The MISS Project: Combining Contingency Management with Best Practice to Promote Prenatal Smoking Cessation

1. 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 Bentz, MD; Providence Health System Funded by The RWJF- Smoke-Free Families: Phase II; ID# 040669 The MISS Project: Combining Contingency Management with Best Practice to Promote Prenatal Smoking Cessation

2. Outline of Presentation • Overview and Rationale for Innovation • Previous Research: • Oregon WIC Outcomes and Conclusions • Implementation of the MISS Project • MISS Progress to Date: Issues & Challenges

3. Contingency Management (Rewards) Theory • Drug-taking behavior appears to be maintained by the reinforcing effects of the drug (Schuster & Thompson, 1969) • 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)

4. CM Approaches with Other Substances • Cocaine • Opiates • Marijuana • Alcohol • Multiple-drug • Tobacco: Mental illness and Adolescents • Tobacco: Pregnant Women?

5. Contingency Management: Key Components • Ideal CM Programs have these components: • Reward increases over time • Reset the reward level for “miss” or “failure” • Provide a bonus for reaching a milestone • Reward is valued by participant • Deliver the reward immediately (Higgins et al., 1991)

6. 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

7. Summaryof SOS Ia, II, IIIa(Donatelle*, Prows*, Champeau, Hudson, 2000)

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

9. 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 • Is testing an important component of the intervention?

10. 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 • Abstinence 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

11. Eligibility Criteria • Pregnant smoker (smoked even a puff in the last 7 days) • ≥15 years of age • < 29 weeks gestation at first OB visit • English speaker/reader

12. 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

13. Secondary Project ObjectivesDetermine: • 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.

14. MISS Methodology at Prenatal Clinics • Screen all pregnant patients at 1st prenatal visit • Determine eligibility • Obtain informed consent; Randomize* • Baseline Survey + CO + salivary cotinine for all • Provider 5A’s • A Pregnant Woman’s Guide to Quit Smoking • Importance of quitting during pregnancy • Local cessation resource guide *Task performed by Research Team

15. MISS Methods: Continued • Monthly Assessment (CO + salivary cotinine for quits) • Monthly Incentives to Treatment Group Quitters up to 29-32 weeks gestation (by mail $25 or $75)* • Follow-up survey (29-32 wks gest.) + CO + salivary cotinine • 2 month and 6 month postpartum telephone assessments of intervention quitters (salivary cotinine if abstinent)* *Task performed by Research Team

16. Biochemical Confirmation: MISS • Utilize variety of measures/collection methods • Follow Evidence Based Recommendations • Values for abstinence: • Saliva Cotinine (GCMS) ≤ 30 ng/ml • CO Expired air ≤ 05 ppm

17. MISS Project: To Date (Preliminary)

18. Summary of MISS Project (RWJF-SFF:II)

19. MISS Project to Date (Preliminary)(*Transferred, Pregnancy Termination, Delivered Early, Withdrew; ^unable to contact)

20. Preliminary Description of MISS Participants at Baseline (Pilot and RCT)

21. Preliminary Baseline Demographics (Pilot and RCT)

22. Preliminary Baseline Demographics (Pilot and RCT)

23. Percentage of Light Vs. Heavy Smokers at Baseline (Pilot and RCT)

24. Preliminary Indications (Please do not cite) • We expect to see an incentive effect • It does not appear we will have significant differences between High ($75) and Low ($25) value incentive groups • It looks like the Low ($25) group abstinence rate will be close to or slightly lower than results at WIC

25. Lessons Learned • CM reinforcement is dependant on fast turn-around of lab results • Although Providers are interested in smoking cessation during pregnancy and say it is a priority – they report barriers: • Time; Patient resistance, Feelings of futility, Lack of patient resources, Lack of provider training/skills, Smoking cessation may not be the priority, Hesitation to nag patients • Provide a frequent, positive, presence in the clinic: monitor & support staff with trainings/booster sessions and performance feedback

26. Overcoming Challenges to Implementation • Twice-monthly visits to each prenatal clinic • MISS project staff serve as a resource to clinics • Incentives to clinic: $1,100 • Identify internal champion at each clinic • Minimize research overlay • Create local Resource List: Providers have little idea of what is available in their community • Make available for ALL patients

27. MISS Research Staff • Cardiff-TeleForm software/scanner system • Monitor/Track monthly recruitment efforts by clinics • Advisors/Mentors within Research Team • Long-term student staff assistance

28. Remember • Stay connected in State/Region • Many agencies/programs/other funded projects promote 5A’s • Cooperate/collaborate • Interesting: One clinic noted elevated CO indoor air level

29. MISSProject: Yet to Do • Monthly Assessments • Follow-up Assessments • 2 mo. and 6 mo. Postpartum Assessments • Data Analysis • Disseminate Results

30. References • Donatelle R, Hudson D, Dobie S, Goodall A, Hunsberger M, and Oswald K. Incentives in Smoking Cessation: Status of the Field and Implications for Research and practice with Pregnant Smokers. Nicotine and Tobacco Research Special Supplement. In Press, expected in 2004. • 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. • 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.

31. References - more • Higgins ST, Delaney DD, Budney AJ, Bickel WK, Hughes J, Foerg F, et al. A Behavioral Approach to Achieving Initial Cocaine Abstinence. American J of Psychiatry 1991;148:1218-1224. • Higgins ST. The Influence of Alternative Reinforcers on Cocaine Use and Abuse: A Brief Review. Pharmacology Biochemistry and Behavior 1997;57(3)419-427. • 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.

32. References – more • 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. • Schuster CR & Thompson T. Self administration of and behavioral dependence on drugs. Annual Review of Pharmacology 1969;9, 483-502. • Silverman K, Wong CJ, et al. Increasing Opiate Abstinence Through Voucher-Based Reinforcement Therapy. Drug and Alcohol Dependence 1996;41:157-165.