1. 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. 2 Change a Population ? Change a Population ? o Population IMPACT to reduce Disease Burden. o COMPREHENSIVE Intervention: individual and “systems” o IMPACT = reach x effectiveness / unit cost (EFFICIENCY) o STEPPED-CARE: distributes a range of evidence-based interventions efficiently from least to most intensive o LONG -TERM INVESTMENT - sustained commitment Population change takes time can make a BIG difference

3. 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. 4 5000 4000 3000 1000 2000 0 Number 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 19001910192019301940195019701960 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

5. A U.S. Public Health Service Clinical Practice Guideline June 2000 Reviewed over 6,000 studies since 1970 and conducted meta analyses on over 190 and clinical consensus on over 500 studies that met 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 and Dependence DependencePHS

6. 6 Major Findings and Panel Recommendations 1. Tobacco dependence is a chronic condition that often requires repeated intervention. However, effective treatments exist that can produce long-term or even permanent abstinence.

7. 7 Major Findings and Panel Recommendations 2. Because effective tobacco dependence treatments are available, every person who uses tobacco should be offered one or more of these treatments.

8. 8 Major Findings and Panel Recommendations 3. It is essential that clinicians and health care delivery systems (including administrators, insurers, and purchasers) institutionalize the consistent identification, documentation, and treatment of every tobacco user seen in a health care setting.

9. 9 Major Findings and Panel Recommendations 4. Brief tobacco dependence treatment is effective, and every person who uses tobacco should be offered at least brief treatment.

10. 10 Major Findings and Panel Recommendations 5. There is a strong dose-response relation between the intensity of tobacco dependence counseling and its effectiveness. Treatments involving person-to-person contact (via individual, group, or proactive telephone counseling) are consistently effective, and their effectiveness increases with treatment intensity (e.g., minutes of contact).

11. 11 Major Findings and Panel Recommendations 6. Three types of counseling and behavioral therapies were found to be especially effective and should be used with all patients attempting tobacco cessation: n Provision of practical counseling (problem- solving/skills training) n Provision of social support as part of treatment (intra- treatment social support) n Help in securing social support outside of treatment (extra-treatment social support)

12. 12 Major Findings and Panel Recommendations 7. Numerous effective pharmacotherapies for smoking cessation now exist. Except in the presence of contraindications, these should be used with all patients attempting to quit smoking. n Five first-line pharmacotherapies were identified that reliably increase long-term smoking abstinence rates:  Bupropion SR  Nicotine gum  Nicotine inhaler  Nicotine nasal spray  Nicotine patch

13. 13 Major Findings and Panel Recommendations 8. Tobacco dependence treatments are both clinically effective and cost-effective relative to other medical and disease prevention interventions.

14. 14 Translating Findings into Practice

15. 15 Reducing Population Disease Burden --proactive, reach, access, --efficacy, --organizational infrastructure, --sustained societal commitment Impact = Participation (reach) x Efficacy EFFICIENCY = Impact / Unit Cost Source: Abrams et al., Annals of Behavioral Medicine, 1996

16. 16 High Low Participation (Reach) Intervention Effectiveness Intensive Counseling clinic Self-help Brief Counseling Efficiency Cost Population IMPACT of Stepped-Care Model

17. 17 Efficacy of Treatment (n = 58 studies) Format Estimated Abstinence Rate Odds Ratio (95%) CI No format (reference group) 10.8%1.0 13.9%1.3(1.1-1.6) Self-help Proactive phone counseling Group counseling 12.3% 13.1% 1.2(1.1-1.4) 1.2(1.02-1.3) Individual counseling 16.8% 1.7(1.4-2.0)

18. 18 Tailored Behavioral Communications o Credible information created especially for an individual based on unique information from that person (and updated as they change over time) o Advances in computers make it possible for real time interaction o Can be combined with other interventions (e.g. brief counseling) o Everywhere we look, the concept of mass customization is being applied mass customization is being applied Internet based intervention has potentially large reach, available 23/7/365 -- now being evaluated with efficacy 12-23 % at 3 mo.

19. 19 High Low Participation (Reach) Intervention Effectiveness Intensive Counseling NRT Self-help Brief Counseling + NRT Efficiency Cost Population IMPACT of Stepped-Care Model

20. 20 Brief Clinical Interventions o The “5 A’s” for patients willing to make a quit attempt o The “5 R’s” for patients unwilling to make a quit attempt at this time o Relapse prevention for patients who have recently quit o Health care administrators, insurers, and purchasers should institutionalize guideline findings

21. 21 Opportunity for Intervention o 70% of smokers have made at least one unsuccessful quit attempt o 46% try to quit each year o More than 70% of smokers visit a health care setting each year

22. 22 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 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,

23. 23

24. 24 Pharmacological Intervention Effectiveness 1.5 - 3 X more effective than placebo 1.5 - 3 X more effective than placebo Not related to level of Nicotine Dependence Not related to level of Nicotine Dependence Retains effectiveness when provided with minimal support Retains effectiveness when provided with minimal support Most effective when provided with behavioral treatment Most effective when provided with behavioral treatment

25. 25 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 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. 26

27. 27 Eventually From Pharmacogenomics to...  Context  Culture  Community  Behavior  Cognitive Schema  Neuroscience pharmacogenomic - bio behavioral - socio - cultural tailoring + x x =

28. 28 Systems Interventions o Health care administrators, insurers, and purchasers should implement systems interventions to promote the consistent identification and treatment of tobacco users:  Implement a tobacco-user identification system in every clinic (screening)  Provide education, resources, and feedback to promote provider intervention

29. 29 Vital Signs Stamp VITAL SIGNS Pulse: Temperature : Respiratory Rate: (circle one) CurrentFormerNever Tobacco Use: Blood Pressure: Weight :

30. 30 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 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

31. 31 High Low Reach Effectiveness Individual Counseling CLINIC Group Program Self- change Educational Pamphlets Self-help guides Brief Counseling Efficiency Population IMPACT of Stepped-Care Model Behavioral Stepped Care PLUS PHARMACOTHERAPY Plus Tailored Mass Customization Cost

32. 32 Estimated Efficacy and Utilization of Approaches to Smoking Cessation

33. 33 Change a Population ? Change a Population ? o Population IMPACT to reduce Disease Burden. o COMPREHENSIVE Intervention: individual and “systems” o IMPACT = reach x effectiveness / unit cost (EFFICIENCY) o STEPPED-CARE: distributes a range of evidence-based interventions efficiently from least to most intensive o LONG -TERM INVESTMENT - sustained commitment Population change takes time can make a BIG difference