Mental Health Care Clinical Trial
— EVA_PfalzOfficial title:
Wissenschaftliche Evaluation Des Modellvorhabens (§ 64b SGB V) am Pfalzklinikum (EVA_Pfalz)
NCT number | NCT05181982 |
Other study ID # | EVA_Pfalz |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 30, 2022 |
Est. completion date | July 2026 |
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.
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | July 2026 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - less than one year follow-up data available - non-permanent residence in Germany during observation period |
Country | Name | City | State |
---|---|---|---|
Germany | Center For Evidence-Based Healthcare, Technische Universität Dresden | Dresden |
Lead Sponsor | Collaborator |
---|---|
Technische Universität Dresden | ISMG, Medical Faculty, Otto-von-Guericke University Magdeburg, Scientific Institute for Health Economics and Health System Research, Leipzig (WIG2) |
Germany,
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. — View Citation
March 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. — View Citation
Neumann A, Hense H, Baum F, Kliemt R, Seifert M, Harst L, Kubat D, Maicher B, Schrey C, Schmitt J, Pfennig A, Weinhold I, Swart E, Soltmann B. Evaluation of a flexible and integrative psychiatric care model in a department of child and adolescent psychiatry in Tubingen, Germany: study protocol (EVA_TIBAS). BMC Health Serv Res. 2021 Nov 22;21(1):1262. doi: 10.1186/s12913-021-07226-1. — View Citation
Neumann 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. — View Citation
Petzold T, Neumann A, Seifert M, Kuster D, Pfennig A, Weiss J, Hackl D, Swart E, Schmitt J. [Identification of Control Hospitals for the Implementation of the Nationwide and Standardized Evaluation of Model Projects According to section sign 64b SGB V: Analysis of Data from Structured Quality Reports]. Gesundheitswesen. 2019 Jan;81(1):63-71. doi: 10.1055/s-0042-116436. Epub 2016 Nov 15. German. — View Citation
Quan 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. — 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). | one year prior to recruitment compared to first to fourth year after recruitment | |
Primary | Sick leave days | The number of sick leave days due to any mental disorder among employed persons will be counted. | one year prior to recruitment compared to first to fourth year after recruitment | |
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). | 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 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. | one year prior to recruitment compared to first to fourth year after recruitment | |
Secondary | 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. | one year prior to recruitment compared to first to fourth year after recruitment | |
Secondary | 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. | 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. | first year after first full inpatient psychiatric discharge after recruitment | |
Secondary | 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. | one year prior to recruitment compared to first to fourth year after recruitment | |
Secondary | 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. | one year prior to recruitment compared to first to fourth year after recruitment | |
Secondary | 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. | one year prior to recruitment compared to first to fourth year after recruitment | |
Secondary | 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. | one year prior to recruitment compared to first to fourth year after recruitment | |
Secondary | 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. | 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 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. | 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. | one year prior to recruitment compared to first to fourth year after recruitment |
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