320 likes | 483 Views
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
E N D
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
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
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)
CM Approaches with Other Substances • Cocaine • Opiates • Marijuana • Alcohol • Multiple-drug • Tobacco: Mental illness and Adolescents • Tobacco: Pregnant Women?
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)
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
Summaryof SOS Ia, II, IIIa(Donatelle*, Prows*, Champeau, Hudson, 2000)
SOS I, II & III: Quit Rates at 8 months Gestation (%) I-C I-Tx II III Cx III Tx1 III Tx2
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?
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
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
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
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.
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
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
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
MISS Project to Date (Preliminary)(*Transferred, Pregnancy Termination, Delivered Early, Withdrew; ^unable to contact)
Preliminary Description of MISS Participants at Baseline (Pilot and RCT)
Percentage of Light Vs. Heavy Smokers at Baseline (Pilot and RCT)
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
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
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
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
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
MISSProject: Yet to Do • Monthly Assessments • Follow-up Assessments • 2 mo. and 6 mo. Postpartum Assessments • Data Analysis • Disseminate Results
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.
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.
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.