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Integration of AHRQ-Smoking Cessation or Reduction in Pregnancy Treatment Methods Maternity Care.

Integration of AHRQ-Smoking Cessation or Reduction in Pregnancy Treatment Methods Maternity Care. Richard Windsor, MS, PhD, MPH Professor Department of Prevention and Community Health School of Public Health and Health Services George Washington University Medical Center 2175 K Street, NW

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Integration of AHRQ-Smoking Cessation or Reduction in Pregnancy Treatment Methods Maternity Care.

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  1. Integration of AHRQ-Smoking Cessation or Reduction in Pregnancy Treatment Methods Maternity Care. Richard Windsor, MS, PhD, MPH Professor Department of Prevention and Community Health School of Public Health and Health Services George Washington University Medical Center 2175 K Street, NW Washington, DC 20037 (202) 416-0086

  2. TOPICS • Examine smoking status-trends during pregnancy and postpartum for the decade. • Discuss the validity of patient self reports. • Describe the AHRQ-SCRIPT methods. • Present meta-evaluation of cessation methods. • Estimate the behavioral impact on birth weight and cost benefit of effective methods. • A brief update on pharmacological treatment. • Discuss the integration of SCRIPT by MCO’s.

  3. Smoking Rates and Trends During Pregnancy: Validity? • 4 million births: 1990-2000 • CDC-PRAMS: Mailed Survey-PP • SAMSHA: Household Surveys • Patient Deception?

  4. Table 1 Smoking Rates During Pregnancy and Percent Change: 1990-2000 Years Total Black White Hispanic Other 1990 18.4% ---- ---- ---- ---- 1993 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% ---- ---- ---- ---- 2000 12.2% 9.1% 15.7% 3.7% 5.9% % Change -34% -43% -25.% -45% -46% < Smokers -240,000+ ---- ---- ---- ---- NCHS-NVSS-CDC, Vol. 48, No. 14, August 18, 2000 and Vol. 49, No. 7, August 28, 2001, Table 1, and Vol. 50,No.5, February 12, 2002, Table 32. + = Crude Estimate

  5. Table 2 Average Smoking Rates+ Among Women Ages 15-44 from 1990 to 2001* Smoking Rates Survey Pregnant Non-Pregnant * Cigarettes & Cigars in Last Month, National Household Survey on Drug Abuse, SAMHSA, Office of Applied Studies, Annual Reports: 1990 to 2000.

  6. Smoking and Low Birth Weight (LBW) Trends: CDC • LBW Rates: 6.97 (1990) to 7.80 (2000) • 1990: 276,000 LBW Infants • 2002: 316,000 LBW Infants • LBW Smokers: 11.90 - - Non-Smokers: 7.20 • Pregnant Smoker PAR = 30,000 LBW/10% • < 34% S Rate: ≤ 10,000 LBW Infants

  7. Table 3 LBW Rates by Self-Reported Smoking Status: 1990 to 2000 Black Excerpted Data – NCHS, NVSS, CDC, August 28,2001 & February 12, 2002—Estimated Data.

  8. Table 4 Patient Assessment of Smoking Status in Clinical Practice Assess pregnant woman’s tobacco use status using a multiple–choice question to improve disclosure. Many pregnant women deny smoking. A multiple-choice question format may improve disclosure. For example: Which best describes your cigarette smoking? • I smoke regularly now- about the same, as before finding out I was pregnant. • I smoke regularly now, but I’ve cut down since I found out I was pregnant. • I smoke every once in a while. • I have quit smoking since finding out I was pregnant . • I wasn’t smoking when I found out I was pregnant, and I don’t smoke now. AHRQ 2000 (P. 95).

  9. SCRIPT Natural History Study: Baseline DataSmoking Status By Cotinine Levels Cot. <30 Cot. >30 Insufficient No Sample Total A 2 18 4 0 24 B 7 58 13 6-4 84 C 31 24 12 2-2 69 D 24 20 5 1 50 E 171* 28* 50 121-8 215 Total 235* 148* 50 134-15 446 416/446 = 93% Cotinine Confirmed Deception Rate = 24% (W = 36% -- B = 12%) A = Current Smoker D = Quit Before Pregnancy B = Reduced but Current Smoker E = Never Smoked C = Quit After Becoming Pregnant Prevalence Rates: Black = 20% White = 62% Total = 44% * Estimate based on 40% Sub-Sample NHS 2: Deception Rate = 6%

  10. Smoking Status Assessment in Maternity Care: Periodicity • First Visit • Third or Fourth Visit • Post-Partum Visit • Biochemical Confirmation: CO Urine Cotinine Dipstick

  11. D. Parker, T. Lasater, R. Windsor, et al. (2002). The Accuracy of Self-Reported Smoking Status Assessed by Cotinine Test Strips. Nicotine & Tobacco Research: Vol 4, pages 305-309. We evaluated a new urine cotinine test (CT) strip, gas chromatography (GC) and a self-administered questionnaire to assess smoking status in pregnancy (n = 95).

  12. 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 plus self-reports provided a very accurate measure. • This was the first study to evaluate the CT strip, using the CT strip prototype. • A larger trial is needed to evaluate the validity of the CT strip, compared to GC and self report.

  13. Table 5: Evaluation Phases For Health Promotion-Disease Prevention Interventions: Science – Policy - Practice Windsor, Clark, Boyd, and Goodman, “Evaluation of Health Promotion- Disease Prevention Programs”, Chapter 1, 3rd Ed., McGraw-Hill Publisher, St. Louis, MO, In Press, 2003.

  14. Table 6 Examples of Effective Interventions With Pregnant Patients Brief health educator discussion of risks (3-5 minutes); advised of a free cessation class; and pregnancy-specific self-help materials mailed weekly for 7 weeks. Physician advice on risk (2-3 minutes); videotape with information on risks, barriers, and tips for quitting; midwife counseling in one 10-minute session; self-help manual; and follow up letters. Pregnancy–specific self-help materials (Pregnant Woman’s Guide To Quit Smoking) and one 10-minute counseling session with a health educator. Cessation skills and risk counseling in one 15-minute session by a health counselor; education on how to use pregnancy-specific self-help materials (same Guide as Windsor et al., 1985); follow up medical letter; social support with a buddy letter, a contract, and a tip sheet. Windsor, et al (2000) AJ OB/GYN SCRIPT Methods: Guide & Commit to Quit Video (10 min.) & Patient Counseling (5 min.). AHRQ 2000 (P. 94).

  15. The “Smoking Cessation and Reduction in Pregnancy Treatment” (SCRIPT) Model (1981-2001) was designed to be successfully integrated into patient education methods for women into public health and managed care organizations. The “effectiveness” of SCRIPT delivered as part of routine care by physicians, nurses social workers, and nutritionists has been rigorously evaluated.

  16. Figure 1 SCRIPT Model: Counseling Procedures For Pregnant Smokers PROCEDURE COMPLETED ASK AND ASESS: 1 minute 1. Document smoking status and cigarettes per day (cpd) A. Never smokerD. Smoker: reduced cpd B. Quit before pregnantE. Smoker: same cpd C. Quit since pregnant ADVISE  1 minute 2. Provide clear, strong messages about risks of smoking to mother/fetus 3. Provide clear, strong and personal advice to quit and stay quit ASSIST  2-3 minutes 4. Provide “Commit to Quit” Video to View 5. Provide A Pregnant Woman’s Guide to Quit Smoking to Review 6. Briefly review cessation skills in Video-Guide get an agreement to use guide 7. Express confidence that use of the Guide and methods will help patient quit 8. Encourage patient to seek family & social support and to stop ETS ARRANGE  1 minute 9. Remind patient of next visit and put “smoking as vital sign” label in chart 10. Assess status during pregnancy: if a smoker, encourage cessation

  17. The SCRIPT Model: “ASSIST” • Component #1: Commit to Quit Smoking – During and After Pregnancy Video • Component #2: A Pregnant Women’s Guide to Quit Smoking • Component #3: Patient-centered counseling session

  18. Patient Education Prescription Form STEP ACTIVITY PAGE COMPLETED PATIENT NAME___________________ CHART #___________ 1 2 3 4 5 6 7 8 9 10 Smoking Risks-Benefits of Cessation Commit to Quit- Building Self-Efficacy Smoking Diary- # Scheduled Smoking Deep Breathing Buddy Support Buddy Contract and Tip Sheet Smoke- Tasting Quit Date- Sign the Contract to Use Guide Telephone Call- Quit Day 8 Guide Page 2 Guide Page 3 Guide Page 5 Guide Page 8 Guide Page 9 Guide Page 11 Attachments C & D Guide Page 16 Guide Page 3 Take Control Get Support Use the Guide Summarized Counseling Session

  19. Table 7 Behavioral Impact of AHRQ-SCRIPT Methods U.S. Studies * Total= 15.4% 6.9% +8.5% Non U.S. Studies Total= 15.0% -8.8% +6.2% Total= 15.2% 7.5% +7.7% + = Multiple systems changes -reduced rate Effect Size Range= 4.0% to 15.7%

  20. Table 8 Estimated Behavioral Impact of AHRQ-SCRIPT Methods * May be eligible for NRT? ** Eligible for NRT? + SAMSHA- 2001.

  21. TABLE 9 ESTIMATED IMPACT, COST AND SAVINGS OF AHRQ-SCRIPT METHODS • x 800,000 = (B) (B) x $2,000 = (C) * (C1-2-3) - (D1-2-3) = (E1-2-3) • * Miller, et al. N&TR, 2001: Adjusted by BLS-CPI to 12-31-02.

  22. Marks, J.S., et al. “A cost benefit-cost effectiveness analysis of smoking cessation for pregnant women” American J of Preventive Medicine, 1990; 6(5), 282-289.Li, C.Q., Windsor, R., Lowe, J., et al. “Evaluation of the impact of dissemination of smoking cessation methods on the low birthweight rate and health care costs in the U.S.: Achieving the year 200 infant health objectives” American J of Preventive Medicine, 1992; 8: 171-177.Miller, D.P., et al. “Birth and first-year costs for mothers and infants attributable to maternal smoking” Nicotine & Tobacco Research, 2001; 3: 25-35.

  23. 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. Journal of the American Medical Women’s Association, Vol. 55(5), 304-309, 2000.

  24. PREGNANCY Recommendation: Pharmacotherapy should be considered when a pregnant woman is unable to quit, and when the likelihood of quitting, with its potential benefits, outweighs the risk of pharmacotherapy and potential continued smoking. If the clinician and pregnant or lactating patient decide to use NRT pharmacotherapy, the clinician should consider: • Monitoring urine cotinine/CO levels to assess level of smoking activity. • Using medication doses at the low end of the effective dose range, and • Choosing a delivery system that yields intermittent, rather than continuous, drug exposure (e.g., gum rather than the patch). Because no NRT medications have been tested in pregnant women for efficacy in treating tobacco dependence, the relative ratio of risks to benefits is unclear. AHRQ, 2000 (Page 2).

  25. Integration of Guidelines into Practice for MCO’s • Science-Evidence Base: AHRQ/SCRIPT • Organizational Policy-Development • Training: Basic Counseling Skills • Practice-Patient Flow Analysis (PFA) • Practice Pilot Tests • Final Practice Guidance-Policy

  26. Figure 1.1 Foundation Domains in Planning and Evaluation of HP-DP Programs: THEORY PRACTICE POLICY PROGRAM PLANNING AND EVALUATION PRACTICE SCIENCE

  27. Aim #1A – Establish Public Health Science and Practice Partnership SCRIPT MANAGEMENT COMMITTEE Richard Windsor, PhD, MPH Tom Miller, MD, MPH Michael Hardin, PhD Lesa Woodby, PhD, MPH Myra Crawford, PhD, MPH Carlo DiClemente, PhD Sharon Gerogiannia, MSW Phyllis Gilchrist, RN, BNS James Richard Laurie Stout, RN, BSN P.I. and Director Co-P.I., Director, Bureau of Family Health Services Investigator Deputy Director Investigator Investigator Social Work Consultant Director, Women’s Health Branch Director, Division of WIC Consultant, Clinical Services Support

  28. Aim #1B – Define and select a sample of representative, eligible sites for SCRIPT.Aim #1C – Conduct a natural history study of tobacco exposure among a sample of new patients from Aim #1B sites.

  29. SCRIPT Patient-Site Flow AnalysisJefferson County--Eastern 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 Content Summary Nurse Interview: History, appointment with midwife, SCRIPT, drug/alcohol prevention 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 out of 10 scheduled patients came • Patients stay with same nurse throughout pregnancy

  30. Aim #2 – Train SCRIPT maternity clinic staff to perform patient assessments and to deliver patient education methods. Maternity clinic staff will be able to: • Describe the process to introduce SCRIPT to patients; • Demonstrate how to assess smoking status using CO or urine dipsticks and interpret results to patients; • Demonstrate patient education skills and counseling by delivery of video, guide, patient education prescription forms and role plays; • Describe when and how to conduct follow-up assessments; • Describe how to translate the process of data collection into a simple cost analysis; and • Describe how to assess cessation and significant reduction.

  31. Windsor, Whiteside, Jr., Solomon, et al. (2000) A process evaluation model for patient education programs for pregnant smokers. Tobacco Control. 9(Suppl III):iii28-iii35.

  32. Table 10 SCRIPT Process Evaluation Example • Patient • Clinical Procedures (P) • 1. Smokers recruited (S1) • 2. S1 baseline form (O1A) • 3. S1 baseline cotinine (O1B) • 4. E group-Video (X1) • 5. E group-Guide (X2) • 6. E group-Counseling (X3) • 7. Follow up O2A • 8. Follow up O2B • 9. Follow up O3A • 10. Follow up O3B Eligible Patients (A) 100 100 100 100 100 100 100 100 100 100 Exposed Patients (B) 70 100 100 98 100 99 85 80 75 75 Performance Standard (C) 80% 100% 100% 100% 100% 100% 95% 95% 95% 95% Implementation Index (B/C) (D) 0.88 1.00 1.00 0.98 1.00 0.99 0.90 0.84 0.79 0.79 Program implementation index = Σ e/Pn = (0.88 + 1.00 + 1.00 + 0.98 + 1.00 + 0.99 + 0.90 + 0.84 + 0.79 +0.79) / 10 = 0.92 X = E group intervention component; O, patient observation-smoking status;A= form & B = Cot; P, procedure

  33. Windsor, Woodby, Miller, et al. (2000). Effectiveness of Agency for Health Care Policy and Research Clinical Practice Guidelines and Patient Education Methods for Pregnant Smokers in Medicaid Maternity Care. American Journal of Obstetrics and Gynecology. Vol 182: No. 1, 68-75.

  34. Table 11: E and C Effectiveness Rates* Behavior Smoking cessation rate (%) Significant reduction rate (%) No significant change (%) Experimental Group 17.3 21.7 61.0 Control Group 8.8 15.8 75.4 Odds Ratio 2.2 1.5 0.51 95% Confidence Interval (l-tailed) 2.2-4.1 1.5-2.6 0.51-0.80 TOTAL SAMPLE N = 139 N = 126 *Preliminary Rates:Significant Historical Events <Final Rates

  35. Table 12: E and C Group Cotinine Values at Baseline and Follow-up Control Group Experimental Group Behavior Smoking cessation Significant reduction No significant change Baseline 97 228 218 Follow-up 4 77 188 Baseline 40 238 195 Follow-up 4 79 183 All values are in nanogram per milliliter.

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