Implementation of Family Involvement for Persons With Psychotic Disorders.

Psychotic Disorders Clinical Trial

— IFIP  

Official title:

Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869177
• Other study ID #: NFR 262863
• Status: Completed
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: January 2023
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: May 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility criteria apply to participants in both quantitative and qualitative sub-studies, except that participation in family psychoeducation as described below is NOT an exclusion criterion in the qualitative sub-study.

Inclusion criteria for patients:

• 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.

Exclusion criteria for patients:

• 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.

Inclusion criteria for relatives:

• 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 for relatives:

• 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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
Norway	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

Sponsors (11)

Lead Sponsor	Collaborator
University of Oslo	Diakonhjemmet Hospital, Helse Fonna, Helse Sor-Ost, Oslo Metropolitan University, Oslo University Hospital, Sykehuset i Vestfold HF, Sykehuset Telemark, The Research Council of Norway, University Hospital, Akershus, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (21)

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Helsedirektoratet. (2013). Utredning, behandling og oppfølging av personer med psykoselidelser. Retrieved March 22, 2018, from https://helsedirektoratet.no/Lists/Publikasjoner/Attachments/326/Nasjonal-faglig-retningslinje-for-utredning-behandling-og-oppfolging-av-personer-med-psykoselidelser-IS-1957.pdf.

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Keetharuth 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. — View Citation

McHugo GJ, Drake RE, Whitley R, Bond GR, Campbell K, Rapp CA, Goldman HH, Lutz WJ, Finnerty MT. Fidelity outcomes in the National Implementing Evidence-Based Practices Project. Psychiatr Serv. 2007 Oct;58(10):1279-84. doi: 10.1176/ps.2007.58.10.1279. — View Citation

Pharoah 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. — View Citation

Priebe 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. — View Citation

Quirk, 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

Saunders 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. — View Citation

Szmukler 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. — View Citation

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Vermeulen, B., Lauwers, H., Spruytte, N., Van Audenhove, C., Magro, C., Saunders, J. & Jones, K. (2015). Experiences of family caregivers for persons with severe mental illness: an international exploration. Leuven: LUCAS KU Leuven/EUFAMI.

Wiedemann 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. — View Citation

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Yesufu-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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient quantitative sub-study: Alcohol abuse	The Alcohol Use Disorders Identification Test - (AUDIT) - 10 items on a five-point scale. Completed by patients.	0 months - baseline screening only
Other	Patient quantitative sub-study: Drug abuse	The Drug Use Disorders Identification Test - (DUDIT) - 11 items on a three to five-point scale. Completed by patients.	0 months - baseline screening only
Other	Patient quantitative sub-study and implementation study: Exposure to family psychoeducation.	Participation in family psychoeducation measured in number and type of sessions. Reported by both patient and clinician.	Baseline screening, then 6 and 12 months
Other	Relative quantitative sub-study and implementation study: Exposure to psychoeducation.	Participation in family psychoeducation measured in number and type of sessions. Reported by relative.	Baseline screening, then 6 and 12 months
Other	Relative quantitative sub-study and implementation study: Exposure to family involvement.	Use of different services to involve and support relatives: Family therapy, group support meetings, meetings with the patients' health care personnel, therapy, education on mental health and illness.	Baseline screening, then 6 and 12 months
Other	Implementation study: Clinician readiness for change	Implementation Process Assessment Tool - (IPAT) a questionnaire (27 items rated 1-6) regarding experience of implementation of a specified practice. Completed by clinicians	0, 6 and 12 months, approximately.
Primary	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).	Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Primary	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).	Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Primary	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).	Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Primary	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).	Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Primary	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).	Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Secondary	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.	0, 6 and 12 months.
Secondary	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.	0, 6 and 12 months.
Secondary	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.	0, 6 and 12 months.
Secondary	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.	0, 6 and 12 months.
Secondary	Patient quantitative sub-study: Perceived warmth and criticism from relative.	Hooley 1989 - 5 items rated 1-10. Completed by patients.	0, 6 and 12 months.
Secondary	Patient quantitative sub-study: Experienced shared decision making.	The CollaboRATE questionnaire (3 items rated 0-9), plus two additional items. Completed by patients.	0, 6 and 12 months.
Secondary	Patient quantitative sub-study: Adherence with medication	A single question answered by patient, relative and clinician.	0, 6 and 12 months for patients and relatives. 0 and 12 months for clinicians.
Secondary	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).	0 and 12 months.
Secondary	Patient quantitative sub-study: Clinician assessment of patient global functioning	Global Assessment of Functioning Scale - (GAF), split version for symptoms and functioning	0 and 12 months.
Secondary	Patient quantitative sub-study and economic sub-study: Change in number of hospital admissions.	Retrieved from the Norwegian patient registry.	Measured from 18 months before inclusion to 18 months after inclusion.
Secondary	Patient quantitative sub-study and economic sub-study: Change in number of days spent admitted to hospital.	Retrieved from the Norwegian patient registry.	Measured from 18 months before inclusion to 18 months after inclusion.
Secondary	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.	0, 6 and 12 months.
Secondary	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.	0, 6 and 12 months.
Secondary	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.	0, 6 and 12 months.
Secondary	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.	0, 6 and 12 months.
Secondary	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.	0, 6 and 12 months.
Secondary	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.	0, 6 and 12 months.
Secondary	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 from 18 months before inclusion to 18 months after inclusion.
Secondary	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 from 18 months before inclusion to 18 months after inclusion.
Secondary	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 before baseline and then throughout the implementation period (0-18 months).