Addressing Barriers to Treating Pregnant Women’s Tobacco use and Dependence

1. Addressing Barriers to Treating Pregnant Women’s Tobacco use and Dependence Richard Windsor, MS PhD MPH Professor of Public Health & NIH SCRIPT Trials Principal Investigator: 1982-2012Department of Prevention & Community HealthSchool of Public Health & Health ServicesGeorge Washington University Medical Center2175 K Street, NW #701 Washington, DC 20037Phone: 202-994-3572, rwindsor@gwu.eduPresidential Professor of Public Health (2007-12)University of Alaska, Anchorage

2. Disclosure I have no real or perceived vested interests that relate to this presentation nor do I have any relationships with pharmaceutical companies, and/or other corporations whose products or services are related to pertinent therapeutic areas. 

3. Objectives • To summarize the relationship of maternal smoking and secondhand smoke exposure to maternal & infant health 2. To describe current best practice treatment for tobacco use, dependence and exposure 3. To discuss successes and challenges in treating tobacco use in pregnancy

4. Health effects of smoking during pregnancy • Tobacco use is the most important modifiable cause of adverse pregnancy outcomes in the U.S. (Fang, 2004) • Smoking accounts for 20% of low birth weight deliveries (<2500 grams), 8% of preterm births and 5% of all perinatal deaths (Orleans, 2001)

5. Health effects of smoking during pregnancy • Fetus is exposed to harmful chemicals such as tar, nicotine and CO • CO lowers the amount of oxygen received • Nicotine is a vasoconstrictor: less oxygen and nutrients reach the fetus (ACOG, 2011)

6. Health effects of smoking during pregnancy • Greater risk of ectopic pregnancy, pre-term delivery, stillbirth, and low birth weight (Dietz, 2010) • Continued risk from secondhand smoke after birth: sudden infant death syndrome (SIDS), asthma, infantile colic and childhood obesity (Li, 2005, Sondergaard, 2001, von Kries, 2002); cognitive, emotional and behavioral problems in children (HHS, 2006, ACOG, 2005)

7. Health effects of smoking during pregnancy Low birth weight is associated with increased risk for neonatal, perinatal and infant morbidity and mortality (CDC, Surgeon General’s Report, 2010)

8. Average Doses of Selected Chemicals Per Pregnancy Chemicals 5 CPD 10 CPD 20 CPD NRT (10 wks) 1. CO 44,550 89,100 178,200 mg 0 2. Nicotine (PATCH) 2,700 5,400 10,800 mg < 50% 3. Hydrogen cyanide 607,500 1,215,000 2,430,000 mg 0 4. Nitrogen oxide 472,500 945,000 1,890,000 mg 0 5. Methanol 236,250 472,500 945,000 mg 0 6.. Ammonia 94,500 189,000 378,000 mg 0 7. Hydrogen sulfide 67,500 135,000 270,000 mg 0 8. Arsenic 108,000 216,000 432,000 mg 0 9. Hex. Chromium 49,950 99,900 199,800 ng 0 10. Cadmium 49,950 99,900 199,800 ng 0 11. Nickel 405,000 810,000 1,620,000 ng 0 12. Lead 80,325 160,650 413,100 ng 0

9. Ave. Dose of Carcinogens by Selected Chemicals During Pregnancy Chemicals 5 CPD 10 CPD 20 CPD NRT(10 wks) 1. PAH 168,750 337,500 675,000 ng 0 2. Heterocyclic comp. 11,475 22, 550 140,400 ng 0 3. N-nitrosamines 3,442,500 6,885,000 13,770,000 ng 0 4. Aromatic-amines 472,500 945,000 1,890,000 ng 0 5. N-heterocyclic amines 229,500 459,000 918,000 ng 0 6. Aldehydes 1,401,300 2,794,500 5,589,000 ng 0 7.Volatile Hydrocarbons 1,113,750 2,227,500 4,455,000 ng 0

10. Smoking Rate During Pregnancy and % Change: 1990-2006 • Years Total Black White Hispanic Other • 1990 18.4% --- --- --- --- • 15.8% 15.9% 21.0% 6.7% 8.6% • 1995 13.9% --- --- --- --- • 1997 13.2% 10.6% 17.1% 4.3% 7.5% • 1999 12.3% --- --- --- -- • 2002 11.4% 9.0% 13.0% 3.2% 6.8% • 2004 10.2% --- --- --- --- • 2006 10.0% No National Survey with a Valid Biomarker of Self-Reports • ---------------------------------------------------------------------------------------------------------- • % Change < 45% < 43% < 25.% < 45% < 46% • Source: NCHS-NVSS-CDC 10

11. Smoking Rates of Women 15-44:1990- 2006 * Survey Pregnant Non-Pregnant 1990-92 Average 20.0% (N=800K) 30.0% 1994-96 Average 20.6% 31.8% 1999-01 Average 19.4% 30.2% 2003-06 Average 18.0% (N=768K) 30.7% No National Survey with a Valid Biomarker of Self-Reports National Epidemiologic Survey, 2001-02, Goodwin, et al, Obstetrics & Gynecology, 2007, 21.7% Pregnant Smokers *Tobacco Use--Last Month, National Home Survey on Drug Use & Health, SAMHSA, Office of Applied Studies, Annual Reports 11

12. Effective Interventions- Pregnant Patients Brief health educator discussion of risks (3-5 min) + advised of cessation class+ pregnancy-specific self-help materials mailed weekly for 7 wks . Brief MD risk advice (2-3 min.); Video about risks, barriers, and quitting tips + one 10-minute session by CNM + self-help manual; and follow up letters. Pregnancy–specific self-help materials (Pregnant Woman’s Guide To Quit Smoking) + one 10- minute counseling session with a health educator. Cessation counseling:15-minute session-how to use pregnancy- specific self-help materials (Guide—Windsor et al., 1985); follow up MD letter + social support + buddy letter + contract + tip sheet. Windsor, et al (2000) PHASE III - AJOb/Gyn SCRIPT Methods: Guide & Commit to Quit Video 10 min.) & Patient Counseling (5 min.). NOTE: Published >>> AHRQ, 2000 Review Agency for Health Care Research & Quality (AHRQ, 2000, 94) 12

13. U.S.P.H.S. Clinical Practice Guidelines, 2008 Update • 1. Pregnant smokers should be offered face- to-face psychosocial interventions that exceed minimal advice to quit (Strength of evidence = A) (HHS, 2008) • 2. Clinicians should offer effective tobacco dependence interventions to pregnant smokers at the first prenatal visit as well as throughout the course of pregnancy (Strength of evidence = B)

14. U.S.P.H.S. Clinical Practice Guidelines, 2008 Update • 1. Evidence for Psychosocial interventions n = 8 studies: usual care (<3 minutes, self-help material, referral) vs. psychosocial intervention with intensive counseling

15. U.S.P.H.S. Clinical Practice Guidelines, 2008 Update 1. Components of Psychosocial interventions • MD advice (2-3 minutes); video on risks, barriers to and tips for quitting; midwife counseling (10 minutes); self-help manual; follow-up letters (Walsh, 1997) • Pregnant Woman’s Self-Help Guide to Quit Smoking; counseling (10 minutes) (Windsor, 1985, 1993) • 90-minute counseling; bimonthly follow-up phone calls; monthly calls after delivery (Dornelas, 2006)

16. U.S.P.H.S. Clinical Practice Guidelines, 2008 Update 2. Clinical practice suggestions for assisting pregnant smokers in quitting ASK:assess tobacco use status using a multiple-choice question to improve disclosure (e.g. smoke same #, smoke less #, quit before finding out I was pregnant) ADVISE: Motivate quit attempts by providing educational messages about health impact ASSESS: Assess the patient’s willingness to quit

17. U.S.P.H.S. Clinical Practice Guidelines, 2008 Update 2. Clinical practice suggestions for assisting pregnant smokers in quitting ASSIST: Provide self-help materials (book, video) ARRANGE: Arrange for follow-up assessments throughout pregnancy

18. U.S. P.H.S. Clinical Practice Guidelines, 2008 Update • Rationale for assisting pregnant smokers during prenatal visits • Many women are motivated to quit during pregnancy; 46% of smokers quit directly before or during pregnancy (Colman, 2003) • *Up to 60% of those who quit during pregnancy will relapse within 6 months postpartum, and 80-90% by 12 months postpartum (Floyd, 1993, Fingerhut, 1990) • Health benefits result from quitting at any time (Husten, 2008, England, 2001, Lieberman, 1994, DiClemente, 2000)

19. U.S. P.H.S. Clinical Practice Guidelines, 2008 Update • NRT for pregnant smokers? • U.S. P.H.S. Clinical Practice Guidelines • Evidence on both safety and effectiveness of NRT is inconclusive • Nicotine may contribute to adverse effects of smoking during pregnancy and result in injury to the fetus (Jacobsen, 2007, Ginzel, 2007, Slotkin, 2007) • Cases should be considered in context – nicotine from NRT vs. nicotine from cigarettes (plus 4,000 chemicals and toxins)

20. “Behavioral and Pharmacotherapy Treatment Strategies for Pregnant Smokers: Issues for Clinical Practice” R. Windsor, PhD, MPH, C. Oncken, MD, J. Henningfield, PhD, K. Hartmann, MD, PhD, and N. Edwards, PhD, RN., J. of the American Medical Women’s Association, Vol. 55(5), 304-309, 2000. Conclusion: The judicious use of NRT medications may significantly reduce harm to the infants of heavy smokers. More evidence derived from large population-based research, however, is needed to provide guidance to the physician about NRT eligibility, dose, scheduling, and effectiveness in clinical practice. ---------------------------------------------------------------------------------------- “Pharmacotherapy for Smoking Cessation during Pregnancy” Benowitz, Neal., Dempsey, Delia. Nicotine & Tobacco Research, Vol.6, Supp. 2, April, 2004, S189-S202. Conclusion: Clinicians should consider the use of nicotine replacement therapies as an adjunct to smoking cessation in pregnant women who cannot quit smoking with behavioral treatments alone. Available clinical trial data suggest that nicotine replacement therapy is safe during pregnancy, although its efficacy in aiding cessation has not been demonstrated. --------------------------------------------------------------------------------------------------------------------- Coleman, et al, “A RCT of NRT-Patches in Pregnancy”, NEJM, March 1, 2012 E NRT Group = 521- 9.4% vs C Group = 529 – 7.6% (NS) 20

21. “Nicotine Replacement and Behavioral Therapy for smoking cessation in pregnancy”K.Pollak, et al., Vol.33, No.4, 2007, American Journal of Preventive Medicine Methods and Results Eligibility: ≥ 5 CPD, 13-25 weeks gestational age, ≥ 18 years old Intervention Group: 6 counseling sessions + NRT (patch, gum or lozenge) Control Group: 6 counseling sessions Measurement: saliva cotinine and self-report -------------------------------------------------------------------------------------------------------- Behavioral Impact: At 7 weeks, the intervention group had a 24% quit rate, compared to 8% in the control group. At 3 months postpartum, the intervention group had a 20% quit rate, compared to 14% in the control group.

22. “Nicotine Gum for Pregnant Smokers: a RCT” C. Oncken , et al. Vol. 112, No. 4, 2008, Obstetrics & Gynecology Methods and Results --------------------------------------------------------------------------------------- Eligibility: > 1 cigs per day, < 26 weeks gestational age, > 16 years old Intervention Group: Two, 35-min counseling sessions, 2mg nicotine gum Control Group: Two, 35-min counseling sessions, placebo gum Measurement: 1st , 2nd, 3rd, 4th, 5th visit, based on CO & Self Report Process: 71% of the intervention group attended visits. 60% of the control group attended visits. Gum use did not differ significantly between the groups. Behavioral Impact: Quit rate for intervention group was 18.0%, compared to 14.9% for the control group. Birth weight for the intervention group was 3287g, compared to 2950g for the control group.

23. Successes and challenges in the treatment of smoking during pregnancy: feasibility, and barriers to implementation and sustainability

24. What is the Smoking Cessation and Reduction In Pregnancy Treatment (SCRIPT) Program?

25. Evaluation PHASES: Producing the SCRIPT Process-Impact Evidence for Prenatal Care – Practice - Patients

26. SCRIPT Evaluations: E vs C Group Quit Rates

27. SCRIPT Procedures for Clinical Practice Procedures Completed ASK < 1 minute 1.Document smoking status + cigarettes per day (cpd) + CO Sample  A. Never smoker or quit before pregnant B. Quit since pregnant  C. Smoker: reduced cpd  D. Smoker: same cpd  Response A and B: Congratulate her on success and stop home & social ETS Response C and D: ASSESS--ADVISE--ASSIST--ARRANGE ASSESS <1 minute 2.Document readiness to quit ADVISE <1 minute 3.Provide clear, strong messages about risks of smoking to mother/fetus  4.Provide clear, strong and personal advice to quit and stay quit ASSIST >10 minutes 5.Review cessation skills in Video-Guide & sign an agreement to use Guide  6.Express confidence that use of the Guide and methods will help them to quit  7.Encourage patient to seek family & social support to quit 8.Advise patient to stop ETS exposure at home, car and social  9.Remind patient of next visit and put "smoker" label in notes  ARRANGE < 1 minute 10.Schedule next visit for patient & Call Patient on Quit Date (Optional)  27

28. The Core SCRIPT Procedures --------------------------------------------------------------- Component #1: Commit to Quit Smoking During & After Pregnancy Video (10 Min.) * Component #2: A Pregnant Women’s Guide to Quit Smoking (5th-6th grade literacy) * Component #3:Patient-centered counseling session (10-15 Minutes) * ---------------------------------------------------------------- *Society for Public Health Education (SOPHE) 28

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31. SCRIPT Patient-Practice Flow Analysis (PFA) Prenatal Clinic #1 Patient #1 Total Time By Personnel = 2 hours, 25 minutes Sign In → Clerk → Lab → Nurse → Social → Nutritionist → Appointment Clerk Interview Worker Sign Out 8:05 am 8:50 to 8:55 to 9:20 to 9:42 to 10:00 to 10:25 to 8:55 9:11 9:35 9:55 10:25 10:30 Patient #2 Total Time By Personnel = 2 hours_______________ Sign In → Clerk → Lab → Nurse → Social → Nutritionist → Appointment Clerk Interview Worker Sign Out 10:30 am 10:30 to 10:35 to 10:50 to 11:17 to 12:00 pm to 12:25 to 10:35 10:45 11:15 11:55 12:25 12:30 Education/Counseling Content Summary Nurse Interview: History, appointment with midwife, SCRIPT, drug/alcohol prevention counseling Social Worker: Education, home environment, feeling about pregnancy, Medicaid, birth control options Nutritionist: Nutrition assessment/recommendations, WIC, voter registration, no vouchers available today Remarks Only 4 of 10 scheduled patients her appointment Patients stay with same RN throughout pregnancy 31

32. Smoking Cessation and Reduction In Pregnancy Treatment (SCRIPT) Procedures: Provider Counseling Manual & Guidelines ----------------------------------------------------------------------- Richard Windsor, MS PhD MPH SCRIPT Principal Investigator

33. 1st Steps: Prepare a Valid Epidemiologic-Behavioral Profile >>> SAR of the adverse Perinatal Rates and Trends --------------------------------------------------------------- How many pregnant smokers do you Have at each/all of your care sites and how large a problem to you have ? 33

34. What is the evidence-base for measurement of active tobacco use during prenatal care in the U.S and at your Prenatal Care Program?

35. SCRIPT Trial III Smoking History Study: Baseline Smoking Status + Cotinine Levels of 416/446 = 93% (A.J.Ob/Gyn,2000) Group Cot. < 20ng Cot. > 21ng No Sample Total Deception RATE A 2 18 0 20 B 7 58 6 73 C 31 24 2 57 35% D 24 20 1 45 40% E 171 * 28 * 120 205 * 13% Total 235 * 148 * 128 416 24% A = Current Smoker D = Quit < Pregnancy B = Reduced but Current Smoker E = Never Smoker C = Quit > Pregnant Cotinine Confirmed Deception Rate = 24.2% White = 36% & African-American = 12% 35

36. Time after cessation to cut-off concentration: Distinguishing Smokers from Non-Smokers

37. “Accuracy of Self-Reported Smoking Status Assessed by CotinineTest Strips” • D. Parker, T. Lasater, R. Windsor, et al. (2002). Nicotine & Tobacco Research, Vol. 4, pp. • 305-09. (New England SCRIPT Trial) • -------------------------------------------------------------------------------------- • We evaluated a new urine cotinine test (CT) strip gas • chromatography (GC) and self-reports to assess smoking • status in pregnancy (n = 95) from 22 sites in MA, CT, and RI. • The 1st study to evaluate the accuracy of CT strip--(NicAlertTM). • CT strips confirmed smokers with a very high level of agreement (97% = 100 ng/ml and 97% = 250 ng/ml cutoff) and non- smokers with a moderate level of agreement (79% = 100 ng/ml and 86% = 250 ng/ml cutoff). • CT strips + self-reports were almost 100% accurate. • A larger trial is needed to evaluate the validity of the CT strip, compared to GC and self report. -------------------------------------------------------------------

38. LITERATURE SYNTHESIS ------------------------------------------------------------------------------------- Recommended VALID Assessment of smoking status in Prenatal Care includes: Patient Self Reports + Biomarker ------------------------------------------------------------------------------------------------------- A. Carbon Monoxide (CO): >8 PPM is considered smoker B. Urine Cotinine Dipstick: >100 ng/ml is considered smoker C. Saliva Cotinine Strips-Dipstick (NicAlert): > 50 ng/ml is considered smoker D. Saliva or Urine Cotinine Test : 7-10 days in Lab; Saliva: > 20 ng/ml is considered smoker, & Urine: > 80- 100ng/ml is considered smoker ------------------------------------------------------------------------------------

39. Discussion of Measurement --------------------------------------------------------------- What evidence is available that regular prenatal care staff (RN/SW) can deliver the SCRIPT Program with fidelity for > 1 year: A Process Evaluation Model (PEM)?

40. Steps to plan a SCRIPT Dissemination Program for a Prenatal Care System, Regular Providers and Population of Pregnant Smokers? ----------------------------------------------------------------- What are we doing now and what/why do we want to introduce new, “Best Practice” methods- procedures into our Prenatal Care Program and Ob Practices: A Multi-Level Challenge?

41. 1st Steps >>> Primary Partners to Plan - Disseminate - Adopt - Evaluate a SCRIPT Program Practices-People Policies-Programs Planning - Problem Solving Partners at the Table Trans-Disciplinary Science

42. What is the SCRIPT evidence-base that defines the assessment (O’s) and treatment (X’s) methods that a trained professional should routinely provide to their patients at prenatal care visit 1-2-3? ----------------------------------------------------------------- Cochrane + AHRQ + NIH + ACOG Systematic Reviews: Treatment-Practice Guidelines for Specific Problems > MD/CNM/RN/SW ----------------------------------------------------------------- The SCRIPT Committees Reviews the Evidence: How do we fit the evidence to its program?

43. Planning a Performance-Process Evaluation -------------------------------------------------------------------------- Major problem documented by all Meta-Evaluations: Did ALL staff deliver all Program Assessment (O) + Treatment (X) Procedures (P) to all patients? ------------------------------------------------------------------------- What is the Process and Behavioral Impact? 43

44. __________________________________________________ Objectives Factors: Issues-Barriers to SCRIPT ____________________________________________________________ >>> Feasibility Policy-Structure-Process-Time-Frequency- Complexity-Content-Materials/Staff Cost/Patient >>> Acceptability Staff Skill-KAP-Self Efficacy Patient Skill-KAP-Self Efficacy >>> Efficacy- Behavioral Impact-Clinical Outcomes Effectiveness <<< Cost Economic Savings or Cost Neutral >>> Efficiency Health-Financial Benefits (CEA-CBA) ____________________________________________________ Other Factors? Rogers: “Diffusion of an Innovation in an Organization” 44

45. National Committee for Quality Assurance 1100 13th St., NW, Suite 1000 Washington, DC 20005 (www.ncqa.org or 1-888-275-7585) -------------------------------------------------------------------------- Healthcare Effectiveness Data Information System (HEDIS) Consumer Assessment of Healthcare Providers and Systems (CAHPS) 4.0H Survey by Managed Care Plans (90%) 45

46. “A Process Evaluation Model (PEM) * for Patient Education Programs for Pregnant Smokers” Windsor, R. Whiteside, P. Jr., Solomon, L. et al. Tobacco Control, 2000, 9 (Supp. III): iii 28-35------------------------------------------------------------------------ Process Evaluation Model: 1. Definition of the eligible patient sample 2. Documentation of patient exposure to each procedure 3. Computation of procedure exposure rate 4. Specification of a practice performance standard or benchmark 5. Computation of an implementation index or rate --------------------------------------------------------------------------------- * Developed for the RWJF-SFF-NPO: 1994-02 46

47. SCRIPT Program Evaluation III Performance Measurement-Process Evaluation Results * ----------------------------------------------------------------------------------------------------- Twenty-eight staff (RN/SW/WIC)at the 10 randomly selected clinics in eight counties implemented Trial III CORE patient assessment (O) and intervention (X1 + X2 + X3) Procedures (P) for patients as part of routine practice without additional compensation. A Process Evaluation confirmed that 6514 patients were screened overa 36 (42 months) period:77% of eligible smokers (1340/1736) agreed to participate (P1). Regular Staff performed 100% of baseline (P2) and 82% of follow-up assessments (P7), and collected 99% of baseline (P3) and 72% of the follow-up (P8)saliva samples. Based on patient follow-up reports, staff provided the Video to 95% (P4), the Guide to 99% (P5), and counseling methods (P6) to 97% of the Experimental (E) Group. ------------------------------------------------------------------------------------------------------ *R. Windsor, L. Woodby, T. Miller, & M. Hardin, “Effectiveness of SCRIPT Methods in Medicaid Supported Prenatal Care: Trial III, Health Education and Behavior, No 4, August, 2011 47

48. SCRIPT Process Evaluation Model (544 Patients) Patient Clinical Procedures (P) P#1. Smokers (S) recruited P#2. S Baseline Form: O1A P#3. Smoker Cotinine: O1B P#4. E group-Video: X1 P#5. E group-Guide: X2 P#6. E group-Counseling: X3 P#7. Follow-up Form: O2A P#8. Follow-up Cot. :O2B Eligible Patients (A) 100 100 100 100 100 100 100 100 Exposed Patients (B) 77 100 99 95 99 97 85 72 Exposure Rate (C) 77% 100% 100% 95% 99% 97% 85% 72% Performance Standard (D) 80% 100% 100% 100% 100% 100% 90% 90% Implementation Rate-Index( I ) (E) 0.96 1.00 0.99 0.95 0.99 0.97 0.94 0.80 Program Implementation Index (PII) : Measures Program Fidelity of Delivery by 1 or ALL Professional Staff (28 RN/SW/RD) in 10 Clinics 48

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