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Make it Happen! Breaking Through Barriers to Implement Critical Care Nutrition Guidelines

Sponsor Disclosure: Financial support for this presentation was provided by Nestlé HealthCare Nutrition, Inc. The views expressed herein are those of the presenter and do not necessarily represent Nestlé’s views. The material herein is accurate as of the date it was presented, and is for educational purposes only and is not intended as a substitute for medical advice. Reproduction or distribution of these materials is prohibited. Copyright 2012 Nestlé. All rights reserved. 1

Welcome Dr Juan Ochoa MD, Dr. MD FACS z

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Tenured Professor of Surgery and Critical Care Associate Medical Director of Trauma Services University of Pittsburgh Medical Center (UPMC)

Disclosures • Medical consultant for Nestlé HealthCare Nutrition, Inc.

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Objectives ¾ Identify

common barriers to implementing guidelines guidelines. z Find solutions.

¾ Describe

educational protocols designed to improve delivery of enteral nutrition.

¾ Describe

a protocol for use of immunemodulating formulas in surgical patients. 3

Barriers and Facilitators to Making it Happen! Dr. Daren Heyland MD, FRCPC, MSc Full Professor of Medicine, Queen’s University, y, Kingston g General Hospital, ON Canada

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Disclosures Research Contracts with the Following Companies: • Nestlé Nutrition • Baxter • Fresenius Kabi • Abbott Nutrition

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% calories received d/prescribed

Results of 2007 International Nutrition Practice Audit

ICU Day Best Performance Site Worst Performance Site

Mean

Average time to start of EN : 46.5 hours (site average range: 8.2-149.1 hours) In patients with high gastric residual volumes: ¾use of motility agents 58.7% (site average range: 0-100%) 6 ¾use of small bowel feeding 14.7% (range: 0-100%) Cahill N Crit Care Med 2010 (in press)

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% received/prescrib bed

Adequacy of EN: Kcals

Canada

Australia & New Zealand

USA

Europe & South Africa

China

India

Latin America

Total

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Cahill N Crit Care Med 2010 (in press)

Relationship Between Increased Calories and 60 day Mortality BMI Group

Odds Ratio

Overall

0.76

0.61

0.95

0.014

3days

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5.16

3.92

*4.92

*Reflects a 1 day increase in the average number of days >3 days 53 53

Project Successes & Barriers Successes • Increased NPO/CL awareness • Engaged Nursing in data collection • Residents meet weekly for “lunch & learns” • “President’s Cup” Quality Fair Award – Facility Awareness/recognition

Barriers • Setting up physician inservices – Appropriate contact – Getting them to attend

• Lead time needed for Medical Grand Rounds • Staff turnover – Lead Dietitian – Nurses – MD Resident ICU rotations 54 54

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UPMC Future Considerations • Monitor the clinical benefits/outcomes of early enteral nutrition – Decreased length of hospital stay and/or days in ICU – Reduced days on mechanical ventilator – Reduced infectious complications

• Pop-Up alert in EHR once NPO/CL >3 days • Ongoing education and inservicing of medical staff on benefits of early feeding in the critical/ICU patient – A MUST! • Implement an “Early Enteral Feeding Protocol” 55 55

Summary/Key Points • Educational approach improves compliance with Early Enteral Feeding • Staff buy-in, especially MD Champion • Organized approach • Baseline data – “current state” – Justifies • Enough lead time to schedule MD inservices • Ongoing education/inservicing YOU CAN MAKE IT HAPPEN!! 56 56

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Interdisciplinary Team

Sherri Jones, MS, MBA, RD, LDN; Emily Plumb, RD, LDN, CNSD; Joyce Scott-Smith, MS, RD, LDN; Ronald Stiller, MD; Steven Clute, MD; Sharon McEwen, RN; Marcy Zoller, MSN, CRNP 57 57

Immune-modulating ImmuneNutrition Protocols: Key Aspects of Success ¾

Dr. Robert Martindale MD, PhD, Professor and Chief

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Division of General Surgery Medical Director, Hospital Nutrition Services Oregon Health and Science University

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Disclosures: Advisor, Nestlé Nutrition

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CNW 2010 Breakfast Symposium Immune Immune--modulating Nutrition Protocols: Key Aspects of Success Robert G. Martindale MD, PhD Professor and Chief Division of General Surgery Oregon Health and Science University Portland Oregon USA 59

Introduction: Nutrition Guidelines • Basic Recommendations Not absolute requirements Do not project or guarantee outcome or mortality benefits Not a substitute for clinical judgment • Supportive evidence Current literature National, international guidelines Expert opinion Clinical practicality • Target population Adult critically ill medical and surgical patients Expected to stay in ICU ≥ 2-3 days Not a homogeneous population 60

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Model for New Guidelines

CCM 2004;32:858-873 JPEN 2003:27:355-373 61

Model for New Guidelines Surviving Sepsis

• Topic-driven •

Brevity



Clarity



Specificity



Transparency p y



Renewable



Free access 62

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Grading of Literature • Definition of large trial Fulfill endpoint criteria per power analysis Size > 100 subjects •

Use of Meta-Analysis Organize information Derive overall treatment effect N t tto grade Not d recommendation d ti



Review papers, consensus statements = Expert opinion



Grade based on level of evidence of individual studies 64

Grading of Recommendations • Grade of Recommendation: A Supported by at least two level I investigations B Supported by one level I investigation C Supported by level II investigations only D Supported by at least two level III investigations E Supported by level IV or level V evidence • Level of Evidence: I Large, randomized trials II Small, S ll randomized d i d trials ti l III Non-randomized, contemporaneous controls IV Non-randomized, historical controls V Case series, uncontrolled studies, expert opinion Adapted from Dellinger (CCM 2004;32:858-873)

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Guidelines: Why do people not follow them ? • Inherent bias • Arguments against implementing standard guidelines • Too expensive to implement » “we are an indigent care hospital…..”

• No internal support to implement » “my doctors don’t really care…”

• Feeling the guidelines will not apply to their patients » “my ICU patients are sicker or somehow different than those described in the guidelines….”

• “What we are currently doing is fine” » Most make this statement without critical evaluation of internal data

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E1. Selection of Appropriate Enteral Formulation • E1. Immune-modulating enteral formulations (supplemented with agents such as arginine, glutamine, nucleic l t i l i acid, id omega-3 3 ffatty tt acids, id and d antiti oxidants) should be used for the appropriate patient population (major elective surgery, trauma, burns, head and neck cancer, and critically ill patients on mechanical ventilation), being cautious in patients with severe sepsis. ((For surgical g ICU patients …..Grade: A)) (For medical ICU patients …..Grade: B) • ICU patients not meeting criteria for immunemodulating formulations should receive standard enteral formulations. (Grade: B)

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ESPEN Guidelines Intensive Care (2006) • Immune-modulating g formulae are superior p to standard enteral formulae: Grade A

Kreymann KG Clin Nutr 2006

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ESPEN Guidelines Surgery (2006) • Patients undergoing surgery who are considered to have no specific risk of aspiration, may drink clear fluids hours anesthesia: Grade A fl ids until ntil 2 ho rs before anesthesia • Use of preop carbohydrate loading in patients undergoing major surgery: Grade B • Use of EN preferably with immune modulating substrates (Arg, omega 3 FA etc) peri-operatively independent of nutritional risk for those patients • Head and Neck, Major GI, Trauma

GRADE A 69 Weimann A Clin Nutr 2006

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“Carbo” Loading Pre-op • Principle is similar to preparation for major sports event ! • 8 hours pre-op 800 cc isotonic CHO solution • 3 hours pre-op 300 cc isotonic CHO solution • Shown to: • Not increase risk of aspiration • Protect lean body mass post-op » Maintain hand grip strength, etc

• Decrease insulin resistance post-op Ljungqvist O 2009 Faria MS WJS 2009

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Example Case Study: Esophageal CA Use of Guidelines • 64 yo male presents to Primary Care with severe dysphagia, 15 pound weight loss • • • • • •

PMH: GERD, HTN PSH: appendectomy 18 yo Meds: prescribed PPI, HCTZ (rarely takes 2nd $ issues) Social: tobacco +, 40 pack yr history PE: no major finding W/U: EGD with mucosal based lesion distal esophagus » 70% of lumen occluded » Biopsy: moderately differentiated adenoCa » Metastatic W/U (CT chest abd, bronch), EUS, lymphadenopathy 71

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Case continued: Esophageal Ca • Discussion at Med/Surg GI Cancer Conference • Sur/Onc, Med/Onc, Radiation/Onc, Nursing, PT, etc • Decision to proceed with surgery following pre-op pre op neoadjuvant therapy (T2N1M0 adenoca of esophagus) • 6 wk of Chemo/Radiation • PEG, Lap J, NJ tube, PO intake ? • Following neoadjuvant therapy tolerating liquids without problems • At pre-op visit – counseled on importance of specific pre-op nutrition (initial discussion done with primary Surgeon) • Nurse in clinic gives pre-op handout – Inclusion in pre-op instruction is the pre-op Immune-modulating formula (IMF) 72

OHSU Pre-surgical Nutrition Protocol Esophagectomy modulating formula • Oral immune immune-modulating • (containing arginine, fish oil, and nucleotides)

• Three 8 oz cartons per day (24 oz per day) 5-7 7 days prior to surgery • 5

Waitzberg World J Surg 2006 Braga M Arch Surg 2002

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Local problems and solutions • Problem: pre-op formula is expensive • Solution: • Shift to pharmacy budget • Appeal with financial argument to administration to cover up front cost » Cost effective argument must have data and tables etc

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Local problems and solutions • Problem: our doctors will never order the formula • Solution: education program; variable arguments based on audience • • • •

MDs ; ??? Nurses; patient benefit, length of stay, tolerance Pharmacy; cost, logistics and science Administration; financial argument

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Local problems and solutions • Problem: How do the patients get the formula as outpatient ? • Solution: • Store product with dietary enteral formula supply – i.e. pay in cafeteria; take receipt to stock room

• Arrange with two or three local pharmacies to carry – Key here is to not dilute the usage too much

• Purchase on-line • Stocking in MD’s office » Not practical in most settings

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Local problems and solutions • Problem: Patients leave with good intentions and g with buying y g the formula do not follow through • Solution: MD discusses with patient • Simple discussion of the data on infection, length of stay etc

• Problem: Patients forget what they need when th arrive they i att the th pharmacy h • Solution: Patients given pre-op handout with name, quantity needed, etc • Make it very easy to follow 77

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Old Subject… new data coming • Problem: “I thought arginine is toxic” • Solution: No adverse data ever shown in surgical patients ti t • Drover, Heyland, Wischmeyer et al. Ann Surg 2009 Submitted • 28 RCT with 3055 patients • Primary outcomes: • Reduced infections P=0.00001

• Secondary outcomes • Reduced length of stay • - 1.74 days P=.0008 • No change in mortality 78

Arginine in Surgery and Critical Care: • AA relationships • Competitive for cell transport – Arginine Lysine A i i /L i ratios ti

• Arg increases Gln • Patient on steroids • Significant increase ARGase

• Arginine in obese trauma patient • Increase insulin sensitivity • Glucose control • Lipid lowering (TG)



Arginine in cardiovascular / endothelial function • Restore NO, decreases SO• Decrease platelet and leukocyte adherence

• Liver /GI function • Activates mTOR, MAP kinase to enhance protein synthesis, cell migration (enterocytes) • Improves GI function • Decrease injury from I/R • Improve GI ulcer healing

• Wound healing / muscle strength • • • • •

mTOR activation Decrease proteolysis (indirect) Increase proline Increase tensile strength Local mechanisms – DM foot

• Antioxidant effects • Increases creatine; decreases 79 inflammation

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OHSU - Pre-operative nutrition protocol implementation • Steps to get protocol implemented – Education program • Residents, faculty arguments) Residents fac lt (science arg ments) • Nurses (science argument, add practical portion) • Administration (cost effectiveness argument)

– Finding a Physician advocate, supporter • “can’t teach old dogs new tricks”

– Determine funding or who will pay the increased “cost” • Hospital based • Patient based – Internet – Local pharmacy

– Make it easy for patients and MDs ordering • Handouts for patients: make if very easy • Make it standard unless otherwise indicated 80

Current ICU protocols in effect - OHSU • Trauma ICU: • Immune-modulating formula (IMF), Antioxidant, probiotics

• Surgery ICU: • IMF, Antioxidant, probiotic

• Medicine ICU • Probiotic

• Neurosurgery ICU • Early enteral feeding, probiotics, IMF

• BMT ICU • None

• Cardiac ICU • Anti-inflammatory diet (Mar 10) 81

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OHSU Post-operative Nutrition Protocol Trauma • Upon IV access – Vitamin C – Selenium

• Within 48 hours – Enteral feeding tube placement – Vitamin E via feeding tube – Glutamine via feeding tube

• Gastric or small bowel feeding – Start Immune modulating formula 20 cc /h • Immune-modulating formula (IMF) contains arginine, fish oil and nucleotides • Advance as directed in protocol

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Local problems and solutions • Problem: “How long should we give the Immuneg formula (IMF)?” ( ) modulating • Solution: No exact data yet published • Pre-op at least 5 days

– Braga 02, Gianotti 02, Ryan 09 • Post-op

– Not needed if nutritionally replete pre-op – 7 to 10 days?

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ICU Nutrition Protocol Development Strategy • Nutrition “therapy” team discussion of pro and con • Does the data support pp making g it a standard protocol p ?

• Once the decision is made to develop protocol • Committee member prepares outline draft in hospital format (for incorporation into chart, electronic record) • Distribute to key services for comments (this is key)

– Committee accumulates data pro and con and presents to ICU committee or equivalent – Key here is to have clearly designated inclusion and exclusion criteria » Be as broad as possible » Error on safe side (example Arginine 2003 vs 2007) » Have financial data ready

• Implement protocol • Have references available and be ready for “attack”

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Summary and Conclusion • Guidelines are just that, Guidelines g • No guarantees

• Clinical judgment always takes precedent over guidelines • Guidelines will change with ongoing trials, keep an open mind • For patients and health care team to support • It must be easy • It should respect work load of implementing individuals • It must be science-based and data driven, showing positive outcome

• Protocols incorporating guidelines improve outcome 85

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Summary and Conclusion • Focus your energy on matters with greatest p potential for success • Get $ support first ! • Education: – Get an advocate with as much “horse power “ as possible – Specific education program for each group » One size fits all does not work

• You will have some failures and many who “won’t listen” • i.e. CHO loading, NPO after Midnight, probiotics

• Pick your battles carefully 86

Call to Action ¾ Consider

being more aggressive (when appropriate) with Early Enteral Nutrition protocols to meet Guideline recommendations z Starting at or near target rate for caloric g goals z Starting motility agents when the feed starts z PEP uP Protocol to be published soon 87

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Call to Action ¾ Use z

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ALL the tricks in your bag Benchmark, Educate, and Monitor data ongoing Use Enteral Quality Initiative Programs and reminders! Develop Standing Orders and Bedside Algorithms incorporating Guidelines 88

Call to Action ¾ Remember,

immune-modulating nutrition protocols may have pre pre-surgical surgical and/or post-surgical applications. z Make science based case focused on outcomes z Find a champion; determine funding z Create clear exclusion/inclusion criteria z Keep it simple for staff and patients 89

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Thank you !

Sponsor Disclosure: Financial support for this presentation was provided by Nestlé HealthCare Nutrition, Inc. The views expressed herein are those of the presenter and do not necessarily represent Nestlé’s views. The material herein is accurate as of the date it was presented, and is for educational purposes only and is not intended as a substitute for medical advice. Reproduction or distribution of these materials is prohibited. Copyright 2012 Nestlé. All rights reserved. 90

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