EPIC EPIC Evidence-based PracticeEvidence-based PracticeIdentification and ChangeIdentification and Change

Past, Present, and FuturePast, Present, and Future

Shoo K. Lee, MBBS, FRCPC, PhDDirector, Canadian Neonatal Network™

Scientific Director, iCAREProfessor of Pediatrics, University of Alberta

EPIC/PHSI Training WorkshopNovember 9 & 10, 2006

Toronto ON

Presentation ObjectivesPresentation Objectives

• Overview how EPIC evolved

• Describe the science behind EPIC

• Describe future EPIC plans

BackgroundBackground• Continuous Quality Improvement (CQI)

methods have been investigated for reducing bronchopulmonary dysplasia (BPD) and nosocomial infection (NI) in the NICU

• Limitation - existing CQI techniques employ a subjective, uncritical approach to practice change that may not be evidence based

How did EPIC Evolve?How did EPIC Evolve?

Problems with traditional continuous quality improvement (CQI) approachesSubjectiveNot always evidence-basedSeldom use data from institutions in questionMostly intra-institutional in natureResults are not always generalizeable

We developed EPIC to improve upon traditional CQI approaches

EPIC ObjectivesEPIC Objectives• To develop a new scientific method for QI – EPIC

that is:(a) Evidence-based – uses published evidence(b) Objective – uses data from individual hospitals to identify practices for targeted intervention(c) Collaborative – uses a national network to share expertise and experience

• To test whether EPIC reduces BPD and NI in a cluster randomized controlled trial of Canadian NICUs

The Thee Pillars of EPICThe Thee Pillars of EPIC

1. Objective Systematic reviews of evidence

2. Quantitative analysis Multi-centre outcomes and practices Identifies practices associated with outcome

variation that can be targeted for intervention

3. Utilizes collective multi-disciplinary expertise Infection control, quality improvement, etc

MethodMethod• Prospective cluster randomized controlled trial 12 NICUs• Randomization – 6 BPD, 6 NI• Each group Control for other • Additional controls - 5 other NICUs in CNN that were not

participating in the study • All infants < 32 weeks gestation were enrolled• Definition: (a) BPD – O2 need at 36 weeks GA

(b) NI – Positive Blood, CSF or Urine culture

• 2 phases (a) Baseline period (1 year)(b) Intervention period (2 years)

• Funded by Canadian Institutes of Health Research

EPIC - Baseline Period (Year 1)EPIC - Baseline Period (Year 1)

• Baseline data collection on outcomes and practices• Train multi-disciplinary hospital teams• Review of published literature• Meeting to share findings• Identify Critical Care Pathways• Qualitative research – identify barriers to change• Data analysis – identify practice differences associated

with outcome variation for targeted intervention

Data Analysis to Identify Practices for Data Analysis to Identify Practices for Targeted InterventionTargeted Intervention

• Grouped Data Analysis- compare outcome variations among NICUs- identify non-therapy and therapy related risk factors - estimate the attributable risk of risk factors

• Individual Hospital Data Analysis- calculate hospital specific incidence rates- identify hospital specific risk factors for targeted intervention- conduct trend analysis using control charts

• Generalized linear mixed effects model- to adjust results for the cluster randomized design

• Monte Carlo Bootstrap Simulation- to estimate the 95% confidence limits for control charts

Therapy Related Risk Factor for NI - PICCTherapy Related Risk Factor for NI - PICC

• Therapy related risks - central lines, - mechanical ventilation, - parenteral nutrition, - lack of enteral feeding

• 40% of nosocomial infection associated with central lines

• PICC lines carried highest risk

Adjusted probability for developing Adjusted probability for developing nosocomial infection for PICC linesnosocomial infection for PICC lines

Line type Risk-Ratio for NI

Umbilical catheters 2.0

Broviac cathethers 3.1

PICC catheters 3.5

EPIC – Intervention Period (2 Years)EPIC – Intervention Period (2 Years)

• Develop practice change strategies• Prepare supporting materials• NICU staff communication and training• Implement practice change strategies• Quarterly change cycles• Control Chart feedback• Revise strategies, reinforce change

ResultsResults

EPIC12 NICU

Group A NI

Group B

BPD

Excluded1 NICU

NI5 NICU

BPD6 NICU

N = 2666 N = 3275

Group C Non-EPIC

5 NICU

Control5 NICU

N = 1129

Selected Patient CharacteristicsSelected Patient CharacteristicsCharacteristics NI BPD Control

Number 2336 2316 1129

Mean Gestation (wk) 28.5 28.9 28.9

Mean Birthweight (kg) 1246 1315 1150

Mean SNAP-II 11.2 9.8 12.6

Male sex (%) 57.2 55.5 56.3

Outborn (%) 37.5 18.0 14.9

Cesarean section (%) 54.1 55.5 58.8

Apgar <7 at 5 min (%) 20.3 19.1 44.0

Antenatal steroids (%) 71.1 70.7 90.5

Group A (NI) – Incidence of NIGroup A (NI) – Incidence of NITheoretical Infection Rate of Infant in NIT Group, NI Study (Monte Carlo Bootstrap,

n=1000)

24.1%

16.1%

19.5%

12.6%

18.3%

15.9% 16.0%

17.1%16.5%

9.0%

11.0%

13.0%

15.0%

17.0%

19.0%

21.0%

23.0%

25.0%

27.0%

Baseline Oct-Dec.2003

J an-Mar.2004

Apr-J un.2004

J ul-Sept.2004

Oct-Dec.2004

J an-Mar.2005

Apr-J un.2005

J ul-Sept.2005

Study period

Perc

en

tag

e o

f in

fecte

d b

ab

y

Group A (NI) – Incidence of Group A (NI) – Incidence of BPDBPD

Observed Incidence Rate of CLD Baby at Week 36 in NIT Group, CLD Study

28.2%

25.4%

38.9%

31.7%

23.8%23.1%

29.3%

24.2%

27.3%

16.0%

20.0%

24.0%

28.0%

32.0%

36.0%

40.0%

44.0%

48.0%

Baseline Oct-Dec.2003 Jan-Mar.2004 Apr-Jun.2004 Jul-Sept.2004 Oct-Dec.2004 Jan-Mar.2005 Apr-Jun.2005 Jul-Sept.2005

Study period

Perc

enta

ge o

f C

LD

baby

Group A (NI) – Duration of Group A (NI) – Duration of Oxygen NeedOxygen Need

Observed Length of Oxygen Support for CLD Baby in NIT Group, CLD Study

8.628.39

9.28.91

7.46

6.13

7.34

6.35 6.25

4

5

6

7

8

9

10

11

12

Baseline Oct-Dec.2003 Jan-Mar.2004 Apr-Jun.2004 Jul-Sept.2004 Oct-Dec.2004 Jan-Mar.2005 Apr-Jun.2005 Jul-Sept.2005

Study period

Mean le

ngth

of oxygen s

upport

(day)

Group B (BPD) – Incidence of Group B (BPD) – Incidence of BPDBPD

Theoretical Incidence Rate of CLD Baby in CLD Group (Monte Carlo Estimates, n=1500)

24.0%

22.0%

20.2%

27.2%

20.6%21.3%

16.2%

22.4%

19.1%

14.0%

16.0%

18.0%

20.0%

22.0%

24.0%

26.0%

28.0%

30.0%

Baseline Oct-Dec.2003 J an-Mar.2004 Apr-J un.2004 J ul-Sept.2004 Oct-Dec.2004 J an-Mar.2005 Apr-J un.2005 J ul-Sept.2005

Study period

Group B (BPD) – Duration of Group B (BPD) – Duration of Oxygen NeedOxygen Need

Theoretical Length of Oxygen Support in CLD Group, CLD Study (Monte Carlo Bootstrap, n=1000)

13.06

8.365

6.589

9.2959.668

8.822

7.859

8.683

5.508

4

5

6

7

8

9

10

11

12

13

14

15

Baseline Oct-Dec.2003 J an-Mar.2004 Apr-J un.2004 J ul-Sept.2004 Oct-Dec.2004 J an-Mar.2005 Apr-J un.2005 J ul-Sept.2005

Study period

Group B (BPD) – Incidence of Group B (BPD) – Incidence of NINI

Theoretical Infection Rate of Infant in CLD Group, NI Study (Monte Carlo Bootstrap, n=1000)

19.9%

17.3%

12.6%

10.4%

12.7%

16.5%

13.7%

11.2%

13.8%

7.0%

9.0%

11.0%

13.0%

15.0%

17.0%

19.0%

21.0%

23.0%

Baseline Oct-Dec.2003

J an-Mar.2004

Apr-J un.2004

J ul-Sept.2004

Oct-Dec.2004

J an-Mar.2005

Apr-J un.2005

J ul-Sept.2005

Study period

Perc

en

tag

e o

f in

fecte

d b

ab

y

Group C (Controls) – Incidence Group C (Controls) – Incidence of BPDof BPD

Observed Incidence Rate of CLD Baby at Week 36 in Control Group, CLD Study

22.3% 22.6%

14.9%

22.5%

24.7%

18.6%

23.2%

18.5%

14.7%

6.0%

11.0%

16.0%

21.0%

26.0%

31.0%

36.0%

Baseline Oct-Dec.2003 Jan-Mar.2004 Apr-Jun.2004 Jul-Sept.2004 Oct-Dec.2004 Jan-Mar.2005 Apr-Jun.2005 Jul-Sept.2005

Study period

Per

centa

ge

of C

LD

bab

y

Group C (Controls) – Duration of Group C (Controls) – Duration of Oxygen NeedOxygen Need

Observed Length of Oxygen Support for CLD Baby in Control Group, CLD Study

11.48

12.58

8.62

13.7313.33

12.76

14.64

10.43

11.88

4

6

8

10

12

14

16

18

20

22

Baseline Oct-Dec.2003 Jan-Mar.2004 Apr-Jun.2004 Jul-Sept.2004 Oct-Dec.2004 Jan-Mar.2005 Apr-Jun.2005 Jul-Sept.2005

Study period

Mean le

ngth

of oxygen s

upport

9day)

Group C (Controls) – Incidence Group C (Controls) – Incidence of NIof NI

control group (Non-EPIC group)

12.3%

6.0%

14.5%16.0%

13.7%

7.2%

11.8%10.3%

14.0%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

baseline Oct03-Dec03

Jan04-Mar04

Apr04-Jun04

Jul04-Sept04

Oct04-Dec04

Jan05-Mar05

Apr05-Jun05

Jul05-Sept05

Quarter

Per

cent

age

of N

I(ev

er in

fect

ed)

Mortality, ROP, IVHMortality, ROP, IVH

Group A (NI) Group B (BPD) Group C (Control)

Baseline 8th quarter

Pvalue

Baseline 8th quarte

r

Pvalue

Baseline 8th quarter

Pvalue

Mortality5.7 5.4 NS 5.0 4.2 NS 6.0 3.3 NS

ROP >stage 3 9.5 8.5 NS 4.8 5.4 NS 5.1 7.9 NS

IVH>grade 3

10.3 9.9 NS 7.8 9.6 NS 8.5 14.6 NS

ConclusionsConclusions

• EPIC is effective at reducing NI and BPD in the NICU

• Interventions targeting one outcome may affect other outcomes

• EPIC may be more effective and less costly at improving quality of care than traditional CQI methods

EPIC Research ProgramEPIC Research Program

EPIC Process

EPIC-I2002-2005

NIT reduced by 60%CLD reduced by 40%

Target multiple outcomes

EPIC/PHSI2006-2009

Target two outcomesTest generalizeabilityImprove upon EPIC-I

EPIC-II2007-2010

Target multiple outcomesTest generalizeability

Improve upon EPIC/PHSI

Improvements in EPIC/PHSIImprovements in EPIC/PHSI

Eliminate feedback delaysone button reportsshort term feedback & unverified data

Decrease onus of data collectionUse only relevant CNN data

Facilitate communicationKnowledge BrokerDivide NICUs into 4 groups for quarterly

teleconferences, site visits, mentorship Ease implementation

4 groups will have mix of experienced EPIC sites

EPIC/PHSI PlanEPIC/PHSI Plan

Make what we learned in EPIC-I available to all Canadian NICUs in EPIC/PHSI

Training of Infection Teams – MD, RN, QI Introduce the EPIC interventions-best practice

template Review EPIC-I literature reviews Review qualitative findings from EPIC-I

Barriers and facilitators to change Develop change strategies for each NICU

Implementation of EPIC interventions

Acknowledgements to CIHR, Micheal Smith Foundation, & Acknowledgements to CIHR, Micheal Smith Foundation, & Canadian Neonatal NetworkCanadian Neonatal NetworkTMTM EPIC Investigators EPIC Investigators

• Khalid Aziz, Memorial U• Ross Baker, U of Toronto• Keith Barrington, McGill U• Catherine Cronin, U Manitoba• Jill Hoube, UBC• Andrew James, U Toronto• Joanne Langley, Dalhousie• David SC Lee, UWO• Shoo K Lee, U Alberta• Robert Liston, UBC• Ying MacNab, UBC• Claudio Martin, UWO• Derek Matthew, Victoria Gen H• Jochen Moehr, U Victoria

• Arne Ohlsson, U Toronto• Abraham Peliowski, U Alberta• Robert Platt, McGill U• K. Sankaran, U Saskatchewan• Mary Seshia, U Manitoba• Nalini Singhal, U Calgary• Bonnie Stevens, U Toronto• Anne Synnes, UBC• Paul Thiesen, BC Children’s H• Peter Von Dadelszen, UBC• Robin Walker, U Ottawa• Elizabeth Whynot, BC

Women’s• Robin Whyte, Dalhousie U • John Zupancic, Harvard U