Clinical trial NCT00662428: Increasing Cost-effectiveness of Inpatient Treatment of Affective Disorders
Official title: Evaluation of a Guideline-based Net Care Intervention to Reduce the Duration of Inpatient Depression Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Keywords: cost-benefit analysis
practice guideline
inpatients
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: German Medical Association
First posted: 2008-04-21
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Cost-effectiveness: ratio of treatment response and treatment costs
timeFrame: one year after discharge
Secondary outcomes:
measure: Symptom reduction
timeFrame: at discharge, 6 month after discharge, and one year after discharge
measure: patient satisfaction
timeFrame: at discharge
Other outcomes:
Locations:
city: Hofheim
country: Germany
facility: Krankenhaus Hofheim
state: Hessen
city: Bayreuth
country: Germany
facility: Bezirkskrankenhaus Bayreuth
city: Freiburg
country: Germany
facility: Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Weinsberg
country: Germany
facility: Klinikum am Weissenhof
Study officials:
affiliation: Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
name: Martin Härter, Prof. Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
name: Isaac Bermejo, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Freiburg University Medical Center, Dept. of Psychiatry and Psychotherapy
name: Lars P Hölzel, Dr.
role: STUDY_CHAIR
References:
citation: 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.