Nationwide Uniform Scientific Evaluation of Flexible and Integrated Treatment Projects From 2022 Onwards

Mental Health Clinical Trial

— EVA64_2  

Official title:

Bundesweit Einheitliche Wissenschaftliche Evaluation Von Modellvorhaben Nach § 64b SGB V ab 2022

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855720
• Other study ID #: EVA64.2
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: July 2041

Study information

• Verified date: May 2023
• Source: Technische Universität Dresden
• Contact: Anne Neumann, PhD
• Phone: +4 351 458
• Email: anne.neumann[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The introduction of Section 64b of the German Social Code, Book V (SGB V) created the possibility of agreeing so-called FIT (flexible and integrated treatment) model projects for the further development of care for mentally ill people in Germany. The objective is to improve cross-sectoral care or optimize patient care. More than 20 FIT projects have been established at German psychiatric hospitals since 2013. Some FIT projects were prolonged after eight years (max. 15 years in sum). New FIT projects are planned. In accordance with § 65 SGB V, all FIT projects under § 64b SGB V, must be scientifically evaluated by an independent expert. The aim of this evaluation is to examine the achievement of the objectives of the FIT model projects based on anonymized claims data. The effectiveness, costs, and cost-effectiveness of the FIT model hospital care compared to standard care are to be examined. FIT projects include those starting before 2022 and being prolonged and those FIT projects starting between 2022 and June 2026. 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 intervention hospitals (any FIT design) is compared to information of comparable patients from structurally similar psychiatric hospitals in the same federal state (Petzold et al, Gesundheitswesen 2019, 81(1):63-71).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cohort Studies
• Cross-sectoral Treatment
• Flexible and Integrated Treatment
• Mental Health
• Psychiatry

Intervention

Other:
• FIT model project
Several statutory health insurance (SHI) funds have established contracts with hospitals for an alternative remuneration / financing of patients treated in the hospital (FIT hospital). Some of those contracts already started in 2013 and were prolonged. Some FIT contracts will start freshly (until June 2026). These contracts encourage FIT hospitals to test alternative treatment options for their patients (insured with the involved SHI funds), for example fewer inpatient and more outpatient treatment.

Locations

Country	Name	City	State
Germany	Institute for Social Medicine and Health System Research (ISMG), Medical Faculty, Otto-von-Guericke-University Magdeburg	Magdeburg

Sponsors (3)

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

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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