title: 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.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry ACTRN12614000457640.
authors: The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia.
authors: Victoria J
authors: VJ
authors: Palmer
authors: The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia.
authors: Patty
authors: P
authors: Chondros
authors: School of Health, University of New England, Armidale, New South Wales, Australia.
authors: Donella
authors: D
authors: Piper
authors: Carer Research and Evaluation Unit, Tandem Representing Victorian Mental Health Carers, Abbotsford, Victoria, Australia.
authors: Rosemary
authors: R
authors: Callander
authors: Consumer Research and Evaluation Unit, Victorian Mental Illness Awareness Council, East Brunswick, Victoria, Australia.
authors: Wayne
authors: W
authors: Weavell
authors: The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia.
authors: Kali
authors: K
authors: Godbee
authors: The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia.
authors: Maria
authors: M
authors: Potiriadis
authors: The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia.
authors: Lauralie
authors: L
authors: Richard
authors: The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia.
authors: Konstancja
authors: K
authors: Densely
authors: Orygen, The National Centre of Excellence in Youth Mental Health and Centre for Youth Mental Health, The University of Melbourne, Parkville, Victoria, Australia.
authors: Helen
authors: H
authors: Herrman
authors: The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia.
authors: John
authors: J
authors: Furler
authors: Rural Health Academic Centre, Melbourne Medical School, The University of Melbourne, Ballarat, Victoria, Australia.
authors: David
authors: D
authors: Pierce
authors: Clinical Epidemiology and Biostatics Unit, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
authors: Tibor
authors: T
authors: Schuster
authors: School of Nursing and Midwifery, University of Tasmania, Hobart, Tasmania, Australia.
authors: Rick
authors: R
authors: Iedema
authors: The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia.
authors: Jane
authors: J
authors: Gunn
mesh_terms: D000328:Adult; D001315:Australia; D017028:Caregivers; D003153:Community Health Services; D003362:Cost-Benefit Analysis; D006801:Humans; D001523:Mental Disorders / Q000628:therapy*; D008603:Mental Health; D008605:Mental Health Services; D009520:New Zealand; D017063:Outcome Assessment, Health Care; D011570:Psychiatry; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
keywords: PRIMARY CARE; PSYCHIATRY