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

Paratz, Jennifer D., Kenardy, Justin, Mitchell, Geoffrey, Comans, Tracy, Coyer, Fiona, Thomas, Peter, Singh, Sunil, Luparia, Louise and Boots, Robert J. (2014) 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. BMJ Open, 4 5: . doi:10.1136/bmjopen-2014-004966


Author Paratz, Jennifer D.
Kenardy, Justin
Mitchell, Geoffrey
Comans, Tracy
Coyer, Fiona
Thomas, Peter
Singh, Sunil
Luparia, Louise
Boots, Robert J.
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
Journal name BMJ Open   Check publisher's open access policy
ISSN 2044-6055
Publication date 2014
Year available 2014
Sub-type Article (original research)
DOI 10.1136/bmjopen-2014-004966
Open Access Status DOI
Volume 4
Issue 5
Total pages 7
Place of publication London, United Kingdom
Publisher B M J Group
Collection year 2015
Language eng
Formatted 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.
Keyword Post sepsis syndromes
Intensive care medicine
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article ID: e004966

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Medicine Publications
 
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