.0000182534.19832.83.
- 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.
- Background: PubMed 31962364March S, Zimmermann L, Kubat D, Neumann A, Schmitt J, Baum F, Schoffer O, Arnold K, Seifert M, Kliemt R, Hackl D, Pfennig A, Swart E. [Methodological Challenges when Using Claims Data of more than 70 Statutory Health Insurances - A Progress Report from the EVA64 Study]. Gesundheitswesen. 2020 Mar;82(S 01):S4-S12. doi: 10.1055/a-1036-6364. Epub 2020 Jan 21. German.
- Background: PubMed 29776348Neumann A, Swart E, Hackl D, Kliemt R, March S, Kuster D, Arnold K, Petzold T, Baum F, Seifert M, Weiss J, Pfennig A, Schmitt J. The influence of cross-sectoral treatment models on patients with mental disorders in Germany: study protocol of a nationwide long-term evaluation study (EVA64). BMC Psychiatry. 2018 May 18;18(1):139. doi: 10.1186/s12888-018-1721-z.
- Background: 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.
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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.
Anne Neumann, Dr. study chair
Center For Evidence-Based Healthcare (ZEGV), Technische Universität Dresden, Germany
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, 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Neumann, Dr. (+49 (0)351 458 5634, Anne.Neumann@uniklinikum-dresden.de), or a site near the patient. 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 NCT05181982, which also lists 6 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 27 Aug 2026.