Open-door policy versus treatment-as-usual in urban psychiatric inpatient wards: a pragmatic, randomised controlled, non-inferiority trial in Norway.

BACKGROUND: Open-door policy is a recommended framework to reduce coercion in psychiatric wards. However, existing observational data might not fully capture potential increases in harm and use of coercion associated with open-door policies. In this first randomised controlled trial, we compared coercive practices in open-door policy and treatment-as-usual wards in an urban hospital setting. We hypothesised that the open-door policy would be non-inferior to treatment-as-usual on the proportion of patients exposed to coercive measures. METHODS: We conducted a pragmatic, randomised controlled, non-inferiority trial comparing two open-door policy wards and three treatment-as-usual acute psychiatric wards at Lovisenberg Diaconal Hospital in Oslo, Norway. An exemption from the consent requirements enabled inclusion and random allocation of all patients admitted to these wards using an open list (2:3 ratio) administrated by a team of ward nurses. The primary outcome was the proportion of patient stays with one or more coercive measures, including involuntary medication, isolation or seclusion, and physical and mechanical restraints. The non-inferiority margin was set to 15%. Primary and safety analyses were assessed using the intention-to-treat population. The trial is registered with ISRCTN registry and is complete, ISRCTN16876467. FINDINGS: Between Feb 10, 2021, and Feb 1, 2022, we randomly assigned 556 patients to either open-door policy wards (n=245; mean age 41·6 [SD 14·5] years; 119 [49%] male; 126 [51%] female; and 180 [73%] admitted to the ward involuntarily) or treatment-as-usual wards (n=311; mean age 41·6 [4·3] years; 172 [55%] male and 138 [45%] female; 233 [75%] admitted involuntarily). Data on race and ethnicity were not collected. The open-door policy was non-inferior to treatment-as-usual on all outcomes: the proportion of patient stays with exposure to coercion was 65 (26·5%) in open-door policy wards and 104 (33·4%) in treatment-as-usual wards (risk difference 6·9%; 95% CI -0·7 to 14·5), with a similar trend for specific measures of coercion. Reported incidents of violence against staff were 0·15 per patient stay in open-door policy wards and 0·18 in treatment-as-usual wards. There were no suicides during the randomised controlled trial period. INTERPRETATION: The open-door policy could be safely implemented without increased use of coercive measures. Our findings underscore the need for more reliable and relevant randomised trials to investigate how a complex intervention, such as open-door policy, can be efficiently implemented across health-care systems and contexts. FUNDING: South-Eastern Norway Regional Health Authority and The Research Council of Norway.

Protocol for the Lovisenberg Open Acute Door Study (LOADS): a pragmatic randomised controlled trial to compare safety and coercion between open-door policy and usual-care services in acute psychiatric inpatients.

INTRODUCTION: The reduction of coercion in psychiatry is a high priority for both the WHO and many member countries. Open-door policy (ODP) is a service model for psychiatric ward treatment that prioritises collaborative and motivational measures to better achieve acute psychiatric safety - and treatment objectives. Keeping the ward main door open is one such measure. Evidence on the impact of ODP on coercion and violent events is mixed, and only one randomised controlled trial (RCT) has previously compared ODP to standard practice. The main objectives of the Lovisenberg Open Acute Door Study (LOADS) are to implement and evaluate a Nordic version of ODP for acute psychiatric inpatient services. The evaluation is designed as a pragmatic RCT with treatment-as-usual (TAU) control followed by a 4-year observational period. METHODS AND ANALYSIS: In this 12-month pragmatic randomised trial, all patients referred to acute ward care will be randomly allocated to either TAU or ODP wards. The primary outcome is the proportion of patient stays with one or more coercive measures. Secondary outcomes include adverse events involving patients and/or staff, substance use and users' experiences of the treatment environment and of coercion. The main hypothesis is that ODP services will not be inferior to state-of-the art psychiatric treatment. ODP and TAU wards are determined via ward-level randomisation. Following conclusion of the RCT, a longitudinal observational phase begins designed to monitor any long-term effects of ODP. ETHICS AND DISSEMINATION: The trial has been approved by the Regional Committees for Medical and Health Research Ethics (REC) in Norway (REC South East #29238), who granted LOADS exemption from consent requirements for all eligible, admitted patients. Data are considered highly sensitive but can be made available on request. Results will be published in peer-reviewed journals and presented at scientific conferences and meetings. TRIAL REGISTRATION NUMBER: ISRCTN16876467. PROTOCOL VERSION: 1.4, 21 December 2021.

Effectiveness of the Labour Inspection Authority's regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegian home-care workers.

INTRODUCTION: There is a need to evaluate whether, and to what degree, labour inspections or other regulatory tools have the desired effects on psychosocial, organisational and mechanical work environment, and employee health. The Norwegian Labour Inspection Authority (NLIA) uses different tools and strategies to enforce compliance with occupational safety and health (OSH) legislation. The aim of the present study is to evaluate the effects of labour inspections and other regulatory tools employed by the NLIA. The home-care service is one of the fastest growing occupations and a prioritised area for the NLIA, hence the present study will investigate regulatory tools in this sector. METHODS AND ANALYSIS: The research project has been designed as a longitudinal, cluster-randomised, controlled trial and will be conducted among Norwegian home-care workers. The objective of the research project is to evaluate the effects of the NLIA's regulatory tools (inspection and guidance) on: (1) compliance with OSH legislation and regulation; (2) psychosocial, organisational and mechanical work environment; (3) employee health in terms of musculoskeletal and mental health complaints; and (4) sickness absence. Public home-care services have been randomised to three intervention groups and one control group. Home-care services in the intervention groups will receive one of three intervention activities from the NLIA: (1) inspection from the Labour Inspection Authority; (2) guidance through an online interactive risk-assessment tool; and (3) guidance on psychosocial, organisational and mechanical work environment through workshops. The interventions will be performed at the organisational level (home-care service), and the effects of the interventions on the working environment and health complaints will be measured at the individual level (home-care employees). ETHICS AND DISSEMINATION: This project has been approved by the Regional Committees for Medical and Health Research Ethics (REC) in Norway (REC South East) (2018/2003/REK sør-øst C), the Norwegian Center for Research Data (566128), and will be conducted in accordance with the World Medical Association Declaration of Helsinki. The results will be reported in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03855163.

Workplace Bullying and Medically Certified Sickness Absence: Direction of Associations and the Moderating Role of Leader Behavior.

The aim of this study was to determine (1) associations between workplace bullying and subsequent risk and duration of medically certified sickness absence, (2) whether employees' perceptions of supportive, fair, and empowering leader behavior moderate the association between bullying and absence, and (3) whether prior sickness absence increases the risk of being a new victim of bullying. Altogether, 10,691 employees were recruited from 96 Norwegian organizations in the period 2004-2014. The study design was prospective with workplace bullying and leader behavior measured at baseline and then linked to official registry data on medically certified sickness absence for the year following the survey assessment. For analyses of reverse associations, exposure to bullying was reassessed in a follow-up survey after 24 months. The findings showed that workplace bullying was significantly associated with risk (risk ratio = 1.23; 95% CI = 1.13-1.34), but not duration (incidence rate ratio = 1.05; 95% CI = 0.89-1.25) of medically certified sickness absence after adjusting for age, gender, and supportive, fair, and empowering leader behavior. None of the indicators of leader behavior moderated the association between bullying and sickness absence (both risk and duration). Adjusting for baseline bullying, age, and gender, prior long-term sickness absence (>21 days) was associated with increased risk of being a new victim of bullying at follow-up (odds ratio = 1.86; 95% CI = 1.28-2.72). Effective interventions toward workplace bullying may be beneficial with regard to reducing sickness absence rates. Organizations should be aware that long-term sickness absence might be a social stigma as sick-listed employees have an increased risk of being bullied when they return to work.

Emotional Dissonance, Mental Health Complaints, and Sickness Absence Among Health- and Social Workers. The Moderating Role of Self-Efficacy.

Health- and social workers are frequently exposed to emotionally demanding work situations that require emotion regulation. Studies have demonstrated a direct relationship between emotion regulation and health complaints and sickness absence. In order to prevent health complaints and to reduce sickness absence among health- and social workers, there is need for greater attention to mechanisms explaining when and how emotionally demanding work situations are related to employee health and sickness absence. The overarching aim of this study was therefore to examine the moderating role of generalized self-efficacy on the association between emotional dissonance, employee health (mental distress and exhaustion), and registry based sickness absence. The sample consisted of 937 health- and social workers. Data on emotional dissonance, generalized self-efficacy, exhaustion, and mental distress was collected through questionnaires, whereas official registry data were used to assess sickness absence. A two-step hierarchical regression analysis showed that emotional dissonance was significantly associated with exhaustion, mental distress, and sickness absence, after adjusting for sex, age, and occupation. Interaction analyses with simple slope tests found that self-efficacy moderated the association between emotional dissonance and both exhaustion and mental distress, but not the association with sickness absence. This study shows that health- and social workers who frequently experience emotional dissonance report higher levels of exhaustion and mental distress, and have a higher risk of medically certified sickness absence. Further, health- and social workers with lower self-efficacy beliefs are apparently more sensitive to the degree of emotional dissonance and experienced higher levels of exhaustion and mental distress.

Emotional Dissonance and Sickness Absence Among Employees Working With Customers and Clients: A Moderated Mediation Model via Exhaustion and Human Resource Primacy.

Emotional dissonance, i.e., a discrepancy between required and felt emotions, has been established as a predictor of sickness absence in studies, but little is known about mechanisms that can explain this association. In order to prevent and reduce the impact of emotional dissonance on sickness absence, there is a need for greater attention to variables explaining when and how emotional dissonance is related to sickness absence. The overarching aim of this study was to examine whether emotional dissonance has an indirect association with sickness absence through exhaustion. In addition, we examined whether human resource primacy (HRP), which is the employer's degree of concern for human resources, moderates this indirect effect. A sample of 7758 employees, all working with customers and clients, were recruited from 96 Norwegian organizations. Emotional dissonance, exhaustion, and HRP were measured through surveys and then linked to registry data on medically certified sickness absence for the year following the survey assessment. Results showed that exhaustion is a mediator for the relationship between emotional dissonance and sickness absence. Furthermore, higher levels of HRP were found to reduce the positive association between emotional dissonance and exhaustion, and the indirect effect of emotional dissonance on sickness absence through exhaustion is found to be weaker when HRP is high. By testing this moderated mediation model, the current study contributes to the literature on emotion work by clarifying mechanisms that are crucial for the development of targeted interventions that aim to reduce and prevent sickness absence in client-driven work environments.

Emotional dissonance and sickness absence: a prospective study of employees working with clients.

PURPOSE: (1) Determine the relationship between emotional dissonance and medically certified sickness absence among employees working with clients and (2) compare the impact of emotional dissonance on medically certified sickness absence with the impact of other psychological and social work factors. METHODS: A sample of 7758 employees was recruited from 96 Norwegian organizations in the period 2004 to 2014, all working with clients. The study design was prospective with emotional dissonance measured at baseline and then linked to official registry data of medically certified sickness absence for the year following the survey assessment. Quantitative demands, decision demands, role clarity, role conflict, control over work intensity, and decision control were included as additional work exposures. The impact of the study variables on the presence and duration of medically certified sickness absence was investigated with a negative binomial hurdle model. RESULTS: In the fully adjusted model, emotional dissonance and role conflict significantly predicted the presence of medically certified sickness absence. Control over work intensity and decision control were negatively related to presence of sickness absence. Only role conflict was a risk factor for the duration of sickness absence when all factors were analysed simultaneously. CONCLUSION: Emotional dissonance is a risk factor for the presence of medically certified sickness absence in client-driven work environments. Theoretical models of sickness absence, as well as interventions aiming to prevent sickness absence in such environments, should be aware of the effect emotional dissonance may have on employees.

Workplace bullying and sickness absence: a systematic review and meta-analysis of the research literature.

OBJECTIVE: The association between workplace bullying and sickness absence remains unclear. This paper presents a systematic review and meta-analysis of research on the association. METHOD: We conducted a systematic review and meta-analysis of published primary studies on workplace bullying and sickness absence. Studies based on prospective design or registry data on sickness absence were included. Cross-sectional studies with self-reported sickness absence were excluded. RESULTS: Seventeen primary studies were included in the review, sixteen originated from the Nordic countries and fifteen included registry data on sickness absence. All but one study found that exposure to workplace bullying was associated with increased risk of sickness absence. A meta-analysis of ten independent studies showed that exposure to bullying increased the risk of sickness absence (odds ratio 1.58, 95% CI 1.39-1.79). Five studies included variables that moderated the association between bullying and absenteeism. None of the studies included mediating variables. No studies examined sickness absence as a risk factor for later exposure to bullying. Following the GRADE guidelines, the evidence for an association between bullying and sickness absence is moderate. CONCLUSIONS: Workplace bullying is a risk factor for sickness absence, but the mechanisms to explain this relationship are not sufficiently described. It is unclear whether sickness absence predicts later exposure to bullying. While, the methodological quality of the reviewed studies was high, the knowledge base is small. There is a need for more research on how and when bullying is related to sickness absence and the possible bidirectional relationships involved.

The new workplace II: protocol for a prospective full-panel registry study of work factors, sickness absence, and exit from working life among Norwegian employees.

BACKGROUND: Previous studies on the effects of work factors on absence and disability retirement have only addressed a limited set of factors and little is known about the mechanisms that govern relationships between work exposures and sickness absence/disability retirement. The main aims of the present project are (1) to examine the impact of a comprehensive set of psychological, social, organizational, and mechanical work factors work factors on sickness absence and disability retirement, and (2) to identify moderating and mediating variables that determine how and when exposures at the workplace are related to sickness absence and disability retirement. METHODS: The study design is prospective and based on longitudinal survey data linked to registry data on sickness absence and disability. Altogether 14,501 respondents have given their permission to the linking of their survey questionnaire data to registry data. The project has been approved by the Regional Committees for Medical and Health Research Ethics and has permission from The Norwegian Data Protection Authority. The questionnaire instruments contain psychometrically validated items and inventories on demographic background factors, work exposures, individual dispositions and attitudes, somatic health, mental distress, well-being, lifestyle factors, and work ability. DISCUSSION: The findings will have relevance for, and benefit working life and the larger society in a number of ways. Firstly, it will lead to a more knowledge about which work factors that contribute to health, sickness absence, and participation in/exit from the labour force. Secondly, a better understanding of which mediators and moderators that modify and govern these relationships. Both are central to the development of laws and regulations and to any political decision on measures to tackle sickness absence and early retirement.

Modern health worries, subjective health complaints, health care utilization, and sick leave in the Norwegian working population.

BACKGROUND: Modern health worries (concerns about aspects of modern life affecting health) heve been associated with subjective health complaints and health care utilization. PURPOSE: The aim of this study was to investigate the association between modern health worries (MHW) and subjective health complaints (SHC), health care utilization, and sick leave related to such complaints in the Norwegian working population. METHODS: A sample of the Norwegian working population (N = 569) answered a questionnaire which included the Subjective Health Complaints Inventory and a Norwegian version of the Modern Health Worries Scale. RESULTS: Ninety-one percent of the participants reported at least one complaint in the past 30 days, and 96 % of the participants reported concerns for at least one of the items in the MHW scale. Women reported significantly more and more severe complaints compared to men and significantly more concern about aspects of modern life affecting health. Participants who reported a high level of MHW showed nearly twice the risk of reporting a high level of SHC (odds ratio (OR) = 1.83; 95 % confidence interval (CI) = 1.30-2.71; p = 0.001), and they showed twice the risk for self-certified sick leave related to SHC (OR = 2.04; 95 % CI = 1.01-3.92; p = 0.048). High levels of MHW showed no significant association with health care utilization or doctor-certified sick leave. CONCLUSIONS: Subjective health complaints and concerns about aspects of modern life affecting health are very common, even among healthy workers. Women have more complaints and more concerns compared to men. Within the health care system, it may be advantageous to pay close attention to the association between high levels of MHW and high levels of SHC.