Condition category
Mental and Behavioural Disorders
Date applied
05/08/2005
Date assigned
15/08/2005
Last edited
15/09/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Becker

ORCID ID

Contact details

University of Ulm
Department of Psychiatry II
Ludwig-Heilmeyer-Str. 2
Guenzburg
D-89312
Germany
+49 (0)8221 96 2001
t.becker@bkh-guenzburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01 GL 0504

Study information

Scientific title

Acronym

EMM

Study hypothesis

To examine whether continuous monitoring and management of outcome (EMM) improves the quality of inpatient psychiatric care and contributes to an adaptive allocation of treatment resources. Hypotheses are that EMM:
1. Leads to a short and medium-term improvement of the clinical treatment outcome
2. Is cost effective because of a reduction of length of stay (LOS) and decrease of subsequent treatment costs
3. Is feasible i.e. can also be used with severely impaired patients
4. Causes higher clinician and patient satisfaction with treatment

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Severe mental disorder

Intervention

Outcome monitoring and management (intervention group) versus outcome monitoring (control group)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Independent rating of treatment outcome (psychological impairment)

Secondary outcome measures

a. Patient and clinician rating of outcome
b. Costs for utilisation of health care services (from health insurance files and patient information)
c. Patient and clinician satisfaction

Overall trial start date

01/09/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients at the age of 18 to 65 years admitted to a large psychiatric hospital in rural Bavaria ('Bezirkskrankenhaus Guenzburg')

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

294

Participant exclusion criteria

Primary diagnosis of substance disorder, organic brain disorder, or dementia; insufficient knowledge of the German language, limited reading and/or writing abilities.

Recruitment start date

01/09/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Germany

Trial participating centre

University of Ulm
Guenzburg
D-89312
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research, Project Management by the German Aerospace Center (DLR)

Sponsor details

German Aerospace Center (DLR)
Health Research
Heinrich-Konen-Str. 1
Bonn
53227
Germany
+49 (0)228 3821 0
gesundheitsforschung@dlr.de

Sponsor type

Government

Website

http://www.bmbf.de

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes