Transcript Addressing Tobacco Cessation During Pregnancy

The MISS Project: Combining Contingency Management
with Best Practice 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 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
a, II, III
Summary
of
SOS
I
a
(Donatelle*, Prows*, Champeau, Hudson, 2000)
Study
Advice/Info
Partner
Cx 108
YES
-
-
-
9
Tx 112
YES
$50/$25
$50
-
32
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
SOS-II
Participant Feedback
% Quit
SOS I, II & III:
Quit Rates at 8 months Gestation (%)
35
32
28
30
25
22
19
20
15
10
12
9
5
0
I-C
I-Tx
II
III Cx III Tx1 III Tx2
SOS I Cx
SOS I Tx
SOS II
SOS III Cx
SOS III Tx1
SOS 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 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.
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:
Cotinine (GCMS) ≤ 30 ng/ml
 CO Expired air ≤ 05 ppm
 Saliva
MISS Project: To Date (Preliminary)
Activity
Screened
Eligible
Enrolled
Participation Rate
Pilot
787
RCT
(8/01-9/03)
5,709
136
895
84
609
62%
68%
Summary of MISS Project (RWJF-SFF:II)
MISS-RCT
Cx
Tx 1
Tx 2
Tailored
Education
/Advice
Local
Resource
Pamphlet
Woman
Incentives
/ Month
YES
YES
YES
YES
YES
YES
$25.
$75.
MISS Project to Date (Preliminary)
(*Transferred, Pregnancy Termination, Delivered Early, Withdrew; ^unable to contact)
Activity
# Completed/Eligible for
Follow-up Assessment
# Completed/Eligible for
2 mo. Postpartum Assessment
# Completed/Eligible for
6 mo. Postpartum Assessment
Pilot
RCT
(8/01-9/03)
63*/84
407*/494
13^/15
50^/56
12^/15
33^/43
Preliminary Description of MISS
Participants at Baseline (Pilot and RCT)
Medicaid/Oregon Health Plan
76%
Work outside the home
Seriously thinking about quitting
smoking during this pregnancy
41%
Planning to quit smoking completely
within the next 30 days
98%
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)
38%
Light <10 cigs/day
Heavy >=10 cigs/day
62%
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.