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: 1. 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? 2. What are important barriers to and facilitators for implementing the national guidelines among the stakeholders at the clinical, organisational, and policy level? 3. What are important moral dilemmas and conflicting interests related to family involvement, and how can these be resolved? 4. Is implementation of the selected recommendations increased by a comprehensive implementation support program, compared with no such support? 5. Is a higher level of implementation of the selected recommendations associated with improvements in selected outcomes for patients and relatives? 6. Is implementation of family involvement during primary psychotic disorders a cost-effective intervention? Hypotheses: 1. The current implementation of the selected recommendations in the national guidelines on family involvement for persons with psychotic disorders is low. 2. There are important barriers to and facilitators for implementing the national guidelines among the stakeholders, at the clinical, organisational and policy level. 3. There are important moral dilemmas and conflicting interests, and these can be dealt with through systematic triadic approaches and ethics reflection. 4. 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. 5. Higher implementation of the selected recommendations is associated with improved outcomes for patients and relatives. 6. Outcomes for relatives, patients and the public health- and welfare services justify the costs of implementing family involvement for persons with psychotic disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
460
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
Asker DPS - Vestre Viken HF
Asker, Norway
Drammen DPS - Vestre Viken HF
Drammen, Norway
Ringerike DPS - Vestre Viken HF
Hønefoss, Norway
Kongsberg DPS - Vestre Viken HF
Kongsberg, Norway
DPS poliklinikk Vestmar/stathelle - Sykehuset Telemark
Kragerø, Norway
Vestfold DPS - Sykehuset i Vestfold HF
Larvik, Norway
Nedre Romerike DPS - Akershus Universitetssykehus HF
Lillestrøm, Norway
Groruddalen DPS - Akershus Universitetssykehus HF
Oslo, Norway
Søndre Oslo DPS - Oslo Universitetssykehus HF
Oslo, Norway
Voksenpsykiatrisk avdeling Vinderen - Diakonhjemmet Sykehus
Oslo, Norway
...and 5 more locations
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0, 6 and 12 months.
Patient quantitative sub-study: Adherence with medication
A single question answered by patient, relative and clinician.
Time frame: 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).
Time frame: 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
Time frame: 0 and 12 months.
Patient quantitative sub-study and economic sub-study: Change in number of hospital admissions.
Retrieved from the Norwegian patient registry.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured before baseline and then throughout the implementation period (0-18 months).
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