Implementation of Family Involvement for Persons With Psychotic Disorders.
NCT ID: NCT03869177
Last Updated: 2023-01-04
Study Results
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Basic Information
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COMPLETED
NA
460 participants
INTERVENTIONAL
2019-03-21
2022-05-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention arm
Clusters (psychiatric outpatient clinics) in the intervention arm receives a comprehensive implementation support program during the trial period.
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
Control arm
Clusters (psychiatric outpatient clinics) in the control arm receives no implementation support during the trial period.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* To be 18 years or older at the time of inclusion.
* 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
* 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.
• 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.
18 Years
ALL
No
Sponsors
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Oslo Metropolitan University
OTHER
University Hospital, Akershus
OTHER
Helse Fonna
OTHER
Diakonhjemmet Hospital
OTHER
Vestre Viken Hospital Trust
OTHER
Oslo University Hospital
OTHER
Sykehuset i Vestfold HF
OTHER
Sykehuset Telemark
OTHER_GOV
The Research Council of Norway
OTHER
Helse Sor-Ost
OTHER_GOV
University of Oslo
OTHER
Responsible Party
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Reidar Pedersen
Professor
Principal Investigators
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Reidar Pedersen, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor and head of department, Centre for medical ethics,University of Oslo
Locations
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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
DPS poliklinikk Porsgrunn - Sykehuset Telemark
Porsgrunn, , Norway
Bærum DPS -Vestre Viken HF
Sandvika, , Norway
DPS poliklinikk Seljord - Sykehuset Telemark
Seljord, , Norway
DPS poliklinikk Skien - Sykehuset Telemark
Skien, , Norway
Vestfold DPS - Sykehuset i Vestfold HF
Tønsberg, , Norway
Countries
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References
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Hestmark L, Romoren M, Heiervang KS, Hansson KM, Ruud T, Saltyte Benth J, Norheim I, Weimand B, Pedersen R. Implementation of Guidelines on Family Involvement for Persons with Psychotic Disorders (IFIP): A Cluster Randomised Controlled Trial. Adm Policy Ment Health. 2023 May;50(3):520-533. doi: 10.1007/s10488-023-01255-0. Epub 2023 Feb 16.
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Hansson KM, Romoren M, Pedersen R, Weimand B, Hestmark L, Norheim I, Ruud T, Hymer IS, Heiervang KS. Barriers and facilitators when implementing family involvement for persons with psychotic disorders in community mental health centres - a nested qualitative study. BMC Health Serv Res. 2022 Sep 12;22(1):1153. doi: 10.1186/s12913-022-08489-y.
Hestmark L, Heiervang KS, Pedersen R, Hansson KM, Ruud T, Romoren M. Family involvement practices for persons with psychotic disorders in community mental health centres - a cross-sectional fidelity-based study. BMC Psychiatry. 2021 Jun 2;21(1):285. doi: 10.1186/s12888-021-03300-4.
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Other Identifiers
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NFR 262863
Identifier Type: -
Identifier Source: org_study_id
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