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Clinical Trials and Patient Education
for Smoking CessationMaureen George PhD RN
AE-C FAANUniversity of Pennsylvania
School of Nursing
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http://www.cdc.gov/nchs/data/nvsr/nvsr50/nvsr50_15.pdf
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• Number of new smokers is unchanged– Few start after age of 25– No change in the lowest income groups
• 36% of 20-24 year olds are smokers• More men are quitting or not starting• Increasing cost decreases smoking
rates
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Why do people smoke?• When initiating smoking
– Risk denial; Unrealistic optimism– Social aspects
• When continuing to smoke– Social activity, stress reduction, “approved”
break– Perceived lack of control over behavior – Enjoy the effects– Develop dependence
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Characteristics of Dependence
Clinical Assessment• Morning smoking
behaviors
• Smoke > 1 ppd
• Sneak cigarettes
• Smoke when ill
• Time intensive
• Conditioned response
Physical Assessment
• Tolerance• Useful effects• Withdrawal
symptoms– Drug seeking
Know health hazards
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Key components in cessation educational
interventions• Motivation; not fear arousal communication
• Support• Reducing exposure to
second hand smoke• Linking health messages
back to the product
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Educational interventions must be targeted • Gender • Those most resistant
to quitting• High-risk smokers
– Menthol cigarettes
• Benefits of cessation at any time
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Benefit to quitting smoking at any age
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What can we do to help smokers quit?• How do you define
success?• 2/3rds of smokers use
ineffective methods– NRT 8-30% success – Psychological approaches
10-20% success
• Multiple approaches best
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The 5 A’s• Ask at every contact• Advise to quit• Assess willingness• Assist in making quit plan• Arrange f/u
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Give smoking cessation message at each visit
“Quitting is difficult for everyone. As your (nurse/doctor) I have an obligation to tell you that smoking is bad for your health. I can tell you about the benefits to quitting and can help you whenever you’re ready to quit.”
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Principles of Motivational Interviewing• MI is a client-centered
method for enhancing motivation to change by exploring and resolving ambivalence– Advise– Remove barriers– Provide choice– Express empathy, share your
understanding of their perspective; curiosity but low investment
– Provide feedback that creates discrepancy,
– Clarify goals– Actively help
• Roll with resistance, accept their reluctance to change as natural rather than pathological.
• Support self-efficacy, embrace their autonomy (even when they choose to not change) and help them move toward change successfully and with confidence.
• Avoid argumentation (and direct confrontation).
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Potential impact
• 70% of smokers see a physician annually– ~ 33 million adult smokers
• If 50% of physicians delivered a brief quitting message and were successful 1 in 10 times, there would be1.75 million new ex-smokers every year. – more than double the national
annual quit rate.
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Barriers to quit advice • Physicians feel unprepared or
ineffective to help their patients quit• Physicians do not receive smoking
cessation intervention training in medical school
• Lack of time and reimbursement• Nurse advise may best fit within a
team provider approach or be accompanied by specialized training
Cantor et al., 1993; Cummings et al., 1989; Spangler et al., 2002; Ferry et
al., 1999; Fiore et al., 1994; Fiore et al., 2000 Gorin & Heck, 2004;
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Factors associated with successful quitting• Having made previous
attempt(s)• Has a plan for avoiding
temptation• Uses cigarette reduction
rather than cold turkey• Older age• Higher SES• Has a significant other
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The 5 R’s: Treating patients who are not ready to quit
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Clinical trials @ www.clinicaltrials.gov
259 open trials• Most are trials of products
– Several seek to see what quit rates are when treatment is free
– CAM• Exercise• Relaxation• Yoga• Hypnotherapy• MBSR• Auricular acupressure
Testing in all patient groups
• Pregnancy• Prisoners• Expectant Latino
fathers• Overweight • Veterans• American Indians• Substance users• Mental health
disorders• Adolescents• Medical conditions
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Clinical trials @ www.clinicaltrials.gov
Testing at all POC
• EDs• Pre-admission• Inpatient• Outpatient
Testing all approaches• Behavioral• Drug• Technology-assisted
– Web-based,– Mobile phones: SMS
support– IVR
• Individual vs. group• Quit and win
contests• Testing messages
specific for literacy levels