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临床试验/NCT00662428
NCT00662428已完成不适用

Evaluation of a Guideline-based Net Care Intervention to Reduce the Duration of Inpatient Depression Treatment

University Hospital Freiburg10 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2008年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
202
试验地点
10
主要终点
Cost-effectiveness: ratio of treatment response and treatment costs

研究概览

简要总结

The cost-effectiveness of a new, guideline oriented sequential inpatient - outpatient treatment model will be investigated. Secondary outcomes are: patient satisfaction, practitioners' satisfaction and influence on work.

详细描述

Great diversity concerning duration of inpatient treatment of depression in psychiatric-psychotherapeutic hospitals is often used as an argument for the possible reduction of length of stay. Yet shorter duration of inpatient treatment of depressive episodes has not been examined systematically concerning clinical outcomes and health economic consequences. In this study the cost-effectiveness of a new sequential inpatient-outpatient treatment model will be examined. The research hypothesis is that the new treatment model will be more cost-effective than treatment as usual. The design provides a randomized controlled trial (RCT) in four psychiatric-psychotherapeutic clinics with a total of 240 patients. First medical practitioners and psychologist will receive a retraining concerning guideline-based care and the new treatment model will be implemented in the hospitals. New patients admitted to one of the hospitals will then be assigned randomly to one of the two study conditions und prospectively examined at five measuring times: Condition A (control group) contains treatment as usual (individual treatment programme, discharge after remission), Condition B (intervention group) contains the sequential inpatient-outpatient treatment (guideline-based treatment, discharge after partly remission: BDI <20, outpatient treatment in the hospital and guided transfer to outpatient care).

Primary outcome is the reduction of costs of treatment in relation to reduction of symptoms. Secondary outcomes will be reduction of the depressive pathology as well as the extent of satisfaction among patients and practitioners. A total of 240 patients will be examined from admission until 12 month after discharge. Both information from the patients and the practitioners will be charged with well implemented and established instruments (psychiatric basic documentation system, BADO). A specific questionnaire will be used to measure the practitioners' satisfaction and the consequences of the sequential inpatient-outpatient treatment. To answer the main question about the cost-effectiveness analyses of central health economic outcome variables (direct and indirect costs of treatment) will be performed. This study is going to give differentiated and scientific evidence of the efficiency of a new sequential inpatient-outpatient treatment for depressive disorders. The participation of psychiatric-psychotherapeutic hospitals with different functions and structures in the public health care systems (academic medical centre, psychiatric department of general hospital, psychiatric centres) enable the evaluation of the new treatment model under diverse structural and organizational conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current depressive episode at time of admission
  • ICD-10 diagnosis:
  • Depressive episode, F 32.xx
  • Recurrent depressive episode, F 33.xx
  • Depression is primary treatment indication
  • The ability to give informed consent
  • Sufficient German language skills
  • Being resident sufficiently close to the hospital for being able to take part in the outpatient program
  • permanent residence

排除标准

  • Alcohol or drug dependence (not misuse)
  • Psychotic symptoms
  • Schizoaffective disorders
  • Bipolar disorders
  • Schizophrenia

结局指标

主要结局

Cost-effectiveness: ratio of treatment response and treatment costs

时间窗: one year after discharge

次要结局

  • patient satisfaction(at discharge)
  • Symptom reduction(at discharge, 6 month after discharge, and one year after discharge)

研究者

发起方
University Hospital Freiburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Härter

Prof. Dr. Dr.

University Hospital Freiburg

研究点 (10)

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