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.

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.

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.

Salutogenic service user involvement in nursing research: A case study.

AIM: The aim was to explore the process of involving mental healthcare service users in a mental health promotion research project as research advisors and to articulate features of the collaboration which encouraged and empowered the advisors to make significant contributions to the research process and outcome. BACKGROUND: There is an increasing interest in evaluating aspects of service user involvement in nursing research. Few descriptions exist of features that enable meaningful service user involvement. We draw on experiences from conducting research which used the methodology interpretative phenomenological analysis to explore how persons with mental disorders perceived mental health. Apart from the participants in the project, five research advisors with service user experience were involved in the entire research process. DESIGN: We applied a case study design to explore the ongoing processes of service user involvement. METHODS: Documents and texts produced while conducting the project (2012-2016), as well as transcripts from multistage focus group discussions with the research advisors, were analysed. RESULTS: The level of involvement was dynamic and varied throughout the different stages of the research process. Six features: leadership, meeting structure, role clarification, being members of a team, a focus on possibilities and being seen and treated as holistic individuals, were guiding principles for a salutogenic service user involvement. These features strengthened the advisors' perception of themselves as valuable and competent contributors. CONCLUSION: Significant contributions from research advisors were promoted by facilitating the process of involvement. A supporting structure and atmosphere were consistent with a salutogenic service user involvement.

Service user involvement enhanced the research quality in a study using interpretative phenomenological analysis - the power of multiple perspectives.

AIM: The aim of this study was to examine how service user involvement can contribute to the development of interpretative phenomenological analysis methodology and enhance research quality. BACKGROUND: Interpretative phenomenological analysis is a qualitative methodology used in nursing research internationally to understand human experiences that are essential to the participants. Service user involvement is requested in nursing research. DESIGN: We share experiences from 4 years of collaboration (2012-2015) on a mental health promotion project, which involved an advisory team. METHODS: Five research advisors either with a diagnosis or related to a person with severe mental illness constituted the team. They collaborated with the research fellow throughout the entire research process and have co-authored this article. We examined the joint process of analysing the empirical data from interviews. Our analytical discussions were audiotaped, transcribed and subsequently interpreted following the guidelines for good qualitative analysis in interpretative phenomenological analysis studies. RESULTS: The advisory team became 'the researcher's helping hand'. Multiple perspectives influenced the qualitative analysis, which gave more insightful interpretations of nuances, complexity, richness or ambiguity in the interviewed participants' accounts. The outcome of the service user involvement was increased breadth and depth in findings. CONCLUSION: Service user involvement improved the research quality in a nursing research project on mental health promotion. The interpretative element of interpretative phenomenological analysis was enhanced by the emergence of multiple perspectives in the qualitative analysis of the empirical data. We argue that service user involvement and interpretative phenomenological analysis methodology can mutually reinforce each other and strengthen qualitative methodology.

Challenges for group leaders working with families dealing with early psychosis: a qualitative study.

BACKGROUND: Family work is one of the best researched psychosocial interventions for patients with chronic psychosis. However, family work is less studied for patients with a first episode psychosis and the studies have revealed contradicting results. To our knowledge, no previous studies have examined qualitatively group leaders' experiences with family work. In the present study we wanted to explore challenges faced by mental health professionals working as group leaders for family interventions with first episode psychosis patients. METHOD: A qualitative exploratory study was carried out based on digitally recorded in-depth interviews and a focus group interview with nine experienced mental health professionals. The interviews were transcribed in a slightly modified verbatim mode and analysed by systematic text condensation. RESULTS: Challenges faced by group leaders was classified into six categories: (1) Motivating patients to participate, encouraging potential participants was demanding and time-consuming; (2) Selecting participants by identifying those who can form a functional group and benefit from the intervention; (3) Choosing group format to determine whether a single or multi-family group is best for the participants; (4) Preserving patient independence, while also encouraging them to participate in the intervention; (5) Adherence to the protocol, while customizing adjustments as needed; (6) Fostering good problem-solving by creating a fertile learning environment and choosing the most appropriate problem to solve. CONCLUSIONS: Group leaders face challenges related to recruitment and selection of participants for family work, as well as in conducting sessions. Awareness of these challenges could help health professionals more specifically to tailor the intervention to the specific needs of patients and their families.

Implementation of guidelines on Family Involvement for persons with Psychotic disorders: a pragmatic cluster randomized trial. Effect on relatives' outcomes and family interventions received.

Background: Family interventions (FI) are recommended as part of the treatment for psychotic disorders, but the implementation in mental health services is generally poor. Recently, The Implementation of guidelines on Family Involvement for persons with Psychotic disorders (IFIP) trial, demonstrated significant improvements in implementation outcomes at cluster-level. This sub-study aims to examine the effectiveness of the IFIP intervention on relatives' outcomes and received FI. Methods: A cluster randomized controlled trial, was conducted in 15 Norwegian Community Mental Health Center (CMHC) units that were randomized to either the IFIP intervention, including implementation interventions and clinical interventions, or treatment as usual (TAU). The clinical interventions consisted of FI: basic family involvement and support (BFIS) to all patients and family psychoeducation (FPE) to as many as possible. Patients with psychotic disorders and their closest relative were invited to fill in questionnaires at inclusion and 6 months and 12 months follow-up. Received FI was reported by both relatives and clinicians. The relatives' primary outcome was satisfaction with health service support, measured by the Carer well-being and support questionnaire part B (CWS-B). The relatives' secondary outcomes were caregiver experiences, expressed emotions and quality of life. Patients' outcomes will be reported elsewhere. Results: In total 231 patient/relative pairs from the CMHC units were included (135 intervention; 96 control).The relatives in the intervention arm received an increased level of BFIS (p=.007) and FPE (p < 0.05) compared to the relatives in the control arm, including involvement in crisis planning. The primary outcome for relatives' satisfaction with health service support, showed a non-significant improvement (Cohen's d = 0.22, p = 0.08). Relatives experienced a significant reduced level of patient dependency (Cohen's d = -0.23, p = 0.03). Conclusion: The increased support from clinicians throughout FI reduced the relatives' perceived level of patient dependency, and may have relieved the experience of responsibility and caregiver burden. The COVID-19 pandemic and the complex and pioneering study design have weakened the effectiveness of the IFIP intervention, underscoring possible potentials for further improvement in relatives' outcomes. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT03869177.

"The most important thing is that those closest to you, understand you": a nested qualitative study of persons with psychotic disorders' experiences with family involvement.

Introduction: Family interventions constitute effective treatment for persons with psychotic disorders. However, the active ingredients and beneficial processes of these interventions are insufficiently examined, and qualitative explorations of patients` experiences are lacking. This study was nested in a cluster randomised trial that implemented national guidelines on family involvement in Norwegian community mental health centres, including family psychoeducation and basic family involvement and support. The aim of this sub-study was to explore how patients with psychotic disorders experience systematic family involvement, and its significance. Methods: We conducted semi-structured, individual interviews with 13 persons with a psychotic disorder after systematic family involvement. The participants were recruited through purposive sampling. Qualitative content analysis guided the analysis. Results: Participants reported overall positive experiences with systematic family involvement. It was significant that the relatives increasingly understood more about psychosis and their situation, while they themselves also gained more insight into the relatives` situation. The participants emphasised the need to enable both patients and relatives to safely share experiences in a containing space, led by professionals. Shared understanding and awareness of each other's situation further improved communication, coping with the illness, reduced stress, and stimulated a more caring family environment. The therapist seemed crucial to facilitate these beneficial communication processes, and also to provide continuous support to the relatives. Reported challenges included that the participants felt vulnerable in the initial phase, a need for tailored approaches, and too late start-up. Conclusion: Findings from this study suggest that persons with psychotic disorders may benefit greatly from participating in systematic family involvement. This study also gives new insight into possible mediators of positive outcomes both for the patients and the relatives. Systematic family involvement should be implemented a standard approach in the early phase of the disease, using a step-wise and tailored process.

Participants' perceived benefits of family intervention following a first episode of psychosis: a qualitative study.

AIM: To explore the perceived benefits for patients and family members of psychoeducational family intervention following a first episode of psychosis. METHODS: A qualitative exploratory study using data from interviews with 12 patients and 14 family members who participated in a psychoeducational multi- or single-family treatment programme. Semi-structured interviews were digitally recorded and transcribed verbatim with slight modifications, after which they were analysed by systematic text condensation. RESULTS: Patients and family members reported benefits that could be classified in five categories: (i) developing insight and acceptance requires understanding of the fact that the patient has an illness, and recognizing the need for support; (ii) recognizing warning signs requires an understanding of early signs of deterioration in the patient; (iii) improving communication skills is linked to new understanding and better communication both within the family and in groups; (iv) Learning to plan and solve problems requires the ability to solve problems in new ways; (v) becoming more independent requires patients to take responsibility for their own life. CONCLUSION: The study suggests that developing insight and acceptance, learning about warning signs, improving communications skills, learning to plan and solve problems, and becoming more independent are perceived as benefits of a psychoeducational family intervention.