Informing the development of a decision aid: Expectations and wishes from service users and psychiatrists towards a decision aid for antipsychotics in the inpatient setting.

OBJECTIVES: Decision aids (DAs) are promising tools to foster evidence-based shared decision-making between practitioners and service users. Nevertheless, it is still obscure how an evidence-based DA for people with severe mental illness, especially psychosis, should look in an inpatient treatment setting to be useful and feasible. Therefore, we conducted focus groups with psychiatrists and service users to collect and assess their expectations and wishes regarding an evidence-based DA. From these findings, we derived immediate recommendations for the future development of DAs. METHODS: We held two group interviews with service users (n = 8) and three group interviews with psychiatrists (n = 10). We used an open, large-scale topic guide. First, we presented data from a current meta-analysis on antipsychotics to the interviewees and, in a second step, asked for their expectations and wishes towards a DA that integrates these data. RESULTS: Our thematic analysis revealed six key themes addressed by the respondents: (1) general considerations on the importance and usefulness of such a DA, (2) critical comments on psychiatry and psychopharmacotherapy, (3) communicative prerequisites for the use of a DA, (4) form and content of the DA, (5) data input, data processing and output as well as (6) application of the DA and possible obstacles. CONCLUSIONS: Participants identified several important features for the development of DAs for selecting antipsychotics in inpatient psychiatric treatment. The digital format was met with the greatest approval. Especially the adaptability to different needs, users and psychopathologies and the possibility to outsource information dissemination via app seemed to be a decisive convincing argument. Further research is required to test specific features of DAs to be developed in clinical settings.

[Development of a Return-to-work Intervention for Psychiatric Inpatients]. / Entwicklung einer Intervention zur Unterstützung von stationär-psychiatrisch behandelten Patienten bei der Rückkehr an den Arbeitsplatz im Rahmen der RETURN-Studie.

OBJECTIVE: Patients with mental illnesses often face difficulties when returning to workplace after an episode of inpatient treatment. Available resources intended to support the return-to-work process are often not used. It was the aim of the present study to develop an intervention that facilitates the implementation of patient support at the interface of in- and outpatient care. METHODS: We used a structured development process for the establishment of a return-to-work intervention for psychiatric inpatients. RESULTS: The intervention consisted of the use of return-to-work experts who worked on the basis of a manual. In clearly defined modules, patients were given information on social law basics and details of the return process. Difficult situations (e. g., dealing with the disclosure of the diagnosis, return interview) were discussed and rehearsed. After discharge, further care took place, above all with regard to experiences on the first working day, accompaniment to discussions with the employer and support with any other upcoming difficulties. CONCLUSION: The results of the ongoing study will show whether the chosen approach actually yields the expected results, namely an improvement of the return-to-work process.

Evidence-based Shared-Decision-Making Assistant (SDM-assistant) for choosing antipsychotics: protocol of a cluster-randomized trial in hospitalized patients with schizophrenia.

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).

[Inpatient equivalent home-treatment: an overview]. / Stationsäquivalente Behandlung: Ein Überblick zum Status quo.

Inpatient equivalent home-treatment (IEHT) was implemented in Germany in 2018. Persons with a mental disorder can be admitted to acute multiprofessional IEHT to avoid or shorten inpatient hospital treatment. Exclusion criteria are amongst others lack of consent of cohabitants or endangerment of self and others. Advantages of IEHT include normalization and reduction of stigma. Nevertheless, administrative requirements are high. While there is international evidence for home treatment and crisis resolution teams, there is still a lack of evidence for the concept of IEHT, although specific studies are currently being carried out (e.g. AktiV study financed by the Innovation Fund). Overall, IEHT is important for mental health services and should be further developed.

[Is the role of mental illness in suicide overestimated?] / Wird die Rolle von psychischen Erkrankungen beim Suizid überbewertet?

In the scientific literature, it is often said that 90% of all suicides are the consequences of a mental illness. Nevertheless, recent reports and comments cast doubt on this view and point out that such a limitation might hamper effective suicide prevention. In this overview we will outline and discuss important results on how often suicides are the consequence of mental illnesses and whether the association between mental illnesses and suicide might be overestimated.Mental illnesses and especially affective disorders increase the risk of suicide by 30 to 50 times. Nevertheless, they explain only a certain percentage of all suicides. Observational and treatment studies indicate that mental illness is only one factor of several that lead to suicide. Among other factors are relationship problems, drug abuse, severe somatic illnesses, job problems, financial worries or juridical threats.Suicidal behaviour is an indicator of deep unhappiness but not necessarily caused by a mental illness. Many persons with mental illnesses do not show suicidal behaviour. On the other hand, not all people who take their own lives have a mental illness. This has significant consequences for universal and indicated prevention of suicide.

Implementation, efficacy, costs and processes of inpatient equivalent home-treatment in German mental health care (AKtiV): protocol of a mixed-method, participatory, quasi-experimental trial.

BACKGROUND: Over the last decades, many high-income countries have successfully implemented assertive outreach mental health services for acute care. Despite evidence that these services entail several benefits for service users, Germany has lagged behind and has been slow in implementing outreach services. In 2018, a new law enabled national mental health care providers to implement team-based crisis intervention services on a regular basis, allowing for different forms of Inpatient Equivalent Home Treatment (IEHT). IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user's home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity. METHODS/DESIGN: The presented naturalistic, quasi-experimental cohort study will evaluate IEHT in ten hospitals running IEHT services in different German regions. Within a multi-method research approach, it will evaluate stakeholders' experiences of care, service use, efficacy, costs, treatment processes and implementation processes of IEHT from different perspectives. Quantitative surveys will be used to recruit 360 service users. Subsequently, 180 service users receiving IEHT will be compared with 180 matched statistical 'twins' receiving standard inpatient treatment. Assessments will take place at baseline as well as after 6 and 12 months. The primary outcome is the hospital re-admission rate within 12 months. Secondary outcomes include the combined readmission rate, total number of inpatient hospital days, treatment discontinuation rate, quality of life, psycho-social functioning, job integration, recovery, satisfaction with care, shared decision-making, and treatment costs. Additionally, the study will assess the burden of care and satisfaction with care among relatives or informal caregivers. A collaborative research team made up of researchers with and without lived experience of mental distress will conduct qualitative investigations with service users, caregivers and IEHT staff teams to explore critical ingredients and interactions between implementation processes, treatment processes, and outcomes from a stakeholder perspective. DISCUSSION: By integrating outcome, process and implementation research as well as different stakeholder perspectives and experiences in one study, this trial captures the various facets of IEHT as a special form of home treatment. Therefore, it allows for an adequate, comprehensive evaluation on different levels of this complex intervention. TRIAL REGISTRATION: Trial registrations: 1) German Clinical Trials Register (DRKS), DRKS000224769. Registered December 3rd 2020, https://www.drks.de/drks_web/setLocale_EN.do ; 2) ClinicalTrials.gov, Identifier: NCT0474550 . Registered February 9th 2021.

'Triadic' shared decision making in mental health: Experiences and expectations of service users, caregivers and clinicians in Germany.

BACKGROUND: Shared decision making (SDM) in mental health may contribute to greater patient satisfaction and is sometimes associated with better health outcomes. Here, SDM should not only involve service users and clinicians but also involve the service users' caregivers. AIM: This study aimed to achieve better insight into the current SDM patterns of triads of service users, caregivers and clinicians in inpatient mental health care and the three parties' expectations towards the prospects of triadic SDM. DESIGN: The current research uses data from a representative cross-sectional study on caregivers in psychiatric inpatient treatment. We analysed data on n = 94 triads of service users, their caregivers and their clinicians. RESULTS: All three parties acknowledge caregivers to be of great support to monitor the progress with mental disease. The caregiver's role during consultations is most often described as being an expert, receiving or providing information and supporting service users. However, caregivers at times try to seek support for themselves during caregiver-clinician interaction, or their behaviour was described as unhelpful. The potential prospects of caregiver involvement are clearly acknowledged despite the low implementation of caregiver involvement in this sample (only in one-third of the cases). CONCLUSION: Triadic SDM rarely takes place in routine inpatient care. First, there should be a focus on interventions aiming at inviting caregivers to consultations. Only in the second step should a better conceptualisation of triadic SDM be undertaken. PUBLIC CONTRIBUTION: Early results were discussed with a local peer support group for caregivers of individuals living with mental illness.

Barriers and facilitators of shared decision making in acutely ill inpatients with schizophrenia-Qualitative findings from the intervention group of a randomised-controlled trial.

BACKGROUND: Shared decision making (SDM) is appreciated as a promising model of communication between clinicians and patients. However, in acute mental health settings, its implementation is still unsatisfactory. OBJECTIVE: The aim of this study is to examine barriers and facilitators of SDM with acutely ill inpatients with schizophrenia. DESIGN: A qualitative interview study was performed. SETTING AND PARTICIPANTS: The analysis is based on interviews with participants (patients and staff members) of the intervention group of the randomised-controlled SDMPLUS trial that demonstrated a significant improvement of SDM measures for patients with schizophrenia on acute psychiatric wards. MAIN VARIABLES STUDIED: Interviews addressed treatment decisions made during the current inpatient stay. The interviews were analysed using qualitative content analysis. RESULTS: A total of 40 interviews were analysed and 131 treatment decisions were identified. According to the interviewees, SDM had taken place in 29% of the decisions, whereas 59% of the decisions were made without SDM. In 16%, a clear judgement could not be made. Barriers and facilitators of SDM were categorised into patient factors, clinician factors, setting factors and others. Clinicians mostly reported patient factors (e.g., symptoms) as barriers towards SDM, which were not mirrored on the patients' side. Facilitators included patient as well as clinician behaviour during consultations. CONCLUSION: Even in the context of a successful SDM intervention, the implementation of SDM for patients in the very acute stages of schizophrenia is often not possible. However, strong facilitators for SDM have also been identified, which should be used for further implementation of SDM. PATIENT OR PUBLIC CONTRIBUTION: During the development of the study protocol, meetings with user representatives were held.

Return-to-work-experts for inpatient treatment of patients with mental illnesses- a proof-of-concept-study (RETURN): the study protocol.

BACKGROUND: Patients with mental illnesses often have massive difficulties returning to work after inpatient treatment at a psychiatric clinic and are often at risk of losing their jobs. The psychosocial support for this patient group at the interface of clinic/outpatient care is often insufficient. METHODS/DESIGN: The RETURN-study prospectively assesses and surveys 200 patients with mental disorders in a cluster randomized intervention study, i.e. treatment teams and patients from intervention wards receive a return-to-work (RTW) intervention. Patients in control wards obtain treatment as usual (TAU). Pairs of comparable wards (similar patient population, similar staff density) have been identified and then randomized for control and intervention (n = 14 for each condition). On intervention wards return-to-work experts (RTW experts) who focus treatment on the workplace-related needs of patients with mental illnesses have been established. These RTW experts ensure the use of available resources within the framework of work-related discharge management and should lead to a more successful return to the workplace. The days at work in the year after release will be evaluated in a mixed methods approach as well as the return rate in the year after release, disability days in the year after return, relapse rate after 12 months, cost-benefit ratio of the intervention, analysis of the predictors / barriers for a successful return to the workplace (e.g. psychopathology, cognition, stigma, social-psychiatric support, company support, etc.), possibilities to implement the concept of RTW experts in standard psychiatric care (TAU - treatment as usual), the impact of the RTW experts' approach on the treatment process in standard psychiatric care. DISCUSSION: This approach is already internationally established in the field of somatic rehabilitation and supported employment [Am J Psychiatry 171:1183-90, 2014; Lancet 370:1146-52, 2007; Cochrane Database Syst Rev, doi:10.1002/14651858.CD006237.pub3, 2014]; the innovative aspect of this project is to implement and evaluate it in standard psychiatric care in Germany. This project requires no new interventions to be developed and tested, as the techniques of the case manager/job coach is applied to the field of return to work. TRIAL REGISTRATION: The study was registered in Deutsches Register Klinische Studien searchable via its Meta-registry (http://apps.who.int/trialsearch/), Trial registration number: DRKS00016037, Date of registration: 21/12/2018, URL of trial registry record.

Nocebo effects by providing informed consent in shared decision making? Not necessarily: a randomized pilot-trial using an open-label placebo approach.

BACKGROUND: Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo (or placebo) effects. METHODS: We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, patients received an open-label placebo pill instead of their sleeping medication. RESULTS: No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter (a visual analogue scale indicating impairment by the new pill). CONCLUSION: In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic. TRIAL REGISTRATION: Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered.

[Development of a decision aid for participative advance planning for people with dementia and their relatives]. / Entwicklung einer Entscheidungshilfe für partizipative Vorausplanungen für Menschen mit Demenz und deren Angehörige.

BACKGROUND: Patients with a diagnosis of dementia face various important social and health-related decisions. Due to the progression of the disease it seems crucial that patients try to deal with these decisions early in the course of the disease to have the opportunity to make decisions autonomously. Professional support can help to plan in advance according to the wishes and possibilities in an effective and individualized manner. MATERIAL AND METHODS: The instrument was developed in a multiphase process based on advance care planning and shared decision-making. The prototype was pretested on 8 patient-relative dyads from a special outpatient department for early recognition and adapted as best as possible to their needs. Subsequently, in a pilot study the applicability of the decision aid was tested as an intervention in a further 19 patient-relative dyads with trained conversion attendants (diagnosis of Alzheimer's dementia or mixed form; mini mental state examination, MMSE (Mini-Mental-State-Test-Summenwert) >20 and <27). RESULTS: The result was a written decision-making aid for people with early stage dementia and their relatives, which supports the decision-making process (health care proxy, advance directive, living and care, driving ability). The first results showed good acceptance and handling. Patients and relatives dealt with the individual topics to a high degree and found them to be highly relevant. CONCLUSION: Despite positive feedback from the participants with respect to acceptance and applicability, there were major difficulties in recruiting. In the future, the systematic use of decision support as part of routine care could help to support the decision-making process in this patient group.

[How do employees of psychiatric hospitals evaluate medical ethical conflicts in coercive measures]. / Wie bewerten Mitarbeiter einer psychiatrischen Klinik medizinethische Konflikte bei Zwangsmaßnahmen.

BACKGROUND: The practice of coercive treatment in psychiatric hospitals raises numerous medical, juridical and ethical questions. Moreover, coercive measures lead to the contradiction of certain medical ethical principles. We examined the attitudes of psychiatric hospital employees towards ethical conflicts in medicine and asked them how they decide for or against coercive measures through the help of a hypothetical case. METHOD: In a questionnaire, 73 psychiatric hospital employees of various professions were asked about their attitudes towards several ethical conflicts in medicine. They were requested to decide for or against the use of coercive measures in the case of a hypothetical patient suffering from schizophrenia. RESULTS: The majority of the respondents agreed that in conflicts between principles of medical ethics the focus of treatment should be on the wellbeing of the patient (89 %) rather than on that of society (11 %). They also favored the principle of autonomy (58 %) over paternalism (42 %). The principle of nonmaleficence appeared to be equally important as beneficence (51 % vs. 49 %). Less invasive coercive measures (assistance through a person in charge) were preferred to more invasive ones (coercive medication), as our case vignette showed. There were no highly significant correlations found between sociodemographic factors (taking work experience and profession into account), judgement about medical ethical conflicts and the decision for or against coercive treatment. Both employees of closed wards with mid-long work experience (6-15 years) as well as nursing staff were more likely to choose coercive treatment. No statistically significant correlation could be determined between the preference of medical ethical principles and decisions about coercive treatment. CONCLUSION: Coercive treatment leads to ethical conflicts in medicine. The impact of such conflicts on the application of coercive measures through employees of psychiatric hospitals should be further explored and examined.

[Death certificates for suicides: quality investigation based on police records]. / Todesbescheinigungen zu Suiziden: Qualitätsuntersuchung auf Grundlage von Polizeiakten.

BACKGROUND: Death certificates are the basis for German mortality statistics, including suicide statistics. OBJECTIVES: To examine death certificates that are issued in the context of suicide with special focus on the quality of doctors' entries, especially indications of suicide and the stated association between underlying illness and cause of death. MATERIALS AND METHODS: Data from the Allgäu Suicide Study were used. Police records (N = 626) containing the results of suicide investigations as well as death certificates were analysed. RESULTS: There is great heterogeneity as to how physicians issue death certificates in the context of suicide. Clear indications of suicide are often missing and underlying illnesses are seldom mentioned. Nevertheless, there are only minor differences between the number of suicides recorded by the police compared to official statistics. CONCLUSIONS: To improve the quality of death certificates in the context of suicide, physicians should give clearer indications of suicide and put more focus on logically explaining the causes of death. The mortality of mental illnesses might be underestimated when mental illnesses are not regularly mentioned as a potential cause for suicide.

Shared decision making PLUS - a cluster-randomized trial with inpatients suffering from schizophrenia (SDM-PLUS).

BACKGROUND: Shared decision making (SDM) is a model of how doctors and patients interact with each other. It aims at changing the traditional power asymmetry between doctors and patients by strengthening the exchange of information and the decisional position of the patient. Although SDM is generally welcomed by mental health patients as well as by mental health professionals its implementation in routine care, especially in the more acute settings, is still lacking. SDM-PLUS has been developed as an approach that addresses both patients and mental health professionals and aims at implementing SDM even for the very acutely ill patients. METHODS: The SDM-PLUS study will be performed as a matched-pair cluster-randomized trial in acute psychiatric wards. On wards allocated to the intervention group personnel will receive communication training (addressing how to implement SDM for various scenarios) and patients will receive a group intervention addressing patient skills for SDM. Wards allocated to the control condition will continue treatment as usual. A total sample size of 276 patients suffering from schizophrenia or schizoaffective disorder on 12 wards is planned. The main outcome parameter will be patients' perceived involvement in decision making during the inpatient stay measured with the SDM-Q-9 questionnaire. Secondary objectives include the therapeutic relationship and long term outcomes such as medication adherence and rehospitalization rates. In addition, process measures and qualitative data will be obtained to allow for the analysis of potential barriers and facilitators of SDM-PLUS. The primary analysis will be a comparison of SDM-Q-9 sum scores 3 weeks after study inclusion (or discharge, if earlier) between the intervention and control groups. To assess the effect of the intervention on this continuous primary outcome, a random effects linear regression model will be fitted with ward (cluster) as a random effect term and intervention group as a fixed effect. DISCUSSION: This will be the first trial examining the SDM-PLUS approach for patients with schizophrenia or schizoaffective disorder in very acute mental health inpatient settings. Within the trial a complex intervention will be implemented that addresses both patients and health care staff to yield maximum effects. TRIAL REGISTRATION: German Clinical Trials Register DRKS00010880 . Registered 09 August 2016.

Training patients with schizophrenia to share decisions with their psychiatrists: a randomized-controlled trial.

PURPOSE: Many patients with schizophrenia have a desire for shared decision-making (SDM). However, in clinical practice SDM often does not take place. One cause might be that many patients behave passively in the medical encounter, therefore not facilitating SDM. It was the aim of the study to evaluate the effects of a patient directed SDM-training on patients' communicative behavior in the consultation, their attitudes towards decision-making and their long-term adherence. METHODS: Randomized-controlled trial comparing a five-session SDM-training for inpatients with schizophrenia with five sessions of non-specific group training. The SDM-training sessions included motivational (e.g. prospects of participation, patient rights) and behavioral aspects (e.g. role plays) and addressed important aspects of the patient-doctor interaction such as question asking or giving feedback. RESULTS: N = 264 patients were recruited in four psychiatric hospitals in Germany. The SDM-training yielded no group differences regarding the main outcome measure (treatment adherence) at 6 and 12 months after discharge. However, there were short-term effects on patients' participation preferences, their wish to take over more responsibility for medical decisions and (according to their psychiatrists' estimate) their behavior in psychiatric consultations. CONCLUSIONS: While there was no effect regarding treatment adherence, the shared decision-making training for inpatients with schizophrenia has been shown to increase patients' active behavior in psychiatric consultations during their inpatient treatment. When implemented it should be combined with complementary SDM interventions (decision support tools and communication training for professionals) to yield maximum effects.

A "Mental-Health-at-the-Workplace" Educational Workshop Reduces Managers' Stigma Toward Depression.

Stigma and discrimination are important factors hindering people with mental health conditions to stay employed or successfully make their careers. We surveyed 580 German managers before and after visiting a "mental-health-at-the-workplace" educational workshop using the Depression Stigma Scale. The workshop significantly reduced stigma toward depression. Managers at baseline already exhibited lower stigma toward depression compared with the general population. In addition, female gender and higher education predicted lower stigma, which is in line with findings from other studies. We conclude that an educational workshop giving practical guidance regarding "mental-health-at-the-workplace" reduces managers' stigma toward depression and improves knowledge regarding depression, its course, and its treatment.