Implementation of Family Involvement for Persons With Psychotic Disorders.
NCT03869177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460
Last updated 2023-01-04
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.
Conditions
- Psychotic Disorders
Interventions
- OTHER
-
Implementation support program
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
Sponsors & Collaborators
-
Oslo Metropolitan University
collaborator OTHER -
University Hospital, Akershus
collaborator OTHER -
Helse Fonna
collaborator OTHER -
Diakonhjemmet Hospital
collaborator OTHER -
Vestre Viken Hospital Trust
collaborator OTHER -
Oslo University Hospital
collaborator OTHER -
Sykehuset i Vestfold HF
collaborator OTHER -
Sykehuset Telemark
collaborator OTHER_GOV -
The Research Council of Norway
collaborator OTHER -
Helse Sor-Ost
collaborator OTHER_GOV -
University of Oslo
lead OTHER
Principal Investigators
-
Reidar Pedersen, PhD · Professor and head of department, Centre for medical ethics,University of Oslo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-21
- Primary Completion
- 2021-11-30
- Completion
- 2022-05-30
Countries
- Norway
Study Locations
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