1. Premature Birth and Low Birth Weight Prevention Family Medicine IMPLICIT Network Interventions to Minimize Preterm and Low birth weight Infants through Continuous Improvement Techniques

2. Co-Authors  Andrew Coco, Steve Ratcliffe, Michael Horst – Lancaster General Family Medicine Residency  Janice Anderson, Forbes Family Medicine  Ian Bennett, Univ of Pennsylvania  Wendy Barr, Beth Israel Family Medicine NYC

3. Low Birth Weight Multi-site PI Study Participating SitesCityState Schenectady Family Medicine Residency Beth Israel Family Medicine ResidencyNew YorkNY Central Maine Medical CenterPortlandMe Chestnut Hill Family Medicine ResidencyPhiladelphiaPA Forbes Family Medicine ResidencyMonroevillePA Good Sam Hosp. Family Medicine ResidencyLebanonPA Lancaster General Hospital Family Medicine ResidencyLancasterPA Reading Hosp-Medical Center Family Medicine ResidencyReadingPA University of Pennsylvania Family Medicine ResidencyPhiladelphiaPA UPMC-McKeesport Family Medicine ResidencyMcKeesportPA UPMC-Shadyside Family Medicine ResidencyPittsburghPA UPMC-St. Margaret Family Medicine ResidencyPittsburghPA Montefiore Family Medicine ProgramNew YorkNY Williamsport Family Medicine ResidencyWilliamsportPA York Hospital Family Medicine ResidencyYorkPA

4. Current Definitions Gestation Length - Premature (preterm delivery) - < 37 weeks - Early preterm delivery - < 32 weeks Birth Weight - Low Birth Weight - < 2500 grams or 5.5 lbs Growth Restriction - < 10 th percentile for gestational age IUGR – applies to fetuses SGA – applies to neonates

5. Overlap in Preterm and LBW  Among LBW: 2/3 are preterm  Among preterm: almost 50% are LBW  In 2002, preterm birthrate reached 12.1%, a 29% increase over the past two decades  Rate for very preterm has been stable at 2%

6. Why Preterm Birth?  #1 obstetric challenge in the U.S.  Leading problem in pediatrics  Common, serious, and costly

9. Objectives  Overview of the genesis of the Family Medicine IMPLICIT Network  Describe the “nuts and bolts” of the Preterm birth/LBW performance improvement prevention program  Present baseline data from the network  Describe how PI data will be used over time to improve processes and hopefully outcomes.

10. The Family Medicine Educational Consortium  Since 1993, the FMEC has hosted the Northeast Regional STFM  Fosters collaboration with family medicine  Builds bridges between family medicine and logical community partners  Steve Ratcliffe and Larry Bauer in 2003

11. March of Dimes  Developed internal “champion” at national level: Karla Damus RN, Ph.D.  Active partner of Fammed IMPLICIT  Provides research, administrative and funding support with start up grant

12. Sustaining the Network 2004-2006  Recruited network members  STFM Meetings in Rye, NY (2004) AND Hershey, Pa (2005) and 10/28/06 in Boston  Monthly audioconferences  Evidence Summaries—Multiple programs with editorial group leaders

13. ACT TAKE APPROPRIATE ACTION(S ) DEVELOP OBJECTIVES DEFINE KEY INDICATORS PLAN DEVELOP PLANS DO DEVELOP ACTION STEPS EDUCATE/TRAIN IMPLEMENT PLANS TRANSFORM DATA INTO USABLE INFORMATION STUDY AP DS PI

14. Interventions and Risk Factors for LBW/Prematurity  Bacterial vaginosis  Smoking  Nutritional factors: folate, calcium, iron  Asymptomatic bacteriuria  Depression  Domestic violence  Inter-pregnancy interval  Periodontal disease  History of PTD  Occupational risk factors  Progesterone use in patient with prior PTD  Substance abuse  Maternal stress  Other vaginal infections: yeast, trich, GC/Chlam

15. 6 Focus Interventions  Bacterial Vaginosis  Depression  Smoking Cessation  Inter-pregnancy Interval  Asymptomatic Bacteriuria  Progesterone Use in high-risk Pregnancies

16. Bacterial Vaginosis  Cochrane review  Good evidence (A) to treat pregnant women at high risk for preterm delivery or low birth weight  What is unclear: Timing: early 2 nd trimester vs. late 2 nd trimester Length of treatment: 3 vs. 7 days Type of med: oral vs. vaginal cream  The trend to ensure efficacy: earlier treatment, longer treatment, oral treatment, and re-treatment if persistent BV  Possible harms: vaginal creams, treating women who don’t really have BV  Currently insufficient data to support routine screening and treatment of BV in low risk pregnancy

17. CQI Intervention: Bacterial Vaginosis  Screen – for high risk patients at beginning of 2 nd trimester -Only patients w/ history of PTD or LBW delivery -Use of Nugent criteria -Use usual screening method (Amsel’s criteria) -discourage culture  Treat – within 2 weeks of diagnosis -1st: metronidazole 250 mg PO TID x 7 days -2 nd : clindamycin 300 mg po BID x 7 days -3 rd : clindamycin gel qhs x 7 days  Rescreen – for BV @ next PNV; if positive, oral treatment recommended with clindamycin

18. Depression  Depressive symptoms occur in 20-40% of women in or following pregnancy  Major depression effects 10-15% of women in the peri-partum  Women with a history of depression have a peri-partum recurrence rate of 41%  Women at greatest risk of PTB and LBW are the same women at risk for depression (minority, single parent, young age, no high school diploma, housing dissatisfaction, stressful life events)

19. Unintended rapid repeat pregnancy and low education status: Any role for depression and contraceptive use?  Prospective observational cohort study of 643 sexually active, low-income, inner-city adult women (age > or = 19)  CONCLUSION: Low educational status was associated with more than twice the risk of unintended pregnancy 1 year after delivery. We found no evidence that depression or poor contraceptive use mediate this relationship.  Bennett I. et al. Am J of Obstet &Gynecol (2006) 194, 749–54.

20. Value of Depression Assessment  Results Among the 201 women in the sample, 86 (43%) experienced a relapse of major depression during pregnancy. Among the 82 women who maintained their medication throughout their pregnancy, 21 (26%) relapsed compared with 44 (68%) of the 65 women who discontinued medication. Women who discontinued medication relapsed significantly more frequently over the course of their pregnancy compared with women who maintained their medication (hazard ratio, 5.0; 95% confidence interval, 2.8-9.1; P<.001).  JAMA. 2006;295:499-507.

21. CQI Intervention: Depression  Screen for depression @ initial prenatal visit and again in 3 rd trimester Edinburgh Postnatal Depression Scale  Sensitivity 80-100%  Specificity 68-94% Two question screen:  1. little interest or pleasure in doing things  2. feeling down, depressed or hopeless  Treat according to usual guidelines Psychotherap y SSRI’s are preferred except Paxil; no evidence of teratogenicity

22. CQI Intervention: Smoking Cessation  5 A’s Can increase cessation rates in pregnant smokers by 30 to 70%  Use 5 A’s Ask Advise to quit Assess willingness to quit within next 30 days Assist with ways to quit Arrange follow-up

23. CQI Intervention: Smoking Cessation  Ask: I have never smoked or have smoked fewer than 100 cigarettes in my lifetime. I stopped smoking before I found out I was pregnant, and I am not smoking now. I stopped smoking after I found out I was pregnant, and I am not smoking now. I smoke some now, but I have cut down on the number of cigarettes I smoke since I found out I was pregnant. I smoke regularly now, about the same as before I found out I was pregnant.

24. CQI Intervention: Asymptomatic Bacteruria  Screen all patients for ASB with mid-stream clean catch urine specimen sent for culture Positive Ucx: > 100,000CFU/ml of one organism 80% specificity in women, 2 sequential: 95% spec. Only 1% of pts with negative initial screen will develop UTI  Treat according to antimicrobial sensitivities Good 1st choices: amoxicillin 500 mg TID, 1 st generation cephalosporins (cephalexin 250 mg QID), or nitrofurantoin 100 mg BID (doesn’t alter vaginal flora)  Test of Cure with 1 month – immediate culture  Treat persistent infections with suppression therapy

25. Contraception  Goal: Improve ability of women to successfully use contraception  Result: Longer inter-pregnancy interval  Barriers: Lost opportunities Loss of insurance

26. Birth Spacing and Risk of Adverse Perinatal Outcomes A Meta-analysis JAMA. 2006;295:1809-1823  Interpregnancy intervals shorter than 18 months and longer than 59 months are significantly associated with increased risks of preterm birth, low birth weight, and small for gestational age infants.

27. Contraception Plan  Minimum of 6 opportunities to discuss contraception plan  Contraceptive flyer for clients without insurance  28 and 36 weeks gestation  Discharge instructions  Post partum at well child 1, 2 & 4 month visits  Every chart at 28 weeks gets patient handout on all methods  All nurses stations in clinic have access to contraceptive teaching box  Pamphlet for contraception for clients without insurance

28. CQI Intervention: Increase Inter-pregnancy Interval  Universal PP contraception counseling Plan for PP contraception documented in prenatal chart prior to delivery Discharged home PP with contraception plan and supplies Process outcomes: contraception provision and documentation of plan Patient-oriented outcomes: contraception use @ 6 weeks and 6 months PP, IPI, subsequent LBW and PTB rates

29. Progesterone  Weekly intramuscular injections of 250mg of 17 alpha hydroxyprogesterone caproate administered pregnancies with a history of preterm delivery result in fewer deliveries prior to 37 weeks (NNT=6). Incidence of birthweight <2500gm is decreased (NNT=7) as well as other complications of prematurity. Injections begin at 16-20 weeks and continue until 36 weeks. Other than injection site discomfort, few adverse effects occur. N Engl J Med 2003;348(24):2379-85

30. Our Population Outcome Variable All Sites (n=2404) Mean Maternal Age (years)24.10 Medical assistance insurance74% White48% Black36% Latino12% Mean Birth Weight (grams)3228 Mean Gestational Age (weeks)38.65 Preterm Birth Rate11.4% Low Birth Weight Rate (% less than 2500 grams)8.29% Overall C-section Rate20.7%

31. Provider Performance Number screened/ treated Total patients eligible* Percentage Asymptomatic Bacteriuria screened 2,0942,30491 positives treated 20930169 test of cure 17420983 Asymptomatic Bacterial Vaginosis (history of SPTB) screened before 16 weeks gestation 7819041 positives treated 263184 test of cure 202677 Perinatal Depression screened prenatally 1,0102,22645 screened postpartum 1,0262,09749 *Total less than 2,404 due to missing values during chart review. SPTB – spontaneous preterm birth

32. Provider Performance Number screened/ treated Total Patients eligible* Percentage Smoking Cessation screened at first visit 2,1582,32993 intervention suggested 65275586 stopped smoking 25362740 Postpartum Contraception prenatal plan on chart 1,0312,21647 plan at postpartum visit 1,4021,54291 * Total less than 2,404 due to missing values during chart review. SPTB – spontaneous preterm birth

33. Associations that Support Program Potential Predictor VariableOdds Ratio with 95% confidence interval adjusted age, race, and other listed variables Smoking cessation0..40 (0.19 to 0.85) Interpregnancy interval (6 month increments up to 24 months) 0.83 (0.71 to 0.98) History of depression 1.63 (1.09 to 2.65) Outcome Variable - Preterm Birth

34. Resident/Faculty Collaboration  Active resident leadership in at least 8 of the network sites  Translates into fulfilling required CQI projects and research presentations  Opportunities for resident/faculty collaboration  Potential for grant writing/funding

35. Role of Performance Improvement Data  Measures individual program’s performance meeting prenatal interventions  Use web portal to input and retrieve data  Compare program with other participating programs and with baseline performance  Ultimately will measure preterm birth and LBW outcomes

39. Project will continue to refine its interventions and develop new ones based upon supportive evidence and feasibility to implement them

40. Potential New Interventions  Periodontal Disease  Domestic Violence  Iron deficiency/supplementation  Levothyroxine for euthyroid pregnant women with positive thyroid peroxidase (TPO) antibodies. NNT = 7 to prevent preterm birth.

41. Potential to Expand or Replicate Project in other Geographic Areas

42. Questions/Discussion  Contact:  Steve Ratcliffe, Lancaster General FM sdratcli@lancastergeneral.org  Janice Anderson, Forbes FM janderso@wpahs.org