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Abstract Background Clinical practice guidelines are crucial for enhancing healthcare quality and patient outcomes. Yet, their implementation remains inconsistent across various professions and disciplines. Previous findings on the implementation of the German guideline for schizophrenia (2019) revealed low adherence rates among healthcare professionals. Barriers to guideline adherence are multifaceted, influenced by individual, contextual, and guideline-related factors. This study aims to investigate the effectiveness of a digital guideline version compared to print/PDF formats in enhancing guideline adherence. Methods A multicenter, cluster-randomized controlled trial was conducted in South Bavaria, Germany, involving psychologists and physicians. Participants were divided into two groups: implementation of the guideline using a digital online version via the MAGICapp platform and the other using the traditional print/PDF version. The study included a baseline assessment and a post-intervention assessment following a 6-month intervention phase. The primary outcome was guideline knowledge, which was assessed using a guideline knowledge questionnaire. Results The study included 217 participants at baseline and 120 at post-intervention. Both groups showed significant improvements in guideline knowledge; however, no notable difference was found between both study groups regarding guideline knowledge at either time points. At baseline, 43.6% in the control group (CG) and 52.5% of the interventional group (IG) met the criterion. There was no significant difference in the primary outcome between the two groups at either time point (T0: Chi2 (1) = 1.65, p = 0.199, T1: Chi2 (1) = 0.34, p = 0.561). At post-intervention, both groups improved, with 58.2% in the CG and 63.5% in the IG meeting this criterion. Conclusions While the study did not include a control group without any implementation strategy, the overall improvement in guideline knowledge following an implementation strategy, independent of the format, was confirmed. The digital guideline version, while not superior in enhancing knowledge, showed potential benefits in shared decision-making skills. However, familiarity with traditional formats and various barriers to digital application may have influenced these results. The study highlights the importance of tailored implementation strategies, especially for younger healthcare providers. Trial registration https://drks.de/search/de/trial/DRKS00028895

Abstract Background Choosing an antipsychotic medication is an important medical decision in the treatment of schizophrenia. This decision requires risk-benefit assessments of antipsychotics, and thus, shared-decision making between physician and patients is strongly encouraged. Although the efficacy and side-effect profiles of antipsychotics are well-established, there is no clear framework for the communication of the evidence between physicians and patients. For this reason, we developed an evidence-based shared-decision making assistant (SDM-assistant) that presents high-quality evidence from network meta-analysis on the efficacy and side-effect profile of antipsychotics and can be used as a basis for shared-decision making between physicians and patients when selecting antipsychotic medications. Methods The planned matched-pair cluster-randomised trial will be conducted in acute psychiatric wards (n = 14 wards planned) and will include adult inpatients with schizophrenia or schizophrenia-like disorders (N = 252 participants planned). On the intervention wards, patients and their treating physicians will use the SDM-assistant, whenever a decision on choosing an antipsychotic is warranted. On the control wards, antipsychotics will be chosen according to treatment-as-usual. The primary outcome will be patients’ perceived involvement in the decision-making during the inpatient stay as measured with the SDM-Q-9. We will also assess therapeutic alliance, symptom severity, side-effects, treatment satisfaction, adherence, quality of life, functioning and rehospitalizations as secondary outcomes. Outcomes could be analysed at discharge and at follow-up after three months from discharge. The analysis will be conducted per-protocol using mixed-effects linear regression models for continuous outcomes and logistic regression models using generalised estimating equations for dichotomous outcomes. Barriers and facilitators in the implementation of the intervention will also be examined using a qualitative content analysis. Discussion This is the first trial to examine a decision assistant specifically designed to facilitate shared-decision making for choosing antipsychotic medications, i.e., SDM-assistant, in acutely ill inpatients with schizophrenia. If the intervention can be successfully implemented, SDM-assistant could advance evidence-based medicine in schizophrenia by putting medical evidence on antipsychotics into the context of patient preferences and values. This could subsequently lead to a higher involvement of the patients in decision-making and better therapy decisions. Trial registration German Clinical Trials Register (ID: DRKS00027316 , registration date 26.01.2022).

Abstract Migration rates increase globally and require an adaption of national mental health services to the needs of persons with migration background. Therefore, we aimed to identify differences between persons with and without migratory background regarding (1) treatment satisfaction, (2) needed and received mental healthcare and (3) utilization of mental healthcare. In the context of a cross-sectional multicenter study, inpatients and day hospital patients of psychiatric settings in Southern Germany with severe affective and non-affective psychoses were included. Patients’ satisfaction with and their use of mental healthcare services were assessed by VSSS-54 and CSSRI-EU; patients’ needs were measured via CAN-EU. In total, 387 participants (migratory background: n = 72; 19%) provided sufficient responses for analyses. Migrant patients were more satisfied with the overall treatment in the past year compared to non-migrant patients. No differences between both groups were identified in met and unmet treatment needs and use of supply services (psychiatric, psychotherapeutic, and psychosocial treatment). Despite a comparable degree of met and unmet treatment needs and mental health service use among migrants and non-migrants, patients with migration background showed higher overall treatment satisfaction compared to non-migrants. The role of sociocultural and migrant-related factors may explain our findings.

German abstract Hintergrund Berufliche Beschäftigung ist von großer Bedeutung für den Einzelnen, da sie mit verschiedenen positiven Effekten verbunden ist. Menschen mit schweren psychischen Erkrankungen sind oft vom allgemeinen Arbeitsmarkt ausgeschlossen. Aktuelle Daten zur Beschäftigung von Menschen mit psychischen Erkrankungen liegen kaum vor und die Einflussfaktoren sind bisher wenig erforscht. Die vorliegende Studie untersucht mögliche Prädiktoren für eine wettbewerbsfähige Beschäftigung bei Menschen mit schweren psychischen Erkrankungen. Methoden Berichtet werden Ergebnisse einer multizentrischen Querschnittsstudie mit 300 Menschen mit schweren psychischen Erkrankungen im Alter von 18 bis 65 Jahren. Die folgenden Einschlusskriterien wurden verwendet: (I) Diagnose einer Schizophrenie, schizotypen oder wahnhaften Störung (ICD-10 F2x) oder affektiven Störung (ICD-10 F3x), (II) Dauer der psychiatrischen Erkrankung ≥ 2 Jahre und (III) erhebliche Auswirkungen der Erkrankung auf das soziale Funktionsniveau. Die Teilnehmenden wurden von geschultem Personal mit standardisierten Instrumenten befragt. Der Zusammenhang zwischen möglichen Prädiktoren (Alter, Geschlecht, Bildung, Familienstand, Wohnsituation, Migrationshintergrund, psychosoziale Funktionsfähigkeit, Alter bei ersten psychischen Problemen, körperliche Erkrankung, Arbeitsfähigkeit) und der Beschäftigung wurde mittels eines hierarchischen binären logistischen Regressionsmodells analysiert. Ergebnisse Nur ein Drittel (34 %) der Teilnehmenden war kompetitiv beschäftigt. Fast ein Drittel der Teilnehmenden war arbeitslos (30 %), und 28 % berichteten über eine Frühverrentung aufgrund der psychischen Erkrankung. Die psychosoziale Funktionsfähigkeit war positiv mit kompetitiver Beschäftigung assoziiert (OR = 1,09, 95% CI: 1,05 - 1,13, p < 0,001); gleichzeitige chronische körperliche Erkrankungen waren negativ mit kompetitiver Beschäftigung assoziiert (OR = 0,38, 95% CI: 0,21 - 0,71, p = 0,002). Schlussfolgerungen Die Ergebnisse bestätigen ein hohes Risiko des Ausschlusses von kompetitiver Beschäftigung bei Menschen mit schwerer psychischer Erkrankung. Gleichwohl ist ein beträchtlicher Anteil beschäftigt. Die Bemühungen, die Erwerbsbeteiligung der Betroffenen zu erhalten bzw. zu erweitern, müssen intensiviert werden. Ein besonderer Fokus sollte dabei auf die körperliche Gesundheit sowie die Stärkung der psychosozialen Funktionen gelegt werden.

Abstract Background Prescription rates for long-acting injectable (LAI) antipsychotic formulations remain relatively low in Europe despite improved adherence over alternative oral antipsychotic treatments. This apparent under-prescription of LAI antipsychotics may have multiple contributing factors, including negative mental health practitioner attitudes towards the use of LAIs. Methods The Antipsychotic Long acTing injection in schizOphrenia (ALTO) non-interventional study (NIS), conducted across several European countries, utilised a questionnaire that was specifically designed to address physicians’ attitudes and beliefs towards the treatment of schizophrenia with LAI antipsychotics. Exploratory principal component analysis (PCA) of feedback from the questionnaire aimed to identify and characterize the factors that best explained the physicians’ attitudes towards prescription of LAIs. Results Overall, 136/234 solicited physicians returned fully completed questionnaires. Physicians’ mean age was 48.5 years, with mean psychiatric experience of 20.0 years; 69.9% were male, 84.6% held a consultant position, and 91.9% had a clinical specialty in general adult care. Most physicians considered themselves to have a high level of clinical experience with LAI antipsychotics (77.2%), with an increased rate of LAI antipsychotics prescription over the last 5 years (59.6%). Although the majority of physicians (69.9%) declared feeling no difference in stress levels when offering LAI compared to oral antipsychotics, feelings of ‘no/more stress’ versus ‘less stress’ was found to influence prescription patterns. PCA identified six factors which collectively explained 66.1% of the variance in physician feedback. Multivariate analysis identified a positive correlation between physicians willing to accept usage of LAI antipsychotics and the positive attitude of colleagues (co-efficient 3.67; p = 0.016). Conclusions The physician questionnaire in the ALTO study is the first to evaluate the attitudes around LAI antipsychotics across several European countries, on a larger scale. Findings from this study offer an important insight into how physician attitudes can influence the acceptance and usage of LAI antipsychotics to treat patients with schizophrenia.

Abstract Background The German guideline on psychosocial interventions for people with severe mental disorders recommends a broad spectrum of evidence-based treatments. Structured implementation of the associated patient version of the guideline is missing to date. The study aims to assess whether structured implementation of a patient guideline improves the empowerment of patients with severe mental disorders, as well as knowledge, attitudes and experiences regarding psychosocial interventions, service use, treatment satisfaction, treatment needs, quality of life and burden of care. Methods The study is a multicentre, cluster-randomised, controlled study with two parallel groups. Inpatients and day hospital patients (all sexes; 18–65 years) with severe mental disorders will be included. Additionally, relatives of patients with mental disorders (all sexes; ≥ 18 years) will be included. In the experimental group, the patient guideline will be implemented using a multimodal strategy. Participants in the control group will receive treatment as usual but will be made aware of the patient guideline. The primary outcome is the change of empowerment, assessed by using the ‘empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders’ (EPAS) scale. In addition, knowledge, attitudes and experiences regarding psychosocial interventions will be assessed as secondary outcomes, as well as service use, satisfaction with care, patient need and quality of life and participation and social inclusion. For relatives, the perceived burden of care also will be recorded. Results will be analysed using hierarchical linear models. For the health economic evaluation, the incremental cost-utility ratios will be computed using the differences in total costs of illness and the differences in quality-adjusted life years (QALY) between study groups. Discussion The study will be the first to assess the effects of a structured implementation of the patient version of a psychiatric treatment guideline. The study has some limitations regarding the transferability of the results to other patients and other regions. Furthermore, problems with the recruitment of patients and relatives and with the implementation of intervention could occur during the study. Trial registration The study is registered in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00017577 (Date of registration: 23 October 2019.

Abstract Background Clozapine is known to be a highly effective antipsychotic agent and additionally provides a significant reduction in suicide-risk and aggression. Clozapine-induced cardiomyopathy is a very rare but nonetheless dangerous side-effect, with an incidence of 0.02–0.1%, depending on the literature, and a mortality rate of up to 17.9%. Case presentation We report on the case of a 25 year-old patient, who was admitted for the evaluation of a potential electroconvulsive therapy due to persistent auditory hallucinations under clozapine. Shortly after admission he was found to be suffering from dilated cardiomyopathy, likely caused by his antipsychotic treatment. Conclusion Clozapine-induced cardiomyopathy should be taken into account when monitoring patients treated with this antipsychotic and regular electrocardiograms should be performed in order to detect possible alterations as soon as possible.