6/27/2018

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Webinar forSynova AssociatesJune  27, 2018

An Overview of Successful 

Implementation Strategies for 

Innovative Therapies in the NICU

From Bench to Bedside and Back

• Disclosure Statements

• Terry S. Johnson, APN, NNP‐BC, ASPPS, CLEC, MN

– Prolacta Bioscience employee

– Abbott Nutrition Health Institute (ANHI) as a presenter

• Pam Middleton, RN, BSN, MPA

– Member of the Prolacta Bioscience Nurse Practice Advisory Council (NPAC)

• Kim Carmignani, MSN, RNC‐NIC, CNE, CPN, CLC

– Member of the Prolacta Bioscience Nurse Practice Advisory Council (NPAC)

From Bench to Bedside and Back

• Disclosure Statements

• We personally developed this slide deck for strictly educational purposes and audiences

– Images & photographs used in the presentation are from publicly accessed sources

– It without bias, branding or commercial influence               and it is evidenced‐based

– We will make no recommendation for an off‐label use of  any drug, nutritional, or medical device

From Bench to Bedside and Back

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From Bench to Bedside and Back

Awareness, adoption and implementation of emerging, innovative therapies is a critical skill for today’s nurse leader. 

This presentation will review the process of identifying clinical needs, negotiating barriers, and facilitating successful implementation 

of new therapies and products for the NICU patient population.

From Bench to Bedside and Back

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“Innovation is the application of creativity or problem solving that results in a widely adopted 

strategy, product or service that meets a need in a new and different way.” 

From Bench to Bedside and Back

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it is the starting point for change. 

From Bedside to Bench From Bench to Bedside

Innovation in Healthcare

From Bench to Bedside and Back

From Bench to Bedside and Back

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AAP: Breastfeeding & Use of Human Milk 2012Mother’s own 

milk,  

– fresh or frozen, should                   

– be the primary diet.”

American Academy of Pediatrics. Breastfeeding and the Use of Human Milk. Section on Breastfeeding.[originally published online February 27, 2012]. Pediatrics. DOI: 10.1542/peds.2011-3552

“The use of  banked human  milk   as the “first 

alternative” to  own mother’s milk.”

““It should be fortified appropriately for                  

infants born weighing             less than 1.5 kg.” 

“The potent benefits of human milk are such that   all preterm infants should 

receive human milk.”

“Mother’s own milk,  fresh or frozen, should                   be the primary diet.”

“Mother’s milk should be fortified

appropriately for the infant

born weighing less than1.5 kg.”

From Bench to Bedside and Back

6/27/2018

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AAP: Breastfeeding & Use of Human Milk 2016M”other’s 

own milk,  

– fresh or frozen, should                   

– be the primary diet.”“Biologics are medical 

products…they come from natural sources.”

“Provides health benefits for all newborns. Role as a 

a bridge to mom.”

“Particular importance forthose born VLBW (<1500 

g) and decreasing the rates of NEC.”

“Human Milk is a

Biologic.”“Biologics are intended     to treat diseases and medical conditions;           

biologics are intended             to treat …prevent or diagnose diseases 

U.S. Food and Drug Administration. FDA Basics; What is a biological product? U.S. Department of Health and HumanServices.

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194516.htmPage Last Updated: 05/31/2016

American Academy of Pediatrics. Donor human milk for the high-risk infant: preparation, safety and options in the United States. Committee on Nutrition, Section on Breastfeeding, Committee on Fetus and Newborn. Pediatrics, vol 139, number1, January 2017:e20163440. DOI: 10.1542/peds.2016-3440.

From Bench to Bedside and Back

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What is the Exclusive

Human Milk Diet?

T Johnson, In Presentation, 2017

From Bench to Bedside and Back

• EHMD: Multicenter Retrospective Cohort Study

– Objective• To compare clinical outcomes in 1,587 Extremely Premature infants (birth weight <1250 g) before and after an institutional change to the use of an exclusive human milk–based diet (EHMD) including fortifiers from a diet that included cow milk‐based (CMD) products (formulas and/or fortifiers)

– Method

• Conducted at four geographically disparate hospitals:  Texas, California, Illinois, and Florida. Each of the four hospitals reviewed charts from an equal period before and after implementing an exclusive human milk‐based protocol

11Hair A, et al., "Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. " Breastfeeding Medicine. 2016; 0:1-5

From Bench to Bedside and Back

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• Study Hospital’s Feeding Protocols

Hair A, et al., "Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. " Breastfeeding Medicine. 2016; 0:1-5

Texas Children’s Hospital • <1250 g BW to 34 weeks PMA• EHMD fortification initiated at 60 mL/kg/day• At 100 mL/kg/day fortification increased to 26 calories/oz• If weight gain was <15 g/kg/day, fortification was increased 

to provide 28 cal/oz and then 30 cal/oz. of an EHMD.

Good Samaritan San Jose• <1000 g BW protocol continued until 60 days of age• EHMD fortification initiated at 100 mL/kg/day at 24 cal/oz• At 150 ml/kg/day fortification increased to Pan EHMD fortified 

to 26 cal/oz and 28 cal/oz as needed

Winnie Palmer Hospital • ≤750 g BW and ≤26 weeks gestational age to 32 weeks PMA• EHMD fortification initiated at 100‐120 mL/kg/day • If weight gain was deemed suboptimal by the attending doctor 

based on growth curve velocity, an additional 2‐4 cal/oz of EHMD fortification was added to the feeds for a total of 26‐28 kcals/oz

Northwestern • <1000 g BW to 34 weeks PMA or 1500 g, then transitioned 

off• EHMD was initiated at 100‐120 mL/kg/day at 24 cal/oz• If weight gain was <15 g/kg/day, fortification increased to an 

EHMD of 26 cal/oz.• Increased to a 28 cal/oz EHMD if low weight gain continued

From Bench to Bedside and Back

6/27/2018

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• Oxygen Radical Disease of Neonatology

Trindade & Rugolo. Free Radicals and neonatal diseases. NeoReviews 2007;8(12); e522-e632; DOI: 10.1542/neo.8-12-e522

Inflammation

Infection

Ischemia

Reperfusion

Increased ROS Production

Deficient Antioxidant Defenses

Cell/Tissue/Organ Injury

Retinopathy of PrematurityChronic Lung Disease/BPD

Periventricular LeukomalaciaIntraventricular Hemorrhage

Necrotizing EnterocolitisPatent Ductus Arteriosus

Cerebral Palsy

From Bench to Bedside and Back

Oxidative Stress

• EHMD: Multicenter Retrospective Cohort Study

– EHMD group had significantly lower incidence of: 

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CMD EHMD P Value

NEC 16.7% 6.9% p < 0.00001

Mortality 17.2% 13.6% p = 0.04

BPD 56.3% 47.7% p = 0.0015

ROP 9.0% 5.2% p = 0.003

PDA 64.7%  55.1%  p = 0.0001

Late‐Onset Sepsis  30.3%  19.0% p < 0.00001

? What are we seeing here?

? Role of similar  pathophysiology of disease?

? Similar protective benefits of an EHMD?

Hair A, et al., "Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. " Breastfeeding Medicine. 2016; 0:1-5

From Bench to Bedside and Back

Source: The Deming Institute, The PDSA Cycle https://deming.org/explore/p‐d‐s‐a

From Bench to Bedside and Back

PLAN

DOSTUDY

ACT

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Implementation of  an EHMD to reduce the incidence of 

necrotizing enterocolitis (NEC)  in VLBW Infants

Pam Middleton, RN, BSN, MPA

6/27/2018

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• Community Level III NICU in the heart of Oakland, CA

– In 2009 the rate NEC in our unit was slightly over 16% 

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“We had to do something.”

From Bench to Bedside and Back

• Community Level III NICU in the heart of Oakland, CA

– NICU Leadership Team• Medical Director

• NICU Department Manager

• Lactation Nurses

• Neonatal Nurse Practitioner

• Clinical Educator (CE)

• Clinical Nurse Specialist (CNS)

• NICU Dietitian

• Staff Nurses

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From Bench to Bedside and Back

• Determining the Cost of NEC in Our Facility

– Cost for One Patient over a 2 week period

– Additional hospital stay x 14 days at Level III facility rates

– NPO and on TPN and intralipids

– Insult to gut being NPO

– Central line insertion and maintenance

– Antibiotics x 10‐14 days

– Numerous X‐rays (KUB’s and chest) 

– Labs i.e., chemistry, drug level, CBC, cultures, etc.

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From Bench to Bedside and Back

• Determining the Cost of NEC in Our Facility

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Cost to Organization

Cost of EHMD Feeding Products

Cost to Infant  and Family

From Bench to Bedside and Back

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• Determining the Cost of NEC in Our Facility

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$ 300.00‐$1,000.00 per infant per day

$500,000 per year for all neonates < 1250g

Immeasurable

From Bench to Bedside and Back

• Determining the Cost of NEC in Our Facility

– Cost Analysis completed

– Presentation to the Executive Board

– Approved by unanimous decision

– Prioritize  of implementation strategy

– Time line for implementation events

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From Bench to Bedside and Back

• Factors that Facilitated Adoption Process

– We were the 5th Level III NICU in the Kaiser System to          bring products and EHMD into the system

– We already had a Tissue Bank License in established                as Required in California, New York, and Maryland

– We already had Scientific/Commercial grade  refrigerator and freezer  in place  due to using banked breast milk 

– We saw it as a way to decrease our NEC rate

– Where do we move forward from here?

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From Bench to Bedside and Back

• Implementation in Facility and NICU

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From Bench to Bedside and Back

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• Implementation in Facility and NICU

– Contacted the product representative

– Determined amount/type of product for use

– Worked with purchasing to set up an account

– Determine equipment and space needs for product 

– Establish documentation  model for  medical record

– Create log to document serial numbers, exp. date, etc.

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From Bench to Bedside and Back

• Implementation in Facility and NICU

– Write procedures on how to use product

– Began plan/schedule for implementation of diet

– Notify other departments who will be impacted

– In‐service NICU staff

– Delivery, storage,  equipment check, metrics

– Specific in‐service/demonstration on mixing product

– Presentation at staff meetings  for L&D, Mother‐Baby staff

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From Bench to Bedside and Back

Log Sheets

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From Bench to Bedside and Back

• RESULT

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From Bench to Bedside and Back

NEC rate reduction from 16% in 2009 to < 2% in 2016

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• RESULT

Diane Spatz, PhD,  RN‐BC, FAAN

From Bench to Bedside and Back

“In the NICU, human milk must be viewed as a medical intervention  

that is just as important asIV nutrition or a ventilator.”

• RESULTS:

– Cost savings

‐ Less central line days

‐ Less TPN days

‐ Less CLABSI

‐ Shortened length of stay

‐ Improved breastfeeding/MOM production

‐ Staff satisfaction with outcomes

‐ Hospital satisfaction with outcomes30

From Bench to Bedside and Back

• It’s NEVER Just One Thing Changing…

– Use of feeding calculator by MD/NP/RD for               volume and fortification needs

– Daily rounds with NICU interdisciplinary team:

• PICC line/TPN need/management

• Monitor mom’s available milk volume

• Need for intervention from Lactation Consultants

– Incorporation of lessons learned in new facility31

From Bench to Bedside and Back

• Regional Center Level III NICU in heart of Oakland, CA

– New NICU and Hospital opened in July 2014

– New unit had designated milk room

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From Bench to Bedside and Back

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Milk Room

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From Bench to Bedside and Back

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Kim Carmignani, MSN, RNC‐NIC, CNE, CPN, CLC

Implementation of  an EHMD for  

multiple gestation preterm infants                                                                                                  secondary to a parent driven 

request

• First Community Level III NICU in the Chicago Suburbs 

• Unit opened in 2000

• 28 NICU beds

• Received both maternal and neonatal transports

• Part of multi‐site healthcare system

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“We had to do something.”

From Bench to Bedside and Back

• First Community Level III NICU in the Chicago Suburbs 

• In December 2015 a 26 weekG2P1 mom with quadsrequested an exclusivehuman milk diet for herinfants

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“We had to do something.”

From Bench to Bedside and Back

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• Determining the Cost/Risk Benefit Ratio in Our NICU 

– Cost of not honoring a family’s request

– Cost Analysis completed

– Presentation to the Executive Team

– Approved by unanimous decision

– Prioritize  of implementation strategy

– Time line for implementation events

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From Bench to Bedside and Back

Determining the Cost to Meet Parent’s Request

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Cost to Organization

Cost of EHMD Feeding Products

Cost to Infants  and Family

From Bench to Bedside and Back

• Determining the Cost to Meet Parent’s Request

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$12,500 per infant

$650,000 per yearFor all neonates <1250 g n=52

Short term benefits Long  term benefits

From Bench to Bedside and Back

• Implementation in Facility and NICU

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From Bench to Bedside and Back

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Who do you need on your team?

• Neonatologists, NNP’s

• Lactation Consultant

• Dietitian

• The entire nursing team

• Parents

• Finance/Billing/EMR Expert/Charge master

• Inventory expert

• Product Representative

From Bench to Bedside and Back From Bench to Bedside and Back

Some Considerations Before Implementation: 

• Establish a feeding protocol 

‐ Not only for how to feed but who to feed

• Providing the right tools/supplies/support  will encourage pumping and storage

• Communication with and within the team

• Weaning/transition protocol review and discussion 

From Bench to Bedside and Back

Onboarding L+D Labor and Delivery

• Pumping – research based studies show the sooner that Moms pump post delivery for their NICU baby the move consistent their milk production (Parker, 2012)

• Providing the right tools/supplies/support will encourage pumping and storage

• Early and frequent skin‐to‐skin (Spatz, 2015)

• Communication with the team

From Bench to Bedside and Back

Onboarding Lactation

• Teaching moms to pump in L&D within                             1st hour of delivery and q 3 hours after

• Teach plan to provide benefits of oral care with colostrum q 3 hours

• Maintain mother’s milk production and volume during postpartum period and after discharge

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From Bench to Bedside and Back

Onboarding Nursing Staff

• Mixing at bedside or at feed preparation station

• Freezer with temperature monitoring /Warming units/Refrigerator storage location

• Staff Training

• EMR scanning/verifications

• Recipes readily available and reviewed with staff for accuracy

• Encouraging utilization of tools provided rather than work arounds

From Bench to Bedside and Back

Onboarding Parents

• Parent is a team member

• Informed consent

• Transition protocol

• Commitment to pumping

• Commitment to skin‐to‐skin

• Commitment to infant’s care

From Bench to Bedside and Back

Onboarding the Finance Team 

• Who is the right person? 

• What billing codes and where to place the charges depend on payor mix and contracts

• Daily charge vs pharmacy

• Recheck revenue

From Bench to Bedside and Back

Onboarding Medical/NNP Team 

• Education on product  specifics

• Feeding protocol toolkit

• Transition protocol management

• Establish data metrics 

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From Bench to Bedside and Back

Onboarding Inventory Expert

• Determine needs and order

• Shipping/receiving  (product arrives frozen)

• Tracking product/expiration dates

• Monitoring usage

• Managing dry Ice

• Always train two!

• RESULTS

– 52 VLBW infants placed on EHMD 

– 12 sets of multiples (one set was split                  because of protocol)

– Increased parent satisfaction and involvement 

– Improved breastfeeding at time of discharge from 45% to 67%

From Bench to Bedside and Back

ZERO CASES OF Medical or Surgical NEC!

• Lessons Learned 

– Multiples are different

– Splitting product bottles

– Special patient circumstances

– Don’t forget the transports!

From Bench to Bedside and Back From Bench to Bedside and Back

• Lessons Learned 

– Data collection

– Answering to the C‐suite when the first bill arrives

– Take Pauses: 1 week, 2 weeks, 1 month

– Make a timeline for how often to review

– Be on the look out for work arounds

– Celebrate outcomes

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• Benefits 

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From Bench to Bedside and Back

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Describes how seemingly opposite or contrary forces may actually be complementary, interconnected, and interdependent 

and how they may give rise to each other, two halves that together complete wholeness –

it is the starting point for change. 

From Bedside to Bench From Bench  to Bedside

From Bench to Bedside and Back