title: Effectiveness and efficiency of integrated mental health care programmes in Germany: study protocol of an observational controlled trial.
abstract: BACKGROUND
  Since 2009 some German health insurance companies have implemented integrated mental health care services along the principles of assertive community treatment in collaboration with local mental health service providers across Germany. Focus of this study is the analysis of effectiveness and cost-effectiveness of this integrated care programme compared to care as usual in routine care surroundings in five regions in Germany.
  
  
  METHODS
  In this 18-month multi-centre observational trial 250 patients enrolled in an integrated mental health care programme and 250 patients who receive treatment as usual from five catchment areas will be included. In addition, in each group about 125 relatives of the participating patients will be included. The primary outcome criterion is the improvement of empowerment; secondary outcomes are subjective quality of life, functional impairment and costs of illness. Data will be collected at baseline and three follow-ups after 6, 12 and 18 months. Data will be analysed by means of mixed effects regression models. Propensity score methods are used for selection bias control.
  
  
  CONCLUSIONS
  Study results are expected to provide information about how integrated care programmes in their present form contribute to the improvement of mental health care. In addition, the study will provide hints to weaknesses of the current integrated care programme and options to overcome them. The major strengths of this study are the real-world character of the study intervention with a simultaneous high level of academic rigour. However, the fact that patients are not randomised to study groups and that there is no blinding might limit the study.
  
  
  BACKGROUND
  German Clinical Trial Register DRKS00005111.
authors.affiliation: Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Germany. Annabel-Sandra.Stierlin@bkh-guenzburg.de.
authors.forename: Annabel Sandra
authors.initials: AS
authors.lastname: Stierlin
authors.forename: Katrin
authors.initials: K
authors.lastname: Herder
authors.forename: Marina Julia
authors.initials: MJ
authors.lastname: Helmbrecht
authors.forename: Stefanie
authors.initials: S
authors.lastname: Prinz
authors.forename: Julia
authors.initials: J
authors.lastname: Walendzik
authors.forename: Marco
authors.initials: M
authors.lastname: Holzmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Becker
authors.forename: Matthias
authors.initials: M
authors.lastname: Schützwohl
authors.forename: Reinhold
authors.initials: R
authors.lastname: Kilian
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D003156:Community Mental Health Services / Q000191:economics; D003362:Cost-Benefit Analysis; D005858:Germany; D007348:Insurance, Health; D008603:Mental Health; D008605:Mental Health Services / Q000191:economics; D015397:Program Evaluation; D011788:Quality of Life; D064887:Observational Studies as Topic