Table 1 Summary of the CORE study stepped wedge cluster randomised controlled trial protocol

Context User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement in re-designing services improve health outcomes?

Objective To test the effectiveness of engaging service users, carers and staff in community mental health services in an experience-based co-design intervention to improve individual psychosocial recovery, carer well-being, staff attitudes to recovery and the recovery orientation of services.

Design setting participants A stepped wedge cluster randomised controlled trial with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four community mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. Data will be collected at baseline and at completion of each intervention wave (9, 18 and 27 months). Participants will be 30 service users, 30 carers and 10 staff working in each cluster (team) of four major mental health service providers.

Intervention The intervention is a modified version of Mental Health Experience Co-Design (MH ECO). MH ECO is a two-staged method. Stage 1 involves the identification of positive experiences and the aspects of service experience that could improve. Stage 2 involves smaller groups of service users, carers and staff participating in structured and facilitated meetings to co-develop improvements and action plans for change.

Outcome measures The primary outcome is improvement in psycho-social recovery score using the 24-item Revised Recovery Assessment Scale (RAS-R) for service users. Secondary outcomes are improvements to user and carer quality of life and well-being using the shortened 8-item version of the World Health Organisation Quality of Life (WHOQOL) scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale (STARS) and recovery orientation of services using the 36-item Recovery Self Assessment Scale (RSA-provider version).

Analysis Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group to which the cluster was assigned at each time point.