Implementation of Family Involvement for Persons With Psychotic Disorders.

Study Overview
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Brief Summary
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This study will develop and evaluate a complex intervention to implement guidelines on family involvement for patients with psychotic disorders (F20-29 in International Classification of Diseases ICD-10) in community mental health centres, by using a cluster randomised design. Fifteen Norwegian outpatient units participate in the study, and each of them constitutes a single cluster, except for two collaborating clinics who are considered one cluster. Of the fourteen clusters, half will receive implementation support and training immediately, whereas the other half will receive it one and a half year later. The study will assess both service level outcomes, by measuring fidelity scores, and selected outcomes for patients and relatives, by collecting questionnaires and data from central health registers and patient records. In addition, qualitative interviews will be performed with patients, relatives and health care personnel. The study will also include a cost-effectiveness analysis and a political economy analysis.

Detailed Description
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Background: Family involvement during severe mental illness, such as psychotic disorders, is both important and challenging. Evidence suggest that family interventions for persons with psychotic disorders are associated with positive outcomes for both relatives and patients, and economic analyses of such interventions consistently report net saving. There are also important moral imperatives to involve those providing unpaid and informal care. Yet research has shown that relatives of patients with severe mental illness experience little involvement, and that the implementation of family interventions is patchy. The Norwegian national guidelines on family involvement in the public health- and care services and the national guidelines on psychotic disorders, both give recommendations on family involvement. However, there is little knowledge about how to achieve their implementation, and whether a high degree of implementation will be associated with improvements in selected outcomes for patients and relatives. Setting: Fifteen outpatient units from community mental health centres in the South-Eastern Norway Regional Health Authority. Research questions: What is the current level of implementation of the selected recommendations in the national guidelines on family involvement for persons with psychotic disorders in participating clinical units? What are important barriers to and facilitators for implementing the national guidelines among the stakeholders at the clinical, organisational, and policy level? What are important moral dilemmas and conflicting interests related to family involvement, and how can these be resolved? Is implementation of the selected recommendations increased by a comprehensive implementation support program, compared with no such support? Is a higher level of implementation of the selected recommendations associated with improvements in selected outcomes for patients and relatives? Is implementation of family involvement during primary psychotic disorders a cost-effective intervention? Hypotheses: The current implementation of the selected recommendations in the national guidelines on family involvement for persons with psychotic disorders is low. There are important barriers to and facilitators for implementing the national guidelines among the stakeholders, at the clinical, organisational and policy level. There are important moral dilemmas and conflicting interests, and these can be dealt with through systematic triadic approaches and ethics reflection. A comprehensive implementation program for the selected recommendations is associated with a significantly higher implementation of family involvement for persons with psychotic disorders, compared to no such specific program. Higher implementation of the selected recommendations is associated with improved outcomes for patients and relatives. Outcomes for relatives, patients and the public health- and welfare services justify the costs of implementing family involvement for persons with psychotic disorders.

Official Title
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Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Other: Implementation support program


Participation Criteria
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Eligibility Criteria
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Eligibility criteria apply to participants in both quantitative and qualitative sub-studies, except that participation in family psychoeducation as described below is NOT an exclusion criterion in the qualitative sub-study. Inclusion criteria for patients: To have an established psychotic disorder (F20-29 in ICD-10) or a tentative diagnosis of psychotic disorder, certain enough to begin treatment. This need not be the patient's primary diagnosis. To be 18 years or older at the time of inclusion. Exclusion criteria for patients: To be sentenced to psychiatric treatment. Not being competent to consent to participation in research. Having completed more than five joint sessions of family psychoeducation in single-family groups (patient and relative together) or more than ten joint sessions (multiple families together) in multiple-family groups, or a similarly structured family intervention. Not having any relatives or next of kin. Inclusion criteria for relatives: Being a relative of a patient with a diagnosis as described above. To be 18 years or older at the time of inclusion. Exclusion criteria for relatives: • Having completed more than five joint sessions (patient and relative together) of family psychoeducation in single-family groups or more than ten joint sessions (multiple families together) in multiple-family groups, or a similarly structured family intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a cluster randomised controlled trial. Fourteen clusters will be stratified into three strata according to their estimated number of patients with psychotic disorders currently in treatment. The clusters within each stratum will then be randomised to either intervention or control arms with an allocation ratio of 1:1.The seven outpatient units in the intervention arm receives a comprehensive implementation support program, whereas the outpatient clinics in the control arm receives no implementation support. A similar number of patients and relatives will be recruited from both arms, preferably in dyadic pairs, for the quantitative patient- and relative sub study. Employees from the clusters in the intervention arm will be recruited to answer a questionnaire, as part of the implementation study. Patients, relatives and employees will be recruited from the clusters in the intervention arm to take part in qualitative interviews.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention arm<br>Clusters (psychiatric outpatient clinics) in the intervention arm receives a comprehensive implementation support program during the trial period. | Other: Implementation support program<br>* The IFIP intervention consists of the following elements: I. Clinical interventions 1.1 A basic level of family involvement and support 1.2 Family psychoeducation in single-family groups II. Implementation interventions 2.1 Training and guidance of health care personnel 2.2 A family coordinator 2.3 Other implementation measures<br>|
| No Intervention: Control arm<br>Clusters (psychiatric outpatient clinics) in the control arm receives no implementation support during the trial period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation study: Fidelity to the intervention model - Family psychoeducation 1 | Change in score on fidelity scale for performance and content of family psychoeducation. Rated from 1 (low) to 5 (high). | Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 
| Implementation study: Fidelity to the intervention model - Family psychoeducation 2 | Change in score on fidelity scale for penetration rate and general organisation of family psychoeducation. Rated from 1 (low) to 5 (high). | Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 
| Implementation study: Fidelity to the intervention model - Family involvement and support 1 | Change in total fidelity measured by the fidelity scale for family involvement and support. Rated from 1 (low) to 5 (high). | Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 
| Implementation study: Fidelity to the intervention model - Family involvement and support 2 | Change in penetration rate, measured by the fidelity scale for family involvement and support. Rated from 1 (low) to 5 (high). | Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 
| Implementation study: Fidelity to the intervention model - Family involvement and support 3 | Change in content, structure and implementation, measured by the scale for family involvement and support. Rated from 1 (low) to 5 (high). | Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient quantitative sub-study: Patient experiences of their own mental health and functioning. | The Behavior and Symptom Identification scale - (BASIS-24) with 24 questions on mental health, functioning and substance use, on a scale 1-5. Completed by patients. | 0, 6 and 12 months. | 
| Patient quantitative sub-study and economic sub-study: Quality of life | The Recovering Quality of Life - (ReQoL-10) questionnaire with 10 mental health items, and one physical health item on a scale 1-5. Completed by patients. | 0, 6 and 12 months. | 
| Patient quantitative sub-study: General satisfaction. | The Manchester Short Assesment of Quality of Life - (MANSA) questionnaire - first question only, on a scale 1-7. Completed by patients. | 0, 6 and 12 months. | 
| Patient quantitative sub-study: Experienced burden of mental health problems. | A single question - Produced for this study on a scale 1-7. Completed by patients. | 0, 6 and 12 months. | 
| Patient quantitative sub-study: Perceived warmth and criticism from relative. | Hooley 1989 - 5 items rated 1-10. Completed by patients. | 0, 6 and 12 months. | 
| Patient quantitative sub-study: Experienced shared decision making. | The CollaboRATE questionnaire (3 items rated 0-9), plus two additional items. Completed by patients. | 0, 6 and 12 months. | 
| Patient quantitative sub-study: Adherence with medication | A single question answered by patient, relative and clinician. | 0, 6 and 12 months for patients and relatives. 0 and 12 months for clinicians. | 
| Patient quantitative sub-Study: Clinician assessment of patient mental health and functioning | Health of the Nation Outcome Scale - (HoNOS) scale rated by clinicians on 12 items rated 0-4 (no problem - very serious problem). | 0 and 12 months. | 
| Patient quantitative sub-study: Clinician assessment of patient global functioning | Global Assessment of Functioning Scale - (GAF), split version for symptoms and functioning | 0 and 12 months. | 
| Patient quantitative sub-study and economic sub-study: Change in number of hospital admissions. | Retrieved from the Norwegian patient registry. | Measured from 18 months before inclusion to 18 months after inclusion. | 
| Patient quantitative sub-study and economic sub-study: Change in number of days spent admitted to hospital. | Retrieved from the Norwegian patient registry. | Measured from 18 months before inclusion to 18 months after inclusion. | 
| Relative quantitative sub-study and economic sub-study: Caregiver quality of life 1 | The Care Related Quality of Life - (CarerQoL) questionnaire - Seven questions on a three-point scale. Completed by relatives. | 0, 6 and 12 months. | 
| Relative quantitative sub-study and economic sub-study: Caregiver quality of life 2 | The Care Related Quality of Life - (CarerQoL) questionnaire - One visual analogue scale (VAS)-question on an 11-point scale, which is also part of the same measure. Completed by relatives. | 0, 6 and 12 months. | 
| Relative quantitative sub-study: Experience of caregiving | The Experience of Caregiving inventory - (ECI) questionnaire - 66 items on a five-point scale covering various aspects of being a caregiver. Completed by relatives. | 0, 6 and 12 months. | 
| Relative quantitative sub-study: Expressed emotion | The Family questionnaire - (FQ) - 20 items on a four-point scale, measuring criticism and emotional over-involvement. Completed by relatives. | 0, 6 and 12 months. | 
| Relative quantitative sub-study: Experienced involvement and shared decision making | An adapted version of the CollaboRATE questionnaire (3 items rated 0-9), plus two additional items completed by relatives. | 0, 6 and 12 months. | 
| Relative quantitative sub-study: Experienced support | Carer Well-being and Support questionnaire (CWS) v2 short part B - 18 items rated on a four-point scale. Completed by relatives. | 0, 6 and 12 months. | 
| Patients' and relatives' quantitative sub-studies and economic sub-study: Use of public health services and resources. | Patients' and relatives' use of public health services and resources: Number of appointments with health services, investigations, treatments and medical prescriptions, translated into costs. Retrieved from national registries. | Measured from 18 months before inclusion to 18 months after inclusion. | 
| Patients' and relatives' quantitative sub-studies and economic sub-study: Work participation | Patients' and relatives' work participation measured in percentage of a regular full time position. Retrieved from national registries. | Measured from 18 months before inclusion to 18 months after inclusion. | 
| Economic sub-study: Increased costs related to implementing and practicing family involvement | Increased costs related to implementing and practicing family involvement in the clinical units in the intervention arm. Compared to normal costs before baseline. | Measured before baseline and then throughout the implementation period (0-18 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental health care services, Family psychoeducation, Schizophrenia, Implementation science, Clinical ethics, Family involvement, Family intervention