Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER).

INTRODUCTION: Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care. METHODS AND ANALYSIS: The trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions. ETHICS AND DISSEMINATION: Ethical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications. TRIAL REGISTRATION NUMBER AND REGISTRY NAME: ClinicalTrials.gov (NCT03459664), RECOVER PROTOCOL VERSION: 19 March 2020 (V.3.0).

[Innovative care models for people with schizophrenia]. / Innovative Versorgungsmodelle für Menschen mit schizophrenen Erkrankungen.

Schizophrenia is a complex mental disorder. Hence, the mental health system faces enormous structural, therapeutic, and health-economic challenges. Innovative models of healthcare can facilitate making treatment more efficient and effective.This paper aims to give an overview of evidence-based and innovative models of care and treatment for schizophrenia and severe mental illnesses. For this purpose, we performed a literature search covering the last 10 years of publications regarding "care or treatment models" and "schizophrenia," "psychosis," or "severe mental illness."Many publications do not provide details about the tested care model. Innovative care models for schizophrenia comprise early psychosis services (EPSs) or models for severe mental illnesses (SMI) integrating, combining and/or developing the treatment models crisis resolution team (CRT), assertive community treatment (ACT), and/or (intensive) case management (ICM). For illustration, the innovative models Early Psychosis Prevention and Intervention Centre (EPPIC) in Australia, the Flexible Assertive Community Treatment model in the Netherlands, and the Therapeutic Assertive Community Treatment model in Hamburg are explained. All three models regularly offer integrated, specialized, and assertive care.In Germany, innovative models of care have not been implemented sufficiently: neither EPS nor ACT are part of standard care; CRT can now be funded by health insurances via "ward-equivalent treatment" as defined by a new German law (§§ 39 und 115d SGB V). Regarding the implementation of CRT and ACT in Germany, a clinical study evaluating the RECOVER model is underway. This is a stepped-care, trans-sectorally coordinated and evidence-based treatment model, the evaluation of which is supported by the innovation fund of the Joint Federal Committee (Gemeinsamen Bundesausschuss, G­BA) from 2017 to 2020.