title: Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses.
abstract: Engagement is essential in trials research but is rarely embedded across all stages of the research continuum. The development, use, effectiveness and value of engagement in trials research is poorly researched and understood, and models of engagement are rarely informed by theory. This article describes an innovative methodological approach for the development and application of a relational model of engagement in a stepped wedge designed cluster randomised controlled trial (RCT), the CORE study. The purpose of the model is to embed engagement across the continuum of the trial which will test if an experience-based co-design intervention improves psychosocial recovery for people affected by severe mental illness.
  
  
  
  The model was developed in three stages and used a structured iterative approach. A context mapping assessment of trial sites was followed by a literature review on recruitment and retention of hard-to-reach groups in complex interventions and RCTs. Relevant theoretical and philosophical underpinnings were identified by an additional review of literature to inform model development and enactment of engagement activities.
  
  
  
  Policy, organisational and service user data combined with evidence from the literature on barriers to recruitment provided contextual information. Four perspectives support the theoretical framework of the relational model of engagement and this is organised around two facets: the relational and continuous. The relational facet is underpinned by relational ethical theories and participatory action research principles. The continuous facet is supported by systems thinking and translation theories. These combine to enact an ethics of engagement and evoke knowledge mobilisation to reach the higher order goals of the model.
  
  
  
  Engagement models are invaluable for trials research, but there are opportunities to advance their theoretical development and application, particularly within stepped wedge designed studies where there may be a significant waiting period between enrolment in a study and receipt of an intervention.
authors.affiliation: The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.|The Department of General Practice and Rural Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: Lauralie
authors.initials: L
authors.lastname: Richard
authors.affiliation: School of Health, University of New England, Armidale, Australia.
authors.forename: Donella
authors.initials: D
authors.lastname: Piper
authors.affiliation: The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
authors.forename: Wayne
authors.initials: W
authors.lastname: Weavell
authors.affiliation: The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
authors.forename: Rosemary
authors.initials: R
authors.lastname: Callander
authors.affiliation: Monash Centre for Health Research and Implementation, Monash University, Clayton, Australia.
authors.forename: Rick
authors.initials: R
authors.lastname: Iedema
authors.affiliation: The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Furler
authors.affiliation: Department of Rural Health, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Pierce
authors.affiliation: The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
authors.forename: Kali
authors.initials: K
authors.lastname: Godbee
authors.affiliation: The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia.
authors.forename: Jane
authors.initials: J
authors.lastname: Gunn
authors.affiliation: The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, 200, Berkeley Street, Melbourne, VIC, 3052, Australia. v.palmer@unimelb.edu.au.
authors.forename: Victoria J
authors.initials: VJ
authors.lastname: Palmer
mesh_terms: D006801:Humans; D001523:Mental Disorders / Q000175:diagnosis / Q000523:psychology*; D010358:Patient Participation; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D035842:Research Subjects / Q000523:psychology*; D012720:Severity of Illness Index; D057188:Workflow
keywords: Cluster randomised controlled trial; Complex interventions; Engagement model; Experience-based co-design; Stepped wedge design