# Presentation: 523041

## Q II Case Study: Surfactant Use in Preterm Infants 

- Laura C. Leviton, PhD
- Gautham Suresh, MD
- for the TRIP Investigators

**Notes:**
Gautham

## 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**

**Notes:**
Gautham

## 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

**Notes:**
Gautham

## Slide 4

**Notes:**
Gautham

## 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.**

**NICUs**

**Infants**

**1991 to 2002**

**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

- 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*_

**Notes:**
Gautham

## Preparing for the Trial

- Multidisciplinary research team:
- Neonatology
- Outcomes research (Cochrane Collaboration)
- Statisticians / data base manager
- Practice improvement
- Evaluation /  behavioral science

**Notes:**
Gautham

## 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

**Notes:**
Gautham

## 335 Hospitals

**N America in 1998 or 1999**

**188 Hospitals**
**Eligible**

**57 Intervention**
**57 Control**

**114 Hospitals**
**Enrolled**

**Notes:**
Gautham

## 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

**Notes:**
Gautham

## SURFACTANT TREATMENT AND ENDOTRACHEAL INTUBATION BY GESTATIONAL AGE

- Gestational Age (weeks)

- 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

*Infants*
*Practitioners*
*NICUs*
*Hospitals*
*Referral systems.*

**Assessed Directly**

**Assessed Indirectly ****(outborn infants)**

**Notes:**
Laura

## Delivery Room Surfactant

**Delivery Room Surfactant**

-                     **All  Infants           Inborn              Outborn****   **

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

**Notes:**
Laura

## 1st Surfactant > 2 Hrs after Birth

**1st Surfactant > 2 Hrs after Birth**

-                       **All  Infants         Inborn             Outborn   **

**Adjusted**
**Odds Ratio****             ****0.4****	****	****  ****0.3****	****	****          ****0.6**
**  ****(95% CI) ****          (0.2 - 0.5)          (0.2 - 0.5)             (0.4 – 0.9)**

**Notes:**
Laura

## Time to 1st  Surfactant Dose

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

**Percent**

**Intervention: Median 21 minutes**
**Control: Median 78 minutes**
**                   **

**Time to 1st  Surfactant Dose**

**p< 0.001**

**Notes:**
Laura

## The Road Not Taken:  Understanding Mechanisms

- Large N studies

- In-depth Studies

**Notes:**
Laura

## For Discussion

- How to use this as a researcher?
- How to use this in QII?
- What about more challenging designs and settings?

**Notes:**
Laura