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临床试验/NCT04727359
NCT04727359已完成不适用

[Wissenschaftliche Evaluation Modellvorhaben in Der Kinder- Und Jugendpsychiatrie (§ 64b SGB V) - Therapeutische Intensivbehandlung im Ambulanten Setting (TIBAS) am Universitätsklinikum Tübingen]

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 1,037 人开始时间: 2021年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,037
试验地点
1
主要终点
Health related quality of life

研究概览

简要总结

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)) (FIT64b) in the child and adolescent psychiatry at the University Hospital Tübingen (UKT). The central concern of this evaluation is to answer the question whether FIT64b models offer advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible treatment intensities.

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 FIT64b model projects for the further development of care for mentally ill people. The objective is to improve cross-sectoral care or optimize patient care. The statutory health insurance (SHI) funds AOK Baden-Württemberg and the SVLFG (as an agricultural health insurance fund) have developed a FIT64b model project in child and adolescent psychiatry (KJP) with the UKT, which will be tested for a total of eight years in the care region of Tübingen starting on 01 October 2017. The core of the model care is the Therapeutic Intensive Treatment in the Outpatient Setting (TIBAS, from the German abbreviation of "Therapeutische Intensivbehandlung im Ambulanten Setting").

The goal of this model care is to provide more cross-sectoral service delivery through more flexible treatment intensities. The creation of TIBAS as an intensive outpatient form of treatment is intended to enable earlier discharge from the full inpatient setting. Four TIBAS levels have been implemented, representing different treatment intensities and frequencies, which can be flexibly deployed according to patient needs. A person-centered case manager accompanies patients throughout the treatment period. If necessary, the patients, but especially the family members, are accompanied by the social service of the AOK Baden-Württemberg and supported with regard to stabilizing the overall care situation (psychosocial counseling and networking with other care structures, etc.). For patients fulfilling the diagnostic criteria for either anorexia nervosa or moderate depression, direct access to TIBAS is possible without prior hospitalization.

The aim of the evaluation is to examine the achievement of the objectives of the FIT64b model project on the basis of anonymized claims data and primary data to be collected and to assess the transferability of the care approach to standard care. The main goals of the model project are to shorten the duration of inpatient stays while intensifying outpatient forms of treatment, to reduce the cumulative psychiatric treatment duration and the emergency admission rate, to reduce the symptom burden, to accelerate the return to psychosocial living conditions and to increase the quality of life. Stabilization of the family's overall care situation will be used to sustain these improvements. Through qualitative research methods, the experiences with and the subjective benefit of the social service of the AOK Baden-Württemberg as well as the cooperation of this social service with the UKT will be examined in more detail. The costs of the FIT64b model care should not exceed those of the standard care or, at a maximum of the same costs, better results should be achieved with regard to the above-mentioned patient-related goals.

The effectiveness, costs, and cost-effectiveness of the FIT64b model hospital compared to standard care are examined. The study presented here is a controlled cohort study which utilizes claims data as well as primary data. It will employ quantitative analyses of anonymized SHI data (Module A), quantitative analyses of questionnaires (Module B), and qualitative analyses of semi-structured interviews and a focus group (Module C). The controlled design is based on the fact that information of patients from the intervention hospital, the UKT, is compared to information of comparable patients from structurally similar hospitals of child and adolescent psychiatry 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

入选标准

  • treatment in UKT or control hospital (both KJP) within recruitment phase
  • being insured with AOK Baden-Württemberg
  • at least 6 years of age
  • written consent of the children and adolescents plus written consent of the custodians
  • sufficient cognitive and linguistic ability to participate in the survey
  • Module C1 (semi-structured interviews)
  • sufficient knowledge of German as well as cognitive and linguistic abilities to participate in the interviews
  • written consent of the custodians to participate
  • recommendation for the social service of AOK Baden-Württemberg
  • Module C2 (focus group discussion) • several months of experience in working with the social service of the AOK Baden-Württemberg or the employees of the UKT within the framework of the FIT64b model project at the UKT

排除标准

  • less than one year follow-up data available
  • acute danger to self or others
  • Module C1 (semi-structured interviews) • none
  • Module C2 (focus group discussion)
  • little cooperation with employees of the respective other institution (UKT and social service, e.g. one-time participation in a case conference)

结局指标

主要结局

Health related quality of life

时间窗: cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline

The quality of life for patients will be measured using the KIDSCREEN-27 and compared between IG and CG. (Module B)

Duration of inpatient psychiatric treatment

时间窗: 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). (Module A)

次要结局

  • Outpatient psychiatric treatment in the hospital(one year prior to recruitment compared to first to fourth year after recruitment)
  • Symptom burden(cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline)
  • Return to psychosocial relationships(cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline)
  • Cost-effectiveness (societal costs)(cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline)
  • Offer and effects of social service (qualitative data)(cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022)
  • Emergency admission rate(one year prior to recruitment compared to first to fourth year after recruitment)
  • Cost-effectiveness (direct medical costs)(one year prior to recruitment compared to first to fourth year after recruitment)
  • Treatment satisfaction(cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline)
  • Inpatient psychiatric length of stay(one year prior to recruitment compared to first to fourth year after recruitment)
  • Day care psychiatric length of stay(one year prior to recruitment compared to first to fourth year after recruitment)
  • Inpatient hospital readmission(first year after first full inpatient psychiatric discharge after recruitment)
  • Societal costs(cross-sectional analysis at baseline and / compared with follow-up 24 months after baseline)
  • Duration of day care psychiatric treatment(one year prior to recruitment compared to first to fourth year after recruitment)
  • Direct medical care costs(one year prior to recruitment compared to first to fourth year after recruitment)
  • Cooperation (strengths and potentials for optimization) between UKT and social service employees (qualitative data)(cross-sectional, focus group discussion conducted between spring 2021 and summer 2022)
  • Benefit social service (qualitative data)(cross-sectional, semi-structured interviews conducted between spring 2021 and summer 2022)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Neumann

Principle Investigator

Technische Universität Dresden

研究点 (1)

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