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Q II Case Study: Surfactant Use in Preterm Infants

Q II Case Study: Surfactant Use in Preterm Infants. Laura C. Leviton, PhD Gautham Suresh, MD for the TRIP Investigators. TRIP Investigators. Jeffrey D. Horbar, PI Roger F. Soll Laura L. Leviton Jeffrey Buzas Gautham Suresh Paul E. Plsek

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Q II Case Study: Surfactant Use in Preterm Infants

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  1. Q II Case Study: Surfactant Use in Preterm Infants Laura C. Leviton, PhD Gautham Suresh, MD for the TRIP Investigators

  2. TRIP Investigators Jeffrey D. Horbar, PI Roger F. Soll Laura L. Leviton Jeffrey Buzas Gautham Suresh Paul E. Plsek Joe Carpenter Michael B. Bracken Jack Sinclair Collaborative quality improvement to promote evidence based surfactant for preterm infants: A cluster randomised trial. BMJ 2004329(7473): 1004-1100. Funded by the Agency for Healthcare Research and Quality AHRQ RO1 HS10528-01

  3. 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

  4. VERMONT OXFORD NETWORK To improve the quality and safety of medical care for newborn infants and their families through a coordinated program of research, education and quality improvement projects. Infants NICUs 1991 to 2002 1991 to 2002

  5. Vermont Oxford Network Vermont Oxford Network Vermont Oxford Network Education Education Research: Clinical Trials Research: Clinical Trials QualityImprovement QualityImprovement Databases VLBW All infants Databases VLBW All infants Collaboratives Neonatal Intensive Care Quality Collaboratives Neonatal Intensive Care Quality Quarterly & Annual Outcomes Reports Quarterly & Annual Outcomes Reports

  6. 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

  7. Preparing for the Trial • Multidisciplinary research team: • Neonatology • Outcomes research (Cochrane Collaboration) • Statisticians / data base manager • Practice improvement • Evaluation / behavioral science

  8. 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

  9. Hospital Eligibility • > 10 infants 23 to 29 weeks • > 50% of infants inborn • < 75% early surfactant • Not in quality collaborative 335 Hospitals N America in 1998 or 1999 188 Hospitals Eligible 114 Hospitals Enrolled 57 Intervention 57 Control

  10. A Careful Sequence of Intervention • NICU self-assessment • Compare own vs network data • 2-day workshop: • Principles of evidence-based medicine • Presentation of surfactant evidence • Methods of quality improvement: 4 key habits • “You decide what to do.” • Finalize 3-4 aims at home institution • Ongoing collaboration, faculty support • Email listserv and conference calls • Share logistic ideas, barriers, suggestions

  11. SURFACTANT TREATMENT AND ENDOTRACHEAL INTUBATION BY GESTATIONAL AGE <24 24 25 26 27 28 29 30 31 32 >32 Gestational Age (weeks) 52,397 Infants 401 to 1500 Grams at 335 NICUS in 1998 and 1999

  12. Multi-Level Analysis • Infants • Practitioners • NICUs • Hospitals • Referral systems. Assessed Directly Assessed Indirectly (outborn infants)

  13. Delivery Room Surfactant All Infants Inborn Outborn Adjusted Odds Ratio 5.46.22.0 (95% CI) (2.8 - 10.2) (3.0 - 12.5) (1.1 - 3.5)

  14. 1st Surfactant > 2 Hrs after Birth All Infants Inborn Outborn Adjusted Odds Ratio0.40.30.6 (95% CI) (0.2 - 0.5) (0.2 - 0.5) (0.4 – 0.9)

  15. Time to 1st Surfactant Dose Percent Intervention: Median 21 minutes Control: Median 78 minutes p< 0.001 0 1 2 3 4 5 6 7 8 Hours after Birth

  16. The Road Not Taken: Understanding Mechanisms Large N studies In-depth Studies

  17. For Discussion • How to use this as a researcher? • How to use this in QII? • What about more challenging designs and settings?

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