Q II Case Study: Surfactant Use in Preterm Infants

Laura C. Leviton, PhDGautham Suresh, MD

for the TRIP Investigators

Collaborative quality improvement to promote evidence based surfactant for preterm infants:

A cluster randomised trial. BMJ 2004 329 (7473): 1004-1100.

Funded by the Agency for Healthcare Research and Quality

AHRQ RO1 HS10528-01

Jeffrey D. Horbar, PI Roger F. Soll Laura L. Leviton Jeffrey Buzas Gautham Suresh Paul E. Plsek Joe Carpenter Michael B. Bracken Jack Sinclair

TRIP Investigators

A Gap between Evidence & Practice

Surfactant most effective when given: soon after birth, on a prophylactic basis < 2 hours of birth (if no prophylaxis used)

Of infants treated with surfactant: 19% received 1st dose < 15 minutes of

birth 27% received 1st dose > 2 hours after

birth

Vermont Oxford Network, 1998 data

Relative Risk and 95% CI

Study 0.5 1.0 2.0 4.00.2

Bevilacqua 1997

0.5 1.0 2.0 4.00.2

Dunn 1991

Mortality Risk

Egberts 1993

Kattwinkel 1993

Walti 1995

Bevilacqua 1996

Soll, 2001

TYPICAL ESTIMATETYPICAL ESTIMATE

Kendig 1991

VERMONT OXFORD NETWORKVERMONT OXFORD NETWORK To improve the To improve the qualityquality and and safetysafety of medical care for newborn infants of medical care for newborn infants

and their families through a coordinated program of research, and their families through a coordinated program of research, education and quality improvement projects.education and quality improvement projects.

0

5000

10000

15000

20000

25000

30000

35000

050

100150200250300350400

NICUsInfants

1991 to 2002 1991 to 2002

Vermont Oxford Network

Education

Quality Improvement

Research:

Clinical Trials

Collaboratives

NeonatalIntensiveCareQuality

DatabasesVLBW

All infants

Quarterly & Annual Outcomes Reports

Vermont Oxford NetworkVermont Oxford Network

Education

Quality Improvement

Research:

Clinical Trials

Collaboratives

NeonatalIntensiveCareQuality

DatabasesVLBW

All infants

Quarterly & Annual Outcomes Reports

Good Prospects for the Trial:

Large sample size Members endorse the habit of CQI Low cost, high quality data

Members provide data to the Network

Members get useful information back

Preparing for the Trial

Multidisciplinary research team:

Neonatology Outcomes research (Cochrane

Collaboration) Statisticians / data base manager Practice improvement Evaluation / behavioral science

Focus Groups Prior to Trial To refine and customize design of

intervention Used PRECEDE Framework Neonatal practitioners not affiliated with

the Network Factors affecting surfactant practice Reactions to the evidence

335 HospitalsN America in 1998 or 1999

188 HospitalsEligible

57 Intervention57 Control

Hospital Eligibility

• > 10 infants 23 to 29 weeks

• > 50% of infants inborn

• < 75% early surfactant

• Not in quality collaborative114 Hospitals

Enrolled

A Careful Sequence of Intervention1. NICU self-assessment

• Compare own vs network data

2. 2-day workshop:• Principles of evidence-based medicine• Presentation of surfactant evidence• Methods of quality improvement: 4 key habits• “You decide what to do.”

3. Finalize 3-4 aims at home institution

4. Ongoing collaboration, faculty support• Email listserv and conference calls• Share logistic ideas, barriers, suggestions

0%

20%

40%

60%

80%

100%

NO ETT

ETT

SURFACTANT

Gestational Age (weeks)

SURFACTANT TREATMENT AND ENDOTRACHEAL INTUBATION BY GESTATIONAL AGE

52,397 Infants 401 to 1500 Grams at 335 NICUS in 1998 and 1999

<24 24 25 26 27 28 29 30 31 32

>32

Multi-Level Analysis

1. Infants2. Practitioners

3.NICUs4.Hospitals

5.Referral systems.

Assessed Directly

Assessed Indirectly (outborn infants)

0

10

20

30

40

50

60

Perc

en

t

Rx Control

Delivery Room Surfactant

All Infants Inborn All Infants Inborn OutbornOutborn Adjusted

Odds Ratio 5.4 6.2 2.0 (95% CI) (2.8 - 10.2) (3.0 - 12.5) (1.1 - 3.5)

0

10

20

30

40

Per

cen

t

Rx Control

1st Surfactant > 2 Hrs after Birth

All Infants Inborn All Infants Inborn Outborn Outborn Adjusted

Odds Ratio 0.40.4 0.30.3 0.60.6 (95% CI) (0.2 - 0.5) (0.2 - 0.5) (0.4 – 0.9) (0.2 - 0.5) (0.2 - 0.5) (0.4 – 0.9)

0

10

20

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 Hours after Birth

Per

cen

t

Intervention: Median 21 minutesControl: Median 78 minutes

Time to 1st Surfactant Dose

p< 0.001

The Road Not Taken: Understanding Mechanisms

Large N studies

In-depth Studies

For Discussion

How to use this as a researcher? How to use this in QII? What about more challenging

designs and settings?