Making Evidence-based Clinical Decisions. Paul L. Blackburn, BSN, MNA, RN, VA-BC

Making Evidence-based Clinical Decisions Paul L. Blackburn, BSN, MNA, RN, VA-BC

Disclosures Senior Director of Marketing/Education RyMed Technologies President of the Board of Directors Association for Vascular Access (AVA) Share holder RyMed Technologies, Inc. C.R. Bard, Inc.

Agenda 1 Incidence of CR-BSI in the United States 2 Routes of contamination 3 4 How do clinicians fit into the picture? HATS model 5 Anatomy of a connector 6 Clinical evidence 7 Making an evidence-based clinical decision

CR-BSI in the U.S. 5 million central venous catheters (CVCs) inserted annually in the U.S. 1 87% of bloodstream infections (BSI) due to indwelling vascular catheters 2 Approximately 250,000 BSIs occur yearly 3 Approximately 50,000 deaths per year attributed to CRBSI 4 1. McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003;348:1123-133. 2. Dariouiche R. Clin Infect Dis. 2001: 33: 1567-1572. 3. O Grady N., Alexnder M., Burns L., et al. Guidelines for the prevention of intravascular catheter-related infections, 2011. 4. Smith JSD, et al. J Infus Nurs. 2011: 34: 193-200

CR-BSI in the U.S. Cost per episode: $34,500-$56,000 5 ICU (general and adult ICU and adult surgical ICU) patient costs: $33,000-$75,000 6 $296 million --$2.3 billion annually 4 4. Smith JSD, et al. J Infus Nurs. 2011: 34: 193-200. 5. Moreau N. Nursing. 2009: 34: 14-15. 6. Hollenbeak CS. J Infus Nurs. 2011: 34: 309-311.

Agenda 1 Incidence of CR-BSI in the United States 2 Routes of contamination 3 4 How do clinicians fit into the picture? HATS model 5 Anatomy of a connector 6 Clinical Evidence 7 Making an evidence-based clinical decision

Routes of Infection The CR-BSI Cascade Two major causes of CLABSI 1. Bacteria from the skin migrate down the extraluminal surface of catheters, through the skin tract, and into the blood stream 7 2. Bacteria are introduced into the intraluminal surface of the catheter through manipulation of the needleless connector 7 7. Smith (2011) JIN 34:3 8. Maki D. (2004). Intensive Care Med, 30:62 9. Garland JS et al. (2008). ICHE, 29:243

The CR-BSI Cascade

Bacteria Adhere to Intraluminal Thrombus

Bacteria Adhere to Individual Fibrin Strands

Biofilm Growth

The Role of Biofilm in CR-BSI--Summary Relatively innocuous skin microbes can cause severe illness when attached to artificial devices in the body Fibrin coating has receptors allowing bacterial adhesion Bacteria grow and proliferate As the community matures, colonies are dispersed to insure survival of the species Manifesting as infectious symptoms

Increasing Incidence of CR-BSI Due to high occurrence of nosocomial contamination of needleless connectors 7 CDC recommends Disinfect connectors before use Scrubbing a connector for 15 seconds with 70% isopropyl alcohol prevents bacterial migration 7 7. Smith (2011) JIN 34:3

CR-BSI Trends The CDC has determined that, despite implementation of numerous prevention strategies, CR-BSIs have decreased by only 33% Patients with healthcare-associated infections have an increased risk of hospital readmissions

Agenda 1 Incidence of CR-BSI in the United States 2 Routes of contamination 3 4 How do clinicians fit into the picture? HATS model 5 Anatomy of a connector 6 Clinical Evidence 7 Making an evidence-based clinical decision

The Clinician Factor Other products impact CR-BSI Catheter site dressings Catheter stabilization devices Hub connectors Alcohol caps

The Clinician Factor Evaluations of poor patient outcomes evolved around patient and practice, with little or no thought of product 10 10 Chernecky (2013) JAVA 18:3

Agenda 1 Incidence of CR-BSI in the United States 2 Routes of contamination 3 4 How do clinicians fit into the picture? HATS model 5 Anatomy of a connector 6 Clinical evidence 7 Making an evidence-based clinical decision

Components of the HATS model Practice Patient Product 1. The model focuses on the interplay of three critical variables that influence patient care a. Patient b. Product c. Practice 2. Either alone or in combination, these variables affect patient outcomes. 3. If any of these three variables are not included in a study of patient outcomes, this may need to be addressed as a study limitation. Healthcare and Technology Synergy Model

What is a framework and why do we need one? Would you buy a car without a frame? How about a car kit, frame included, with no directions?

What is a framework and why do we need one? How can you tell what something is if it does not have a frame?

What is a framework and why do we need one? Could you live without your skeleton as a frame?

What is a framework and why do we need one? Conclusion: You need a frame on which to build Scientific research builds on frameworks which aids understanding of patient outcomes

How frameworks can be viewed Written word (ie: can declare if qualitative for data collection and analysis or if qualitative for theory) Map- interactions Diagram - simplicity

What frameworks do for vascular access research Guides studies in identifying nursing needs Provides meaningful knowledge that guides practice, not just because we do it that way Contributes to patient, society, and profession

Why we need a framework that incorporates product Evaluations of poor patient outcomes evolved around patient and practice If product is not a significant variable then why do we have product evaluations for computers, toasters, lamps, cars?

Is technology a significant variable in patient outcomes? Prevention of a majority of CRBSIs is obtainable but there is a need for prospective assessment of hazards associated with new technology (p. 1104) (Cardo et al, 2010)

Examples of uses of framework in types of nursing research Qualitative research Quantitative research Comparative effectiveness research (CER)

Comparative Effectiveness Research (CER) Designed to generate evidence in the real world Cost savings does not always equate with positive patient outcomes To ensure that populations health is enhanced comparative effectiveness research is necessary (Mushlin et al, 1998; Mushlin & Ghomrawi, 2010)

Example of CER in vascular access IV connector products differ on CFU growth and CRBSI rates Dr. Jarvis instructs us in his 2009 article Design Features Matter IV Connector products must have all 10 design features to significantly reduce occlusions and CR-BSI s

Agenda 1 Incidence of CR-BSI in the United States 2 Routes of contamination 3 4 How do clinicians fit into the picture? HATS model 5 Anatomy of a connector 6 Clinical evidence 7 Making an evidence-based clinical decision

Connector design Originally designed to meet OSHA mandate to implement products eliminating needle-stick injuries First universal, swabbable needleless I.V. connector introduced in early 1990s Effective in protecting healthcare workers from accidental needle-stick injuries

Connector Design Negative fluid displacement Must be swabbed with an antiseptic before use to maintain asepsis Draw small amount of fluid into catheter upon disconnect

Negative Fluid Displacement

Connector Design Positive Pressure Mechanical Valve Must be swabbed with antiseptic before each access to maintain asepsis Incorporate a positive fluid displacement feature that creates a bolus of fluid upon disconnection causes reflux upon connection

Positive Pressure Mechanical Valve

39 Connector Design Negative Displacement Valves Provides direct access to the fluid pathway Reflux of blood into catheter upon disconnection Blood coats wall of catheter lumen Fibrin begins to build-up Positive Pressure Mechanical Valves (PPMV) Refluxes blood immediately upon connection Blood coats wall of catheter lumen Fibrin begins to build-up Provides a positive push upon disconnection Minor reduction in occlusions Promotes repeated surface conditioning which may lead to intraluminal thrombotic occlusion

Connector Design Neutral fluid displacement Swab with antiseptic before each access to maintain asepsis Reduce the potential for reflux of blood into the catheter lumen upon connection or disconnection

Neutral Fluid Displacement

Summary IV connector products differ on CFU growth and CRBSI rates Dr. Jarvis instructs us in his 2009 article Design Features Matter IV Connector products must have all 10 design features to significantly reduce occlusions and CR-BSI s

44 Ideal design Septum surface Smooth external surface with few if any gaps Can be thoroughly disinfected Septum seal Tight seal between septum and connector housing Fluid pathway Direct/straight fluid pathway Facilitates adequate flushing Reduces internal surface biofilm development

45 Ideal design Dead space Little or no dead space in fluid pathway Minimize surfaces that infusates can contaminate and biofilm development Internal mechanism Direct and least tortuous fluid pathway No moving parts in fluid pathway Clamping sequence Does not require a clamping sequence

46 Ideal design Visibility Transparent fluid pathway Blood reflux Little or no blood reflux Flushing solution Flushed with saline-only

Agenda 1 Incidence of CR-BSI in the United States 2 3 Routes of contamination How do clinicians fit into the picture? 4 5 HATS model Anatomy of a connector 6 Clinical evidence 7 Making an evidence-based clinical decision

CR-BSI Reduction 9.7 Series 1 Invitro Migration p<0.0001 Mean numbers/day CFUs >= 15 On 4 types of organisms Clinical p<0.00046 Total PRE days: 56,346 Zero days: 65,653 Total study days:121,999 6.75 3.5 3.3 1.9 1.7 0.7 0.15 0.15 0.975 SPLIT SEPTUM NPMV PPMV 1.75 NPMV NEUTRAL NEUTRAL PPMV ZERO Original Zero APIC 2011

2013 Johns Hopkins Study Evaluating Intravenous Needleless Connectors: An Evidenced Based Practice Project Comprehensive market analysis with 19 needleless IV connectors identified and considered based on key factors: septum surface, septum seal, fluid pathway, dead space, internal mechanism, clamping sequence, visibility, blood reflux and flushing solution. RyMed Technologies InVision-Plus with Neutral Advantage IV connector was a clear leader, outperforming positive, negative and other neutral displacement needleless IV connectors (including ICU Medical s MicroClave in in-vivo studies). CR-BSIs were reduced by 33.3% at The Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Hospital. Upon completion of this project, the hospital converted all central lines to the RyMed product. Additional findings include decreased use of Alteplase for declotting catheters in both the Oncology out-patient and inpatient settings. An average of 50% reduction in the use of Alteplase was noted during the evaluation. A complete list of 23 clinical studies conducted by top institutions can be found in the Appendix. These studies have been either published in specialized journals (e.g. the American Journal of Infection Control; Journal of the Association for Vascular Access; British Journal of Nursing) or presented as poster presentations at different congresses.

CR-BSI Reduction University of Louisville Hospital (2013) The CR-BSI rate decreased from 4.92 per 1000 catheter days to 3.13 per 1000 catheter days Equates to a 36% reduction of CR-BSIs in the Bone Marrow Transplant Unit

CR-BSI Reduction Protection of Intraluminal Pathway with Zero Fluid Displacement Connector Reduces Catheter-Related Bloodstream Infections in a Comprehensive Cancer Center Contamination of intraluminal pathway leads to CR-BSI Positive, negative displacement, and Split Septum devices linked to CR-BSI Zero fluid displacement decreased CR-BSI from 4.2 to 0.4/1000 catheter days6 months later, ICU CR-BSI from 2.24 to 0/1000 catheter days JAVA Vol 17, No 2, 2012 JAVA Vol 17, No 2, 2012

CR-BSI Reduction Achieving zero central line-associated blood stream infections: Connector design combined with practice in long-term acute care center 24,870 total catheter days Split Septum 10,479 6.0 Negative 4,257 3.3 Neutral 10,134 0.5 JAVA Vol 17, No 2, 2012

Occlusion Reduction PICC Occlusion Rates: Prospective study comparing positive pressure I.V. connector versus neutral displacement I.V. connector Using the neutral displacement IV connector and saline only flush resulted in: 21% unable to draw blood 15% sluggish to draw 12% totally occluded AVA 2006

Occlusion Reduction Clinical comparative evaluation of split-septum and zero fluid displacement connectors on central venous catheter occlusion ICU occlusion rate from 14.35 to 11.467/1000 catheter days (20%) Pediatric inpa ent from 101.62 to 54.87/1000 catheter days (46%) Pediatric outpa ent from 26.22 to 2.106/1000 catheter days (93%) All areas averaged a 73% in occlusion rates ONS 2011

Agenda 1 Incidence of CR-BSI in the United States 2 Routes of contamination 3 4 How do clinicians fit into the picture? HATS model 5 Anatomy of a connector 6 Clinical evidence 7 Making an evidence-based clinical decision

Evidence-based Practice Nursing research: a systematic process for inquiry that uses rigorous guidelines to produce unbiased, trustworthy answers to questions about nursing practice.

Evidence-based Practice Evidence-based practice is taking the best evidence, partnered with patient values and clinician judgment, to produce safer, higher-quality outcomes. Research practice

Evidence-based Practice According to the Institute of Medicine Learning Healthcare System nurses incorporate research into practice only 10% of the time 0nly 10% of what nurses do on a daily basis is based on any research or evidence

Evidenced-based Practice Moving toward an evidence-based practice culture Think about what is of particular interest Ask about joining other studies or help as a data collector Assist in the analysis of the data to increase comfort with the process

Evidenced-based Practice Moving toward an evidence-based practice culture Observe and question other nurses practice Encourage and support journal clubs Encourage and support staff participation in research and EBP projects

Translating Evidence-based Practice into Vascular access Carefully select a needleless connector based on design features, patient need, & clinical evidence Know type, design, technique required to use appropriately; benefits & risks of selected connector Utilize aseptic technique with each manipulation Disinfect the hub before each access Adhere to policy for connector changes Flush based on hospital policy and access type

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