Implementation of Family Involvement for Persons With Psychotic Disorders.

NCT ID: NCT03869177

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2022-05-30

Brief Summary

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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

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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.

Conditions

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Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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.

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.

Group Type OTHER

Implementation support program

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* 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.


• 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo Metropolitan University

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Helse Fonna

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Sykehuset i Vestfold HF

OTHER

Sponsor Role collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role collaborator

The Research Council of Norway

OTHER

Sponsor Role collaborator

Helse Sor-Ost

OTHER_GOV

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Reidar Pedersen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Drammen DPS - Vestre Viken HF

Drammen, , Norway

Site Status

Ringerike DPS - Vestre Viken HF

Hønefoss, , Norway

Site Status

Kongsberg DPS - Vestre Viken HF

Kongsberg, , Norway

Site Status

DPS poliklinikk Vestmar/stathelle - Sykehuset Telemark

Kragerø, , Norway

Site Status

Vestfold DPS - Sykehuset i Vestfold HF

Larvik, , Norway

Site Status

Nedre Romerike DPS - Akershus Universitetssykehus HF

Lillestrøm, , Norway

Site Status

Groruddalen DPS - Akershus Universitetssykehus HF

Oslo, , Norway

Site Status

Søndre Oslo DPS - Oslo Universitetssykehus HF

Oslo, , Norway

Site Status

Voksenpsykiatrisk avdeling Vinderen - Diakonhjemmet Sykehus

Oslo, , Norway

Site Status

DPS poliklinikk Porsgrunn - Sykehuset Telemark

Porsgrunn, , Norway

Site Status

Bærum DPS -Vestre Viken HF

Sandvika, , Norway

Site Status

DPS poliklinikk Seljord - Sykehuset Telemark

Seljord, , Norway

Site Status

DPS poliklinikk Skien - Sykehuset Telemark

Skien, , Norway

Site Status

Vestfold DPS - Sykehuset i Vestfold HF

Tønsberg, , Norway

Site Status

Countries

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Norway

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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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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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PMID: 33036605 (View on PubMed)

Other Identifiers

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NFR 262863

Identifier Type: -

Identifier Source: org_study_id

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