Increasing Cost-effectiveness of Inpatient Treatment of Affective Disorders

Depressive Disorder Clinical Trial

— INCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662428
• Other study ID #: BÄK 06-69
• Status: Completed
• Phase: N/A
• First received: April 15, 2008
• Last updated: June 20, 2012
• Start date: May 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: August 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Dementia

• Alcohol or drug dependence (not misuse)

• Psychotic symptoms

• Schizoaffective disorders

• Bipolar disorders

• Schizophrenia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Symptom based discharge management
Depressive symptoms of patients are weekly assessed by Beck Depression Inventory (BDI II). Patients are discharged when BDI-score is under 20 points. Patients are treated in the same hospital for two more weeks as outpatients before being referred to outpatient care (general practitioner or specialist).
• Treatment as usual
Treatment as usual is the usual stationary depression treatment which consists of a combination of several psychopharmacological and psychotherapeutical treatments. Duration of treatment is varying widely.

Locations

Country	Name	City	State
Germany	Bezirkskrankenhaus Bayreuth	Bayreuth
Germany	Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy	Freiburg
Germany	Krankenhaus Hofheim	Hofheim	Hessen
Germany	Städtisches Klinikum Karlsruhe	Karlsruhe
Germany	Klinikum am Weissenhof	Weinsberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Freiburg	German Medical Association

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hölzel L.P., Bermejo I. & Härter M. (2011). Geordnetes Entlassmanagement - Bewertung eines neuen Behandlungsmodells zur Verkürzung der Verweildauer bei depressiven Erkrankungen. Deutsches Ärzteblatt, 108, 1050-1051.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-effectiveness: ratio of treatment response and treatment costs		one year after discharge	No
Secondary	Symptom reduction		at discharge, 6 month after discharge, and one year after discharge	No
Secondary	patient satisfaction		at discharge	No