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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
  1. Jennifer D Paratz1,2,3,4,
  2. Justin Kenardy5,
  3. Geoffrey Mitchell6,
  4. Tracy Comans7,
  5. Fiona Coyer8,
  6. Peter Thomas1,2,4,
  7. Sunil Singh9,
  8. Louise Luparia1,3,
  9. Robert J Boots1,2
  1. 1Burn, Trauma and Critical Care Research Centre, The University of Queensland, Brisbane, Queensland, Australia
  2. 2Department of Intensive Care Medicine, Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia
  3. 3School of Rehabilitation Sciences, Griffith University, Brisbane, Queensland, Australia
  4. 4Department of Physiotherapy, Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia
  5. 5CONROD, The University of Queensland, Brisbane, Queensland, Australia
  6. 6School of Medicine (Ipswich Campus), The University of Queensland, Ipswich, Australia
  7. 7School of Medicine, Griffith University, Brisbane, Queensland, Australia
  8. 8Nursing Faculty, Queensland University of Technology, Brisbane, Queensland, Australia
  9. 9Intensive Care Unit, Bundaberg Hospital, Bundaberg, Queensland, Australia
  1. Correspondence to Dr Jennifer D Paratz; j.paratz{at}uq.edu.au

Abstract

Introduction 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 and analysis 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.

Ethics and dissemination 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.

Trial registration number Australian and New Zealand Clinical Trials Registry ACTRN12613000528752.

  • Rehabilitation Medicine

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 3.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/3.0/

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