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

PI: Rebecca J. Donatelle, PhD, CHESPC: Deanne Hudson, RN, MPH, CHES

Co-PI: Edward Lichtenstein, PhDCo-Investigators:

Michael Wall, MD; Oregon Health Sciences UniversityNancy Davis, MPH; Providence Health System COREAdvisor: Chuck Bentz, MD; Providence Health System

Funded by The RWJF- Smoke-Free Families: Phase II; ID# 040669

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

Summary of SOS Ia, II, IIIa(Donatelle*, Prows*, Champeau, Hudson, 2000)

Study Advice/Info Partner Participant Feedback % Quit

SOS-I Cx 108 YES - - - 9

Tx 112 YES $50/$25 $50 - 32

SOS-II 62 YES YES $50 - 28

SOS-III Cx 60 YES - - - 12

Tx1 67 YES YES $25 - 19

Tx2 59 YES YES $25 YES 22

SOS I, II & III: Quit Rates at 8 months Gestation (%)

9

32

28

12

1922

0

5

10

15

20

25

30

35

SOS I Cx

SOS I Tx

SOS II

SOS III Cx

SOS III Tx1

SOS III Tx2

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)

Activity Pilot

RCT

(8/01-9/03)

Screened 787 5,709

Eligible 136 895

Enrolled 84 609

Participation Rate 62% 68%

Summary of MISS Project (RWJF-SFF:II)

Tailored

Education

/Advice

Local Resource Pamphlet

Woman Incentives

/ Month

MISS-RCT

Cx

Tx 1

Tx 2

YES

YES

YES

YES

YES

YES

-

$25.

$75.

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

Activity Pilot

RCT

(8/01-9/03)

# Completed/Eligible for Follow-up Assessment 63*/84 407*/494

# Completed/Eligible for

2 mo. Postpartum Assessment 13^/15 50^/56

# Completed/Eligible for

6 mo. Postpartum Assessment 12^/15 33^/43

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

Medicaid/Oregon Health Plan 76%

Work outside the home 41%

Seriously thinking about quitting smoking during this pregnancy 98%

Planning to quit smoking completely within the next 30 days 81%

Preliminary Baseline Demographics (Pilot and RCT)

Mean Maternal Age 24.2 yrs.

Percent Non-white 7.5%

Percent Latina or Hispanic 6.7%

Mean Weeks Gestation 12.7 wks.

Preliminary Baseline Demographics (Pilot and RCT)

Mean Years of Education Attained 12.3 yrs.

Married OR Living with a Partner 64%

Household Income <$20,000 65%

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

62%

38%

Light <10 cigs/day

Heavy >=10 cigs/day

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

MISS Project: 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.