IFIP: Implementation of Family Involvement for Persons With Psychotic Disorders.

• Sponsor: University of Oslo (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03869177
• Collaborator: Oslo Metropolitan University (Other), University Hospital, Akershus (Other), Helse Fonna (Other), Diakonhjemmet Hospital (Other), Vestre Viken Hospital Trust (Other), Oslo University Hospital (Other), Sykehuset i Vestfold HF (Other), Sykehuset Telemark (Other), The Research Council of Norway (Other), Helse Sor-Ost (Other)
• Enrollment: 644
• Locations: 15
• Arms: 2
• Anticipated Duration (Months): 38.3
• Patients Per Site: 42.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders	Other: Implementation support program	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 644 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Masking Description: Patients and relatives will not be informed about their outpatient clinic's allocation status. However, they may deduce this from the kind of treatment they receive. It's impossible to blind the care providers and for practical reasons we won't be able to blind the investigators or the outcomes assessors.
• Primary Purpose: Health Services Research
• Official Title: Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.
• Actual Study Start Date: Mar 21, 2019
• Actual Primary Completion Date: Nov 30, 2021
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Implementation study: Fidelity to the intervention model - Family psychoeducation 1 [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).

2. Implementation study: Fidelity to the intervention model - Family psychoeducation 2 [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).

3. Implementation study: Fidelity to the intervention model - Family involvement and support 1 [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).

4. Implementation study: Fidelity to the intervention model - Family involvement and support 2 [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).

5. Implementation study: Fidelity to the intervention model - Family involvement and support 3 [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).

Secondary Outcome Measures

1. Patient quantitative sub-study: Patient experiences of their own mental health and functioning. [0, 6 and 12 months.]

   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.

2. Patient quantitative sub-study and economic sub-study: Quality of life [0, 6 and 12 months.]

   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.

3. Patient quantitative sub-study: General satisfaction. [0, 6 and 12 months.]

   The Manchester Short Assesment of Quality of Life - (MANSA) questionnaire - first question only, on a scale 1-7. Completed by patients.

4. Patient quantitative sub-study: Experienced burden of mental health problems. [0, 6 and 12 months.]

   A single question - Produced for this study on a scale 1-7. Completed by patients.

5. Patient quantitative sub-study: Perceived warmth and criticism from relative. [0, 6 and 12 months.]

   Hooley 1989 - 5 items rated 1-10. Completed by patients.

6. Patient quantitative sub-study: Experienced shared decision making. [0, 6 and 12 months.]

   The CollaboRATE questionnaire (3 items rated 0-9), plus two additional items. Completed by patients.

7. Patient quantitative sub-study: Adherence with medication [0, 6 and 12 months for patients and relatives. 0 and 12 months for clinicians.]

   A single question answered by patient, relative and clinician.

8. Patient quantitative sub-Study: Clinician assessment of patient mental health and functioning [0 and 12 months.]

   Health of the Nation Outcome Scale - (HoNOS) scale rated by clinicians on 12 items rated 0-4 (no problem - very serious problem).

9. Patient quantitative sub-study: Clinician assessment of patient global functioning [0 and 12 months.]

   Global Assessment of Functioning Scale - (GAF), split version for symptoms and functioning

10. Patient quantitative sub-study and economic sub-study: Change in number of hospital admissions. [Measured from 18 months before inclusion to 18 months after inclusion.]

    Retrieved from the Norwegian patient registry.

11. Patient quantitative sub-study and economic sub-study: Change in number of days spent admitted to hospital. [Measured from 18 months before inclusion to 18 months after inclusion.]

    Retrieved from the Norwegian patient registry.

12. Relative quantitative sub-study and economic sub-study: Caregiver quality of life 1 [0, 6 and 12 months.]

    The Care Related Quality of Life - (CarerQoL) questionnaire - Seven questions on a three-point scale. Completed by relatives.

13. Relative quantitative sub-study and economic sub-study: Caregiver quality of life 2 [0, 6 and 12 months.]

    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.

14. Relative quantitative sub-study: Experience of caregiving [0, 6 and 12 months.]

    The Experience of Caregiving inventory - (ECI) questionnaire - 66 items on a five-point scale covering various aspects of being a caregiver. Completed by relatives.

15. Relative quantitative sub-study: Expressed emotion [0, 6 and 12 months.]

    The Family questionnaire - (FQ) - 20 items on a four-point scale, measuring criticism and emotional over-involvement. Completed by relatives.

16. Relative quantitative sub-study: Experienced involvement and shared decision making [0, 6 and 12 months.]

    An adapted version of the CollaboRATE questionnaire (3 items rated 0-9), plus two additional items completed by relatives.

17. Relative quantitative sub-study: Experienced support [0, 6 and 12 months.]

    Carer Well-being and Support questionnaire (CWS) v2 short part B - 18 items rated on a four-point scale. Completed by relatives.

18. Patients' and relatives' quantitative sub-studies and economic sub-study: Use of public health services and resources. [Measured from 18 months before inclusion to 18 months after inclusion.]

    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.

19. Patients' and relatives' quantitative sub-studies and economic sub-study: Work participation [Measured from 18 months before inclusion to 18 months after inclusion.]

    Patients' and relatives' work participation measured in percentage of a regular full time position. Retrieved from national registries.

20. Economic sub-study: Increased costs related to implementing and practicing family involvement [Measured before baseline and then throughout the implementation period (0-18 months).]

    Increased costs related to implementing and practicing family involvement in the clinical units in the intervention arm. Compared to normal costs before baseline.

Other Outcome Measures

1. Patient quantitative sub-study: Alcohol abuse [0 months - baseline screening only]

   The Alcohol Use Disorders Identification Test - (AUDIT) - 10 items on a five-point scale. Completed by patients.

2. Patient quantitative sub-study: Drug abuse [0 months - baseline screening only]

   The Drug Use Disorders Identification Test - (DUDIT) - 11 items on a three to five-point scale. Completed by patients.

3. Patient quantitative sub-study and implementation study: Exposure to family psychoeducation. [Baseline screening, then 6 and 12 months]

   Participation in family psychoeducation measured in number and type of sessions. Reported by both patient and clinician.

4. Relative quantitative sub-study and implementation study: Exposure to psychoeducation. [Baseline screening, then 6 and 12 months]

   Participation in family psychoeducation measured in number and type of sessions. Reported by relative.

5. Relative quantitative sub-study and implementation study: Exposure to family involvement. [Baseline screening, then 6 and 12 months]

   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.

6. Implementation study: Clinician readiness for change [0, 6 and 12 months, approximately.]

   Implementation Process Assessment Tool - (IPAT) a questionnaire (27 items rated 1-6) regarding experience of implementation of a specified practice. Completed by clinicians

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asker DPS - Vestre Viken HF	Asker		Norway
2	Drammen DPS - Vestre Viken HF	Drammen		Norway
3	Ringerike DPS - Vestre Viken HF	Hønefoss		Norway
4	Kongsberg DPS - Vestre Viken HF	Kongsberg		Norway
5	DPS poliklinikk Vestmar/stathelle - Sykehuset Telemark	Kragerø		Norway
6	Vestfold DPS - Sykehuset i Vestfold HF	Larvik		Norway
7	Nedre Romerike DPS - Akershus Universitetssykehus HF	Lillestrøm		Norway
8	Groruddalen DPS - Akershus Universitetssykehus HF	Oslo		Norway
9	Søndre Oslo DPS - Oslo Universitetssykehus HF	Oslo		Norway
10	Voksenpsykiatrisk avdeling Vinderen - Diakonhjemmet Sykehus	Oslo		Norway
11	DPS poliklinikk Porsgrunn - Sykehuset Telemark	Porsgrunn		Norway
12	Bærum DPS -Vestre Viken HF	Sandvika		Norway
13	DPS poliklinikk Seljord - Sykehuset Telemark	Seljord		Norway
14	DPS poliklinikk Skien - Sykehuset Telemark	Skien		Norway
15	Vestfold DPS - Sykehuset i Vestfold HF	Tønsberg		Norway

Sponsors and Collaborators

• University of Oslo
• 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

Investigators

• Principal Investigator: Reidar Pedersen, PhD, Professor and head of department, Centre for medical ethics,University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• 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.
• 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.
• 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.
• 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. Review.
• 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.
• 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.
• 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. Review.

• Responsible Party: Reidar Pedersen, Professor, University of Oslo
• ClinicalTrials.gov Identifier: NCT03869177
• Other Study ID Numbers: NFR 262863
• First Posted: Mar 11, 2019
• Last Update Posted: Dec 1, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Reidar Pedersen, Professor, University of Oslo: Family psychoeducation; Schizophrenia; Implementation science; Mental health care services; Clinical ethics; Family involvement; Family intervention
• Additional relevant MeSH terms: Mental Disorders; Psychotic Disorders

Study Results

No Results Posted as of Dec 1, 2021