1

David B. Abrams, Ph.D

National Conference on Tobacco or Health Dec 10-12 2003 Boston

The Centers for Behavioral & Preventive Medicine

Brown Medical School, The Miriam Hospital

Interventions for Tobacco Dependence : An evidence-based, stepped-care, model

2

Change a Population ?Change a Population ?

o Population IMPACT to reduce Disease Burden.Population IMPACT to reduce Disease Burden.

o COMPREHENSIVE Intervention:COMPREHENSIVE Intervention: individual and “systems” individual and “systems”

o IMPACT =IMPACT = reach x effectiveness / unit cost reach x effectiveness / unit cost (EFFICIENCY)(EFFICIENCY)

o STEPPED-CARE:STEPPED-CARE: distributes a range of distributes a range of evidence-basedevidence-based interventions efficiently from least to most intensiveinterventions efficiently from least to most intensive

o LONG -TERM INVESTMENTLONG -TERM INVESTMENT - - sustained commitment sustained commitment Population change takes time can make a BIG difference Population change takes time can make a BIG difference

3

Never Smoked

Current Smoker

Ex Smoker

Initiation Rate

Cessation Rate

Source: Levy, D., Cummings & Hyland 2000 AJPH, 90 (8), 1311-1314

Relapse Rate

DISEASE BURDEN

Population Model of Tobacco Prevalence

Tobacco Industry PUSH

Public Health counter PUSH

- --

--

--

++

+

+

4

5000

4000

3000

1000

2000

0

Nu

mb

er

Great Depression

End of WW 2

1st Surgeon General’s Report

1st. World Conference on Smoking and Health

Broadcast Ad Ban

1st Great American Smoke-out

Nicotine Medications Available Over the Counter

Master Settlement Agreement

1st Smoking Cancer Concern

Federal Cigarette Tax Doubles

Surgeon General’s Report on Environmental Tobacco Smoke

1900 1910 1920 1930 1940 1950 19701960 199819901980

Year

Sources: United States Department of Agriculture; Surgeon General’s Reports.

Annual adult per capita cigarette consumption and major smoking and health events - United States, 1900-2000

Fairness Doctrine Messages on TV and Radio

A U.S. Public Health Service Clinical Practice GuidelineA U.S. Public Health Service Clinical Practice GuidelineJune 2000June 2000

Reviewed over 6,000 studies since 1970 and conducted meta analyses Reviewed over 6,000 studies since 1970 and conducted meta analyses on over 190 and clinical consensus on over 500 studies that met on over 190 and clinical consensus on over 500 studies that met rigorous research design and outcome measurement criteria,rigorous research design and outcome measurement criteria,

Fiore MC, Bailey WC, Cohen, SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline, USDHHS

Treating Tobacco Use andTreating Tobacco Use and DependenceDependence

PHSPHS

6

Major Findings and Major Findings and Panel Recommendations Panel Recommendations

1. Tobacco dependence is a chronic condition 1. Tobacco dependence is a chronic condition that often requires repeated intervention. that often requires repeated intervention. However, effective treatments exist that can However, effective treatments exist that can produce long-term or even permanent produce long-term or even permanent abstinence.abstinence.

7

Major Findings and Major Findings and Panel RecommendationsPanel Recommendations

2.2. Because effective tobacco dependence Because effective tobacco dependence treatments are available, every person who treatments are available, every person who uses tobacco should be offered one or more of uses tobacco should be offered one or more of these treatments.these treatments.

8

Major Findings andMajor Findings and Panel Recommendations Panel Recommendations

3. It is essential that clinicians and health 3. It is essential that clinicians and health care delivery systems (including care delivery systems (including administrators, insurers, and administrators, insurers, and purchasers) institutionalize the purchasers) institutionalize the consistent identification, documentation, consistent identification, documentation, and treatment of every tobacco user and treatment of every tobacco user seen in a health care setting.seen in a health care setting.

9

Major Findings andMajor Findings and Panel Recommendations Panel Recommendations

4. Brief tobacco dependence treatment is 4. Brief tobacco dependence treatment is effective, and every person who uses tobacco effective, and every person who uses tobacco should be offered at least brief treatment.should be offered at least brief treatment.

10

Major Findings and Major Findings and Panel RecommendationsPanel Recommendations

5. There is a strong 5. There is a strong dose-responsedose-response relation relation between the intensity of tobacco dependence between the intensity of tobacco dependence counseling and its effectiveness. Treatments counseling and its effectiveness. Treatments involving person-to-person contact (via involving person-to-person contact (via individual, group, or proactive telephone individual, group, or proactive telephone counseling) are consistently effective, counseling) are consistently effective, and their and their effectiveness increases with treatment effectiveness increases with treatment intensity (e.g., minutes of contact).intensity (e.g., minutes of contact).

11

Major Findings and Major Findings and Panel RecommendationsPanel Recommendations6. Three types of counseling and behavioral 6. Three types of counseling and behavioral

therapies were found to be especially effective therapies were found to be especially effective and should be used with all patients attempting and should be used with all patients attempting tobacco cessation:tobacco cessation: Provision of practical counseling Provision of practical counseling

(problem-solving/skills training)(problem-solving/skills training) Provision of social support as part of treatment (intra-Provision of social support as part of treatment (intra-

treatment social support)treatment social support) Help in securing social support outside of treatment Help in securing social support outside of treatment

(extra-treatment social support)(extra-treatment social support)

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Major Findings andMajor Findings and Panel Recommendations Panel Recommendations7. Numerous effective pharmacotherapies for 7. Numerous effective pharmacotherapies for

smoking cessation now exist. Except in the smoking cessation now exist. Except in the presence of contraindications, these should be presence of contraindications, these should be used with all patients attempting to quit smoking.used with all patients attempting to quit smoking. Five Five first-linefirst-line pharmacotherapies were identified that pharmacotherapies were identified that

reliably increase long-term smoking abstinence rates:reliably increase long-term smoking abstinence rates:

Bupropion SRBupropion SR Nicotine gumNicotine gum Nicotine inhalerNicotine inhaler

Nicotine nasal sprayNicotine nasal spray Nicotine patchNicotine patch

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Major Findings andMajor Findings and Panel Recommendations Panel Recommendations 8.8. Tobacco dependence treatments are Tobacco dependence treatments are

both clinically effective and cost-effective both clinically effective and cost-effective relative to other medical and disease relative to other medical and disease prevention interventions. prevention interventions.

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Translating Findings into PracticeTranslating Findings into Practice

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Reducing Population Disease BurdenReducing Population Disease Burden

--proactive, reach, access, --proactive, reach, access, --efficacy, --efficacy, --organizational infrastructure, --organizational infrastructure, --sustained societal commitment--sustained societal commitment Impact = Participation (reach) x EfficacyImpact = Participation (reach) x Efficacy

EFFICIENCY = Impact / Unit CostEFFICIENCY = Impact / Unit Cost

Source: Abrams et al ., Annals of Behavioral Medicine, 1996

16High

High

Low

Par

tici

pati

on (

Rea

ch)

Intervention Effectiveness

Intensive Counseling

clinic

Self-help

Brief

Counseling

Efficiency

Cost

Population IMPACT of Stepped-Care Model

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Efficacy of Treatment Efficacy of Treatment ( (n n = 58 studies)= 58 studies)

FormatFormatEstimated Estimated

Abstinence RateAbstinence RateOdds RatioOdds Ratio(95%) CI(95%) CI

No format No format (reference group)(reference group) 10.8%10.8%1.01.0

13.9%13.9%1.31.3(1.1-1.6)(1.1-1.6)

Self-helpSelf-help

Proactive phoneProactive phonecounselingcounseling

Group counselingGroup counseling

12.3%12.3%

13.1%13.1%1.21.2(1.1-1.4)(1.1-1.4)

1.21.2(1.02-1.3)(1.02-1.3)

Individual counselingIndividual counseling 16.8%16.8%1.71.7(1.4-2.0)(1.4-2.0)

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Tailored Behavioral CommunicationsTailored Behavioral Communications

o Credible information created especially for an individual based Credible information created especially for an individual based on unique information on unique information from from that person (and updated as they that person (and updated as they change over time)change over time)

o Advances in computers make it possible for real time interaction Advances in computers make it possible for real time interaction

o Can be combined with other interventions (e.g. brief counseling)Can be combined with other interventions (e.g. brief counseling)

o Everywhere we look, the concept of Everywhere we look, the concept of

mass customizationmass customization is being applied is being applied

Internet based intervention has potentially large Internet based intervention has potentially large reach, available 23/7/365 -- now being reach, available 23/7/365 -- now being evaluated with efficacy 12-23 % at 3 mo.evaluated with efficacy 12-23 % at 3 mo.

19High

High

Low

Par

tici

pati

on (

Rea

ch)

Intervention Effectiveness

Intensive Counseling

NRT

Self-help

Brief

Counseling

+ NRT

Efficiency

Cost

Population IMPACT of Stepped-Care Model

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Brief Clinical InterventionsBrief Clinical Interventionso The “5 A’s” for patients willing to make a quit The “5 A’s” for patients willing to make a quit

attemptattempto The “5 R’s” for patients unwilling to make a quit The “5 R’s” for patients unwilling to make a quit

attempt at this timeattempt at this timeo Relapse prevention for patients who have Relapse prevention for patients who have

recently quitrecently quito Health care administrators, insurers, and Health care administrators, insurers, and

purchasers should institutionalize guideline purchasers should institutionalize guideline findingsfindings

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Opportunity for InterventionOpportunity for Intervention

o 70% of smokers have made at least one 70% of smokers have made at least one unsuccessful quit attemptunsuccessful quit attempt

o 46% try to quit each year46% try to quit each year

o More than 70% of smokers visit a health care More than 70% of smokers visit a health care setting each yearsetting each year

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Efficacy of varying intervention intensity levels - total amount of contact time (n = 35 studies)

Total amount of contact time

No Minutes

1-3 Minutes

4-30 minutes

31-90 minutes

91 + minutes

Number of arms

16

12

20

16

16

Estimated odds ratio (95% C.I.)

1.0

1.4 (1.1, 1.8)

1.9(1.5, 2.3)

3.0 (2.3,3.8)

3.2 (2.3, 4.6)

Estimated abstinence rate (95% C.I.)

11.0

14.4 (11.3, 17.5)

18.8 (15.6, 22.0)

26.5 (21.5, 31.4)

28.4 (21.3, 35.5)

Source: Fiore MC, Bailey WC, Cohen, SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline, USDHHS,

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6 Month Self ReportedSmoking Cessation Rates

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

Advice Counseling Counseling + Gum

9%12%

17%

Physician Delivered InterventionFrom Ockene et al., 1991

PercentAbstinent

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Pharmacological Intervention Effectiveness

• 1.5 - 3 X1.5 - 3 X more effective than placebomore effective than placebo

• Not Not related to level of Nicotine Dependencerelated to level of Nicotine Dependence

• Retains effectiveness when provided with Retains effectiveness when provided with minimal support minimal support

• Most effective when provided with Most effective when provided with behavioral treatmentbehavioral treatment

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Efficacy of and estimated abstinence rates for the nicotine patch (n = 27 studies) and for nicotine patch therapy (n = 3)

Pharmocotherapy

Placebo

Nicotine Patch

Placebo

Over-the-counter nicotine patch therapy

Number of arms

28

32

3

3

Estimated odds ratio (95% C.I.)

1.0

1.9(1.7,2.2)

1.0

1.8(1.2,2.8)

Estimated abstinence rate

(95% C.I.)

10.0

17.7 (16.0,19.5)

6.7

11.8(7.5,16.0)

Source: Fiore MC, Bailey WC, Cohen, SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline, USDHHS, June 2000, Rockville, MD

26

1

1.5

2

2.5

3

3.5

bupropionbupropion2.62.6

nicotine patchnicotine patch3.03.0

2.42.42.32.32.12.1

1.71.7

nicotine gumnicotine gum1.61.6

nicotine nasal spray

nicotine nasal spray

2.32.3nicotine inhaler

nicotine inhaler

2.42.4

Odds Ratios for Meta-analysesOdds Ratios for Meta-analyses

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Eventually From Pharmacogenomics to...Eventually From Pharmacogenomics to...

ContextCultureCommunityBehaviorCognitive Schema Neuroscience

pharmacogenomic - biobehavioral - socio - cultural

tailoring

+ x x

=

28

Systems InterventionsSystems Interventions

o Health care administrators, insurers, and Health care administrators, insurers, and purchasers should implement systems purchasers should implement systems interventions to promote the consistent interventions to promote the consistent identification and treatment of tobacco identification and treatment of tobacco users:users: Implement a tobacco-user identification Implement a tobacco-user identification

system in every clinic (screening)system in every clinic (screening) Provide education, resources, and Provide education, resources, and

feedback to promote provider interventionfeedback to promote provider intervention

29

Vital Signs StampVital Signs Stamp

VITAL SIGNSVITAL SIGNS

Pulse:Pulse:

TemperatureTemperature::

Respiratory Rate:Respiratory Rate:

(circle one)(circle one)

CurrentCurrent FormerFormer NeverNeverTobacco Use:Tobacco Use:

Blood Pressure:Blood Pressure:

WeightWeight::

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Impact of having a tobacco use status identification system in place on rates of clinician intervention with their patients who

smoke (n = 9 studies)

Screening System

No Screening system in place to identify smoking status (ref. group)

Screening system in place to identify smoking status

Number of arms

9

9

Estimated odds ratio (95% C.I.)

1.0

3.1 (2.2-4.2)

Estimated intervention rate

(95% C.I.)

38.5

65.6 (58.3-72.6)

Source: Fiore MC, Bailey WC, Cohen, SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline, USDHHS, June 2000, Rockville, MD

31High

High

Low

Rea

ch

Effectiveness

Individual Counseling

CLINIC

Group Program

Self-change

Educational

Pamphlets

Self-help guides

Brief Counseling

EfficiencyPopulation IMPACT of Stepped-Care Model

Behavioral Stepped Care

PLUS PHARMACO

THERAPY

Plus Tailored Mass Custom

ization

Cost

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Estimated Efficacy and Utilization of Estimated Efficacy and Utilization of Approaches to Smoking CessationApproaches to Smoking Cessation

EFFICACY REACH IMPACT (% quit at (# using method (total # Intervention 6 months) annually) quitters)

None (unaided) 3 22,800,000 684,000

Internet 12 6,000,000 720,000

Rx NRT (1995) 14 2,500,000 350,000

OTC NRT (1996) 14 6,300,000 882,000

Behavioral counseling 24 395,000 94,800

Inpatient treatment 32 500 160

Adapted from Shiffman et al. (1998). Annual Review of Public Health.

33

Change a Population ?Change a Population ?

o Population IMPACT to reduce Disease Burden.Population IMPACT to reduce Disease Burden.

o COMPREHENSIVE Intervention:COMPREHENSIVE Intervention: individual and “systems” individual and “systems”

o IMPACT =IMPACT = reach x effectiveness / unit cost reach x effectiveness / unit cost (EFFICIENCY)(EFFICIENCY)

o STEPPED-CARE:STEPPED-CARE: distributes a range of distributes a range of evidence-basedevidence-based interventions efficiently from least to most intensiveinterventions efficiently from least to most intensive

o LONG -TERM INVESTMENTLONG -TERM INVESTMENT - - sustained commitment sustained commitment Population change takes time can make a BIG difference Population change takes time can make a BIG difference