Implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres (IFIP): protocol for a cluster randomised controlled trial.
Clinical ethics
Family intervention
Family involvement
Family psychoeducation
Implementation
Mental health service research
Psychotic disorders
Schizophrenia
Journal
BMC health services research
ISSN: 1472-6963
Titre abrégé: BMC Health Serv Res
Pays: England
ID NLM: 101088677
Informations de publication
Date de publication:
09 Oct 2020
09 Oct 2020
Historique:
received:
17
01
2020
accepted:
01
10
2020
entrez:
10
10
2020
pubmed:
11
10
2020
medline:
2
2
2021
Statut:
epublish
Résumé
Family involvement for persons with psychotic disorders is under-implemented in mental health care, despite its firm scientific, economic, legal and moral basis. This appears to be the case in Norway, despite the presence of national guidelines providing both general recommendations on family involvement and support in the health- and care services, and specific guidance on family interventions for patients with psychotic disorders. The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process. The trial is cluster randomised, where 14 outpatient clusters from community mental health centres undergo stratified randomisation with an allocation ratio of 1:1. The seven intervention clusters will receive implementation support for 18 months, whereas the control clusters will receive the same support after this implementation period. The intervention consists of: 1. A basic level of family involvement and support. 2. Family psychoeducation in single-family groups. 3. Training and guidance of health care personnel. 4. A family coordinator and 5. Other implementation measures. Fidelity to the intervention will be measured four times in the intervention arm and two times in the control arm, and the differences in fidelity changes between the arms constitute the primary outcomes. In each arm, we aim to include 161 patients with psychotic disorders and their closest relative to fill in questionnaires at inclusion, 6 months and 12 months, measuring psychosocial health and satisfaction with services. Clinicians will contribute clinical data about patients at inclusion and 12 months. Use of health and welfare services and work participation, for both patients and relatives, will be retrieved from national registries. We will also perform qualitative interviews with patients, relatives, health care personnel and leaders. Finally, we will conduct a cost-effectiveness analysis and a political economy analysis. This project, with its multilevel and mixed methods approach, may contribute valuable knowledge to the fields of family involvement, mental health service research and implementation science. ClinicalTrials.gov Identifier NCT03869177 . Registered 11.03.19.
Sections du résumé
BACKGROUND
BACKGROUND
Family involvement for persons with psychotic disorders is under-implemented in mental health care, despite its firm scientific, economic, legal and moral basis. This appears to be the case in Norway, despite the presence of national guidelines providing both general recommendations on family involvement and support in the health- and care services, and specific guidance on family interventions for patients with psychotic disorders. The aim of this project is to improve mental health services and the psychosocial health of persons with psychotic disorders and their relatives, by implementing selected recommendations from the national guidelines in community mental health centres, and to evaluate this process.
METHODS
METHODS
The trial is cluster randomised, where 14 outpatient clusters from community mental health centres undergo stratified randomisation with an allocation ratio of 1:1. The seven intervention clusters will receive implementation support for 18 months, whereas the control clusters will receive the same support after this implementation period. The intervention consists of: 1. A basic level of family involvement and support. 2. Family psychoeducation in single-family groups. 3. Training and guidance of health care personnel. 4. A family coordinator and 5. Other implementation measures. Fidelity to the intervention will be measured four times in the intervention arm and two times in the control arm, and the differences in fidelity changes between the arms constitute the primary outcomes. In each arm, we aim to include 161 patients with psychotic disorders and their closest relative to fill in questionnaires at inclusion, 6 months and 12 months, measuring psychosocial health and satisfaction with services. Clinicians will contribute clinical data about patients at inclusion and 12 months. Use of health and welfare services and work participation, for both patients and relatives, will be retrieved from national registries. We will also perform qualitative interviews with patients, relatives, health care personnel and leaders. Finally, we will conduct a cost-effectiveness analysis and a political economy analysis.
DISCUSSION
CONCLUSIONS
This project, with its multilevel and mixed methods approach, may contribute valuable knowledge to the fields of family involvement, mental health service research and implementation science.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov Identifier NCT03869177 . Registered 11.03.19.
Identifiants
pubmed: 33036605
doi: 10.1186/s12913-020-05792-4
pii: 10.1186/s12913-020-05792-4
pmc: PMC7547488
doi:
Banques de données
ClinicalTrials.gov
['NCT03869177']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
934Subventions
Organisme : Norges Forskningsråd
ID : NFR 262863
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