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CONFIDENTIAL WSHA CQIP Peer Review and Quality Improvement Information. Protected from disclosure or discovery under RCW 43.70.510

CONFIDENTIAL WSHA CQIP Peer Review and Quality Improvement Information. Protected from disclosure or discovery under RCW 43.70.510

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CONFIDENTIAL

WSHA CQIP Peer Review and Quality Improvement Information.

Protected from disclosure or discovery under RCW 43.70.510

22

Elliott Main, MDCMQCC Principal Investigatormain@ .org

Chair, Dept OB GYNCalifornia Pacific Medical CenterSan Francisco

Reducing Cesarean Section Rates in the Nulliparous Term Singleton Vertex Populations

: Transforming Maternity Care

Topics:

What are the drivers of the rise in Cesareans? What are the risks to Cesareans? (new data) Marked Variation in CS rates--Public Release NTSV as the focus for Cesarean QI Importance of L&D culture & Labor practices The Joint Commission Measures

: Transforming Maternity Care

: Transforming Maternity Care

Cesarean Births Have Risen by Over 50% in the Last 10 years

: Transforming Maternity Care

Why Have Cesarean Rates Risen?

CesareanRate

PtDesire

MDTime

Sched-ule

MDWorry

Fear ofLabor

Per-fection

MDPride

PeerPressure Safety

Long LOS

What happens if no one cares about the rate?

Cesareans are not Risk-free

New Data

: Transforming Maternity Care

Is There a New Risk/Benefit Calculus for Cesarean Birth?

Old Calculus: “There may be some risks to CS but they are

very small…” With today’s level of care (anesthesia and medical

support) When done on “low risk” women

Therefore, the theoretical “benefits of preserved perineums and less neonatal trauma” (both highly controversial) “outweigh these concerns”.

: Transforming Maternity Care

Recent Data on Cesarean Risks (1)Liu S et al (CMAJ 2007;176:455-60)

Review of all low-risk healthy mothers with elective CS for breech presentation in Canada, compared to healthy mothers attempting vaginal birth (47k vs 2.3m)

Severe morbidity: 27.3 CS, 9.0 Vag (per 1,000) CS increased the risks of: cardiac arrest

(OR=5.1), wound hematoma (OR=5.1), major infection (OR=3.0), anesthetic complication (OR=2.3), hysterectomy (OR 2.1)

: Transforming Maternity Care

Recent Data on Cesarean Risks (2)Schutte JM et al

(Acta Obstet Gynecol Scand 2007;86:240-3)

Review of all elective CS (>8,500) for breech presentation in the Netherlands, 2000-2002

4 maternal mortalities (2 VTE, 2 sepsis)for a rate of 1 per 2,127 elective cesareans

: Transforming Maternity Care

Recent Data on Cesarean Risks (3) Spong CY et al (Obstet Gynecol 2007; 110:801-7)

MFM Network Study comparing:Elective Repeat CS (no indication, no labor), N=14,983 (no previas or accretas)Trial of Labor, N=15,323University Medical Centers with 24/7 coverage

Neonatal Deaths

Maternal Deaths

TOL 12 1

Elec Rpt CS 6 5

Elective Rpt CS: 5 maternal deaths were direct: 3 AFE, 1 hemorrhage, 1 anesthetic related

: Transforming Maternity Care

Recent Data on Cesarean Risks (4)Wen SW et al (AJOG 2004; 110:801-7)

Canadian Network Study comparing:1) Elective Repeat CS (low risk) N=179k2) Trial of Labor (low risk), N=129k

TOL: 2 maternal deaths (1.6/100k) Elec Rpt CS: 10 maternal deaths

(5.6/100k) Risk ratio =3.6

: Transforming Maternity Care

Recent Data on Cesarean Risks (5)Knight et al (Ob Gyn 111:97-105, 2008)

Review of all UK peripartum hysterectomies, rate = 1/2,500 births

Prior CS is a major risk:1 prior CS OR=2.12+ prior CS OR=18.6controlled for maternal age, parity, twins, indication for CS

: Transforming Maternity Care

Data courtesy of David Lagrew, MD

Long Beach Memorial Peripartum Hysterectomy Trends

: Transforming Maternity Care

Risks of Being a Prior Cesarean…

Decisions around VBAC-TOL vs. Rpt CB Risk of Uterine Rupture Risk of Hemorrhage/Transfusions Epidemic of Placenta Previas Epidemic of Placenta Accretas Marked Increase of Peripartum

Hysterectomies

: Transforming Maternity Care

But are neonatal outcomes better with higher CS rates?

Cerebral Palsy rates have been stable for the last 25 years

Term neonatal outcomes (neonatal seizures, NICU LOS, ventilator requirement) have not improved over the last 15 years (with the exception of the reduction of postdates babies)

Surman G, etal. Children with cerebral palsy: severity and trends over time. Paediatr Perinat Epidemiol. 2009 Nov;23(6):513-21.

Strauss D, etal. Survival in cerebral palsy in the last 20 years: signs of improvement? Dev Med Child Neurol. 2007 Feb;49(2):86-92.

: Transforming Maternity Care

Neonatal Outcomes Worsen when the Cesarean Rate is Higher than Predicted (I)

Bailit JL, etal. Hospital primary cesarean delivery rates and the risk of poor neonatal outcomes. Am J Obstet Gynecol. 2002;187:721-7.

Data from Washington State birth linked data set, 1995-1996Cesarean Predictive model from maternal demographics and medical complications resulting in an U-Shape curve for baby outcomes

: Transforming Maternity Care

Neonatal Outcomes Worsen when the Cesarean Rate is Higher than Predicted (II)

Gould JB, etal. Cesarean delivery rates and neonatal morbidity in a low-risk population. Obstet Gynecol. 2004;104:11-9.

Data from California birth linked data set, 1998-2000Cesarean Predictive model for low-risk singletons from maternal demographics and medical complications resulting in an U-Shape curve for baby outcomes. Approximately 40% worse outcomes in either direction.

: Transforming Maternity Care

Consequences…

Neonatal Outcomes NOT improved Maternal Outcomes raise concern

Mortality increasingMorbidity increasing

What is really driving the change?Unit culture

Marked Variation

Public Release of Cesarean Data

: Transforming Maternity Care

: Transforming Maternity Care

NY Public Citizen: Web reports of Hospital CS 2007 Data (released 4/21/10)

: Transforming Maternity Care

: Transforming Maternity Care

: Transforming Maternity Care

Issues: Primary CS rate-

right measure?Any other adjusters?“My patients are high risk…”

Attribution?Midwives, FP

Statistical analysis?

36%48%

37%

52%

16%

16%

5%

Physician Level Reporting of

CS Rates

: Transforming Maternity Care

California Maternity Outcomes Show Large Variation (3 to 20-fold)

County Level Data Maternal Mortality Risk-adjusted Cesarean Birth Infant Mortality

Hospital Level Data Obstetric Hemorrhage (0.5 to 14.2%) Maternal Infection (0.2% to 5.1%) Risk-adjusted Cesarean Birth

(Nuliparous, Term, Singleton, Vertex, age-adjusted) Exclusive Breast-feeding at Discharge 3rd/4th Lacerations (fully risk-adjusted)

: Transforming Maternity Care

: Transforming Maternity Care

Low-Risk Primary Cesarean Section Defined:

Number of Cesarean births per 100 births among women who have not previously had a Cesarean section and excludes abnormal presentations, preterm gestations, fetal deaths, multiple gestations, and breech presentations (all strong reasons to perform a cesarean section and are relatively common: 2-8%);

Primary C/S rates are age-adjusted.

OSHPD Data 2006

: Transforming Maternity Care

Age-Adjusted Low-Risk Primary C/S Rates distributed to quintiles and

applied to regions:

Quintile 1 (0-20%): CS rate: 5-13.9% Quintile 2 (20-40%): CS rate: 14-15.9% Quintile 3 (40-60%): CS rate: 16.1-16.9% Quintile 4 (60-80%): CS rate: 17-19% Quintile 5 (80-100%): CS rate: >19%

Low

High

: Transforming Maternity Care

Top and Bottom two Quintiles (40%) of Age-adjustedLow-Risk Primary C/S Rates: Northern CA

HIGH: Hospitals with rates > 17%

n = 32/124 (25%)

LOW: Hospitals with rates < 16%

n=74/124 (60%)

60%25%

: Transforming Maternity Care

Top and Bottom two Quintiles(40%) of Age-AdjustedTop and Bottom two Quintiles(40%) of Age-AdjustedLow Risk Primary C/S Rates: Southern CALow Risk Primary C/S Rates: Southern CA

Hoag memorial

Scripps La Jolla

HIGH: Hospitals with rates >17%

n=34/80 (43%)

LOW: Hospitals with rates < 16%

n=40/80 (50%)

50%43%

: Transforming Maternity Care

Top and Bottom two Quintiles (40%) of Age-AdjustedLow-Risk Primary C/S Rates: LA County CA

HIGH: Hospitals with rates >17%

n=44/60 (73%)

LOW: Hospitals with rates < 16%

n=12/60 (20%)

20%73%

: Transforming Maternity Care

How Many Labor Cesareans are done Without an Indication?

Surprisingly few

The First Pregnancy is the Focus

NTSV

: Transforming Maternity Care

Which Obstetric Population to Examine? Risk adjustment by logistic regression: (changes each year and difficult to calculate) Case Mix analysis: divide gravidas into 10 groups: (complex) NTSV: Nulliparous, Term, Singleton, Vertex

Allows comparison of “apples to apples” ~40% of most units’ population Accounted for most of the Cesarean variation within Sutter Health’s 20 maternity units Easily calculated with birth certificate data Supported by ACOG (2000) and HP 2010

Main E, etal. Am J Obstet Gynecol 2004; 190: 1747-56.

: Transforming Maternity Care

Importance of NTSV population to the CS rate

98% of inter-institutional variation in overall CS rates can be attributed to NTSV (TSCN) rates

Brennan DJ. Am J Obstet Gynecol 2009; 201: 308.e1-8.

: Transforming Maternity Care

How do Obstetric Practices Effect CS Rates?Definitions:

NTSV: Nulliparous, Term, Singleton, Vertex Induction: use of oxytocin, prostaglandins, AROM, or mechanical techniques to begin

labor between 37 and 41 weeks. For this measure 41 wks was considered a “free pass”. Early Labor Admission: under 3cm dilation at time of decision for hospital admission. For

this measure women with ROM, bleeding, or other reasons not to do an admission cervical exam were excluded

Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

: Transforming Maternity Care

NTSV Induction Rate Correlates with NTSV Cesarean Rate

0%

NTSV <41wks Induction Rate

NT

SV

CB

Ra

te

10%

15%

20%

25%

30%

10% 20% 30% 40%

r = 0.57 (r2 =0.32)p<0.0001

-20 Hospitals-Circle size is proportionate to birth rate

Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

: Transforming Maternity Care

NTSV Early Labor Admit Rate Correlates with NTSV Cesarean Rate

NTSV Early Labor (<3cm) Admission Rate

10%

15%

20%

25%

30%

10% 20% 50% 60%30% 40%

r = 0.62 (r2 =0.38)p<0.0001

NT

SV

CB

Ra

te

-20 Hospitals-Circle size is proportionate to birth rate

Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

: Transforming Maternity Care

Combined Induction+Early Admit Rate Correlates BEST with NTSV Cesarean Rate

10%

15%

20%

25%

30%

20% 40% 60% 80%

NTSV Induction Rate + Early Labor Admission Rate

NT

SV

CB

Ra

te

r = 0.73 (r2 =0.53)p<0.0001

Induc. Early Admit

All Births

Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

: Transforming Maternity Care

Dilation < 3cm at Time of Admit Decision & Risk of Cesarean Birth

Data from Sutter Health FPAD:

2001-2002Elliott Main, MD

(inductions excluded N = 4,151)

Relative Risk = 1.9 p < .00001

: Transforming Maternity Care

Cleveland Metro:3,087 Low Risk NTSV women in

spontaneous labor(1993-2001)

Bailit J etal: Obstet Gynecol 2005;105:77-9.

Dilation < 3cm at time of Admit Decision & Risk of Obstetric Complications

: Transforming Maternity CareBailit J etal: Obstet Gynecol 2005;105:77-9.

More Nullips than Multips present in Latent Phase:51% Nullip v. 28% Multip

OR

Active Phase Arrest 2.2 p<0.001

Oxytocin Use 2.3 p<0.001

IUPC Use 2.2 p<0.001

Chorioamnionitis 2.7 p<0.001

Latent Phase Admits in Nullips had more…

Dilation < 3cm at time of Admit Decision & Risk of Obstetric Complications

: Transforming Maternity Care

Dilation < 3cm at time of Admit Decision Dilation < 3cm at time of Admit Decision & Risk of Obstetric Complications& Risk of Obstetric Complications

Big Question: Are these findings cause or effect?

1) Does early presentation in latent phase lead to physician interventions and subsequent dystocia/FTP? Or…

2) Do inherent labor abnormalities result in latent phase presentation and physician

interventions?

: Transforming Maternity Care

An Early Labor Assessment Program: A Randomized Controlled Trial

McNiven et al: Birth 1998;25:5-10.

•RCT of 209 Low-Risk Nullips <3cm dilationo Assessment: encouraged to go home or walk

extensively after “advice, support and encouragement”

o Direct Admit: admitted without outpt assessment

“Asmnt” “Direct Admit”

Admit to Delivery Time: 8.3 hrs 13.5 hrs p<0.0001

Oxytocin use: 22.8% 40.4% p<0.007

Felt “In control” (score): 158 142 p<0.0002

Cesarean Birth: 7.6% 10.5% n.s

(underpowered for this outcome and this low rate)

: Transforming Maternity Care

What are the concerns of women seeking admission during latent phase?

In-depth interviews 2-6 weeks PP (Sweden)5 Key reasons/themes:

“Longing to complete the pregnancy” “Having difficulty managing the uncertainty” “Having difficulty enduring the slow progress” “Suffering from pain to no avail” “Oscillating between powerfulness and

powerlessness” These provide a base for validating concerns

and supporting women in OB Triage Carlsson IM, Hallberg LR, Odberg Pettersson K. Swedish women's experiences of seeking care and being admitted during the latent phase of labour: a grounded

theory study. Midwifery. 2009;25:172-80.

: Transforming Maternity Care

Principles for Optimal Management of Women in Latent Phase-I

Setting Expectations: “Early labor is best to be done at home”

Office handout about “When to come in for Labor” Direct discussions with providers Discussions and Handouts in Prenatal Classes

about Early Labor

Remember: different rules for Nullips than for Multips!

: Transforming Maternity Care

Principles for Optimal Management of Women in Latent Phase-II

Triage Evaluation & Care: Nursing is Critical!Fetal evaluation = ReassuranceKey Communications: Encouragement, Support,

Alleviation of AnxietyReview of Coping Techniques—Handouts for

PartnerHydration and NutritionA subset: Therapeutic Rest: 15mg of Morphine IM

– OK to send home after MS, 80%+ will awake in active phase labor

Need MD “Buy-in”

: Transforming Maternity Care

Oxytocin Safety and Quality

IHI Perinatal Bundles HCA/Steve Clark Oxytocin Safety Initiative Common features

Pre-use checklistModest increase regimen In-use checklist to confirm fetal wellbeing and

minimize tachysystoleClark S, etal. Implementation of a conservative checklist-based protocol for oxytocin

administration: maternal and newborn outcomes. Am J Obstet Gynecol. 2007;197:480.e1-5.IHI Perintal Bundles:

http://www.ihi.org/IHI/Topics/PerinatalCare/PerinatalCareGeneral/EmergingContent/ElectiveInductionandAugmentationBundles.htm

: Transforming Maternity Care

Davis

Santa RosaCoast

Delta

Saint Lukes

Los Banos

Alta Bates Summit

Auburn

Amador

SystemCPMC

Marin

SacramentoEden

Roseville

Santa Cruz

Mills Peninsula

ModestoSolano

Tracy

Lakeside

10

20

30

40

50

Ra

te %

15.5

Cesarean Delivery for 07Q3

Target: less than or equal to 15.5 percent

*

11.7

15

128

13.8

24

174

14.7

5

34

15.6

14

90

15.7

20

127

16.4

9

55

19.5

139

711

20.0

9

45

21.1

8

38

21.5

814

3782

22.0

148

674

22.3

35

157

22.6

104

461

24.1

21

87

24.3

73

300

24.8

30

121

25.3

44

174

25.6

54

211

29.0

29

100

31.0

18

58

40.5

15

37

Rate %

Num

Den

+

-

: Transforming Maternity Care

04Q304Q4

05Q105Q2

05Q305Q4

06Q106Q2

06Q306Q4

07Q107Q2

15.0%

17.5%

20.0%

22.5%

25.0%

15.5

Statistically unfavorable to target, neutral trend

Note: " + " indicates positive direction; " - " indicates negative direction

+

-

Cesarean Delivery for CPMC

Target: less than or equal to 15.5 percent

: Transforming Maternity Care

0%

10%

20%

30%

40%

50%

60%

Maternal Age (years)

Pe

rce

nt

NT

SV

Ces

are

an

Bir

thEffect of Maternal Age on NTSV Cesarean

Rate is Continuous from Age 17

Sutter Health Data: 2001-2003: 41,416 NTSV births

Age 35

For ages 17 - 42 yrs,r2 = 0.961 (p<0.001)

Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

: Transforming Maternity Care

Age-Adjusted Primary Cesarean Rate, 2006Term, Singleton, Vertex Deliveries

8%

10% 10% 10%

12% 12%13% 13% 13% 13%

14%15% 15%

16% 16%17% 17% 17%

19%

27%

0%

5%

10%

15%

20%

25%

30%

Davis

Santa

Ros

a

St. Lu

ke's

Santa

Cru

z

CPMC

Solano

Mar

inDel

ta

Los B

anos

Coast

Mills

Pen

insul

a

Sacra

men

to

Rosev

ille

ABSMC

Lake

side

Tracy

Eden

Aubur

n

Mod

esto

Amad

or

Statewide Average = 16%

+

-This is an OSHPD measure, similar to FPAD but includes

multips (excludes all prior CS), and is age-adjusted.

: Transforming Maternity Care

In Effort to Limit C-Sections, Two Methods Yield Different Results on Staten Island

Staten Island University Hospital 23.2% Cesarean rate Strong leadership and

determination No elective inductions

prior to 41 wks No elective CS Non-interventionist

policy

Richmond University Medical Center 48.3% Cesarean rate “Perinatal Center” ( for

high-risk pregnancies) “Peer Review” to

reduce CS 2nd opinions for

elective CS (half-hearted?)

Susan Dominus NYT April 19, 2010

National Quality Measures for Obstetrics

NQF

Leapfrog Group

The Joint Commision

: Transforming Maternity Care

Our Strategy….

First, develop measures and identify confidential outcome data

Second, provide high quality QI programs to assist providers in meeting the measures

Third, partner for public release, and alignment of financial incentives

: Transforming Maternity CareJC Core Measure Set-2010

NQF National ObstetricQuality Measures/Quality Standards

(November 2008)

Leapfrog Group Measures-2009

Episiotomy rate Cesarean rate for low-risk first births Elective delivery prior to 39 weeks Prophylactic antibiotics for Cesarean birth DVT prophylaxis for women having a Cesarean birth Exclusive breastfeeding at hospital discharge Birth trauma rate (limited ICD9 codes) Rate of antenatal steroids for under 32 week births Infants under 1500g (VLBW) not delivered at

Level III center

OB/Mom

OB/Baby

( to be added in 2011) CHART: Public Release

VBAC Available?

: Transforming Maternity Care

Keys to Success…Summary Leadership!! Medical and nursing Use external pressures and aligned incentives Focus on the culture on Labor and Delivery Fewer Inductions, more “gentle” oxytocin

(protocol driven), admit in active labor whenever possible

Public and professional education

: Transforming Maternity Care

What has resonated best in our system…

Focus on changing practices that reduce indications to do a cesarean rather than reducing cesareans once the indication is already there…

: Transforming Maternity Care

How to get Cesarean Rates back in the box

CesareanRate

PtEd

MDTime

Sched-ule

MDWorry

Fear ofLabor

Per-fection

Labormgmt

Leader-ship

EdSafety

Align$

Work with medical liability

companies

: Transforming Maternity Care

Thank You!

: Transforming Maternity Care

CONFIDENTIAL

WSHA CQIP Peer Review and Quality Improvement Information.

Protected from disclosure or discovery under RCW 43.70.510