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Mental health
Protocol
The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting
  1. Victoria J Palmer1,
  2. Patty Chondros1,
  3. Donella Piper2,
  4. Rosemary Callander3,
  5. Wayne Weavell4,
  6. Kali Godbee1,
  7. Maria Potiriadis1,
  8. Lauralie Richard1,
  9. Konstancja Densely1,
  10. Helen Herrman5,
  11. John Furler1,
  12. David Pierce6,
  13. Tibor Schuster7,
  14. Rick Iedema8,
  15. Jane Gunn1
  1. 1The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia
  2. 2School of Health, University of New England, Armidale, New South Wales, Australia
  3. 3Carer Research and Evaluation Unit, Tandem Representing Victorian Mental Health Carers, Abbotsford, Victoria, Australia
  4. 4Consumer Research and Evaluation Unit, Victorian Mental Illness Awareness Council, East Brunswick, Victoria, Australia
  5. 5Orygen, The National Centre of Excellence in Youth Mental Health and Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia
  6. 6Rural Health Academic Centre, Melbourne Medical School, The University of Melbourne, Ballarat, Victoria, Australia
  7. 7Clinical Epidemiology and Biostatics Unit, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia
  8. 8School of Nursing and Midwifery, University of Tasmania, Hobart, Tasmania, Australia
  1. Correspondence to Dr Victoria Jane Palmer; vpalmer{at}unimelb.edu.au

Abstract

Introduction User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness.

Methods An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). 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 that the cluster was assigned to at each time point.

Ethics and dissemination The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017.

Trial registration number Australian and New Zealand Clinical Trials Registry ACTRN12614000457640.

  • PRIMARY CARE
  • PSYCHIATRY

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2014-006688

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      Correction
      British Medical Journal Publishing Group
      BMJ Open 2015; 5 - Published Online First: 14 Jul 2015. doi: 10.1136/bmjopen-2014-006688corr1