Population level Distribution of NRT: Means and Effectiveness from an Ontario wide Study Involving over 25,000 Participants

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Population level Distribution of NRT: Means and Effectiveness from an Ontario wide Study Involving over 25,000 Participants Peter Selby, MBBS Clinical Director Centre for Addiction and Mental Health Associate Professor Dalla Lana School of Public Health, Departments of Family and Community Medicine, and Psychiatry University of Toronto

2 Disclosures Schering Canada (Buprenorphine training 2000) Johnson & Johnson Consumer Health Care Canada, Pfizer Inc. Canada, Pfizer Global, Sanofi Synthelabo Canada, GSK Canada, Genpharm and Prempharm Canada, NABI Pharmaceuticals (Paid consultant and advisory board member) V CC Systems Inc. and ehealth Behaviour Change Software Co. (Paid consultant) Alberta Health Services (formerly Alberta Cancer Board), Vancouver Coastal Authority (Research Funding: Principal & Co Investigators) Grants: Health Canada, Smoke Free Ontario, MHP, CTCRI, CIHR

Tobacco Smoking in Canada Tobacco control measures Prevalence of Smoking in Canada Health promotion, education Taxation Advertising bans Restrictions on smoking % of population (age 15+ yrs) 40 30 20 10 0 1985 1991 1996 1999 2001 2005 2006 2007 2008 Cessation needs to be part of the strategy Challenge: Cessation is traditionally domain of clinics; centered on the individual limited population level impact Prevalence data from 1. Gilmore, J. Report on Smoking in Canada, 1985 to 2001 (Statistics Canada, Catalogue 82F0077XIE) 2002; 2. Health Canada, CTUMS Smoking Prevalence 1999-2009. 3

4 Population level Cessation Initiative Take medications with demonstrated efficacy at the clinic setting and make it available to large number of smokers Population-level distribution Treatment at clinics Reach Abhrams 1996 NRT, etc. Efficacy NRT, etc. Expected outcomes: - Lower efficacy - Dramatic increase in users - Net increase in the absolute number of ex-smokers

Population level Cessation Initiative Potential for a sizable impact on prevalence Majority of smokers wish to quit smoking (63% in 2008) 1 Most (59%) attempt to quit without the assistance of cessations aids (NRT, Zyban, Champix) 1 Large pool of smokers not using cessation aids 59% have indicated they would use free NRT 2 But, need novel methods of treatment delivery More than 85% of smokers are expected to make at least one visit to a healthcare provider, but only about half will receive advice to reduce or quit smoking, and even fewer (approximately half of those receiving advice) can expect to receive information on smoking cessation aids 3 1. Health Canada. (2008). CTUMS: Cycle 1 Person File: Health Canada. 2. Cunningham, J. A., & Selby, P. L. (2008). CMAJ, 179(2), 145-146. 3. Health Canada. (2006). CTUMS: Annual Person File: Health Canada. 5

Smoking Treatment for Ontario Objective Patients (STOP) Study Evaluate the effectiveness of various methods of distributing NRT and counseling support to Ontario smokers Methods Working philosophy: leverage the current healthcare infrastructure or devise innovative strategies to deliver smoking cessation treatment to smokers Several different methods tested including some population level methods 6

7 Each study arm is an unique method of treatment delivery Study Arm Provider Type Treatment Intervention Tertiary-care CHC Specialized smoking cessation clinic Community Health Centre/ Aboriginal Health Access Centre 10 weeks NRT +/- 2 or more brief counseling sessions 10 weeks NRT + Up to 3 brief counseling sessions PHU Public Health Unit 10 weeks NRT + Up to 3 brief counseling sessions Pharmacy Community Pharmacy 5 weeks NRT + 1 vs. 3 brief counseling sessions Mail-out STOP on the Road Web-based Mass Distribution Research staff with basic training Local/regional provider of any type Web administrator guided by research staff Call centre agent with basic training 10 weeks NRT + Some elements of behavioural intervention 5 or 10 weeks NRT + One-time group psychoeducation 5 weeks NRT + Periodic motivational emails 5 or 6 weeks NRT + Some elements of behavioural intervention

: population level methods of distribution Mass Distribution Web-based STOP on the Road Enrollment Call 1-800 # Visit study website Attend workshop Inbound calls to Call Centre (trained staff administer study form, questionnaire) Website administers study form, questionnaire Partnerships with local healthcare providers to offer workshops Treatment delivery By mail By mail In-person at the workshops List of eligible participants forwarded by Call Centre or Web Administrator to logistic fulfillment service provider, who packages and delivers NRT kits to participants address Simple and efficient A new idea 8

STOP on the Road Partnerships with local healthcare providers to offer workshops Input a) Informal discussion with select stakeholders (e.g., TCAN, PHU) re: project feasibility b) Research proposal, informed by outcome of above discussion c) Invitation to potential partners (local/regional healthcare providers) via e-mail & word-of-mouth d) STOP and Partners collaborate to Identify localities with greatest need Consider operational limits (i.e., staff resources, funding) Output Partners identified Workshops across a multitude of cities & towns 9

STOP on the Road Partners Partner Profile Partner s Commitment 28 Public Health Units 8 Community Health Centers Regional. Community medicine Local. Primary-care medicine 2 Family Health Teams Local. Family medicine 2 Aboriginal Health Access Centers Regional. Special population Recruit eligible smokers Select localities and arrange settings for holding the workshop Provide necessary staff resources (typically, 1 FTE for one month) 10

Participants Resident of Ontario 18 + years old 10 cigarettes/day Want to quit in the next 30 days NRT not contraindicated Excluded if pregnant, nursing, recent cardiovascular incident 11

12 Results: Reach Study Arm No. of Study Sites Duration of study (months) Mass Distribution I Mass Distribution II Mass Distribution III n/a 3 2 6 Participants (N) 13,158 11,000 8,890 Web-based n/a 9 5,633 STOP on the Road I,II STOP on the Road III 114 workshops 96 workshops 10 7 3,927 2,881 Compare with Tertiary-Care 3 30 2,358 CHC 14 16 534 PHU 12 23 1,766

13 Results: Reach Mass Distribution & Web based Workshops

14 Results: Reach Baseline Characteristics Mass Distribution I Web-based STOP on the Road I, II Gender: % Female 55 57 57 Age: Mean (SD) 44 (12) 40 (12) 49 (12) Education: % with more than high school Employment: % unemployed Employment: % unemployed, part-time, retired, student Income: % with less than $40,000 annual household income 48 54 53 21 23 20 43 47 54 50 63 55

15 Results: Reach Baseline Characteristics Cigarettes per day: 20 (%) Past quit attempts: yes (%) Importance to quit: 1-10, mean (SD) Confidence to quit: 1-10, mean (SD) Mass Distribution I Web-based STOP on the Road I, II 66 63 61 94 88 88 9.2 (1.1) 9.2 (1.3) 9.3 (1.3) 7.6 (1.9) 7.6 (2.0) 7.3 (2.1)

Results: Quit rates 50 % of respondents 40 30 20 10 End of Treatment 6-Month 0 Mass Distribution I Web-based STOP on the Road I, II NOTE: Error bars represent 95% CI (upper) 16

Results: Quit rates (intent to treat analysis) 20 % of sample (ITT) 16 12 8 4 End of Treatment 6-Month 0 Mass Distribution I Web-based STOP on the Road I, II 17

18 Results: Change in smoking behaviour among non quitters (at end of treatment) 100 % of respondents 80 60 40 20 Reduced Quit for a day 0 Mass Distribution I Web-based STOP on the Road I, II

19 Results: Quit rate X gender % of respondents 50 40 30 20 10 Male - End of Treatment Male - 6-Month Female - End of Treatment Female - 6-Month 0 Mass Distribution I Web-based STOP on the Road I, II

20 Conclusions Telephone, internet and community workshops are excellent means to reach large number of smokers across a large geographic area NRT and behavioural intervention delivered via these methods produce desirable short and long term quit rates These strategies can advance the use of NRT at the population level to substantially increase the number of ex smokers

Lessons Learned Crucial components of the success story A grand vision Leverage what is available in the current infrastructure but also innovate Collaboration necessary The STOP Study (CAMH) SHL AHACs CHCs PHUs FHTs CHC FHT workshop Local media smokers 21

Lessons Learned Crucial components of the success story Collaboration improves sustainability Sustainability ultimately dependent on funding, but Partner (e.g., PHU) involvement in the conceptualization process: Partnership founded on mutual interest Identify areas where they can provide in kind contribution keeps cost low Better able to assess local areas where there is need smart management of resources minimize cost A stronger case for continuous funding 22

Our Team www.stopstudy.ca TEACH www.teachproject.ca CAN ADAPTT www.can adaptt.net Nicotine Dependence Clinic Acknowledgements This study was funded by the Ontario Ministry of Health Promotion 23