Bundesweit Einheitliche Wissenschaftliche Evaluation Von Modellvorhaben Nach § 64b SGB V ab 2022
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Sick leave days
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •less than one year follow-up data available
结局指标
主要结局
Sick leave days
时间窗: one year prior to recruitment compared to first to fourth year after recruitment
The number of sick leave days due to any mental disorder will be counted.
Duration of inpatient psychiatric treatment
时间窗: 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
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).
次要结局
- Mortality(event time analysis)
- Discontinuation of contacts for severely mentally ill patients within the psychiatric care system(one year prior to one year after recruitment)
- Disease progression(event time analysis)
- Hopping(one year prior to recruitment compared to first to max year after recruitment)
- Comorbidities(one year prior to recruitment compared to first to max year after recruitment)
- Direct medical care costs(one year prior to recruitment compared to first to max year after recruitment)
- Duration of day care psychiatric treatment(one year prior to recruitment compared to first to max year after recruitment)
- Outpatient psychiatric treatment (within and outside the hospital)(one year prior to recruitment compared to first to max year after recruitment)
- Continuity of care(one year prior to recruitment compared to first to max year after recruitment)
- Inpatient hospital readmission(one year prior to one year after first full inpatient psychiatric discharge after recruitment)
- Cost-effectiveness (direct medical costs)(one year prior to recruitment compared to first to max year after recruitment)