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.

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.

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.

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.

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.