1. HSRU is funded by the Chief Scientist Office of the Scottish Government Health Directorates. The author accepts full responsibility for this talk. Health Services Research Unit University of Aberdeen SuDDICU Project SuDDICU Project Launch June 7 th 2010

2. Health Services Research Unit What ‘s the SuDDICU project again? Brief overview

3. Health Services Research Unit Background The Problem: Hospital Acquired Infections (HAIs) are major clinical problem. HAIs have severe consequences in ICU patients. The Procedure: Selective Decontamination of the Digestive (SDD) tract is used to prevent HAIs and mortality. SDD is the application of topical non-absorbable antibiotics to the throat and stomach and a short course of intravenous antibiotics.

4. Health Services Research Unit Background The Evidence: Effectiveness: Meta-analyses show that SDD is effective in reducing HAIs and, in some cases, mortality. Implementation: Despite favourable evidence, SDD is not used frequently – 10-15 ICUs in the UK. Potential Issues: SDD too complex behavioural problem SDD evidence inadequate e.g. not generalisable, gaps in intervention designs SDD counterintuitive fear of multi-resistant organisms

5. Health Services Research Unit Research Questions 1.What are the clinical and behavioural components of SDD? 2.How has SDD been implemented and delivered into practice? 3.What are stakeholders’ views on consequences of SDD? 4.What are stakeholders’ views on barriers to implementing SDD? 5.What are stakeholders’ views on validity & adequacy of evidence? 6.What are the current SDD practices and intentions of intensivists & microbiologists? 7.If there are uncertainties in the evidence base, what trial design(s) and interventions would be preferred to address these? 8.What are the likely challenges in a large multi-national RCT of SDD?

6. Health Services Research Unit September 2011 – November 2011 Complete by August 2010 SuDDICU Overview CASE STUDIES OF UNITS DELIVERING SDD DELPHI STUDY OF KEY STAKEHOLDERS’ SDD BELIEFS NATIONWIDE SURVEY OF CURRENT SDD PRACTICE AND BELIEFS SEMI-STRUCTURED INTERVIEWS WITH INTENSIVE CARE TRIALISTS STAGE 4 STAGE 3 STAGE 2 STAGE 1 1.What are the clinical and behavioural components of SDD? 2.How has SDD been implemented and delivered into practice? 3.What are stakeholders’ views on consequences of SDD? 4.What are stakeholders’ views on barriers to implementing SDD? 5.What are stakeholders’ views on validity & adequacy of evidence? 6.What are the current SDD practices and intentions of intensivists & microbiologists? 7.If there are uncertainties in the evidence base, what trial design(s) and interventions would be preferred to address these? 8.What are the likely challenges in a large multi-national RCT of SDD? June 2010 - August 2011 April 2011 – September 2011

7. Health Services Research Unit Stage 1: Case Studies Design: Observational and interview study Procedures: Observation of SDD delivery Interviews with stakeholders Sample: Clinical lead Microbiologist Pharmacist ICU nurse Outcomes: Behavioural observation, Interview responses, SDD relevant materials and documents 2 ICUs currently delivering SDD involved in SDD implementation and/or delivery Target n = 2 each

8. Health Services Research Unit Stage 1: Case Studies Analysis: Behavioural Analysis of Complex Clinical Procedure Person 1Person 2Person 3Person 4 Time 1Action 1 Time 2Action 2, 3, 4 Time 3Action 5, 6, 7 Time 4Action 8Action 9, 10Action 11

9. Health Services Research Unit Stage 1: Case Studies Analysis: Behavioural Analysis of Complex Clinical Procedure DoctorPharmacistICU nurseMicrobiologist SDD decision Selects patient Pre delivery Orders and prepares antibiotics SDD delivery Pick up drugs, administer SDD Post delivery Monitoring of antibiotics stocks Disposes of leftovers Monitor ICU environment

10. Health Services Research Unit Delphi Goals of the Delphi interview: Access diverse (rather than representative) expert opinions/beliefs on SDD Develop a questionnaire that includes the key issues and opinions to be able to assess representative in the next stage of the project (i.e. Stage 3: Nationwide Questionnaire Study). Tap into relevant theoretical domains for three specific behaviours: 1.Providing SDD 2.Participating in an effectiveness trial 3.Participating in an implementation trial

11. Health Services Research Unit Theory Skills Social/Role Identity Beliefs about capabilities Environmental context and resources Behavioural regulation Emotion Social influences Memory, attention and decision processes Motivation and goals Beliefs about consequences Knowledge Michie et al., 2005

12. Health Services Research Unit Stage 2: Delphi Survey Design: 4 Delphi ‘rounds’ Procedures: 1.Semi-structured one-to-one telephone interviews 2.Feedback on interviews via email questionnaire 3.Feedback and revisions via email questionnaire 4.International feedback and revisions via email questionnaire Sample: Clinical lead Microbiologist Pharmacist ICU nurse stakeholders involved in SDD implementation and/or delivery Target n = 10 each

13. Health Services Research Unit Stage 3: Nationwide Survey Design: Nationwide survey (based on responses from Delphi) Sample: Clinical leads (n~2000) Microbiologists (n~180) Procedures: One large-scale postal questionnaire Analysis: descriptive statistical methods statistical prediction techniques

14. Health Services Research Unit Stage 4: Trialists interviews Design: Semi-structured interviews Sample: International trialists (published authors of large randomised trials in critical care, target n = 10) Procedures: One-to-one telephone administered interview Analysis: Transcripts analysed using content analysis

15. Health Services Research Unit What ‘s the funding situation? Funding update

16. Health Services Research Unit SuDDICU International SuDDICU protocol adopted in 3 countries: 1.UK 2.Canada 3.Australia/New Zealand

17. Health Services Research Unit TeamThe GeoffBellinganUniversity College London, UK MarionCampbellUniversity of Aberdeen, UK BrianCuthbertsonSunnybrook Health Sciences Centre, Canada StephanDombrowskiUniversity of Aberdeen, UK MartinEcclesNewcastle University, UK JillFrancisUniversity of Aberdeen, UK MarieJohnstonUniversity of Aberdeen, UK GraemeMacLennanUniversity of Aberdeen, UK CraigRamseyUniversity of Aberdeen, UK LouiseRoseUniversity of Toronto, Canada KathyRowanIntensive Care National Audit & Research Centre, UK IanSeppeltUniversity of Sydney, Australia RobShulmanUniversity College Hospital, UK PeterWilsonUniversity College Hospital, UK

18. Health Services Research Unit Any questions? Additional feedback, thoughts, or comments please email Stephan: s.u.dombrowski@abdn.ac.uk Thank you