Dissemination & Back Again: Developing a Research Methodology from Outcomes of a Community Prenatal Smoking Cessatio

1. Dissemination & Back Again:Developing a Research Methodology from Outcomes of a Community Prenatal Smoking Cessation Program Patricia Cluss, Ph.D. University of Pittsburgh School of Medicine/Psychiatry & the Pittsburgh STOP Program ReSET Roundtable January 27, 2009

2. Goals for Today • Brief background on smoking during pregnancy • Evidence-based prenatal tobacco control • The Pittsburgh STOP Program: an E-B community program • Research questions suggested by evidence-based community program outcomes

3. Health Risks of Smoking in Pregnancy • During pregnancy: • Growth retardation (low birth weight, length, head circumference) • Higher risk for ectopic pregnancy, miscarriage and premature delivery • After birth: • Negative long-term effects on children’s cognitive development • Negative effects on children’s growth (height) • Difficulty arousing from sleep (related to SIDS)

4. How many women smoke during pregnancy? • Prevalence between 1990 and 2002 has reduced from 18% to 11% • In PA: 21% in 1990 to 16% in 2002 • Pregnant women are about half as likely as nonpregnant women to be smokers.

5. Who smokes during pregnancy?(Race & ethnicity; 1999 vs. 1990) Was 22% Was 21% % Was 16% Was 7% Was 6% Source: National Center for Health Statistics

6. Who smokes during pregnancy? %

7. Who is most likely tosmoke during pregnancy? • Low socioeconomic status (SES) (23% vs. 5%): • Least educated: high school or less • Lowest income: women on Medicaid are 2X as likely to smoke as those with private insurance • Low status jobs: of employed women, those with the lowest status jobs are 5X more likely to smoke than those with highest status jobs • Other factors: • High levels of pregnancy-related anxiety • High job stress • Exposure to physical/sexual violence

8. Smoking during Pregnancy as a Health Care Crisis for the Underserved • At MWH prenatal clinic, 50% of pregnant women smoke. • Reducing smoking during pregnancy by 1% in U.S. over 7 years would prevent 57,000 LBW infants and save $572M in direct medical costs.

9. Who is most likely to quitwhen pregnant? • 25% quit when they become pregnant (spontaneous quitters) • Lighter smokers • Older smokers • Those having their first baby • Those smoking for a shorter amount of time • More highly educated • Higher income • Have a partner who is a nonsmoker 15-30% relapse during pregnancy

10. Goals for Today • Brief background on smoking during pregnancy • Evidence-based prenatal tobacco control • The Pittsburgh STOP Program • Research questions suggested by evidence-based community program outcomes

11. Master Documents/Road Maps • Surgeon General 1964: Advisory committee’s report Smoking and Health • CDC: • 1999: Best Practices for Comprehensive Tobacco Control Programs • 2007: Update • Public Health Service: • 1996: Clinical Practice Guideline No. 18: Smoking Cessation • 2000: Treating Tobacco Use & Dependence • 2008: Update • IOM 2007: Ending the Tobacco Problem: A Blueprint for the Nation

12. Rates of Smoking in the U.S.:Extremely Successful Public Health Campaign Source: CDC

13. Pittsburgh’s Least Well-Known Claim to Fame: #1 in smoking during pregnancy of any large US City* Source: Annie E. Casey Fdn. Kids Count Special Report, 1999

14. What works for smoking interventions in pregnancy? • Tailoring the intervention for pregnancy • Brief counseling of 5-10 minutes • Nicotine replacement therapy?? (Zyban, Chantix??) • Including nonsmoking partners in treatment?? • Provide cessation interventions for smoking partners??

15. Setting Goals: Quit vs. Cut Down? Alcohol abuse Substance abuse Nonpregnant smokers Pregnant smokers

16. Working with disadvantaged pregnant smokers • Cessation programs are less effective for low vs. high SES smokers • Low SES women report more stressful events, more perceived stress, more negative appraisal from family, less social support & higher addiction to nicotine

17. Interventions for low SES pregnant smokers should include: • More intensive interventions • Focus on reducing stress • Identification of depression & other MH needs • Increased focus on social support

18. Translation/Dissemination of Research to Practice X Research Evidence Base Clinical & Community Practice

19. Goals for Today • Brief background on smoking during pregnancy • Evidence-based prenatal tobacco control • The Pittsburgh STOP Program: an E-B community program • Research questions suggested by evidence-based community program outcomes

20. The Pittsburgh STOP (Stop TObacco in Pregnancy) Program • An outcomes-driven evidence-based program for underserved pregnant smokers • Over 1000 pregnant smokers and recent quitters (84%/16%) have participated since 2000 • Based at WPIC with community outreach at Magee-Womens Hospital and other community health care locations/programs Funding by: UPMC, March of Dimes, Tobacco Free Allegheny, PA DOH, UPMC Health Plan, FISA Foundation

21. Components • Coping strategies, problem solving skills, interpersonal support, NRT if MD willing • Attention to motivations for smoking and quitting • Menu of treatment options • Incentives for attendance (and, for some, abstinence) • Performance feedback (CO monitor) • Biological assessment of quit outcomes

22. 2008 SAMHSAScience and Service Award • Competitive national awards for exemplary implementation of recognized evidence-based MH or SA interventions and that make a positive impact in their communities. • 29 programs received awards in 2008. • STOP is one of two programs addressing tobacco and the only prenatal smoking cessation program to receive an award.

23. STOP Participants 2000-2009: • 1170 participants • Age range: 14-42 • 34% AA, 61% White • 90% MA or uninsured • 41% did not complete high school • 28% work outside the home • 87% single (but 80% in a relationship) • 84% unplanned pregnancy • 24% admit to co-occurring drug and/or alcohol abuse • 43% have sought treatment for depression • 76% of partners smoke

24. STOP Participants • Main reasons for smoking: • Deal with stress (55%) • Addiction to nicotine (40%) • Social or other (5%) • Main reasons for wanting to quit or stay quit: • Baby’s health (84%) • My health (9%) • Save money (2%) • Break the addiction (3%) • Other (2%)

25. Pittsburgh STOP ProgramReadiness-based recruitment & intervention strategies Sure you can’t/don’t want to quit, but willing to think about cutting down? Thinking about quitting, but not sure? Ready to quit?

26. Originally built into the design as an evaluation measure to confirm self report of smoking status Based on participant feedback, CO monitoring is now used as a program element to motivate change. CO Monitoring

27. What has been most helpful? 2% 5%

28. CO Monitoring as a Motivator • Baseline score with printed (4th grade rdg. level) and verbal info about how higher levels of CO/lower levels of oxygen affect the mother and the fetus • Used as an example of other harmful physiological effects of smoking on mother and fetus • Weekly CO goals • Chart for ongoing CO monitoring

29. STOP Program Results • Drop out rate low at 14% • Quit & stay quit rates: • 29.8% quit rate at delivery for those who enter as current smokers; most who do not quit do cut down • 90% stay-quit rate for those who enter as recent quitters

30. Factors Associated withQuit Rate Results • Negative association for: • Treatment for depression (24% vs. 35%; p=.007) • Older than 25 vs. younger (24% vs. 35%; p=.006) • (trend) Partner who smokes vs. not (28% vs. 35%;p=.10) • (trend) White vs. AA (27% vs. 34%; p=.09) • (trend?) Unplanned pregnancy (29% vs. 36%; p=.12) • No differential outcomes for quitting by: • Concurrent alcohol or drug use • Exposure to domestic violence

31. Birth Outcomes

32. Gestational Age Average gestational age of baby at birth Preterm birth = less than 38 weeks 38.4 wks 37.9 wks Gestational weeks Average gestational age at birth: Quitters: 38 wks 3 da Smokers: 37 wks 6 da p=.08

33. Birth Weight Status % Average birth weights: Quitters: 6 lbs. 14oz Smokers: 6 lbs. 8 oz. *c2 =4.6, p=.04

34. Apgar scores by Smoking Outcomes Birth: F=2.9;p=.09 5 minutes: F=4.1;p=.04

35. Neonatal Outcomes by Smoking Status % c2=6.2;p=.02

36. Goals for Today • Brief background on smoking during pregnancy • Evidence-based prenatal tobacco control • The Pittsburgh STOP Program • Research questions suggested by STOP Program outcomes

37. RCT Research Questions Suggested by STOP Outcomes • Does the STOP “package” improve outcomes for low SES pregnant smokers compared to usual care? • Do incentives motivate attendance, quitting, or both for low SES pregnant smokers? • Does CO monitoring motivate quitting? • Effectiveness of STOP interventionists vs. trained clinic staff interventionists

38. Incentives: Not reported as a motivator for quitting May motivate attendance Thus reducing drop out rate CO Monitoring: May motivate quitting Thus: Increasing quit rates Decreasing relapse rates Incentives & CO Monitoring:Guesses as to Mechanisms of Action

39. 2 x 2 research design Incentives Y N CO + incentives CO only Y CO monitoring Incentives only Usual care N

40. Patricia Cluss, Ph.D. clusspa@upmc.edu 412 647-2933