Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oslo
- Enrollment
- 460
- Locations
- 15
- Primary Endpoint
- Implementation study: Fidelity to the intervention model - Family psychoeducation 1
Study Overview
Brief Summary
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
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
Intervention arm
Clusters (psychiatric outpatient clinics) in the intervention arm receives a comprehensive implementation support program during the trial period.
Intervention: Implementation support program (Other)
Control arm
Clusters (psychiatric outpatient clinics) in the control arm receives no implementation support during the trial period.
Outcomes
Primary Outcomes
Implementation study: Fidelity to the intervention model - Family psychoeducation 1
Time Frame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Change in score on fidelity scale for performance and content of family psychoeducation. Rated from 1 (low) to 5 (high).
Implementation study: Fidelity to the intervention model - Family involvement and support 1
Time Frame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Change in total fidelity measured by the fidelity scale for family involvement and support. Rated from 1 (low) to 5 (high).
Implementation study: Fidelity to the intervention model - Family involvement and support 3
Time Frame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Change in content, structure and implementation, measured by the scale for family involvement and support. Rated from 1 (low) to 5 (high).
Implementation study: Fidelity to the intervention model - Family psychoeducation 2
Time Frame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Change in score on fidelity scale for penetration rate and general organisation of family psychoeducation. Rated from 1 (low) to 5 (high).
Implementation study: Fidelity to the intervention model - Family involvement and support 2
Time Frame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Change in penetration rate, measured by the fidelity scale for family involvement and support. Rated from 1 (low) to 5 (high).
Secondary Outcomes
- Patient quantitative sub-study: Patient experiences of their own mental health and functioning.(0, 6 and 12 months.)
- Patient quantitative sub-study: Experienced burden of mental health problems.(0, 6 and 12 months.)
- Patient quantitative sub-Study: Clinician assessment of patient mental health and functioning(0 and 12 months.)
- Patients' and relatives' quantitative sub-studies and economic sub-study: Use of public health services and resources.(Measured from 18 months before inclusion to 18 months after inclusion.)
- Patient quantitative sub-study and economic sub-study: Quality of life(0, 6 and 12 months.)
- Patient quantitative sub-study: Perceived warmth and criticism from relative.(0, 6 and 12 months.)
- Relative quantitative sub-study: Experienced involvement and shared decision making(0, 6 and 12 months.)
- Patient quantitative sub-study: Clinician assessment of patient global functioning(0 and 12 months.)
- Relative quantitative sub-study and economic sub-study: Caregiver quality of life 1(0, 6 and 12 months.)
- Relative quantitative sub-study and economic sub-study: Caregiver quality of life 2(0, 6 and 12 months.)
- Relative quantitative sub-study: Experienced support(0, 6 and 12 months.)
- Patient quantitative sub-study and economic sub-study: Change in number of hospital admissions.(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.(Measured from 18 months before inclusion to 18 months after inclusion.)
- Relative quantitative sub-study: Expressed emotion(0, 6 and 12 months.)
- Economic sub-study: Increased costs related to implementing and practicing family involvement(Measured before baseline and then throughout the implementation period (0-18 months).)
- Patient quantitative sub-study: General satisfaction.(0, 6 and 12 months.)
- Patient quantitative sub-study: Experienced shared decision making.(0, 6 and 12 months.)
- Patient quantitative sub-study: Adherence with medication(0, 6 and 12 months for patients and relatives. 0 and 12 months for clinicians.)
- Relative quantitative sub-study: Experience of caregiving(0, 6 and 12 months.)
- Patients' and relatives' quantitative sub-studies and economic sub-study: Work participation(Measured from 18 months before inclusion to 18 months after inclusion.)
Investigators
Reidar Pedersen
Professor
University of Oslo