Implementation of Family Involvement for Persons With Psychotic Disorders. (IFIP)

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders
• Intervention / Treatment: Other: Implementation support program

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.

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Asker, Norway
    • Asker DPS - Vestre Viken HF
  • Drammen, Norway
    • Drammen DPS - Vestre Viken HF
  • Hønefoss, Norway
    • Ringerike DPS - Vestre Viken HF
  • Kongsberg, Norway
    • Kongsberg DPS - Vestre Viken HF
  • Kragerø, Norway
    • DPS poliklinikk Vestmar/stathelle - Sykehuset Telemark
  • Larvik, Norway
    • Vestfold DPS - Sykehuset i Vestfold HF
  • Lillestrøm, Norway
    • Nedre Romerike DPS - Akershus Universitetssykehus HF
  • Oslo, Norway
    • Groruddalen DPS - Akershus Universitetssykehus HF
  • Oslo, Norway
    • Søndre Oslo DPS - Oslo Universitetssykehus HF
  • Oslo, Norway
    • Voksenpsykiatrisk avdeling Vinderen - Diakonhjemmet Sykehus
  • Porsgrunn, Norway
    • DPS poliklinikk Porsgrunn - Sykehuset Telemark
  • Sandvika, Norway
    • Bærum DPS -Vestre Viken HF
  • Seljord, Norway
    • DPS poliklinikk Seljord - Sykehuset Telemark
  • Skien, Norway
    • DPS poliklinikk Skien - Sykehuset Telemark
  • Tønsberg, Norway
    • Vestfold DPS - Sykehuset i Vestfold HF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention arm; Clusters (psychiatric outpatient clinics) in the intervention arm receives a comprehensive implementation support program during the trial period.	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
No Intervention: Control arm; Clusters (psychiatric outpatient clinics) in the control arm receives no implementation support during the trial period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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.

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Vestre Viken Hospital Trust; Oslo University Hospital; The Research Council of Norway; Diakonhjemmet Hospital; Helse Fonna; Sykehuset Telemark; University Hospital, Akershus; Helse Sor-Ost; Oslo Metropolitan University; Sykehuset i Vestfold HF
• Investigators: Principal Investigator: Reidar Pedersen, PhD, Professor and head of department, Centre for medical ethics,University of Oslo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Helsedirektoratet. (2017). Veileder om pårørende i helse- og omsorgstjenesten. Retrieved March 22, 2018, from https://helsedirektoratet.no/Retningslinjer/Pårørendeveileder.pdf
• 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.
• 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.
• Hansson KM, Romoren M, Pedersen R, Weimand B, Hestmark L, Norheim I, Ruud T, Hymer IS, Heiervang KS. Barriers and facilitators when implementing family involvement for persons with psychotic disorders in community mental health centres - a nested qualitative study. BMC Health Serv Res. 2022 Sep 12;22(1):1153. doi: 10.1186/s12913-022-08489-y.
• Hestmark L, Heiervang KS, Pedersen R, Hansson KM, Ruud T, Romoren M. Family involvement practices for persons with psychotic disorders in community mental health centres - a cross-sectional fidelity-based study. BMC Psychiatry. 2021 Jun 2;21(1):285. doi: 10.1186/s12888-021-03300-4.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Family psychoeducation; Implementation science; Mental health care services; Clinical ethics; Family involvement; Family intervention
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: NFR 262863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No