Condition category
Mental and Behavioural Disorders
Date applied
01/12/2011
Date assigned
27/01/2012
Last edited
12/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The German mental health system often lacks the ability to provide integrated and intensified outpatient care for people with severe mental illness. Assertive Outreach (AO), an approach for an intensive, community-based health care delivery, could help to overcome some of the deficits. A model of AO treatment in which office-based psychiatrists collaborate with ambulatory nursing services to provide a complex model of intensive homecare is currently being used in rural areas of Lower Saxony, Germany. The aim of this study is to investigate the effectiveness and efficiency of this model for adult patients suffering from schizophrenia, a severe long-term mental health condition.

Who can participate?
Patients aged 18 or older with schizophrenia

What does the study involve?
Patients receiving AO are compared to patients who are not eligible for AO because this treatment model is not reimbursed by their health insurance (they receive treatment as usual). The observation period for each patient spans over 12 months with assessments every 3 months for healthcare use and every 6 months for all other parameters (psychopathology, level of functioning, patient satisfaction with care and healthcare costs).

What are the possible benefits and risks of participating?
It is hoped that patients receiving AO require fewer days of hospital treatment than patients receiving treatment as usual. The findings from the study will be of great help for the further development of mental healthcare in Germany.

Where is the study run from?
Leuphana University Lueneburg (Germany)

When is the study starting and how long is it expected to run for?
May 2011 to March 2012.

Who is funding the study?
The study is funded through European Funds for Regional Development and through the Federal State of Lower Saxony within the framework of the Innovation-Incubator at Leuphana University Lueneburg (Germany)

Who is the main contact?
Jörn Moock
joern.moock@inkubator.leuphana.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wulf Roessler

ORCID ID

Contact details

Volgershall 1
Lueneburg
21339
Germany
+49 (0)413 1677 5581
roessler@dgsp.uzh.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DRKS00003351

Study information

Scientific title

Comparing assertive outreach with standard care for people with schizophrenia in Germany: health care utilization, psychopathology and level of functioning after 12 months

Acronym

Study hypothesis

Assertive outreach (AO) is superior to standard care for people with schizophrenia. Patients receiving assertive outreach use significantly fewer days of inpatient treatment than patients receiving standard care. In addition, AO leads to better clinical and functional outcomes, to greater patient satisfaction with care and lower health care costs compared to standard care.

Ethics approval

Ethics Commission & Medical Association in Lower Saxony (Ethikkommission bei der Ärztekammer Niedersachsen), 14/03/2011, ref: Bo/03/2011

Study design

Multi-centred naturalistic quasi-randomised controlled trial

Primary study design

Interventional

Secondary study design

Quasi-randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Schizophrenia

Intervention

1. Assertive Outreach (with home care and case management provided by a mental health nurse, a 24-hour, seven days a week available crisis service, psychoeducation, an evidence informed treatment guideline and a strong collaboration between the psychiatrist and ambulatory nursing service)
2. Treatment as usual

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Number of days spent in inpatient psychiatric care measured with the German version of the Client Socio-demografic and Service Receipt Inventory (CSSRI, interview with the patient) at baseline (t0) and every three month within 1 year (t1-t4).

Secondary outcome measures

1. Psychosocial functioning, measured with the WHO-Disability Assessment Scale II (patient rating) and the Global Assessment of Functioning (physician rating) at baseline (t0) and after 6 month and 12 month (t2 and t4)
2. Psychopathology, measured with the Brief Psychiatric Rating Scale (physician rating) and a 2-item-version of the Alcohol Use and Drug Use Scale (patient rating) at t0, t2 and t4
3. Life satisfaction, measured with single item (11-point scale, patient rating) at t0, t2 and t4
4. Patient satisfaction with care, measured with the short version of the Patient Assessment of Chronic Care (patient rating) at t0, t2 and t4
5. Direct and indirect costs, measured with the CSSRI (interview) at t0-t4

Overall trial start date

03/05/2011

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients (18 years or older) with a clinical diagnosis of schizophrenia (F20) and moderate or severe impairments in the level of functioning rated by the physician using the global assessment of function scale (Global Assessment of Functioning (GAF) ≤ 60)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

536

Participant exclusion criteria

1. Patients with medium or severe cognitive impairments or organic mental disorder
2. Patients with insufficient language ability
3. Individuals who are unwilling or unable to give informed consent to the study participation
4. Patients who refuse Assertive Outreach

Recruitment start date

03/05/2011

Recruitment end date

31/03/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Volgershall 1
Lueneburg
21339
Germany

Sponsor information

Organisation

European Fund for Regional Development (Germany)

Sponsor details

Friedrichswall 1
Hannover
30159
Germany

Sponsor type

Government

Website

http://www.efre.niedersachsen.de

Funders

Funder type

Government

Funder name

European Funds for Regional Development (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federal State of Lower Saxony (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Innovation-Incubator, Leuphana University Lueneburg (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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23414234

Publication citations

  1. Results

    Bramesfeld A, Moock J, Kopke K, Büchtemann D, Kästner D, Radisch J, Rössler W, Effectiveness and efficiency of assertive outreach for Schizophrenia in Germany: study protocol on a pragmatic quasi-experimental controlled trial., BMC Psychiatry, 2013, 13, 56, doi: 10.1186/1471-244X-13-56.

Additional files

Editorial Notes

12/04/2017: Plain English summary added.