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
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
-
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.