Psychotic DisordersIFIPNCT03869177
Implementation of Family Involvement for Persons With Psychotic Disorders.
A study testing Implementation support program in people with Psychotic Disorders, run by University of Oslo at 15 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Implementation support program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 15 sitesNorway
- Study dates
- 21 Mar 2019to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Norway15 sites
Asker DPS - Vestre Viken HF
Asker
Drammen DPS - Vestre Viken HF
Drammen
Ringerike DPS - Vestre Viken HF
Hønefoss
Kongsberg DPS - Vestre Viken HF
Kongsberg
DPS poliklinikk Vestmar/stathelle - Sykehuset Telemark
Kragerø
Vestfold DPS - Sykehuset i Vestfold HF
Larvik
Nedre Romerike DPS - Akershus Universitetssykehus HF
Lillestrøm
Groruddalen DPS - Akershus Universitetssykehus HF
Oslo
Søndre Oslo DPS - Oslo Universitetssykehus HF
Oslo
Voksenpsykiatrisk avdeling Vinderen - Diakonhjemmet Sykehus
Oslo
DPS poliklinikk Porsgrunn - Sykehuset Telemark
Porsgrunn
Bærum DPS -Vestre Viken HF
Sandvika
DPS poliklinikk Seljord - Sykehuset Telemark
Seljord
DPS poliklinikk Skien - Sykehuset Telemark
Skien
Vestfold DPS - Sykehuset i Vestfold HF
Tønsberg
About this study
Official title: Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.
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.
Read the 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:
- 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?
- What are important barriers to and facilitators for implementing the national guidelines among the stakeholders at the clinical, organisational, and policy level?
- What are important moral dilemmas and conflicting interests related to family involvement, and how can these be resolved?
- Is implementation of the selected recommendations increased by a comprehensive implementation support program, compared with no such support?
- Is a higher level of implementation of the selected recommendations associated with improvements in selected outcomes for patients and relatives?
- Is implementation of family involvement during primary psychotic disorders a cost-effective intervention?
Hypotheses:
- The current implementation of the selected recommendations in the national guidelines on family involvement for persons with psychotic disorders is low.
- There are important barriers to and facilitators for implementing the national guidelines among the stakeholders, at the clinical, organisational and policy level.
- There are important moral dilemmas and conflicting interests, and these can be dealt with through systematic triadic approaches and ethics reflection.
- 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.
- Higher implementation of the selected recommendations is associated with improved outcomes for patients and relatives.
- Outcomes for relatives, patients and the public health- and welfare services justify the costs of implementing family involvement for persons with psychotic disorders.
- Conditions
- Psychotic Disorders
- Being tested
- Implementation support program
- Keywords
- Family psychoeducation, Schizophrenia, Implementation science, Mental health care services, Clinical ethics, Family involvement, Family intervention
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation support programOther
The IFIP intervention consists of the following elements:
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | Clusters (psychiatric outpatient clinics) in the intervention arm receives a comprehensive implementation support program during the trial period. Receives: Other: Implementation support program |
| Control arm | No intervention | Clusters (psychiatric outpatient clinics) in the control arm receives no implementation support during the trial period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 6 and 12 months.
Patient quantitative sub-study: Adherence with medication
A single question answered by patient, relative and clinician.
Measured: 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).
Measured: 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
Measured: 0 and 12 months.
Patient quantitative sub-study and economic sub-study: Change in number of hospital admissions.
Retrieved from the Norwegian patient registry.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured before baseline and then throughout the implementation period (0-18 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start21 Mar 2019
- Primary completion30 Nov 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Metropolitan University, University Hospital, Akershus, Helse Fonna, Diakonhjemmet Hospital, Vestre Viken Hospital Trust, Oslo University Hospital, Sykehuset i Vestfold HF, Sykehuset Telemark, The Research Council of Norway, Helse Sor-Ost
- Responsible party
- Principal investigator, Reidar Pedersen, University of Oslo
- Investigators
- Reidar Pedersen, PhD, Principal investigator, Professor and head of department, Centre for medical ethics,University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869177
- Sponsor's protocol ID
- NFR 262863
- Acronym
- IFIP
- Status last verified
- Jan 2023
- First submitted
- 28 Feb 2019
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisen SV, Normand SL, Belanger AJ, Spiro A 3rd, Esch D. The Revised Behavior and Symptom Identification Scale (BASIS-R): reliability and validity. Med Care. 2004 Dec;42(12):1230-41. doi: 10.1097/00005650-200412000-00010.
PubMed 15550803Keetharuth AD, Brazier J, Connell J, Bjorner JB, Carlton J, Taylor Buck E, Ricketts T, McKendrick K, Browne J, Croudace T, Barkham M. Recovering Quality of Life (ReQoL): a new generic self-reported outcome measure for use with people experiencing mental health difficulties. Br J Psychiatry. 2018 Jan;212(1):42-49. doi: 10.1192/bjp.2017.10.
PubMed 29433611Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
PubMed 23768763Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.
PubMed 10443245Szmukler GI, Burgess P, Herrman H, Benson A, Colusa S, Bloch S. Caring for relatives with serious mental illness: the development of the Experience of Caregiving Inventory. Soc Psychiatry Psychiatr Epidemiol. 1996 Jun;31(3-4):137-48. doi: 10.1007/BF00785760.
PubMed 8766459Brouwer WB, van Exel NJ, van Gorp B, Redekop WK. The CarerQol instrument: a new instrument to measure care-related quality of life of informal caregivers for use in economic evaluations. Qual Life Res. 2006 Aug;15(6):1005-21. doi: 10.1007/s11136-005-5994-6.
PubMed 16900281Wiedemann G, Rayki O, Feinstein E, Hahlweg K. The Family Questionnaire: development and validation of a new self-report scale for assessing expressed emotion. Psychiatry Res. 2002 Apr 15;109(3):265-79. doi: 10.1016/s0165-1781(02)00023-9.
PubMed 11959363Quirk, A., Smith, S., Hamilton, S., Lamping, D., Lelliot, P., Stahl, D., Pinfold, V & Andiappan, M. (2012). Development of the carer well-being and support (CWS) questionnaire. Mental Health Review Journal 17:128-38.doi:10.1108/13619321211287184
Wing JK, Beevor AS, Curtis RH, Park SB, Hadden S, Burns A. Health of the Nation Outcome Scales (HoNOS). Research and development. Br J Psychiatry. 1998 Jan;172:11-8. doi: 10.1192/bjp.172.1.11.
PubMed 9534825Berman AH, Bergman H, Palmstierna T, Schlyter F. Evaluation of the Drug Use Disorders Identification Test (DUDIT) in criminal justice and detoxification settings and in a Swedish population sample. Eur Addict Res. 2005;11(1):22-31. doi: 10.1159/000081413.
PubMed 15608468Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
PubMed 8329970Karterud S, Pedersen G, Løvdal H, Friis S. S-GAF: Global Funsjonsskåring - Splittet Versjon [Global Assessment of Functioning - Split version]. Bakgrunn og skåringsveiledning. Klinikk for psykiatri, Ullevål sykehus, Oslo, 1998.
Hooley JM, Teasdale JD. Predictors of relapse in unipolar depressives: expressed emotion, marital distress, and perceived criticism. J Abnorm Psychol. 1989 Aug;98(3):229-35. doi: 10.1037//0021-843x.98.3.229.
PubMed 2768657Pharoah F, Mari J, Rathbone J, Wong W. Family intervention for schizophrenia. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD000088. doi: 10.1002/14651858.CD000088.pub2.
PubMed 21154340Yesufu-Udechuku A, Harrison B, Mayo-Wilson E, Young N, Woodhams P, Shiers D, Kuipers E, Kendall T. Interventions to improve the experience of caring for people with severe mental illness: systematic review and meta-analysis. Br J Psychiatry. 2015 Apr;206(4):268-74. doi: 10.1192/bjp.bp.114.147561.
PubMed 25833867
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03869177
- Acronym / sponsor ID
- IFIP / NFR 262863
- Conditions
- Psychotic Disorders
- Keywords
- Family psychoeducation, Schizophrenia, Implementation science, Mental health care services, Clinical ethics, Family involvement, Family intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo Metropolitan University, University Hospital, Akershus, Helse Fonna, Diakonhjemmet Hospital, Vestre Viken Hospital Trust, Oslo University Hospital, Sykehuset i Vestfold HF, Sykehuset Telemark, The Research Council of Norway, Helse Sor-Ost
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- What are important barriers to and facilitators for implementing the national guidelines among the stakeholders at the clinical, organisational, and policy level?
- What are important moral dilemmas and conflicting interests related to family involvement, and how can these be resolved?
- Is implementation of the selected recommendations increased by a comprehensive implementation support program, compared with no such support?
- Is a higher level of implementation of the selected recommendations associated with improvements in selected outcomes for patients and relatives?
- Is implementation of family involvement during primary psychotic disorders a cost-effective intervention?
Hypotheses:
- The current implementation of the selected recommendations in the national guidelines on family involvement for persons with psychotic disorders is low.
- There are important barriers to and facilitators for implementing the national guidelines among the stakeholders, at the clinical, organisational and policy level.
- There are important moral dilemmas and conflicting interests, and these can be dealt with through systematic triadic approaches and ethics reflection.
- 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.
- Higher implementation of the selected recommendations is associated with improved outcomes for patients and relatives.
- Outcomes for relatives, patients and the public health- and welfare services justify the costs of implementing family involvement for persons with psychotic disorders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Other: Implementation support programClusters (psychiatric outpatient clinics) in the intervention arm receives a comprehensive implementation support program during the trial period. |
| Control arm | No intervention | –Clusters (psychiatric outpatient clinics) in the control arm receives no implementation support during the trial period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation support programThe 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 | Other | Intervention arm |
Primary outcome
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 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 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 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).
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).
20 secondary outcomes
Patient quantitative sub-study: Patient experiences of their own mental health and functioning.
Time frame: 0, 6 and 12 months.
Patient quantitative sub-study and economic sub-study: Quality of life
Time frame: 0, 6 and 12 months.
Patient quantitative sub-study: General satisfaction.
Time frame: 0, 6 and 12 months.
Patient quantitative sub-study: Experienced burden of mental health problems.
Time frame: 0, 6 and 12 months.
Patient quantitative sub-study: Perceived warmth and criticism from relative.
Time frame: 0, 6 and 12 months.
Patient quantitative sub-study: Experienced shared decision making.
Time frame: 0, 6 and 12 months.
Patient quantitative sub-study: Adherence with medication
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
Time frame: 0 and 12 months.
Patient quantitative sub-study: Clinician assessment of patient global functioning
Time frame: 0 and 12 months.
Patient quantitative sub-study and economic sub-study: Change in number of hospital admissions.
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.
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
Time frame: 0, 6 and 12 months.
Relative quantitative sub-study and economic sub-study: Caregiver quality of life 2
Time frame: 0, 6 and 12 months.
Relative quantitative sub-study: Experience of caregiving
Time frame: 0, 6 and 12 months.
Relative quantitative sub-study: Expressed emotion
Time frame: 0, 6 and 12 months.
Relative quantitative sub-study: Experienced involvement and shared decision making
Time frame: 0, 6 and 12 months.
Relative quantitative sub-study: Experienced support
Time frame: 0, 6 and 12 months.
Patients' and relatives' quantitative sub-studies and economic sub-study: Use of public health services and resources.
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
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
Time frame: Measured before baseline and then throughout the implementation period (0-18 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 15550803Eisen SV, Normand SL, Belanger AJ, Spiro A 3rd, Esch D. The Revised Behavior and Symptom Identification Scale (BASIS-R): reliability and validity. Med Care. 2004 Dec;42(12):1230-41. doi: 10.1097/00005650-200412000-00010.
- Background: PubMed 29433611Keetharuth AD, Brazier J, Connell J, Bjorner JB, Carlton J, Taylor Buck E, Ricketts T, McKendrick K, Browne J, Croudace T, Barkham M. Recovering Quality of Life (ReQoL): a new generic self-reported outcome measure for use with people experiencing mental health difficulties. Br J Psychiatry. 2018 Jan;212(1):42-49. doi: 10.1192/bjp.2017.10.
- Background: PubMed 23768763Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
- Background: PubMed 10443245Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.
- Background: PubMed 8766459Szmukler GI, Burgess P, Herrman H, Benson A, Colusa S, Bloch S. Caring for relatives with serious mental illness: the development of the Experience of Caregiving Inventory. Soc Psychiatry Psychiatr Epidemiol. 1996 Jun;31(3-4):137-48. doi: 10.1007/BF00785760.
- Background: PubMed 16900281Brouwer WB, van Exel NJ, van Gorp B, Redekop WK. The CarerQol instrument: a new instrument to measure care-related quality of life of informal caregivers for use in economic evaluations. Qual Life Res. 2006 Aug;15(6):1005-21. doi: 10.1007/s11136-005-5994-6.
- Background: PubMed 11959363Wiedemann G, Rayki O, Feinstein E, Hahlweg K. The Family Questionnaire: development and validation of a new self-report scale for assessing expressed emotion. Psychiatry Res. 2002 Apr 15;109(3):265-79. doi: 10.1016/s0165-1781(02)00023-9.
- BackgroundQuirk, A., Smith, S., Hamilton, S., Lamping, D., Lelliot, P., Stahl, D., Pinfold, V & Andiappan, M. (2012). Development of the carer well-being and support (CWS) questionnaire. Mental Health Review Journal 17:128-38.doi:10.1108/13619321211287184
- Background: PubMed 9534825Wing JK, Beevor AS, Curtis RH, Park SB, Hadden S, Burns A. Health of the Nation Outcome Scales (HoNOS). Research and development. Br J Psychiatry. 1998 Jan;172:11-8. doi: 10.1192/bjp.172.1.11.
- Background: PubMed 15608468Berman AH, Bergman H, Palmstierna T, Schlyter F. Evaluation of the Drug Use Disorders Identification Test (DUDIT) in criminal justice and detoxification settings and in a Swedish population sample. Eur Addict Res. 2005;11(1):22-31. doi: 10.1159/000081413.
- Background: PubMed 8329970Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
- BackgroundKarterud S, Pedersen G, Løvdal H, Friis S. S-GAF: Global Funsjonsskåring - Splittet Versjon [Global Assessment of Functioning - Split version]. Bakgrunn og skåringsveiledning. Klinikk for psykiatri, Ullevål sykehus, Oslo, 1998.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reidar Pedersen, PhD principal investigator
Professor and head of department, Centre for medical ethics,University of Oslo
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation support program in people with Psychotic Disorders, run by University of Oslo at 15 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869177, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.