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Open Access Study protocol

A study of the perceived risks, benefits and barriers to the use of SDD in adult critical care units (The SuDDICU study)

BH Cuthbertson12*, J Francis2, MK Campbell2, L MacIntyre3, I Seppelt4, J Grimshaw5 and the SuDDICU study groups

Author Affiliations

1 Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Av, Toronto, Ontario, Canada

2 Health Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, UK

3 Clinical Epidemiology, Ottawa Health Research Institute (on behalf of the Canadian Critical care Trials Group), Ottawa, Canada

4 Nepean Hospital, Penrith, New South Wales, Australia on behalf of the Australia and New Zealand Intensive Care Society Clinical trials Group and the George Institute for International Health, Sydney, Australia

5 Clinical Epidemiology, Ottawa Health Research Institute, Ottawa, Canada

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Trials 2010, 11:117  doi:10.1186/1745-6215-11-117

Published: 3 December 2010

Abstract

Background-

Hospital acquired infections are a major cause of morbidity and mortality and markedly increased health care costs. Critically ill patients who require management in an Intensive Care Unit are particularly susceptible to these infections which are associated with a very high mortality. Selective decontamination of the digestive tract (SDD) may reduce these infections and improve mortality but it has not been widely adopted into practice. We aim to 1. Clarify reasons why clinicians have avoided implementing SDD into clinical practice despite the current best-evidence 2. Describe barriers to SDD implementation and 3. Identify what further evidence is required before full scale clinical implementation would be considered appropriate and feasible.

Methods-

We have developed an international 'multi-lens' approach to investigate SDD from several perspectives. In case studies we will identify accounts of implementation of SDD in practice, in terms of the behaviours performed by the full range of individual clinicians, accounts of how SDD was first introduced into the Unit and specific content that may be used to populate the content of behaviour change techniques to be used in an implementation intervention and procedures to consider in order to deliver an implementation trial. In a 4 round Delphi study we will identify the range of stakeholders' beliefs, views and perceived barriers relating to the use of SDD. We will generate hypotheses about key beliefs about SDD and will inform the feasibility of any future randomised controlled trial. In large-scale nationwide postal questionnaire surveys of the state of current practice we will identify the factors predicting acceptability of an effectiveness or implementation trial using, and informed by, the theoretical domains structure. In semi-structured interviews with active international clinical trialists we will assess the feasibility of a randomised controlled trial and identify challenges and barriers to undertaking research in the field of SDD research.

Discussion

We believe these methods will allow us to determine whether clinical implementation trials or further large effectiveness trials are required before full scale implementation into clinical practice.