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

Collaborative quality improvement to promote evidence based surfactant for preterm infants: A cluster randomised trial. BMJ (7473): Funded by the Agency for Healthcare Research and Quality AHRQ RO1 HS 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

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. 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. NICUsInfants 1991 to 2002

Vermont Oxford Network Education Quality Improvement Research: Clinical Trials Collaboratives Neonatal Intensive Care Quality Databases VLBW All infants Quarterly & Annual Outcomes Reports Vermont Oxford Network Education Quality Improvement Research: Clinical Trials Collaboratives Neonatal Intensive Care Quality Databases VLBW 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 Hospitals N America in 1998 or Hospitals Eligible 57 Intervention 57 Control Hospital Eligibility > 10 infants 23 to 29 weeks > 50% of infants inborn < 75% early surfactant Not in quality collaborative 114 Hospitals Enrolled

A Careful Sequence of Intervention 1. 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 listserv and conference calls Share logistic ideas, barriers, suggestions

Gestational Age (weeks) SURFACTANT TREATMENT AND ENDOTRACHEAL INTUBATION BY GESTATIONAL AGE 52,397 Infants 401 to 1500 Grams at 335 NICUS in 1998 and

Multi-Level Analysis 1. Infants 2. Practitioners 3. NICUs 4. Hospitals 5. Referral systems. Assesse d Directly Assessed Indirectly (outborn infants)

Delivery Room Surfactant All Infants Inborn Outborn Adjusted Odds Ratio (95% CI) ( ) ( ) ( )

1st Surfactant > 2 Hrs after Birth All Infants Inborn Outborn Adjusted Odds Ratio ( ) ( ) (0.4 – 0.9) (95% CI) ( ) ( ) (0.4 – 0.9)

Hours after Birth Percent Intervention: Median 21 minutes Control: 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?