Implementation of advance care planning in the routine care for acutely admitted patients in geriatric units: protocol for a cluster randomized controlled trial.

BACKGROUND: Acutely ill and frail older adults and their next of kin are often poorly involved in treatment and care decisions. This may lead to either over- or undertreatment and unnecessary burdens. The aim of this project is to improve user involvement and health services for frail older adults living at home, and their relatives, by implementing advance care planning (ACP) in selected hospital wards, and to evaluate the clinical and the implementation interventions. METHODS: This is a cluster randomized trial with 12 hospital units. The intervention arm receives implementation support for 18 months; control units receive the same support afterwards. The ACP intervention consists of 1. Clinical intervention: ACP; 2. Implementation interventions: Implementation team, ACP coordinator, network meetings, training and supervision for health care personnel, documentation tools and other resources, and fidelity measurements with tailored feedback; 3. Implementation strategies: leadership commitment, whole ward approach and responsive evaluation. Fidelity will be measured three times in the intervention arm and twice in the control arm. Here, the primary outcome is the difference in fidelity changes between the arms. We will also include 420 geriatric patients with one close relative and an attending clinician in a triadic sub-study. Here, the primary outcomes are quality of communication and decision-making when approaching the end of life as perceived by patients and next of kin, and congruence between the patient's preferences for information and involvement and the clinician's perceptions of the same. For patients we will also collect clinical data and health register data. Additionally, all clinical staff in both arms will be invited to answer a questionnaire before and during the implementation period. To explore barriers and facilitators and further explore the significance of ACP, qualitative interviews will be performed in the intervention units with patients, next of kin, health care personnel and implementation teams, and with other stakeholders up to national level. Lastly, we will evaluate resource utilization, costs and health outcomes in a cost-effectiveness analysis. DISCUSSION: The project may contribute to improved implementation of ACP as well as valuable knowledge and methodological developments in the scientific fields of ACP, health service research and implementation science. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05681585. Registered 03.01.23.

Barriers and facilitators to implementing advance care planning in naïve contexts - where to look when plowing new terrain?

BACKGROUND: Advance care planning (ACP) is a way of applying modern medicine to the principle of patient autonomy and ensuring that patients receive medical care that is consistent with their values, goals and preferences. Robust evidence supports the benefits of ACP, but it remains an underutilized resource in most countries. This paper goes from the naïve point of view, and seeks to identify the barriers and facilitators to implementation in unfamiliarized contexts and in a whole system approach involving the clinical, institutional and policy level to improve the implementation of ACP. METHODS: Qualitative interviews were chosen to enable an explorative, flexible design. Qualitative interviews were conducted with 40 health care professionals and chief physicians in hospitals and in municipalities. The thematic analysis was done following Braun and Clarke's strategy for thematic analysis. RESULTS: The main reported barriers were the lack of time and space, a lack of culture and leadership legitimizing ACP, lack of common communication systems, and unclear responsibility about who should initiate, resulting in missed opportunities and overtreatment. Policy development, public and professional education, and standardization of documentation were reported as key to facilitate ACP and build trust across the health care system. CONCLUSIONS: Progressively changing the education of health professionals and the clinical culture are major efforts that need to be tackled to implement ACP in unfamiliarized contexts, particularly in contexts where patient's wishes are not legally binding. This will need to be tackled through rectifying the misconception that ACP is only about death, and providing practical training for health professionals, as well as developing policies and legislation on how to include patients and caregivers in the planning of care.

Balancing burdens of infection control: Norwegian district medical officers' ethical challenges during the COVID-19 pandemic.

BACKGROUND: In several countries, district medical officers (DMOs) are public health experts with duties including infection control measures. The Norwegian DMOs have been key actors in the local handling of the COVID-19 pandemic. METHODS: The aim of the study was to explore the ethical challenges experienced by Norwegian DMOs during the COVID-19 pandemic, and how the DMOs have handled these challenges. 15 in-depth individual research interviews were performed and analyzed with a manifest approach. RESULTS: Norwegian DMOs have had to handle a large range of significant ethical problems during the COVID-19 pandemic. Often, a common denominator has been the need to balance burdens of the contagion control measures for different individuals and groups. In another large set of issues, the challenge was to achieve a balance between safety understood as effective contagion prevention on the one hand, and freedom, autonomy and quality of life for the same individuals on the other. CONCLUSIONS: The DMOs have a central role in the municipality's handling of the pandemic, and they wield significant influence. Thus, there is a need for support in decision-making, both from national authorities and regulations, and from discussions with colleagues.

Citizen attitudes to non-treatment decision making: a Norwegian survey.

BACKGROUND: Decisions about appropriate treatment at the end of life are common in modern healthcare. Non-treatment decisions (NTDs), comprising both withdrawal and withholding of (potentially) life-prolonging treatment are in principle accepted in Norway. However, in practice they may give rise to significant moral problems for health professionals, patients and next of kin. Here, patient values must be considered. It is relevant to study the moral views and intuitions of the general population on NTDs and special areas of contention such as the role of next of kin in decision-making. METHODS: Electronic survey to members of a nationally representative panel of Norwegian adults. Respondents were presented with vignettes describing patients with disorders of consciousness, dementia, and cancer where patient preferences varied. Respondents answered ten questions about the acceptability of non-treatment decision making and the role of next of kin. RESULTS: We received 1035 complete responses (response rate 40.7%). A large majority, 88%, supported the right of competent patients to refuse treatment in general. When an NTD was in line with the patient's previously expressed preferences, more respondents tended to find NTDs acceptable. More respondents would accept NTDs for themselves than for the vignette patients. In a scenario with an incompetent patient, clear majorities wanted the views of next of kin to be given some but not decisive weight, and more weight if concordant with the patient's wishes. There were, however, large variations in the respondents' views. CONCLUSION: This survey of a representative sample of the Norwegian adult population indicates that attitudes to NTDs are often in line with national laws and guidelines. However, the high variance among the respondents and relatively large weight given to next of kin's views, indicate a need for appropriate dialogue among all stakeholders to prevent conflicts and extra burdens. Furthermore, the emphasis given to previously expressed opinions indicates that advance care planning may increase the legitimacy of NTDs and prevent challenging decision-making processes.

Two years of ethics reflection groups about coercion in psychiatry. Measuring variation within employees' normative attitudes, user involvement and the handling of disagreement.

BACKGROUND: Research on the impact of ethics reflection groups (ERG) (also called moral case deliberations (MCD)) is complex and scarce. Within a larger study, two years of ERG sessions have been used as an intervention to stimulate ethical reflection about the use of coercive measures. We studied changes in: employees' attitudes regarding the use of coercion, team competence, user involvement, team cooperation and the handling of disagreement in teams. METHODS: We used panel data in a longitudinal design study to measure variation in survey scores from multidisciplinary employees from seven departments within three Norwegian mental health care institutions at three time points (T0-T1-T2). Mixed models were used to account for dependence of data in persons who participated more than once. RESULTS: In total, 1068 surveys (from 817 employees who did and did not participate in ERG) were included in the analyses. Of these, 7.6% (N = 62) responded at three points in time, 15.5% (N = 127) at two points, and 76.8% (N = 628) once. On average, over time, respondents who participated in ERG viewed coercion more strongly as offending (p < 0.05). Those who presented a case in the ERG sessions showed lower scores on User Involvement (p < 0.001), Team Cooperation (p < 0.01) and Constructive Disagreement (p < 0.01). We observed significant differences in outcomes between individuals from different departments, as well as between different professions. Initial significant changes due to frequency of participation in ERG and case presentation in ERG did not remain statistically significant after adjustment for Departments and Professions. Differences were generally small in absolute terms, possibly due to the low amount of longitudinal data. CONCLUSIONS: This study measured specific intervention-related outcome parameters for describing the impact of clinical ethics support (CES). Structural implementation of ERGs or MCDs seems to contribute to employees reporting a more critical attitude towards coercion. Ethics support is a complex intervention and studying changes over time is complex in itself. Several recommendations for strengthening the outcomes of future CES evaluation studies are discussed. CES evaluation studies are important, since-despite the intrinsic value of participating in ERG or MCD-CES inherently aims, and should aim, at improving clinical practices.

Implementation of Guidelines on Family Involvement for Persons with Psychotic Disorders (IFIP): A Cluster Randomised Controlled Trial.

Family involvement is part of the evidence-based treatment for persons with psychotic disorders, yet is under-implemented despite guideline recommendations. This study assessed whether an implementation support programme increased the adherence to guidelines on family involvement, compared to guideline/manual only. In a cluster randomised design, community mental health centre units in South-East Norway went through stratified allocation to the experimental (n = 7) or control (n = 7) arm. Experimental clusters received an implementation support programme including clinical training and supervision, appointing a family coordinator and an implementation team, a toolkit, and fidelity measurements at baseline, 12, 18, and 24 months with on-site feedback and supervision. Control clusters received no such support and had fidelity measurements at baseline and 24 months without feedback. During fidelity measurements, adherence to the guidelines was measured with the basic family involvement and support scale, the general organizational index, and the family psychoeducation fidelity scale, the latter being the primary outcome. The scales consist of 12-14 items rated from 1 to 5. Data was analysed with an independent samples t-test, linear mixed models, and a tobit regression model. At 24 months, the mean scores were 4.00 or higher on all scales in the experimental arm, and the increase in adherence to the guidelines was significantly greater than in the control arm with p-values < 0.001. Large-scale implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres may be accomplished, with substantial implementation support.Trial Registration: ClinicalTrials.gov Identifier NCT03869177. Registered 11.03.19.

The duty of confidentiality during family involvement: ethical challenges and possible solutions in the treatment of persons with psychotic disorders.

BACKGROUND: Family involvement during severe mental illness is still poorly implemented, contrary to evidence-based recommendations. Confidentiality issues are among the most prominent barriers, with mental health professionals facing complex ethical, legal, and practical challenges. However, research focusing on this barrier is very sparse. Nested within a cluster-randomised trial to implement guidelines on family involvement for persons with psychotic disorders in community mental health centres, the aim of this sub-study was to explore ethical challenges related to the duty of confidentiality as experienced by mental health professionals, and to explore key measures that might contribute to improving the handling of such challenges. METHODS: In total 75 participants participated in 21 semi-structured focus groups, including implementation team members at the initial and late phase of the intervention period and clinicians who were not on the implementation teams, at late phase of implementation. We used purposive sampling and manifest content analysis to explore participants' experiences and change processes. RESULTS: Ethical challenges related to the duty of confidentiality included 1) Uncertainty in how to apply the legislation, 2) Patient autonomy versus a less strict interpretation of the duty of confidentiality, 3) Patient alliance and beneficence versus a less strict interpretation of the duty of confidentiality, 4) How to deal with uncertainty regarding what relatives know about the patients' illness, and 5) Relatives' interests versus the duty of confidentiality. Measures to facilitate better handling of the duty of confidentiality included 1) Training and practice in family involvement, and 2) Standardisation of family involvement practices. CONCLUSION: When health professionals gained competence in and positive experiences with family involvement, this led to vital changes in how they interpreted and practiced the duty of confidentiality in their ethical reasoning and in clinical practice. Especially, the need to provide sufficient information to the patients about family involvement became evident during the study. To improve the handling of confidentiality issues, professionals should receive training in family involvement and confidentiality statutes followed by practice. Furthermore, family involvement should be standardised, and confidentiality guidelines should be implemented in the mental health services. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03869177. Registered 11.03.19.

Barriers and facilitators when implementing family involvement for persons with psychotic disorders in community mental health centres - a nested qualitative study.

BACKGROUND: The uptake of family involvement in health care services for patients with psychotic disorders is poor, despite a clear evidence base, socio-economic and moral justifications, policy, and guideline recommendations. To respond to this knowledge-practice gap, we established the cluster randomised controlled trial: Implementation of guidelines on Family Involvement for persons with Psychotic disorders in community mental health centres (IFIP). Nested in the IFIP trial, this sub-study aims to explore what organisational and clinical barriers and facilitators local implementation teams and clinicians experience when implementing family involvement in mental health care for persons with psychotic disorders. METHODS: We performed 21 semi-structured focus groups, including 75 participants in total. Implementation team members were interviewed at the initial and middle phases of the intervention period, while clinicians who were not in the implementation team were interviewed in the late phase. A purposive sampling approach was used to recruit participants with various engagement in the implementation process. Data were analysed using manifest content analysis. RESULTS: Organisational barriers to involvement included: 1) Lack of shared knowledge, perceptions, and practice 2) Lack of routines 3) Lack of resources and logistics. Clinical barriers included: 4) Patient-related factors 5) Relative-related factors 6) Provider-related factors. Organisational facilitators for involvement included: 1) Whole-ward approach 2) Appointed and dedicated roles 3) Standardisation and routines. Clinical facilitators included: 4) External implementation support 5) Understanding, skills, and self-efficacy among mental health professionals 6) Awareness and attitudes among mental health professionals. CONCLUSIONS: Implementing family involvement in health care services for persons with psychotic disorders is possible through a whole-ward and multi-level approach, ensured by organisational- and leadership commitment. Providing training in family psychoeducation to all staff, establishing routines to offer a basic level of family involvement to all patients, and ensuring that clinicians get experience with family involvement, reduce or dissolve core barriers. Having access to external implementation support appears decisive to initiate, promote and evaluate implementation. Our findings also point to future policy, practice and implementation developments to offer adequate treatment and support to all patients with severe mental illness and their families. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03869177. Registered 11.03.19.

Medical students' experiences when empathizing with patients' emotional issues during a medical interview - a qualitative study.

BACKGROUND: There is evidence that empathy decreases as medical students go through clinical training. However, there are few in-depth studies investigating the students' own experiences when trying to empathize in concrete clinical encounters. We therefore wanted to explore medical students' perceptions, experiences, and reflections when empathizing with patients expressing emotional issues. METHODS: A qualitative content analysis of semi-structured interviews with third year medical students (N = 11) was conducted using video-stimulated recall from their own medical interview with a simulated chronically ill patient. Students were led to believe that the patient was real. RESULTS: Five themes which may influence student empathy during history-taking were identified through analysis of interview data: (1) Giving priority to medical history taking, (2) Interpreting the patient's worry as lack of medical information, (3) Conflict between perspectives, (4) Technical communication skill rather than authentic and heart-felt and (5) The distant professional role. CONCLUSIONS: The participating students described conflicts between a medical agenda, rules and norms for professional conduct and the students' own judgments when trying to empathize with the patient. To our knowledge, this is the first study ever to document the students' own perspective in concrete situations as well as how these reported experiences and reflections affect their empathy towards patients. Since we now know more about what is likely to hinder medical students' empathy, educators should actively encourage group reflection and discussion in order to avoid these negative effects of history taking both inside and outside of the clinical setting.

Frequent Violations and Infringements against Users in Mental Health Care Confirmed by Both Users and Professionals - A Quantitative Study.

The main task of mental health care services is to provide good quality of care. Despite this, users are sometimes treated badly by staff. The purpose of this study was to investigate violations and infringements towards users in mental health care services, from the perspectives of both staff and users. Data were gathered through an anonymous online questionnaire sent to staff and users in Norway. Staff were recruited in collaboration with professional organisations and users in collaboration with user-organisations.

Family involvement practices for persons with psychotic disorders in community mental health centres - a cross-sectional fidelity-based study.

BACKGROUND: Family involvement for persons with psychotic disorders is supported by scientific evidence, as well as legal and ethical considerations, and recommended in clinical practice guidelines. This article reports a cross-sectional measurement of the level of implementation of such guidelines in fifteen community mental health centre units in Norway, and presents a novel fidelity scale to measure basic family involvement and support. The aim was to investigate current family involvement practices comprehensively, as a basis for targeted quality improvement. METHODS: We employed three fidelity scales, with 12-14 items, to measure family involvement practices. Items were scored from 1 to 5, where 1 equals no implementation and 5 equals full implementation. Data was analysed using descriptive statistics, a non-parametric test, and calculation of interrater reliability for the scales. RESULTS: The mean score was 2.33 on the fidelity scale measuring basic family involvement and support. Among patients with psychotic disorders, only 4% had received family psychoeducation. On the family psychoeducation fidelity assessment scale, measuring practice and content, the mean score was 2.78. Among the eight units who offered family psychoeducation, it was 4.34. On the general organizational index scale, measuring the organisation and implementation of family psychoeducation, the mean score was 1.78. Among the units who offered family psychoeducation, it was 2.46. As a measure of interrater reliability, the intra-class correlation coefficient was 0.99 for the basic family involvement and support scale, 0.93 for the family psychoeducation fidelity assessment scale and 0.96 for the general organizational index scale. CONCLUSIONS: The implementation level of the national guidelines on family involvement for persons with psychotic disorders was generally poor. The quality of family psychoeducation was high, but few patients had received this evidence-based treatment. Our novel fidelity scale shows promising psychometric properties and may prove a useful tool to improve the quality of health services. There is a need to increase the implementation of family involvement practices in Norway, to reach a larger percentage of patients and relatives. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03869177 . Registered 11.03.19.

Public attitudes and health law in conflict: somatic vs. mental care, role of next of kin, and the right to refuse treatment and information.

BACKGROUND: Norwegian law and regulations regarding patient autonomy and the use of coercion are in conflict with the Convention on the Rights of Persons with Disabilities (CRPD) and the Oviedo Convention on several points. A new law concerning the use of coercion in Norwegian health services has been proposed. In this study we wanted to investigate the attitudes of the Norwegian lay populace with regards to some of these points of conflict. METHODS: An electronic questionnaire with 9 propositions about patient autonomy, the use of coercion, the role of next of kin, and equality of rights and regulations across somatic and mental health care was completed by 1617 Norwegian adults (response rate 8.5%). RESULTS: A majority of respondents support the patient's right to refuse treatment and information in serious illness, that previously expressed treatment preferences should be respected, that next of kin's right to information and authority in clinical decision-making should be strengthened, and that this kind of legal regulations should be equal across somatic and mental health care. CONCLUSIONS: The findings in this study suggest that the opinions of the Norwegian lay populace are in conflict with the national law on several points relating to patient autonomy, the role of next of kin and use of coercive measures, and different legal regulation of somatic vs. mental health care. The study suggests that the populace is more in line with the CRPD, which supports equal rights across somatic and mental health care, and the Oviedo Convention, which does not allow for the same degree of strong paternalism regarding coercive measures as the current Norwegian law. This can be taken to support the recently proposed legislation on the use and limitation of coercion in Norwegian health services.

Positive attitudes to advance care planning - a Norwegian general population survey.

BACKGROUND: Authorities recommend advance care planning and public acceptance of it is a prerequisite for widespread implementation. Therefore, we did the first study of the Norwegian public with an aim of getting knowledge on their attitudes to issues related to advance care planning. METHODS: An electronic survey to a nationally representative web panel of Norwegian adults. RESULTS: From 1035 complete responses (response rate 40.7%), we found that more than nine out of ten of the general public wanted to participate in advance care planning, believed it to be useful for many, and wanted to make important healthcare decisions themselves. Almost nine out of ten wanted to be accompanied by next of kin during advance care planning. Most (69%) wanted health care personnel to initiate advance care planning and preferred it to be timed to serious illness with limited lifetime (68%). Only about 9% stated that health care personnel should have the final say in healthcare decisions in serious illness. CONCLUSIONS: Developing and implementing advance care planning as a public health initiative seems warranted based on the results of this study. Patient perspectives should be promoted in decision-making processes. Nevertheless, training of health care personnel should emphasise voluntariness and an individual approach to initiating, timing and conducting advance care planning because of individual variations.

Nursing home residents with cognitive impairment can participate in advance care planning: A qualitative study.

AIMS: To describe advance care planning in nursing homes when residents with cognitive impairment and/or their next of kin participated and identify associated challenges. DESIGN: A qualitative study of nine advance care planning conversations in four Norwegian nursing home wards. During the implementation of advance care planning, we purposively sampled residents with cognitive impairment, their next of kin and healthcare personnel. The implementation followed a "whole-ward" approach aimed at involving the whole ward in fostering an inclusive, holistic advance care planning discussion. Involving as many residents as possible, preferably together with their next of kin, were central. METHODS: From observed and audio-recorded advance care planning conversations that took place from November 2015 to June 2016, we conducted a thematic analysis of the transcripts and field notes. Reporting adhered to the COREQ guidelines. RESULTS: Residents actively relayed their preferences regarding healthcare and end-of-life issues, despite the cognitive impairment. Next of kin provided constructive support and conversations were largely resident-focused. However, involving residents was also challenging, findings included: residents' preferences were often vague, relevant medical information from healthcare personnel lacked and the next of kin were sometimes unaware of the resident's previously held preferences. Moreover, residents tended to focus more on the past and present than the future end-of-life care. CONCLUSIONS: Residents with cognitive impairment can participate actively and meaningfully in advance care planning, if the healthcare personnel actively listens. However, several challenges can arise. Supported decision-making can improve communication and resident involvement, reinforcing a relational understanding of autonomy. IMPACT: Persons with cognitive impairment should be invited to participate in advance care planning. Their participation may make its benefits and more person-centred care attainable to persons that are often not involved. Successful involvement of persons with cognitive impairment in advance care planning may rely on robust implementation.

Ethical challenges in home-based care: A systematic literature review.

Because of the transfer of responsibility from hospitals to community-based settings, providers in home-based care have more responsibilities and a wider range of tasks and responsibilities than before, often with limited resources. The increased responsibilities and the complexity of tasks and patient groups may lead to several ethical challenges. A systematic search in the databases MEDLINE, CINAHL, and SveMed+ was carried out in February 2019 and August 2020. The research question was translated into a modified PICO (Population, Intervention, Comparison, and Outcome) worksheet. A total of 40 articles were included. The review is conducted according to the Vancouver Protocol. The main findings from the systematic literature review show that ethical challenges experienced by healthcare and social care providers in home-based care are related to autonomy and balancing ethical principles, decisions regarding intensity of care, challenges related to priority settings, truth-telling, and balancing the professional role. Findings regarding ethical challenges within home-based care are in line with findings from institutional healthcare and social care settings. However, some significant differences from the institutional context are also highlighted.

Back to WHAT? The role of research ethics in pandemic times.

The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times. We suggest it might be helpful to think through a lens differentiating between risk, strict uncertainty and ignorance. We provide some examples of lessons learned by harm done in the name of research in the past and discuss the relevance of this legacy in the current situation.

Importance of systematic deliberation and stakeholder presence: a national study of clinical ethics committees.

BACKGROUND: Case consultation performed by clinical ethics committees (CECs) is a complex activity which should be evaluated. Several evaluation studies have reported stakeholder satisfaction in single institutions. The present study was conducted nationwide and compares clinicians' evaluations on a range of aspects with the CEC's own evaluation. METHODS: Prospective questionnaire study involving case consultations at 19 Norwegian CECs for 1 year, where consultations were evaluated by CECs and clinicians who had participated. RESULTS: Evaluations of 64 case consultations were received. Cases were complex with multiple ethical problems intertwined. Clinicians rated the average CEC consult highly, being both satisfied with the process and perceiving it to be useful across a number of aspects. CEC evaluations corresponded well with those of clinicians in a large majority of cases. Having next of kin/patients present was experienced as predominantly positive, though practised by only half of the CECs. The educational function of the consult was evaluated more positively when the CEC used a systematic deliberation method. CONCLUSIONS: CEC case consultation was found to be a useful service. The study is also a favourable evaluation of the Norwegian CEC system, implying that it is feasible to implement well-functioning CECs on a large scale. There are good reasons to involve the stakeholders in the consultations as a main rule.

Implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres (IFIP): protocol for a cluster randomised controlled trial.

BACKGROUND: Family involvement for persons with psychotic disorders is under-implemented in mental health care, despite its firm scientific, economic, legal and moral basis. This appears to be the case in Norway, despite the presence of national guidelines providing both general recommendations on family involvement and support in the health- and care services, and specific guidance on family interventions for patients with psychotic disorders. The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process. METHODS: The trial is cluster randomised, where 14 outpatient clusters from community mental health centres undergo stratified randomisation with an allocation ratio of 1:1. The seven intervention clusters will receive implementation support for 18 months, whereas the control clusters will receive the same support after this implementation period. The intervention consists of: 1. A basic level of family involvement and support. 2. Family psychoeducation in single-family groups. 3. Training and guidance of health care personnel. 4. A family coordinator and 5. Other implementation measures. Fidelity to the intervention will be measured four times in the intervention arm and two times in the control arm, and the differences in fidelity changes between the arms constitute the primary outcomes. In each arm, we aim to include 161 patients with psychotic disorders and their closest relative to fill in questionnaires at inclusion, 6 months and 12 months, measuring psychosocial health and satisfaction with services. Clinicians will contribute clinical data about patients at inclusion and 12 months. Use of health and welfare services and work participation, for both patients and relatives, will be retrieved from national registries. We will also perform qualitative interviews with patients, relatives, health care personnel and leaders. Finally, we will conduct a cost-effectiveness analysis and a political economy analysis. DISCUSSION: This project, with its multilevel and mixed methods approach, may contribute valuable knowledge to the fields of family involvement, mental health service research and implementation science. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03869177 . Registered 11.03.19.

Implementing clinical ethics committees as a complex intervention: presentation of a feasibility study in community care.

BACKGROUND: How should clinical ethics support services such as clinical ethics committees (CECs) be implemented and evaluated? We argue that both the CEC itself and the implementation of the CEC should be considered as 'complex interventions'. MAIN TEXT: We present a research project involving the implementation of CECs in community care in four Norwegian municipalities. We show that when both the CEC and its implementation are considered as complex interventions, important consequences follow - both for implementation and the study thereof. Emphasizing four such sets of consequences, we argue, first, that the complexity of the intervention necessitates small-scale testing before larger-scale implementation and testing is attempted; second, that it is necessary to theorize the intervention in sufficient depth; third, that the identification of casual connections charted in so-called logic models allows the identification of factors that are vital for the intervention to succeed and which must therefore be studied; fourth, that an important part of a feasibility study must be to identify and chart as many as possible of the causally important contextual factors. CONCLUSION: The conceptualization of the implementation of a CEC as a complex intervention shapes the intervention and the way evaluation research should be performed, in several significant ways. We recommend that researchers consider whether a complex intervention approach is called for when studying CESS implementation and impact.

Correction to: Implementing clinical ethics committees as a complex intervention: presentation of a feasibility study in community care.

An amendment to this paper has been published and can be accessed via the original article.