Clinical Trials and Patient Education

for Smoking CessationMaureen George PhD RN

AE-C FAANUniversity of Pennsylvania

School of Nursing

http://www.cdc.gov/nchs/data/nvsr/nvsr50/nvsr50_15.pdf

• 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

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

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

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

Educational interventions must be targeted • Gender • Those most resistant

to quitting• High-risk smokers

– Menthol cigarettes

• Benefits of cessation at any time

Benefit to quitting smoking at any age

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

The 5 A’s• Ask at every contact• Advise to quit• Assess willingness• Assist in making quit plan• Arrange f/u

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.”

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).

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.

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;

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

The 5 R’s: Treating patients who are not ready to quit

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

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