Background/Objectives: Health care reforms in 2004 in Germany financially promoted the establishment of integrated care models. At the same time and due to a pilot project sponsored by the Ministry of Health, the German federal state of Lower Saxony had a relatively well developed structure of outpatient psychiatric nursing services working as independent enterprises. Office-based psychiatrists, who are the main source for outpatient mental health care in Germany, allied with these psychiatric nursing services in order to providing complex and outreaching care with the aim to reduce the need for hospital admission. The care model they developed includes intensive case management and 24-hour crisis services provided by nursing services, regular psychiatric outpatient treatment provided by office-based psychiatrists, occupational therapy, and psychoeducation. The nucleus of the care model is the psychiatric practice that contracts with each services provider as needed. All service providers operate as independent enterprises. A management company (IVPNetworks) coordinates and logistically supports the practices and contracts with health care funds for reimbursement of the complex care. Only patients affiliated with specific health care funds are eligible for reimbursement of the intervention. Aim of the study is to evaluate the complex care model intervention for its effectiveness and efficiency.

Methods: The care model will be evaluated for a 12 months duration in a controlled design. Patients with schizophrenia and eligible for complex care due to their health care fund are compared to controls that are not eligible for complex care reimbursement. Intervention and control patients are recruited in the same practices. Primary outcome parameter is the number of hospital days used. Secondary parameters include symptomatology, disability, quality of life, use of services, and treatment costs.

Results: First results of patient recruitment which starts April 2011 will be reported.

Discussion/Conclusions: This is a naturalistic study evaluating an intervention that is being implemented in routine health care outside the research setting. Using affiliation with health care fund as „quasi randomisation“ criteria is an option in the absence of the possibility for „real randomisation. Affiliation with a specific health care fund is more or less random. This study design assures that basic conditions for intervention and control patients are the same.