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).

Comorbidity of chronic somatic diseases in patients with psychotic disorders and their influence on 4-year outcomes of integrated care treatment (ACCESS II study).

BACKGROUND: People with psychotic disorders fulfilling criteria of a severe and persistent mental illness (SPMI) display a high risk of somatic comorbidity (SC). METHODS: ACCESS II is a prospective, long-term study examining the effectiveness of Integrated Care for people with psychotic disorders fulfilling SPMI criteria. Chronic comorbid somatic disorders were systematically assessed according to ICD-10-GM criteria. Patients treated for ≥4years in ACCESS were categorized as early psychosis (treatment: ≤2years) or non-early psychosis (treatment: >2years) patients. RESULTS: Of 187 patients treated in ACCESS for ≥4years (mean age=41.8years, males=44.4%), 145 (77.5%) had SC, (mean=2.1±2.1). Overall, 55 different diseases from 15 different ICD-10-GM disease areas were identified. Prevalence of ≥1 SC (p=0.09) and specific types of SC (p=0.08-1.00) did not differ between early and non-early psychosis patients, but non-early psychosis patients had a higher mean number of SC (2.3±2.2 vs. 1.3±1.3, p=0.002). SC patients had higher rates of comorbid mental disorders (93% vs. 81%, p=0.002), specifically posttraumatic stress disorder (23% vs. 7%, p=0.002), and suicide attempts (43% vs. 19%, p<0.001). At the 4-year endpoint, both patients with and without comorbidity displayed major improvements in psychopathology, severity of illness, functioning, quality of life and satisfaction with care. CONCLUSIONS: SC is frequent in patients with severe psychotic disorders, even in the early psychosis phase. The magnitude of the problem underlines the need for regular screening, comprehensive assessment, preventive pharmacotherapy, and targeted SC management.

Clowning as a supportive measure in paediatrics - a survey of clowns, parents and nursing staff.

BACKGROUND: Hospital clowns, also known as clown doctors, can help paediatric patients with the stress of a hospitalization and to circumvent the accompanying feelings of fear, helplessness and sadness, thus supporting the healing process. The objectives of the present study were to clarify the structural and procedural conditions of paediatric clowning in Germany and to document the evaluations of hospital clowns, parents and hospital staff. METHODS: A nationwide online survey of hospital clowns currently active in paediatric departments and an accompanying field evaluation in Hamburg hospitals with surveys of parents and hospital staff were conducted. In addition to items developed specifically for the study regarding general conditions, procedures, assessments of effects and attitudes, the Work Satisfaction Scale was used. The sample included n = 87 hospital clowns, 37 parents and 43 hospital staff members. RESULTS: The online survey showed that the hospital clowns are well-trained, motivated and generally satisfied with their work. By their own estimate, they primarily boost morale and promote imagination in the patients. However, hospital clowns also desire better interdisciplinary collaboration and financial security as well as more recognition of their work. The Hamburg field study confirmed the positive results of the clown survey. According to the data, a clown intervention boosts morale and reduces stress in the patients. Moreover, there are practically no side effects. Both parents and hospital staff stated that the patients as well as they themselves benefited from the intervention. CONCLUSIONS: The results match those of previous studies and give a very positive picture of hospital clowning, so that its routine use and expansion thereof can be recommended. Furthermore, the intervention should be subject to the rules of evidence-based medicine like other medical treatments.