1. Using 5 A’s and Incentives to Promote Prenatal Smoking Cessation PI: Rebecca J. Donatelle, PhD, CHES PC: Deanne Hudson, RN, MPH, CHES Co-PI: Edward Lichtenstein, PhD Co-Investigators: Michael Wall, MD; Oregon Health Sciences University Nancy Davis, MPH; Providence Health System CORE Advisor: Chuck Benz, MD; Providence Health System Funded by RWJF- Smoke-Free Families: Phase II

2. Outline of Presentation Overview Previous Research: Oregon WIC Outcomes and Conclusions Overview MISS Project MISS Progress to Date

3. Negative Outcomes From Prenatal Smoking Low birthweight (20%) Preterm Birth (8%) Perinatal Death (5%) SIDS Respiratory Illnesses Decreased lung function * CT Orleans et al (2000)

4. Previous Projects: SOS I, II & III ( Donatelle*, Prows*, Hudson, Champeau) 3-4 Pronged Approaches Positive incentives (vouchers) to participants alone or participants and partners for biochemically confirmed quits Social support/partners (bolstered and natural) Community participation Biomarker feedback

5. Contingency Management (Rewards) Theory Drug abuse is a form of operant behavior that is maintained in part by the reinforcing effects of the drug (Higgins 1996, 1997) Non-drug reinforcer should decrease drug use (Roll et al 1996, Higgins 1997) Voucher incentives provided when drug-free (Silverman et al 1996, Higgins 1997)

6. Measures/Biochemical Confirmation (MISS) Utilize variety of measures/collection methods Follow Evidence Based Recommendations Values for quit: Saliva Cotinine (GCMS)  30 ng/ml CO Expired air  05 ppm

7. Summary of SOS-I (RWJF–SFF: I) Study Tailored Education /Advice Choose Partner Woman Incentives / Month Quit % SOS – I RCT Cx 108 Tx 112 YES - $50./$25. - $50. 9 32 Donatelle*, Prows*, Champeau, Hudson (2000)

8. Summary of SOS-II (RWJF) Study Tailored Education / Advice Choose Partner Woman Incentives / Month Quit % SOS-II Pilot N = 62YES $50.28 Donatelle, Prows, Hudson

9. Summary of SOS – III (OHD) Study Tailored Education / Advice Choose Partner Woman Incentives / Month Feed- back Quit % SOS – III RCT Cx 60 Tx 1 67 Tx 2 59 YES - YES - $25. - YES 12 19 22 Donatelle, Prows, Hudson

10. SOS I, II & III: Quit Rates at 8 months Gestation (%) I-C I-Tx II III Cx III Tx1 III Tx2

11. Conclusions from SOS I, II & III Best Practice-4 A’s are promising in WIC ? Would this be effective in private practice/Medicaid Incentives (Contingency Management) seem to be effective ? What is the threshold for peak behavioral outcome Biomarker feedback Partner Support …? Utilized various biochemical measures of quit - may be an important component of the intervention itself

12. Maternal Interventions to Stop Smoking (MISS) Project Purpose: To significantly increase smoking cessation behavior among predominantly low-income, high risk, pregnant women 9 Oregon private practice prenatal clinics Quit Confirmation (CO and Salivary Cotinine) RCT: 3 group design Best Practice 5 A’s Best Practice 5 A’s plus $25/month voucher Best Practice 5 A’s plus $75/month voucher

13. Eligibility Criteria Pregnant smoker (smoked even a puff in the last seven days)  15 years of age or older < 29 weeks gestation at first OB visit English speaker/reader

14. MISS Objectives Determine whether incentives are more effective than Best Practice in motivating pregnant smokers to quit To assess whether a higher incentive will result in a greater level of smoking cessation than a lower level incentive

15. Secondary Project Objectives Determine: The integrity/consistency of the intervention as delivered in private practice managed care clinics utilizing process measures from both women and providers. The importance of selected psychosocial/environmental factors as predictors of smoking cessation/reduction in this population. The cost-per-quit implications for an incentives model provided in a private practice managed care clinic.

16. MISS Methods Screen all pregnant patients at 1 st prenatal visit Determine eligibility Obtain informed consent – Randomized by patient Provider 5A’s A Pregnant Woman’s Guide to Quit Smoking Importance of quitting during pregnancy Local cessation resource guide

17. MISS Methods Continued Incentives to Treatment Group Quitters Follow monthly through 8 months gestation Postpartum telephone assessments of quitters with salivary collection from nonsmokers

18. Best Practice 5 A’s Ask Advise Assess Assist A Pregnant Woman’s Guide to Quit Smoking Local area cessation resource list Arrange

19. Summary of MISS Project ( RWJF-SFF:II) Tailored Education /Advice Local Resource Pamphlet Woman Incentives / Month MISS-RCT Cx Tx 1 Tx 2 YES - $25. $75.

20. MISS Project To Date ActivityPilot RCT (8/01-9/02) Screened 7872,751 Eligible 136430 Enrolled 84298 Goal: 600 Participation Rate 62%69%

21. MISS Project Baseline Summary (n=298) Medicaid/Oregon Health Plan (%)79 Private Insurance (%)24 Mean Maternal Age (yrs.)24.1 Mean Education (yrs.)11.9

22. MISS RCT: Light Smokers (<10) and Heavy Smokers at Baseline by R Group (n=293)

23. Lessons Learned as of Today! Intervention dependent on fast turn-around for reinforcement, difficult to find a lab able to comply at any cost Although Providers are interested in smoking cessation during pregnancy and say it is a priority – they report TIME pressures and demands Continued clinic monitoring & support/staff trainings/booster sessions a MUST…

24. MORE Lessons Learned Incentives to Clinics Locate Internal Champion in Clinics Research Overlay is Staff Intensive Local Resource List: Providers have Little Idea of What is Going on in Community Available for ALL Patients

25. More….. Important to be connected in State/Region Many agencies/programs/other funded projects promote 5A’s Cooperation/collaboration important

26. References Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: US Department of Health and Human Services. Public Health Service. June 2000. Orleans CT, Barker DC, Kaufman NJ, et al. Helping Pregnant Smokers Quit: Meeting the Challenge in the Next Decade. Tobacco Control 2000;9(Suppl III):iii6-iii11. Donatelle RJ*, Prows S*, Champeau D, et al. Randomized Controlled Trial Using Social Support and Financial Incentives for High Risk Pregnant Smokers: The Significant-Other Supporter (SOS) Program. Tobacco Control 2000;9(Suppl III):iii67-69.

27. References - more Higgins ST. Some Potential Contributions of Reinforcement and Consumer-Demand Theory to Reducing Cocaine Use. Addict Behav 1996;21(6):803-816. Higgins ST. The Influence of Alternative Reinforcers on Cocaine Use and Abuse: A Brief Review. Pharmacology Biochemistry and Behavior 1997;57(3)419-427. Silverman K, Wong CJ, et al. Increasing Opiate Abstinence Through Voucher-Based Reinforcement Therapy. Drug and Alcohol Dependence 1996;41:157-165. Roll JM, Higgins ST, et al. An Experimental Comparison of Three Different Schedules of Reinforcement of Drug Abstinence Using Cigarette Smoking as an Exemplar. Journal of Applied Behavior Analysis 1996;29:495-505.