title: Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.
abstract: BACKGROUND
  Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial.
  
  
  METHODS
  In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model.
  
  
  RESULTS
  We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed.
  
  
  CONCLUSIONS
  Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.
authors.affiliation: Institute of Life Science, College of Medicine, Swansea University, Swansea, UK. marina.koniotou@yahoo.com.
authors.forename: Marina
authors.initials: M
authors.lastname: Koniotou
authors.affiliation: Institute of Life Science, College of Medicine, Swansea University, Swansea, UK. b.a.evans@swansea.ac.uk.
authors.forename: Bridie Angela
authors.initials: BA
authors.lastname: Evans
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK. r.chatters@sheffield.ac.uk.
authors.forename: Robin
authors.initials: R
authors.lastname: Chatters
authors.affiliation: London Ambulance Service, London, UK. rachael.Fothergill@lond-amb.nhs.uk.
authors.forename: Rachael
authors.initials: R
authors.lastname: Fothergill
authors.affiliation: Community Library Service (Home Visits) Hackney Libraries, London, UK. Christopher.Garnsworthy@Hackney.gov.uk.
authors.forename: Christopher
authors.initials: C
authors.lastname: Garnsworthy
authors.affiliation: Institute of Life Science, College of Medicine, Swansea University, Swansea, UK. s.a.gaze@swansea.ac.uk.
authors.forename: Sarah
authors.initials: S
authors.lastname: Gaze
authors.affiliation: Faculty of Health, Social Care and Education, Kingston University and St George's, University of London, London, UK. maryhalter@sgul.kingston.ac.uk.
authors.forename: Mary
authors.initials: M
authors.lastname: Halter
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, UK. s.mason@sheffield.ac.uk.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Mason
authors.affiliation: Institute of Life Science, College of Medicine, Swansea University, Swansea, UK. j.peconi@swansea.ac.uk.
authors.forename: Julie
authors.initials: J
authors.lastname: Peconi
authors.affiliation: Institute of Life Science, College of Medicine, Swansea University, Swansea, UK. a.m.porter@swansea.ac.uk.
authors.forename: Alison
authors.initials: A
authors.lastname: Porter
authors.affiliation: Community and Health Research Unit, School of Health & Social Care, University of Lincoln, London, UK. nsiriwardena@lincoln.ac.uk.
authors.forename: A Niroshan
authors.initials: AN
authors.lastname: Siriwardena
authors.affiliation: Institute of Life Science, College of Medicine, Swansea University, Swansea, UK. alun_toghill@yahoo.com.
authors.forename: Alun
authors.initials: A
authors.lastname: Toghill
authors.affiliation: Institute of Life Science, College of Medicine, Swansea University, Swansea, UK. h.a.snooks@swansea.ac.uk.
authors.forename: Helen
authors.initials: H
authors.lastname: Snooks
mesh_terms: D000058:Accidental Falls; D000367:Age Factors; D001291:Attitude of Health Personnel; D017028:Caregivers; D003256:Community Participation; D003159:Community-Institutional Relations; D003299:Cooperative Behavior; D019033:Delivery of Health Care, Integrated / Q000458:organization & administration* / Q000706:statistics & numerical data; D004632:Emergency Medical Services / Q000458:organization & administration* / Q000706:statistics & numerical data; D004739:England; D007722:Health Knowledge, Attitudes, Practice; D006295:Health Resources / Q000458:organization & administration* / Q000706:statistics & numerical data; D006302:Health Services Research; D006801:Humans; D033183:Interdisciplinary Communication; D017146:Models, Organizational; D010358:Patient Participation; D017064:Process Assessment, Health Care / Q000458:organization & administration*; D012017:Referral and Consultation / Q000458:organization & administration / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014852:Wales