ESCMID Online Lecture Library. by author

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1 Controversy of bundle approach in infection control No, it is not cost effective and evidence based Petra Gastmeier Institute of Hygiene and Environmental Medicine, Charité - University Medicine Berlin

2 Pubmed search for evidence Infection control bundle randomized

3 Pubmed search for evidence Forty-five intensive care units from 35 hospitals in two Adventist healthcare systems. Marsteller JA et al. Crit Care Med 2012; 40:

4 Pubmed search for evidence Marsteller JA et al. Crit Care Med 2012; 40:

5 Pubmed search for evidence Interventions of the bundle: (1) omission of mechanical bowel preparation (2) preoperative and intraoperative warming (3) supplemental oxygen during and immediately after surgery (4) intraoperative intravenous fluid restriction (5) use of a surgical wound protector Anthony t et al. Arch Surg 2011; 46: Colorectal surgery

6 Pubmed search for evidence Anthony T et al. Arch Surg 2011; 46:

7 CONCLUSION No IA evidence for infection control bundles

8 Pubmed search for cost effectiveness Infection control bundle cost effective

9 Pubmed search for cost effectiveness Halton et al. PLOSone 2010; 5: e12815

10 Pubmed search for cost effectiveness Background: A bundled approach to CVC care is currently being promoted as an effective way of preventing CR-BSI. Consumables used in the bundled approach are relatively inexpensive which may lead to the conclusion that the bundle is cost-effective. However, this fails to consider the nontrivial costs of the monitoring and education activities required to implement the bundle, or that alternative strategies are available to prevent CR-BSI. We evaluated the cost-effectiveness of a bundle to prevent CR-BSI in Australian intensive care patients. Halton et al. PLOSone 2010; 5: e12815

11 Cost and effectiveness thresholds for a catheter care bundle versus alternative infection control interventions Halton et al. PLOSone 2010; 5: e12815

12 Pubmed search for cost effectiveness Conclusions: A catheter care bundle has the potential to be cost-effective in the Australian intensive care setting. Rather than anticipating cash-savings from this intervention, decision makers must be prepared to invest resources in infection control to see efficiency improvements. Halton et al. PLOSone 2010; 5: e12815

13 Pubmed search for cost effectiveness Infection control bundle cost effective

14 Pubmed search for cost effectiveness Branch-Elliman W et al. Quality and Safety in Health Care 2013; 22:357-61

15 Pubmed search for cost effectiveness CONCLUSION: Nurses estimated that standard ventilator bundle requires a median of 115 min. per day. Although the majority of nurses did not perceive that patient care tasks were delayed by these prevention activities, this was not universal; 29% of respondents reported other patient care tasks were sometimes delayed because time was allocated to ventilator bundle activities Branch-Elliman W et al. Quality Safety in Health Care 2013; 22:357-61

16 CONCLUSION No clear cost effectiveness of infection control bundles

17 The effectiveness of a bundle approach depends on the baseline situation in the own institution the individual bundle components the compliance with bundle components

18 The effectiveness of a bundle approach depends on the baseline situation in the own institution the individual bundle components the compliance with bundle components

19 The baseline situation in the own institution: CVC BSI rates 66% reduction The CVC bundle was introduced Before-after study with 108 ICUs participating

20 External study validity: Distribution of CVC associated BSI in interdisciplinary ICUs (in hospitals > 400 beds) in Germany Mean incidence at the end of the study Mean baseline incidence CVC BSI rate (per 1000 CVC days)

21 The baseline situation in the own institution: VAP rates The ventilator bundle was introduced Before after study with 112 ICUs participating Berenholtz et al. ICHE 2011; 32:

22 Development over time Incidence rate ratio 0.51 CI95 0,41-0,64 following 18 months and 0.29 following 30 months Berenholtz et al. ICHE 2011; 32:

23 External study validity: Distribution of VAP in interdisciplinary ICUs (in hospitals > 400 beds) in Germany Mean incidence at the end of the study Mean baseline incidence VAP rate (per 1000 ventilator days)

24 The effectiveness of a bundle approach depends on the baseline situation in the own institution the individual bundle components the compliance with bundle components

25 The individual bundle components

26

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28 1. Elevation of the head of the bed to degrees RR= 0.28 (CI ) Reproducibility? Drakulovic MB et al. Lancet 1999; 354:

29 1. Elevation of the head of the bed to degrees

30 1. Elevation of the head of the bed to degrees Supine position n=109 (target backrest elevation of 10 ) Semirecumbent position n=112 (target backrest elevation of 45 ) Average elevation at day 1 at day Van Nieuwenhoven et al. Crit Care Med 2006; 34: was not achieved for 85 %

31 Niel-Weise et al. Crit Care 2011; 15:R1-11

32 Niel-Weise et al. Crit Care 2011; 15:R1-11

33 Elevation of the head RESULTS: All eight pigs kept orientated with the trachea 45 above horizontal developed VAP. None of the 18 pigs kept oriented with the trachea below horizontal developed VAP. Zanella et al. Intensive Care Med 2012; 38:677-85

34 2. Daily sedation vacations and assessment of readiness to extubate CONCLUSION: Our results suggest that a wake up and breathe protocol that pairs daily spontaneous awakening trials (ie, interruption of sedatives) with daily spontaneous breathing trials results in better outcomes for mechanically ventilated patients in intensive care than current standard approaches and should become routine practice. Girard et al. Lancet 2008; 371:126-34

35 3. Peptic ulcer disease prophylaxis Other target: stress ulcer instead of VAP? It must be clearly noted that this is not related to VAP prevention; the use of histamine-2 antagonists or proton pump inhibitors for stress ulcer prophylaxis may even increase the risk of VAP

36 4. Deep venous thrombosis (DVT) prophylaxis Other target: venous thrombosis instead of VAP? DVT prophylaxis has not been demonstrated to reduce the risk of VAP

37 5. Daily oral care with Chlorhexidine Benefit for cardiac surgery patients, trauma patients Labeau SI et al. Lancet Infect Dis 2011; 11:845-54

38 Only two of the 5 bundle elements seem be useful for prevention of pneumonia

39 Composite your own bundle? European care bundle for prevention of VAP - non-ventilatory circuit changes unless specifically indicated - alcohol based hand hygiene - appropriately educated and trained staff - incorporation of sedation control and weaning protocols into patient care - oral care with chlorhexidine Rello et al. Intensive Care Med 2010

40 The effectiveness of a bundle approach depends on the baseline situation in the own institution the individual bundle components the compliance with bundle components

41 Compliance with bundle components Bouadma et al. Crit Care Med 2010; 38:

42 Compliance with bundle components ICU with 20 beds Education and observation periods with feedback (8 measures were selected) Reduction of VAP rate by 51 % (p<0,001) Bouadma et al. Crit Care Med 2010; 38:

43 Compliance with bundle components Bundle elements: - Periop. antibiotic prophylaxis (15-60 min. before incision) - Hair removal before surgery (not performed or with clipper) - Perioperative normothermia (36-38 C) - Discipline in the OR (counted by the number of door openings)

44 Bundle compliance was measured every 3 months in a random sample of procedures

45 Significant decrease of SSI rates by 36 %

46 Own experience with a centrally supervised approach ISEP = Intervention study to reduce catheter associated bloodstream infections (septicemia) in ICUs NEO-ISEP = Intervention study to reduce catheter associated bloodstream infections (septicemia) in Neonatal ICUs

47 CVC- BSI intervention study: ISEP KISS ICUs with high CVC-BSI rates > median KISS surveillance sample n=32 educational program 12 months Intervention period: 12 months Endpoint: CVC-BSI rate KISS surveillance

48 Components of intervention Handout about sepsis prevention for HCWs self-study, including background information on CLABSI and evidence-based recommendations 2 educational sessions in each ICU A standardised, modifiable PowerPoint presentation including background information on CLABSI, evidence-based recommendations and modifiable graphs for feedback of the ICUs surveillance data 2 Multiple choice tests Poster

49 A bundle which focused on indications for hand hygiene, insertion of central lines using maximal barrier precautions, cleaning the skin with adequate skin disinfectant, promoting subclavian site for insertion dressing care (including the disinfection of insertion site) management of parenteral medication (preparation and application of IV fluids) the recommendation of a strict indication for central lines

50 Posters focussing on BSI prevention

51 Development of CVC-BSI rates Hansen et al. submitted

52 ISEP Results: CVC associated BSI rates Baseline April 06-March 07 During intervention period April 07-March 08 After intervention period April 08-March 10 * CVC BSI cases per 1000 CVC days Hansen et al. submitted Pooled CVC associated BSI* Relative risk (CI95) 2.29 Reference value ( ) ( ) Time series analysis: 1.1 % decrease per month

53 Neonatal ICUs with more BSI cases as expected n=53 NEO-KISS NEO-ISEP-Study ICUs n=33 Intervention program 12 months Sepsis rate NEO-KISS

54 Intervention program for sepsis prevention Education material* Power point presentation * NEO-ISEP-Study Case discussions Posters* All members of the neonatal ICU team Check lists* *Development by NRZ

55 NEO-ISEP-Study Development of Standardized infection ratios (SIR) for CVC associated BSI NEO-ISEP Before Intervention Follow up participants RR Intervention period = 0.79 (CI ) RR Follow up period = 0.58 (CI )

56 Conclusions from ISEP and NEO-ISEP Many colleagues want to improve the situation in their hospitals but do not have the power to start an intervention program or the time to develop the necessary materials However, when such an intervention program is provided and the awareness for this topic increased they are very interested to use the material provided

57 Summary The evidence for bundles is weak. The introduction of bundles is associated with additional workload, the question of cost effectiveness is not solved. Care bundles are not the answer to everything. The bundle measures should be adjusted to the needs of the own institution. Education and communication are crucial elements.

58 Moreno/Rhodes Crit Care Med 2010; 38:S528-32

59 Recommendations Determine baseline infection rates (Is there a need for intervention?) Determine existing compliance with IC measures in your institution (Which measures should be included in the bundle?) Develop your own bundle for introduction Measure compliance with bundle elements Determine infection rates during and following intervention Adjusting of bundle measures?