Open Access Study protocol

Effectiveness and efficiency of assertive outreach for Schizophrenia in Germany: study protocol on a pragmatic quasi-experimental controlled trial

Anke Bramesfeld12, Jörn Moock1, Kirsten Kopke1, Dorothea Büchtemann1, Denise Kästner1, Jeanett Radisch1 and Wulf Rössler13*

Author Affiliations

1 Innovation Incubator, Leuphana University Luneburg, Luneburg, Germany

2 Institute Epidemiology, Social Medicine and Health System Research, Hanover Medical School, Hanover, Germany

3 Clinic for Social and General Psychiatry, University of Zurich, Zurich, Switzerland

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BMC Psychiatry 2013, 13:56  doi:10.1186/1471-244X-13-56

Published: 15 February 2013



A model of assertive outreach (AO) in which office-based psychiatrists collaborate with ambulatory nursing services for providing intensive home-treatment is currently being implemented in rural areas of Lower Saxony, Germany. The costs of the model are reimbursed by some of the statutory health insurance companies active in Lower Saxony. Effectiveness and efficiency of this model for patients suffering from schizophrenia is evaluated in a pragmatic and prospective trial.


Quasi-experimental controlled trial: patients receiving the intervention are all those receiving AO; controls are patients not eligible for AO based on their health insurance affiliation. Eligibility criteria: clinical diagnosis of schizophrenia (ICD-10 F.20), aged at least 18 years and being moderately to severely impaired in global functioning. Primary outcome: admission and days spent in psychiatric inpatient care; secondary outcomes: clinical and functional status; patient satisfaction with chronic care; health care costs. Follow-up time: 6 and 12 months.


The study faces many challenges typical to pragmatic trials such as the rejection of randomisation by service providers, the quality of treatment as usual (TAU) to which the intervention will be compared, and the impairment of the study subjects. Solutions of how to deal with these challenges are presented and discussed in detail.

Trial registration

International Standard Randomised Controlled Trial Number: http://ISRCTN34900108 webcite, German Clinical Trial Register: http://DRKS00003351 webcite

Home treatment; Psychiatry; Integrated care; Seriously mentally ill; Controlled trial