Clinical trial NCT03869177: Implementation of Family Involvement for Persons With Psychotic Disorders.
Official title: Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Family psychoeducation
Schizophrenia
Implementation science
Mental health care services
Clinical ethics
Family involvement
Family intervention
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
name: University Hospital, Akershus
name: Helse Fonna
name: Diakonhjemmet Hospital
name: Vestre Viken Hospital Trust
name: Oslo University Hospital
name: Sykehuset i Vestfold HF
name: Sykehuset Telemark
name: The Research Council of Norway
name: Helse Sor-Ost
First posted: 2019-03-11
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implementation study: Fidelity to the intervention model - Family psychoeducation 1
timeFrame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
measure: Implementation study: Fidelity to the intervention model - Family psychoeducation 2
timeFrame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
measure: Implementation study: Fidelity to the intervention model - Family involvement and support 1
timeFrame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
measure: Implementation study: Fidelity to the intervention model - Family involvement and support 2
timeFrame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
measure: Implementation study: Fidelity to the intervention model - Family involvement and support 3
timeFrame: Baseline, 6, 12 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
Secondary outcomes:
measure: Patient quantitative sub-study: Patient experiences of their own mental health and functioning.
timeFrame: 0, 6 and 12 months.
measure: Patient quantitative sub-study and economic sub-study: Quality of life
timeFrame: 0, 6 and 12 months.
measure: Patient quantitative sub-study: General satisfaction.
timeFrame: 0, 6 and 12 months.
measure: Patient quantitative sub-study: Experienced burden of mental health problems.
timeFrame: 0, 6 and 12 months.
measure: Patient quantitative sub-study: Perceived warmth and criticism from relative.
timeFrame: 0, 6 and 12 months.
measure: Patient quantitative sub-study: Experienced shared decision making.
timeFrame: 0, 6 and 12 months.
measure: Patient quantitative sub-study: Adherence with medication
timeFrame: 0, 6 and 12 months for patients and relatives. 0 and 12 months for clinicians.
measure: Patient quantitative sub-Study: Clinician assessment of patient mental health and functioning
timeFrame: 0 and 12 months.
measure: Patient quantitative sub-study: Clinician assessment of patient global functioning
timeFrame: 0 and 12 months.
measure: Patient quantitative sub-study and economic sub-study: Change in number of hospital admissions.
timeFrame: Measured from 18 months before inclusion to 18 months after inclusion.
measure: Patient quantitative sub-study and economic sub-study: Change in number of days spent admitted to hospital.
timeFrame: Measured from 18 months before inclusion to 18 months after inclusion.
measure: Relative quantitative sub-study and economic sub-study: Caregiver quality of life 1
timeFrame: 0, 6 and 12 months.
measure: Relative quantitative sub-study and economic sub-study: Caregiver quality of life 2
timeFrame: 0, 6 and 12 months.
measure: Relative quantitative sub-study: Experience of caregiving
timeFrame: 0, 6 and 12 months.
measure: Relative quantitative sub-study: Expressed emotion
timeFrame: 0, 6 and 12 months.
measure: Relative quantitative sub-study: Experienced involvement and shared decision making
timeFrame: 0, 6 and 12 months.
measure: Relative quantitative sub-study: Experienced support
timeFrame: 0, 6 and 12 months.
measure: Patients' and relatives' quantitative sub-studies and economic sub-study: Use of public health services and resources.
timeFrame: Measured from 18 months before inclusion to 18 months after inclusion.
measure: Patients' and relatives' quantitative sub-studies and economic sub-study: Work participation
timeFrame: Measured from 18 months before inclusion to 18 months after inclusion.
measure: Economic sub-study: Increased costs related to implementing and practicing family involvement
timeFrame: Measured before baseline and then throughout the implementation period (0-18 months).
Other outcomes:
measure: Patient quantitative sub-study: Alcohol abuse
timeFrame: 0 months - baseline screening only
measure: Patient quantitative sub-study: Drug abuse
timeFrame: 0 months - baseline screening only
measure: Patient quantitative sub-study and implementation study: Exposure to family psychoeducation.
timeFrame: Baseline screening, then 6 and 12 months
measure: Relative quantitative sub-study and implementation study: Exposure to psychoeducation.
timeFrame: Baseline screening, then 6 and 12 months
measure: Relative quantitative sub-study and implementation study: Exposure to family involvement.
timeFrame: Baseline screening, then 6 and 12 months
measure: Implementation study: Clinician readiness for change
timeFrame: 0, 6 and 12 months, approximately.
Locations:
city: Asker
country: Norway
facility: Asker DPS - Vestre Viken HF
city: Drammen
country: Norway
facility: Drammen DPS - Vestre Viken HF
city: Hønefoss
country: Norway
facility: Ringerike DPS - Vestre Viken HF
city: Kongsberg
country: Norway
facility: Kongsberg DPS - Vestre Viken HF
city: Kragerø
country: Norway
facility: DPS poliklinikk Vestmar/stathelle - Sykehuset Telemark
city: Larvik
country: Norway
facility: Vestfold DPS - Sykehuset i Vestfold HF
city: Lillestrøm
country: Norway
facility: Nedre Romerike DPS - Akershus Universitetssykehus HF
city: Oslo
country: Norway
facility: Groruddalen DPS - Akershus Universitetssykehus HF
city: Oslo
country: Norway
facility: Søndre Oslo DPS - Oslo Universitetssykehus HF
city: Oslo
country: Norway
facility: Voksenpsykiatrisk avdeling Vinderen - Diakonhjemmet Sykehus
city: Porsgrunn
country: Norway
facility: DPS poliklinikk Porsgrunn - Sykehuset Telemark
city: Sandvika
country: Norway
facility: Bærum DPS -Vestre Viken HF
city: Seljord
country: Norway
facility: DPS poliklinikk Seljord - Sykehuset Telemark
city: Skien
country: Norway
facility: DPS poliklinikk Skien - Sykehuset Telemark
city: Tønsberg
country: Norway
facility: Vestfold DPS - Sykehuset i Vestfold HF
Study officials:
affiliation: Professor and head of department, Centre for medical ethics,University of Oslo
name: Reidar Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Elwyn 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.
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.
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.
citation: Brouwer 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.
citation: 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.
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
citation: 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.
citation: Berman 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.
citation: 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.
citation: Karterud 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: Helsedirektoratet. (2017). Veileder om pårørende i helse- og omsorgstjenesten. Retrieved March 22, 2018, from https://helsedirektoratet.no/Retningslinjer/Pårørendeveileder.pdf
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.
citation: 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.
citation: Torrey WC, Drake RE, Dixon L, Burns BJ, Flynn L, Rush AJ, Clark RE, Klatzker D. Implementing evidence-based practices for persons with severe mental illnesses. Psychiatr Serv. 2001 Jan;52(1):45-50. doi: 10.1176/appi.ps.52.1.45.
citation: Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.
citation: 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.
citation: 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.
citation: Hestmark L, Romoren M, Heiervang KS, Weimand B, Ruud T, Norvoll R, Hansson KM, Norheim I, Aas E, Landeweer EGM, Pedersen R. Implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres (IFIP): protocol for a cluster randomised controlled trial. BMC Health Serv Res. 2020 Oct 9;20(1):934. doi: 10.1186/s12913-020-05792-4.