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.

Associations between personal recovery and service user-rated versus clinician-rated clinical recovery, a cross-sectional study.

BACKGROUND: This study examined the relationship between service user-rated personal recovery and clinician-rated and service user-rated clinical recovery. The relationships between different subdomains of clinical recovery and personal recovery were also assessed. METHODS: In total, 318 mental health service users with a psychosis diagnosis and their clinicians from 39 sites across Norway completed standardized questionnaires regarding personal recovery, clinical symptoms and psychosocial functioning. Regression models were used to investigate the relationship between personal and clinical recovery. RESULTS: Overall, clinical recovery was positively associated with personal recovery, when rated both by service users and by clinicians. Personal recovery was associated with lower levels of depression, self-harm and problems with relationships when rated by the service users. Among the subdomains rated by the clinicians, personal recovery was associated with fewer problems with relationships and higher aggressiveness. CONCLUSIONS: These findings suggest that affective symptoms are associated with personal recovery, indicating the need for greater focus on depression treatment among people with psychosis. Improving social connections is of importance for personal recovery, and might be an area where clinicians and service users can meet and find agreement on important treatment goals.

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.

Can systematic implementation support improve programme fidelity by improving care providers' perceptions of implementation factors? A cluster randomized trial.

BACKGROUND: Investigations of implementation factors (e.g., collegial support and sense of coherence) are recommended to better understand and address inadequate implementation outcomes. Little is known about the relationship between implementation factors and outcomes, especially in later phases of an implementation effort. The aims of this study were to assess the association between implementation success (measured by programme fidelity) and care providers' perceptions of implementation factors during an implementation process and to investigate whether these perceptions are affected by systematic implementation support. METHODS: Using a cluster-randomized design, mental health clinics were drawn to receive implementation support for one (intervention) and not for another (control) of four evidence-based practices. Programme fidelity and care providers' perceptions (Implementation Process Assessment Tool questionnaire) were scored for both intervention and control groups at baseline, 6-, 12- and 18-months. Associations and group differences were tested by means of descriptive statistics (mean, standard deviation and confidence interval) and linear mixed effect analysis. RESULTS: Including 33 mental health centres or wards, we found care providers' perceptions of a set of implementation factors to be associated with fidelity but not at baseline. After 18 months of implementation effort, fidelity and care providers' perceptions were strongly correlated (B (95% CI) = .7 (.2, 1.1), p = .004). Care providers perceived implementation factors more positively when implementation support was provided than when it was not (t (140) = 2.22, p = .028). CONCLUSIONS: Implementation support can facilitate positive perceptions among care providers, which is associated with higher programme fidelity. To improve implementation success, we should pay more attention to how care providers constantly perceive implementation factors during all phases of the implementation effort. Further research is needed to investigate the validity of our findings in other settings and to improve our understanding of ongoing decision-making among care providers, i.e., the mechanisms of sustaining the high fidelity of recommended practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03271242 (registration date: 05.09.2017).

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.

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.

Relationship between satisfaction with mental health services, personal recovery and quality of life among service users with psychosis: a cross-sectional study.

BACKGROUND: Mental health policy internationally emphasizes patient centredness and personal recovery. This study investigated the relationship between satisfaction with mental health services among service users with psychosis in Norway, and personal recovery, perceived support for personal recovery, and quality of life. METHODS: Cross-sectional data were collected from 292 service users diagnosed with psychosis from 39 clinical sites across Norway. Satisfaction with services was assessed using the Client Satisfaction Questionnaire-8. A linear mixed model was estimated to explore the relationship between satisfaction with services and preselected covariates, and to control for confounding factors. RESULTS: A large majority of participants (89%) reported moderate-to-high levels of satisfaction. Satisfaction with services was positively associated with perceived support for personal recovery, but not with personal recovery or quality of life. In addition, service users under a Community Treatment Order (CTO) were significantly less satisfied than those who were not. CONCLUSIONS: Satisfaction levels among service users were higher compared with similar, international studies. Those who feel supported in their personal recovery were more satisfied with the care they receive, which support the need for implementation of recovery-oriented practices for service users with psychosis. However, satisfaction with services was not related to service user-rated quality of life or level of personal recovery; thus, more follow-up studies are needed. The lower satisfaction of service users placed under CTOs shows the importance of targeted interventions to improve satisfaction with services among this group. TRIAL REGISTRATION: NCT03271242 , date of registration: 5 sept. 2017.

Recovery-oriented care: mental health workers' attitudes towards recovery from mental illness.

BACKGROUND: The Recovery Knowledge Inventory (RKI) was developed to operationalise the recovery construct and in turn contribute to moving mental health services towards recovery-oriented practice. This study validated the RKI in a sample of Norwegian mental health care practitioners and examined mental health workers' knowledge of and attitudes towards patient recovery. METHODS: The RKI was translated into Norwegian and tested on 317 mental health workers from 7 primary and 22 specialised mental health care units within a defined geographical area of Norway. RESULTS: Psychometric challenges to the RKI were observed and called into question the previously proposed four-factor structure. The findings of the scale revealed that the study sample scored significantly lower than a comparable sample in a previous study, suggesting that the Norwegian mental health workers have relatively low orientation towards recovery. This finding was especially applicable to the reduction of symptoms and treatment, which the respondents perceived as essential for recovering from mental illnesses and substance abuse disorders. CONCLUSIONS: To operationalise the recovery construct, the development of a measure such as the RKI needs further attention. For psychiatric practice to be moved in a more recovery-oriented direction, consensus on what constitutes well-functioning recovery must be reached by patients, practitioners and researchers alike.

The Effect of Intensive Implementation Support on Fidelity for Four Evidence-Based Psychosis Treatments: A Cluster Randomized Trial.

PURPOSE: Service providers need effective strategies to implement evidence-based practices (EBPs) with high fidelity. This study aimed to evaluate an intensive implementation support strategy to increase fidelity to EBP standards in treatment of patients with psychosis. METHODS: The study used a cluster randomized design with pairwise assignment of practices within each of 39 Norwegian mental health clinics. Each site chose two of four practices for implementation: physical health care, antipsychotic medication management, family psychoeducation, illness management and recovery. One practice was assigned to the experimental condition (toolkits, clinical training, implementation facilitation, data-based feedback) and the other to the control condition (manual only). The outcome measure was fidelity to the EBP, measured at baseline and after 6, 12, and 18 months, analyzed using linear mixed models and effect sizes. RESULTS: The increase in fidelity scores (within a range 1-5) from baseline to 18 months was significantly greater for experimental sites than for control sites for the combined four practices, with mean difference in change of 0.86 with 95% CI (0.21; 1.50), p = 0.009). Effect sizes for increase in group difference of mean fidelity scores were 2.24 for illness management and recovery, 0.68 for physical health care, 0.71 for antipsychotic medication management, and 0.27 for family psychoeducation. Most improvements occurred during the first 12 months. CONCLUSIONS: Intensive implementation strategies (toolkits, clinical training, implementation facilitation, data-based feedback) over 12 months can facilitate the implementation of EBPs for psychosis treatment. The approach may be more effective for some practices than for others.

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.

Psychometric Properties of a Fidelity Scale for Illness Management and Recovery.

This study examined the psychometric properties and feasibility of the Illness Management and Recovery (IMR) Fidelity scale. Despite widespread use of the scale, the psychometric properties have received limited attention. Trained fidelity assessors conducted assessments four times over 18 months at 11 sites implementing IMR. The IMR Fidelity scale showed excellent interrater reliability (.99), interrater item agreement (94%), internal consistency (.91-.95 at three time points), and sensitivity to change. Frequency distributions generally showed that item ratings included the entire range. The IMR Fidelity scale has excellent psychometric properties and should be used to evaluate and guide the implementation of IMR.Trial registration: ClinicalTrials.gov Identifier: NCT03271242.

Psychometric Properties of the General Organizational Index (GOI): A Measure of Individualization and Quality Improvement to Complement Program Fidelity.

To assess the implementation of effective practices, mental health programs need standardized measures. The General Organizational Index (GOI), although widely used for this purpose, has received minimal psychometric research. For this study, we assessed psychometric properties of the GOI scale administered four times over 18 months during the implementation of a new program in 11 sites. The GOI scale demonstrated high levels of interrater reliability (.97), agreement between assessors on item ratings (86% overall), internal consistency (.77-.80 at three time points), sensitivity to change, and feasibility. We conclude that the GOI scale has acceptable psychometric properties, and its use may enhance implementation and research on evidence-based mental health practices.Trial registration: REK2015/2169. ClinicalTrials.gov Identifier: NCT03271242.

The Physical Health Care Fidelity Scale: Psychometric Properties.

Mental health programs need an instrument to monitor adherence to evidence-based physical health care for people with serious mental illness. The paper describes the Physical Health Care Fidelity Scale and study interrater reliability, frequency distribution, sensitivity to change and feasibility. Four fidelity assessments were conducted over 18 months at 13 sites randomized to implementation support for evidence-based physical health care. We found good to excellent interrater reliability, adequate sensitivity for change, good feasibility and wide variability in fidelity across sites after 18 months of implementation. Programs were more successful in establishing Policies stating physical health care standards than in implementing these Policies. The Physical Health Care Fidelity Scale measures and guides implementation of evidence-based physical health care reliably.Trial registration: ClinicalTrials.gov Identifier: NCT03271242.

The Antipsychotic Medication Management Fidelity Scale: Psychometric properties.

The paper describes the Antipsychotic Medication Management Fidelity Scale and its psychometric properties, including interrater reliability, frequency distribution, sensitivity to change and feasibility. Fidelity assessors conducted fidelity reviews four times over 18 months at eight sites receiving implementation support for evidence-based antipsychotic medication management. Data analyses shows good to fair interrater reliability, adequate sensitivity to change over time and good feasibility. At 18 months, item ratings varied from poor to full fidelity on most items. Use of the scale can assess fidelity to evidence-based guidelines for antipsychotic medication management and guide efforts to improve practice. Further research should improve and better calibrate some items, and improve the procedures for access to information.Trial registration: ClinicalTrials.gov Identifier: NCT03271242.

Significance of Leaders for Sustained Use of Evidence-Based Practices: A Qualitative Focus-Group Study with Mental Health Practitioners.

Evidence-based practices that are implemented in mental health services are often challenging to sustain. In this focus-group study, 26 mental health practitioners with high fidelity scores were interviewed regarding their experiences with implementing the illness management and recovery, an evidence-based practice for people with severe mental disorders, in their services and how this could influence further use. Findings indicate that high fidelity is not equivalent to successful implementation. Rather, to sustain the practice in services, the practitioners emphasized the importance of their leaders being positive and engaged in the intervention, and hold clear goals and visions for the intervention in the clinic. In addition, the practitioners' understanding of outcome monitoring as a resource for practice improvement must be improved to avoid random patient experiences becoming the decisive factor in determining further use.Trial registration: ClinicalTrials.gov NCT02077829. Registered 25 February 2014.

"This is not a Life Anyone would want"-A Qualitative Study of Norwegian ACT Service users' Experience with Mental Health Treatment.

We discuss Norwegian service users' experiences with community mental health treatment in general, and the interprofessional Assertive Community Treatment (ACT) model in particular. To gain the right to treatment, service users have to accept certain limitations, such as medication and community treatment orders (CTOs). Seventy participants responded to five open-ended questions. In addition, eight of them participated in either focus group or interviews. A collaborative approach, using Stepwise-Deductive Induction (SDI) method was used to analyze the participants' experiences. The results showed that the treatment contributes to an experience of autonomy but also one of restriction. It provides service users with enhanced normalcy, but simultaneously a feeling of deviance. There needs to be an ongoing reflection and discussion about those paradoxes in treatment, and service users have to be involved.

Hospitalisation of severely mentally ill patients with and without problematic substance use before and during Assertive Community Treatment: an observational cohort study.

BACKGROUND: Co-occurring substance use increases the risk of hospitalisation in people with severe mental illness, whereas Assertive Community Treatment (ACT) generally reduces hospitalisation in patients with severe mental illness and high inpatient service use. Because the superiority of ACT over standard services amongst patients with problematic substance use is uncertain, the present study examined inpatient service use amongst patients with and without problematic substance use in the 2 years before and the 2 years after they enrolled into ACT teams. METHODS: This naturalistic observational study included 142 patients of 12 different ACT teams throughout Norway. The teams assessed the patients upon enrolment into ACT using clinician-rated and self-reported questionnaires. We obtained hospitalisation data from the Norwegian Patient Register for the 2 years before and the 2 years after enrolment into ACT. We used linear mixed models to assess changes in hospitalisation and to explore associations between problematic substance use and changes in hospitalisation, controlling for socio-demographic and clinical characteristics. RESULTS: A total of 84 (59%) participants had problematic substance use upon enrolment into the ACT teams. In the 2 years after ACT enrolment both participants with and without problematic substance use experienced a reduction in total inpatient days. Those with problematic substance use also had fewer involuntary inpatient days. Exploratory analyses suggested that symptom severity and functioning level interacted with problematic substance use to influence change in total inpatient days. CONCLUSION: These findings may suggest that ACT teams successfully support people with complex mental health problems in the community, including those with problematic substance use, and thereby contribute to a reduction in inpatient service use.

Psychometric properties of the Norwegian version of the Evidence-Based Practice Attitude Scale (EBPAS): to measure implementation readiness.

BACKGROUND: Attitudes can be a precursor to the decision of whether or not to try a new practice. In order to tailor the implementation of evidence-based practices (EBPs) in mental health settings, we must first consider practitioner attitudes towards EBP adoption. To assess these attitudes, the Evidence-Based Practice Attitude Scale (EBPAS) was developed. The purpose of this study was to investigate the psychometric properties of the Norwegian version of the EBPAS, and to examine differences in attitudes towards implementing EBPs among mental health practitioners. METHODS: The EBPAS was translated into Norwegian and administered to 294 practitioners from seven primary and 22 specialized mental care units within a defined geographical area of Norway. RESULTS: The EBPAS showed good psychometric properties. The less clinical experience the practitioner had, the more positive their attitude toward EBPs. Primary care practitioners reported more positive attitudes towards implementing EBPs that were required of them than specialized care practitioners. CONCLUSIONS: The Norwegian version of the EBPAS is a promising tool for measuring implementation readiness in mental health services, and can be used in clinical practice to tailor implementation efforts. TRIAL REGISTRATION: The study was approved by the regional committees for medical and health research ethics [ REK 2013/2035 ] on 25(th) of May, 2014.

Are Users Satisfied with Assertive Community Treatment in Spite of Personal Restrictions?

The purpose of this explorative study was to examine satisfaction among 70 users of 12 Norwegian Assertive Community Treatment teams. The study was carried out among a group of 70 service users, and reveals generally high levels of satisfaction with the service, with satisfaction also being high in comparison to other ACT satisfaction studies. Users under a Community Treatment Order were more satisfied, while users with an alcohol use disorder were less satisfied. Younger service users were less positive than older users. There was no difference in satisfaction between the genders. This study's positive result may reflect the ACT model's focus on user involvement, recovery and building relationships, and the fact that this service has a more holistic approach than previous services that users have experienced.