Implementation of Family Involvement for Persons With Psychotic Disorders. (IFIP)

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

Oslo Metropolitan University, University Hospital, Akershus, Helse Fonna, Diakonhjemmet Hospital, Vestre Viken Hospital Trust, Oslo University Hospital, Sykehuset i Vestfold HF, Sykehuset Telemark, The Research Council of Norway, Helse Sor-Ost

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.

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.

Family psychoeducation, Schizophrenia, Implementation science, Mental health care services, Clinical ethics, Family involvement, Family intervention

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.

Patients and relatives will not be informed about their outpatient clinic's allocation status. However, they may deduce this from the kind of treatment they receive. It's impossible to blind the care providers and for practical reasons we won't be able to blind the investigators or the outcomes assessors.

Clusters (psychiatric outpatient clinics) in the intervention arm receives a comprehensive implementation support program during the trial period.

Clusters (psychiatric outpatient clinics) in the control arm receives no implementation support during the trial period.

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

Change in score on fidelity scale for performance and content of family psychoeducation. Rated from 1 (low) to 5 (high).

Change in score on fidelity scale for penetration rate and general organisation of family psychoeducation. Rated from 1 (low) to 5 (high).

Change in total fidelity measured by the fidelity scale for family involvement and support. Rated from 1 (low) to 5 (high).

Change in penetration rate, measured by the fidelity scale for family involvement and support. Rated from 1 (low) to 5 (high).

Change in content, structure and implementation, measured by the scale for family involvement and support. Rated from 1 (low) to 5 (high).

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.

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.

The Manchester Short Assesment of Quality of Life - (MANSA) questionnaire - first question only, on a scale 1-7. Completed by patients.

Health of the Nation Outcome Scale - (HoNOS) scale rated by clinicians on 12 items rated 0-4 (no problem - very serious problem).

Patient quantitative sub-study and economic sub-study: Change in number of days spent admitted to hospital.

The Care Related Quality of Life - (CarerQoL) questionnaire - Seven questions on a three-point scale. Completed by relatives.

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.

The Experience of Caregiving inventory - (ECI) questionnaire - 66 items on a five-point scale covering various aspects of being a caregiver. Completed by relatives.

The Family questionnaire - (FQ) - 20 items on a four-point scale, measuring criticism and emotional over-involvement. Completed by relatives.

An adapted version of the CollaboRATE questionnaire (3 items rated 0-9), plus two additional items completed by relatives.

Carer Well-being and Support questionnaire (CWS) v2 short part B - 18 items rated on a four-point scale. Completed by relatives.

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.

Patients' and relatives' work participation measured in percentage of a regular full time position. Retrieved from national registries.

Increased costs related to implementing and practicing family involvement in the clinical units in the intervention arm. Compared to normal costs before baseline.

The Alcohol Use Disorders Identification Test - (AUDIT) - 10 items on a five-point scale. Completed by patients.

The Drug Use Disorders Identification Test - (DUDIT) - 11 items on a three to five-point scale. Completed by patients.

Participation in family psychoeducation measured in number and type of sessions. Reported by both patient and clinician.

Participation in family psychoeducation measured in number and type of sessions. Reported by relative.

Use of different services to involve and support relatives: Family therapy, group support meetings, meetings with the patients' health care personnel, therapy, education on mental health and illness.

Implementation Process Assessment Tool - (IPAT) a questionnaire (27 items rated 1-6) regarding experience of implementation of a specified practice. Completed by clinicians

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.

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