Skip to main content
OpenTrials
Completed

NCT Number: NCT03869177

Implementation of Family Involvement for Persons With Psychotic Disorders.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asker DPS - Vestre Viken HF, Asker, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implementation support program

Other

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Secondary outcomes

  1. Patient quantitative sub-study: Patient experiences of their own mental health and functioning.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 0, 6 and 12 months.

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

  6. Patient quantitative sub-study: Experienced shared decision making.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Patient quantitative sub-study: Alcohol abuse

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

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

Registry information

Official study title

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

Acronym: IFIP

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 11, 2019
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.