Mental Health Clinical Trial
— EVA64_2Official title:
Bundesweit Einheitliche Wissenschaftliche Evaluation Von Modellvorhaben Nach § 64b SGB V ab 2022
NCT number | NCT05855720 |
Other study ID # | EVA64.2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | July 2041 |
This study is an evaluation of flexible and integrated psychiatric care models (according to § 64b of the German Social Code Book V (SGB V)) (FIT) including new FIT projects starting after 2022 and the prolongation of any of 19 already established FIT projects (mainly at German psychiatric hospitals). The central concern of this evaluation is to answer the question whether FIT care offers advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible psychiatric treatment intensities. However, FIT program structures depend on the individual situation and organization of the FIT hospital together with the participating statutory health insurance (SHI) funds.
Status | Recruiting |
Enrollment | 30000 |
Est. completion date | July 2041 |
Est. primary completion date | December 2038 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - treatment in any of the participating hospitals or control hospitals within recruitment phase (number of hospitals will be fix until June 2026) - being insured with any of the participating SHI funds Exclusion Criteria: - less than one year follow-up data available |
Country | Name | City | State |
---|---|---|---|
Germany | Institute for Social Medicine and Health System Research (ISMG), Medical Faculty, Otto-von-Guericke-University Magdeburg | Magdeburg |
Lead Sponsor | Collaborator |
---|---|
Technische Universität Dresden | Institute of Social Medicine and Health Services Research, Medical Faculty, Otto-von-Guericke- University Magdeburg, Germany, WIG2 Scientific Institute for Health Economics and Health System Research Leipzig, Germany |
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). | one year prior to recruitment compared to first to max year after recruitment. Max year = latest possible year for maximal observation period depending on the length of FIT project | |
Primary | Sick leave days | The number of sick leave days due to any mental disorder 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 max year after recruitment | |
Secondary | Outpatient psychiatric treatment (within and outside the hospital) | The number of days with a contact in the psychiatric outpatients departments (PIA) and with outpatient treatment due to any psychiatric treatment of patients treated in the IG and CG will be recorded and compared. | one year prior to recruitment compared to first to max year after recruitment | |
Secondary | 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 max 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 hospital stay with any psychiatric diagnosis as main diagnosis and was readmitted with a psychiatric diagnosis as main diagnosis within one year. | one year prior to one year after first full inpatient psychiatric discharge after recruitment | |
Secondary | Discontinuation of contacts for severely mentally ill patients within the psychiatric care system | The frequency of severely mentally ill patients with no contact to the psychiatric care system within 90 and 180 days will be investigated. | one year prior to one year after recruitment | |
Secondary | Hopping | 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 max year after recruitment | |
Secondary | 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 max year after recruitment | |
Secondary | Mortality | The proportion of individuals who die within a defined period of time after inclusion in the evaluation will be analyzed. | event time analysis | |
Secondary | Disease progression | The proportion of patients 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. | event time analysis | |
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 max 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 max year after recruitment |
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