Implementation of guidelines on family involvement for persons with psychotic disorders in community mental health centres (IFIP): protocol for a cluster randomised controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101088677 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6963 (Electronic) Linking ISSN: 14726963 NLM ISO Abbreviation: BMC Health Serv Res Subsets: MEDLINE

Original Publication: London : BioMed Central, [2001-

Practice Guidelines as Topic*; Community Mental Health Centers/*organization & administration ; Family/*psychology ; Psychotic Disorders/*therapy; Clinical Protocols ; Humans ; Norway

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: 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: 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: ClinicalTrials.gov Identifier NCT03869177 . Registered 11.03.19.

Adm Policy Ment Health. 2020 Nov;47(6):920-926. (PMID: 32107674)
Fam Process. 2016 Sep;55(3):460-82. (PMID: 27411376)
Soc Psychiatry Psychiatr Epidemiol. 2019 Mar;54(3):277-290. (PMID: 30349961)
Cochrane Database Syst Rev. 2006 Oct 18;(4):CD000088. (PMID: 17054127)
J Marital Fam Ther. 2012 Jan;38(1):101-21. (PMID: 22283383)
BMJ. 2012 Sep 04;345:e5661. (PMID: 22951546)
BMJ Open. 2014 Oct 03;4(10):e006108. (PMID: 25280809)
Eur Addict Res. 2005;11(1):22-31. (PMID: 15608468)
Implement Sci. 2013 May 10;8:51. (PMID: 23663819)
Schizophr Bull. 2006 Oct;32(4):765-75. (PMID: 16844723)
Addiction. 1993 Jun;88(6):791-804. (PMID: 8329970)
J Indian Med Assoc. 2009 Jun;107(6):403-5. (PMID: 19886379)
Aust N Z J Psychiatry. 2016 May;50(5):410-72. (PMID: 27106681)
Qual Life Res. 2006 Aug;15(6):1005-21. (PMID: 16900281)
Psychiatr Serv. 2001 Jan;52(1):45-50. (PMID: 11141527)
Br J Psychiatry. 2018 Jan;212(1):42-49. (PMID: 29433611)
BMJ. 2008 Sep 29;337:a1655. (PMID: 18824488)
Soc Psychiatry Psychiatr Epidemiol. 1996 Jun;31(3-4):137-48. (PMID: 8766459)
Perspect Psychiatr Care. 2019 Apr;55(2):277-290. (PMID: 30604874)
Psychiatr Serv. 2007 Oct;58(10):1279-84. (PMID: 17914003)
Br J Psychiatry. 2010 Nov;197(5):350-6. (PMID: 21037211)
Med Care. 2004 Dec;42(12):1230-41. (PMID: 15550803)
Annu Rev Public Health. 2017 Mar 20;38:1-22. (PMID: 28384085)
Psychiatr Serv. 2015 Nov;66(11):1194-9. (PMID: 26278227)
Br J Psychiatry. 2009 Oct;195(4):283-5. (PMID: 19794192)
BMJ. 2014 Feb 12;348:g1173. (PMID: 24523363)
Early Interv Psychiatry. 2018 Aug;12(4):535-560. (PMID: 29076263)
Int J Soc Psychiatry. 1999 Spring;45(1):7-12. (PMID: 10443245)
Am J Epidemiol. 1981 Dec;114(6):906-14. (PMID: 7315838)
BMJ. 2010 Mar 23;340:c869. (PMID: 20332511)
J Abnorm Psychol. 1989 Aug;98(3):229-35. (PMID: 2768657)
Br J Psychiatry. 2015 Apr;206(4):268-74. (PMID: 25833867)
Adm Policy Ment Health. 2020 Nov;47(6):894-900. (PMID: 32323217)
Psychiatry Res. 2002 Apr 15;109(3):265-79. (PMID: 11959363)
Psychol Med. 2002 Jul;32(5):763-82. (PMID: 12171372)
BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884)
Australas Psychiatry. 2006 Sep;14(3):267-71. (PMID: 16923036)
BMC Health Serv Res. 2017 May 15;17(1):349. (PMID: 28506296)
Nord J Psychiatry. 2016;70(3):231-40. (PMID: 26328910)
BMJ Open. 2017 Sep 27;7(9):e017680. (PMID: 28963308)
Clin Psychol Rev. 2017 Aug;56:13-24. (PMID: 28578249)
Patient Educ Couns. 2013 Oct;93(1):102-7. (PMID: 23768763)
Adm Policy Ment Health. 2011 Mar;38(2):65-76. (PMID: 20957426)
Scand J Public Health. 2012 Dec;40(8):795-805. (PMID: 23221918)
Front Psychol. 2017 Mar 27;8:371. (PMID: 28396643)
Schizophr Bull. 2010 Jan;36(1):48-70. (PMID: 19955389)
Eur Arch Psychiatry Clin Neurosci. 2015 Apr;265(3):173-88. (PMID: 25384674)
Community Ment Health J. 2016 Nov;52(8):898-907. (PMID: 25648552)
Clin Psychol Rev. 2013 Apr;33(3):372-82. (PMID: 23410719)
Br J Psychiatry. 1998 Jan;172:11-8. (PMID: 9534825)

NFR 262863 Norges Forskningsråd

Keywords: Clinical ethics; Family intervention; Family involvement; Family psychoeducation; Implementation; Mental health service research; Psychotic disorders; Schizophrenia

ClinicalTrials.gov NCT03869177

Date Created: 20201010 Date Completed: 20210201 Latest Revision: 20240802

20240802

PMC7547488

10.1186/s12913-020-05792-4

33036605