title: IMPOSE (IMProving Outcomes after Sepsis)-the effect of a multidisciplinary follow-up service on health-related quality of life in patients postsepsis syndromes-a double-blinded randomised controlled trial: protocol.
abstract: BACKGROUND
  Patients post sepsis syndromes have a poor quality of life and a high rate of recurring illness or mortality. Follow-up clinics have been instituted for patients postgeneral intensive care but evidence is sparse, and there has been no clinic specifically for survivors of sepsis. The aim of this trial is to investigate if targeted screening and appropriate intervention to these patients can result in an improved quality of life (Short Form 36 health survey (SF36V.2)), decreased mortality in the first 12 months, decreased readmission to hospital and/or decreased use of health resources.
  
  
  METHODS
  204 patients postsepsis syndromes will be randomised to one of the two groups. The intervention group will attend an outpatient clinic two monthly for 6 months and receive screening and targeted intervention. The usual care group will remain under the care of their physician. To analyse the results, a baseline comparison will be carried out between each group. Generalised estimating equations will compare the SF36 domain scores between groups and across time points. Mortality will be compared between groups using a Cox proportional hazards (time until death) analysis. Time to first readmission will be compared between groups by a survival analysis. Healthcare costs will be compared between groups using a generalised linear model. Economic (health resource) evaluation will be a within-trial incremental cost utility analysis with a societal perspective.
  
  
  BACKGROUND
  Ethical approval has been granted by the Royal Brisbane and Women's Hospital Human Research Ethics Committee (HREC; HREC/13/QRBW/17), The University of Queensland HREC (2013000543), Griffith University (RHS/08/14/HREC) and the Australian Government Department of Health (26/2013). The results of this study will be submitted to peer-reviewed intensive care journals and presented at national and international intensive care and/or rehabilitation conferences.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry ACTRN12613000528752.
authors.affiliation: Burn, Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Queensland, Australia Department of Intensive Care Medicine, Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia School of Rehabilitation Sciences, Griffith University, Brisbane, Queensland, Australia Department of Physiotherapy, Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Jennifer D
authors.initials: JD
authors.lastname: Paratz
authors.affiliation: CONROD, The University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Justin
authors.initials: J
authors.lastname: Kenardy
authors.affiliation: School of Medicine (Ipswich Campus), The University of Queensland, Ipswich, Australia.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Mitchell
authors.affiliation: School of Medicine, Griffith University, Brisbane, Queensland, Australia.
authors.forename: Tracy
authors.initials: T
authors.lastname: Comans
authors.affiliation: Nursing Faculty, Queensland University of Technology, Brisbane, Queensland, Australia.
authors.forename: Fiona
authors.initials: F
authors.lastname: Coyer
authors.affiliation: Burn, Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Queensland, Australia Department of Intensive Care Medicine, Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia Department of Physiotherapy, Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Thomas
authors.affiliation: Intensive Care Unit, Bundaberg Hospital, Bundaberg, Queensland, Australia.
authors.forename: Sunil
authors.initials: S
authors.lastname: Singh
authors.affiliation: Burn, Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Queensland, Australia School of Rehabilitation Sciences, Griffith University, Brisbane, Queensland, Australia.
authors.forename: Louise
authors.initials: L
authors.lastname: Luparia
authors.affiliation: Burn, Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Queensland, Australia Department of Intensive Care Medicine, Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Boots
mesh_terms: D000359:Aftercare; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D010348:Patient Care Team; D011788:Quality of Life; D012107:Research Design; D018805:Sepsis / Q000628:therapy*; D013577:Syndrome
keywords: Rehabilitation Medicine