Assertive outreach for people with schizophrenia in Germany

ISRCTN	ISRCTN34900108
DOI	https://doi.org/10.1186/ISRCTN34900108
Protocol serial number	DRKS00003351
Sponsor	European Fund for Regional Development (Germany)
Funders	European Funds for Regional Development (Germany), Federal State of Lower Saxony (Germany), Innovation-Incubator, Leuphana University Lueneburg (Germany)

Submission date: 01/12/2011
Registration date: 27/01/2012
Last edited: 12/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Wulf Roessler
Scientific

Volgershall 1
Lueneburg
21339
Germany

Phone	+49 (0)413 1677 5581
Email	roessler@dgsp.uzh.ch

Study information

Primary study design	Interventional
Study design	Multi-centred naturalistic quasi-randomised controlled trial
Secondary study design	Quasi-randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethics Commission & Medical Association in Lower Saxony (Ethikkommission bei der Ärztekammer Niedersachsen), 14/03/2011, ref: Bo/03/2011
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	31/03/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	536
Key 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)
Key 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
Date of first enrolment	03/05/2011
Date of final enrolment	31/03/2013

Locations

Countries of recruitment

Germany

Study participating centre

Volgershall 1

Lueneburg
21339
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/02/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/04/2017: Plain English summary added.