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

Abstract

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.

Family involvement practices for persons with psychotic disorders in community mental health centres – a cross-sectional fidelity-based study

“…After randomisation, half of the clusters will receive training and support for 18 months to implement recommendations from the national guidelines, whereas the other half will be given training and support after the 18 months period. The sample size was calculated for the IFIP trial as a whole [ 26 ]. Table 1 sums up the characteristics of the clinical sites, and demonstrates the variation in organisation and structure among the services offered to patients with psychotic disorders in Norway.…”

“…The study protocol describes how the project group developed the IFIP intervention, by selecting recommendations from the national guidelines and clustering them into the following key elements [ 26 ]:…”

“…In parallel with that process, we identified model dimensions and items for the BFIS scale to cover the key elements of the IFIP intervention, apart from FPE (Table 2 ). A detailed account of the IFIP intervention is available in the study protocol [ 26 ].…”

“…Our hypothesis was that the level of implementation would be low. As part of the ‘Implementation of Family Involvement for persons with Psychotic disorders’ – (IFIP) trial [ 26 ], we conducted a baseline assessment of family involvement practices in all fifteen participating community mental health centre (CMHC) units, using three fidelity scales. Measuring program fidelity is an established strategy in implementation science and mental health services research, providing a standardised assessment of evidence-based practices [ 27 ].…”

Evaluating family knowledge about sexual health in patients with severe mental illness: a qualitative study in Iran

“…Review of the literature indicates that family interventions may improve social function, self-experienced health and adherence with medication. Moreover, it decreases the frequency of relapse, hospital admissions in patients with severe mental illness [15].…”