Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Psychotic Disorders
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.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

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03869177
Collaborators
  • 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