Slide 1

Translating Research into Clinical

Lactation Practice

Karen Wambach,PhD, RN, IBCLC, FILCA

University of Kansas School of Nursing

Slide 2

Objectives

• Define Evidence Based Practice (EBP)• Formulate EBP questions using the PICOT

acronym as a guide: P (population), I (intervention or issue), C (comparison of interest), O (outcome)

• Review and synthesize the evidence from published research or reviews of research

• Prepare a systematic plan for applying research findings to improve lactation practice and evaluating outcomes.

Slide 3

Research Utilization (RU)

• Older and narrower concept - nursing 1970s, 1980s, early 1990s

• Demonstration projects – CURN, NCAST, WICHEN

• Refers to the review and critique of scientific research, and then the application of the findings to clinical practice (Polit & Beck, 2012).

• Starting point is the research itself! How can I use this knowledge/evidence?

Slide 4

Evidence Based Practice (EBP)

• Based in definitions posed by Sackett for evidence based medicine (1996)

• “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”

• Broader than RU – considers patient preferences and values, as well as the context of application

• Starts with the clinical problem!

Slide 5

Research Utilization and EBP Models

• Stetler Model of Research Utilization (Stetler, 2001)

▫ Preparation, validation, decision-making, translation/application, evaluation

• The Iowa Model of Evidence-Based Practice to Promote Quality Care (Titler et al., 2001)

▫ Starts with a knowledge focused or problem focused trigger

Slide 6 The Iowa Model of Evidence-Based

Practice to Promote Quality Care

Slide 7 Triggers

Slide 8

Process

Slide 9

Step one: Formulate PICO Question

• P = patient or problem

• I = intervention

• C = comparison intervention

• O = outcomes

• Use a PICO or PIO Format when the goal is to evaluate the best outcome, or use a PI format when the goal is to understand the meaning or process

Slide 10

Example PICO Formats

• Example (PICO): In ………(population), how effective is ……. versus …….(intervention plus comparison) in the prevention of …….(outcome)?

• Example (PIO): For………(population), the use of……….(intervention) leads to ………….(outcome)?

• Example (PI): What is it like for…….(population) to live with………(Interest area)?

Slide 11

Example PICO Question

• In first-time breastfeeding teenage mothers, how effective is peer counselor support versus lactation consultant support in the prevention of early weaning (before 2 weeks)?

Slide 12 Step Two: Find and Appraise the

Levels of Evidence

• Level I: Systematic review or meta-analysis of all relevant RCTs. Systematic review of nonrandomized trials. Evidence-based clinical practice guidelines based on systematic reviews of RCTs.

• Level II: Single RCT; single nonrandomized trial.

• Level III: Systematic review of correlational/observational studies

• Level IV: Single correlational/observational study (case-control and cohort)

Slide 13

Levels of Evidence - Continued

• Level V: Systematic review of descriptive/qualitative/physiologic studies.

• Level VI: Single descriptive/qualitative/physiologic study

• Level VII: Opinion of authorities and/or reports of expert committees

Slide 14

How to search the literature

• PubMed/Medline

• CINAHL

• PsychInfo

• COCHRANE Collaboration

Slide 15

How to Search

Subject search

Search for topics or key words in the databasepostpartum depression

postpartum depression, breastfeeding

Textword search

Search for specific words in text fields of the database record

Author search

Search for a specific researcherWambach K

Slide 16

Slide 17

Conducting the Literature Review

• Objective▫ To describe the research on the problem▫ To identify what is known and not known▫ To synthesize the evidence for an EBP protocol

Slide 18

Guidelines as Sources of Evidence and

Protocols

Slide 19

Slide 20

Slide 21

Slide 22

Slide 23 Step Three: Synthesize for

Implications for Practice

• Formulate guidelines for care

• Test in practice

• Evaluate the outcomes

Slide 24

What is EBP in Lactation Care?

• Problem solving process

• Evaluation of research in clinical application

• Best and highest level of evidence

• Aims for excellence and quality care

• Aims to incorporate patient and family preferences

• Consideration of culture

Slide 25

Let’s do a quick review on a

common lactation issue!

Slide 26 Where it Starts? A Clinical or

Practice Problem

• Should LCs encourage that pacifiers be avoided as recommended by the 10 Steps and BFHI?

• Should pacifiers be encouraged at sleep time to protect from SIDS?

Slide 27

PICO Question

• For first time breastfeeding mothers of full term infants, the use of patient education to encourage pacifier avoidance in the hospital leads to increased exclusive breastfeeding at hospital discharge, one month and three months?

Slide 28

Slide 29

Looking at the Evidence!

• Systematic Review (O’Connor et al., 2009)

▫ 4 RCT, 20 Cohort Studies, 5 Cross-Sectional Studies – Level of evidence I and V

▫ Results from the 4 RCT showed no difference in breastfeeding outcomes

▫ Results from most observational studies reported a negative association between pacifier use and duration of breastfeeding

Slide 30

Cochrane Review – Jafar et al., 2011

• Review of randomised and non-randomised (quasi-experimental) trials comparing pacifier use versus no pacifier use in healthy full-term newborns

• Three trials found

• Two studies – meta –analysis (N=1302) – (Jenik2009 and Kramer 2001)

• No significant effect on exclusive breastfeeding at 3 months or 4 months

• No significant effect on partial breastfeeding at 3 months and 4 months

Slide 31

Evidence From Newer Studies!

• Multicenter, randomized, non-inferiority, controlled trial – Level of Evidence II (Jenik et al 2009)

• N = 1021 – Exclusive well established BF (2 weeks), intended to EBF 3 months, not using pacifier

• Argentina – 5 tertiary medical centers (2 BFHI)

• Intervention – Encourage Pacifier or No Pacifier

Slide 32

New Evidence- continued

• Telephone contacts monthly 1 – 10 months and 12 months or until breastfeeding stopped

• Outcomes – Exclusive BF at 3 months

• Results: 3 months - 85.8% in pacifier versus 86.2% in no pacifier group – non-significant difference

Slide 33

More Evidence – Level IV

• Brazilian Cohort study of 1,309 mother-child pairs (Vieira et al. 2010)

• Data - in hospital and home visits first month

• What predicted discontinuation of exclusive breastfeeding at 1 month?

▫ Lack of prior breastfeeding experience

▫ Cracked nipples

▫ Use of fixed breastfeeding schedules

▫ Pacifier use

Slide 34

Synthesize the Evidence

• RCTs point to no differences in breastfeeding outcomes but observational studies, of lower evidence level, point to negative association of pacifier use and breastfeeding outcomes!

• Early breastfeeding outcomes (1 month) may be more influenced as suggested by some evidence (e.g. Howard et al., 2003)

• Conclude that encouragement to avoid pacifier use in the hospital may be beneficial in short term outcomes, but evidence is mixed!

Slide 35

Evidence Table

Author (Year) Location

Design Sample

Level of Evidence

Interven-tion/IV

Depen-dent Variable

Measures of Outcome

Results

Jenik et al (2009)Brazil

RCT N = 1021

II Encourage Pacifier --No Pacifier

Exclusive BF at 3 months

Self-report

No difference between groups

Slide 36

Summary

• Evidence can provide direction for practice

• Evidence can be contradictory depending on study design

• State of breastfeeding and lactation knowledge is growing

• Continued research is often needed but must use best evidence available now

Slide 37 Systematic plan for applying research

findings in lactation practice

• Pilot the Change In Practice▫ Select Outcomes▫ Collect Baseline Data ▫ Design EBP Guidelines▫ Implement EBP – Pilot Setting▫ Evaluate Process And Outcomes ▫ Modify the Practice Guidelines As Needed

• Is Change Appropriate? • Institute the Change• Monitor and Analyze Structure, Process, and

Outcomes Data

Slide 38 Published Example of EBP

Implementation

Implementing Skin-To-Skin Contact at Birth Using the Iowa Model: Applying Evidence to Practice

Haxton, Doering, Gingras, & Kelly (2012)

Slide 39

Background and Purpose

• Early SSC is beneficial (based in evidence from RCTs) for mothers and babies

• Implement use of SSC in L & D unit

• Minimum of 1 hour immediately after birth

• Iowa Model

Slide 40

Step 1 – Trigger Identification

• Knowledge Focused Trigger

▫ Many nurses not aware of benefits of SSC

▫ Many did not regularly engage in the practice

▫ Recent guidelines had been published

▫ 30 mothers were interviewed and 10 (30%) had discussed with nurse

▫ 15 had been offered SSC

▫ 12 engaged is SSC between 1 and 20 minutes

▫ None for longer than 20 minutes

Slide 41

Step 2: Endorsement of SSC as Facility

Priority• Goals of the birthing center were consistent with the

Healthy People goals relative to breastfeeding

• Baseline – 74% breastfeeding initiation rate; 45% supplementation rate; 31% exclusive breastfeeding at discharge

• Presented the SSC proposal, initial evidence table detailing most current/relevant evidence, and pilot results on SSC to the Best Practice Committee and the unit and hospital leadership

• Endorsed the project

Slide 42

Step 3: Form a Team

• Development, implementation and evaluation tasks

• Birth Center CNS; L&D nurses (greatest membership and from all shifts); physicians; certified nursing assistants; and lactation consultants

• Champion – director of patient safety and quality for the Department of Obstetrics and Gynecology

Slide 43

Step 4: Assemble Research &

Literature• CNS led the effort and distributed work load

• Cochrane Review and meta-analysis of SSC

• Practice guidelines and position statements from AAP, AABM, and AWHONN

• Selected Quality Outcomes:

▫ Breastfeeding initiation rates

▫ Breastfeeding exclusivity at hospital discharge

▫ Maternal satisfaction levels

Slide 44

Step 5: Critique and Synthesize

Research for Practice• Evidence was strong and SSC immediately after

birth for all healthy term infants should be available to stable newborns and their parents

• Current practice was a major issue

• Back to the literature to find evidence for delaying newborn interventions – AAP Breastfeeding and the Use of Human Milk (Gartner et al, 2005)

Slide 45 Step 5: Critique and Synthesize Research

for Practice – Protocol Development

• Information and consent for mother prior to birth

• Infant placed on warm blanket on mother’s abdomen during cord clamp/cut

• Infant then placed directly on mother’s chest with diaper and cap – warm blanket to cover both mom/babe

Slide 46 Step 5: Critique and Synthesize Research

for Practice – Protocol Development

• APGAR and ID bands placed. Weight could be done quickly

• Self-latch allowed unless mother requested

• Formula feeding mothers encouraged to do SSC for temperature and blood sugar benefits to infant

• Those refusing SSC given baby as done previously

Slide 47

Step 6: Pilot Change & Evaluate

• Order sets modified for SSC

• Documentation system (electronic) altered for SSC

• 4 educational sessions for L&D staff

• Discussions on potential barriers to implementation by nurses

Slide 48

Step 7: Evaluation for Decision to Fully

Implement & Follow-Up• Actual offering of SSC (5 weeks after pilot)

• Medical record review – random audit of 30 healthy newborn records 2 weeks post intervention

• Nurses anecdotally reported no increased workload or delay in transfers to mother-baby

• Prenatal education incorporated SSC flyer

Slide 49

Outcome Evaluation

• Breastfeeding initiation increased from 74% to 84% in the 2 quarters following implementation

• Challenges

▫ Assuring staff that SSC would not take more time/common tasks can be safely delayed

▫ Documentation system changes

▫ Order set changes

▫ Scheduling conflicts for team meetings

▫ Providing education to 100% of staff

Slide 50

Questions on Example EBP Project?

Slide 51

Thank You!!

Slide 52

References

• Haxton, D., Doering, J., Gingras, L., & Kelly, L. (2012). Implementing Skin-To-Skin Contact at Birth Using the Iowa Model: Applying Evidence to Practice. Nursing and Women’s Health, 16, 220-229.

• Howard, Howard, Lanphear, et al.,(2003). Randomized clinical trial of pacifier use and bottle-feeding or cup-feeding and their effect on breastfeeding. Pediatrics, 111, 511-518.

• Jenik, Vain, Gorestein, & Jacobi, Pacifier and Breastfeeding Trial Group. (2009). Does the recommendation to use a pacifier influence the prevalence of breastfeeding? Journal of Pediatrics, 155, 350-354.

Slide 53

References

• O’Connor, Tanabe, Stadaty, & Hauk (2009). Systematic Review of Evidence on Pacifier use and Breastfeeding Outcomes . Archives of Pediatric and Adolescent Medicine, 163, 378-382.

• Polit, D. & Beck, C.T. (2012).Nursing research: Generating and assessing evidence for nursing practice (9th ed.). Philadelphia: Lippincott Williams & Wilkins.

• Sackett, D.L., Rosenberg, W., Muir Gray, J.A., Haynes, R., & Richardson, W. (1996) Evidence-Based medicine: What it is and what it isn’t. British Medical Journal, 312, 71-72.

Slide 54

References

• Stetler, C.B. (2001). Updating the Stetler model of research utilization to facilitate evidence-based practice. Nursing Outlook, 49, 272-279.

• Titler, M.G., Kleiber, G., Steelman, Vlk Rakel, B., Burdreau, G., Everett, L., Buckwalter, K., Tripp-Reimer, T., & Goode, C. (2001). The Iowa model of evidence-based practice to promote quality care. Critical Care Nursing Clinics of North America, 13, 497-509.

• Viero, Martins, Vieira, de Oliveira, & Sylvia. Factors predicting early discontinuation of exclusive breastfeeding in the first month of life. J Pediatr(Rio J). 2010 Aug 23;86(5).