Increasing Cost-effectiveness of Inpatient Treatment of Affective Disorders (INCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662428
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : June 21, 2012
German Medical Association
Information provided by (Responsible Party):
Martin Härter, University Hospital Freiburg

Brief 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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Other: Symptom based discharge management Other: Treatment as usual Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Guideline-based Net Care Intervention to Reduce the Duration of Inpatient Depression Treatment
Study Start Date : May 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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).

Active Comparator: Control Other: 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.

Primary Outcome Measures :
  1. Cost-effectiveness: ratio of treatment response and treatment costs [ Time Frame: one year after discharge ]

Secondary Outcome Measures :
  1. Symptom reduction [ Time Frame: at discharge, 6 month after discharge, and one year after discharge ]
  2. patient satisfaction [ Time Frame: at discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662428

Krankenhaus Hofheim
Hofheim, Hessen, Germany, 65719
Bezirkskrankenhaus Bayreuth
Bayreuth, Germany, D-95445
Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
Freiburg, Germany, D-79104
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany, D-76133
Klinikum am Weissenhof
Weinsberg, Germany, D-74189
Sponsors and Collaborators
University Hospital Freiburg
German Medical Association
Principal Investigator: Martin Härter, Prof. Dr. Dr. Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
Principal Investigator: Isaac Bermejo, Dr. Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
Study Chair: Lars P Hölzel, Dr. Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

Publications of Results:
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.

Responsible Party: Martin Härter, Prof. Dr. Dr., University Hospital Freiburg Identifier: NCT00662428     History of Changes
Other Study ID Numbers: BÄK 06-69
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Martin Härter, University Hospital Freiburg:
cost-benefit analysis
practice guideline

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms