Increasing Cost-effectiveness of Inpatient Treatment of Affective Disorders

NCT ID: NCT00662428

Last Updated: 2012-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-08-31

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.

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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Symptom based discharge management

Intervention Type: OTHER

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).

Control

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Medical Association

OTHER

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

Martin Härter

Prof. Dr. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Härter, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

Isaac Bermejo, Dr.

Role: PRINCIPAL_INVESTIGATOR

Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

Lars P Hölzel, Dr.

Role: STUDY_CHAIR

Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

Locations

Krankenhaus Hofheim

Hofheim, Hesse, Germany

Bezirkskrankenhaus Bayreuth

Bayreuth, , Germany

Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy

Freiburg im Breisgau, , Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Klinikum am Weissenhof

Weinsberg, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

Other Identifiers

BÄK 06-69

Identifier Type: -

Identifier Source: org_study_id