Smoking Cessation Interventions for Quitting Smoking

Recruiting in Palo Alto (17 mi)

Overseen by Michael C Fiore, MD,MPH,MBA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This project seeks to identify ways to enhance the reach of evidence-based smoking cessation treatments among adult primary care patients who smoke daily and are not ready to start treatment at study enrollment. The 2x2x2x2 factorial experiment will evaluate the extent to which 4 intervention components promote the use of evidence-based treatments to help smokers not initially ready to quit to cease smoking over 2 years. The intervention components tested include: modest financial incentives ($40) for completing an initial counseling session in a smoking cessation treatment (vs. none); automated semi-annual outreach materials sent via patients' preferred communication modality using data in the electronic health record to tailor and personalize invitations to use available treatments to quit smoking (vs. untailored letters); direct, proactive telephone outreach from a tobacco care manager who will promote treatment use and deliver motivational intervention twice per year (vs. none); and access to 3 no-cost telephone smoking cessation counseling calls with combination nicotine replacement therapy (C-NRT) or varenicline (vs. state tobacco quitline and primary care provider referral). Proactive treatment offers will be made up to 22 months after enrollment. Smoking status and use of any smoking cessation treatments will be assessed every 6 months through 2 years of study enrollment. Data from 1664 adult primary care patients meeting inclusion/exclusion criteria will be analyzed to see whether the intervention components have an effect on the use of treatment (primary outcome) and smoking status after 2 years of treatment access (secondary outcome). The project will evaluate the manipulated intervention components first in terms of treatment initiation (defined as rates of completing at least 1 smoking cessation counseling session prior to a target stop-smoking date), and then in terms of end-of-study (2 year post-enrollment) abstinence rates (secondary outcome), and cost-effectiveness in promoting reach (tertiary outcome). This experiment will help to identify health system reach interventions that effectively enhance utilization of stop smoking treatments in an effort to help more smokers quit and to prevent tobacco-induced cancer morbidity and mortality.

Eligibility Criteria

This trial is for adult primary care patients who smoke daily, are not ready to quit yet, and can speak/read English. They must smoke at least five cigarettes a day for the past six months and have smoked every day in the week before joining. People with severe allergies or kidney disease that prevent them from using nicotine replacement therapy or varenicline, those with recent suicide attempts or current psychotic disorders, or who want to quit within 30 days are excluded.

Inclusion Criteria

You have smoked at least 5 cigarettes a day for 6 months or more before joining the study.

I am older than 17 years.

Able to speak and read English

Exclusion Criteria

I am currently being treated for schizophrenia or a psychotic disorder.

You have attempted suicide within the past 10 years before joining the trial.

I am willing to quit smoking within 30 days.

Treatment Details

Interventions

• Automated tailored outreach (Behavioural Intervention)
• Care management (Behavioural Intervention)
• Combination nicotine patch and nicotine mini-lozenge treatment (Nicotine Replacement Therapy)
• Monetary incentives for initiating treatment (Behavioural Intervention)
• Multiple smoking cessation coaching calls (Behavioural Intervention)
• Primary care provider referral (Other)
• Untailored outreach (Behavioural Intervention)
• Varenicline (Smoking Cessation Agent)
• Wisconsin Tobacco Quit Line referral (Other)

Trial Overview The study tests whether financial incentives, tailored outreach materials, proactive calls from a tobacco care manager, and access to free smoking cessation counseling and medication help smokers start treatment. It's a complex experiment comparing different combinations of these methods over two years to see which helps more people stop smoking.

Participant Groups

Group I: No Incentive,Untailored,No Care Manage,IntensiveTreatment Experimental Treatment 4 Interventions

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Group II: No Incentive,Untailored,Care Manage,Standard Treatment Experimental Treatment 4 Interventions

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Group III: No Incentive,Untailored,Care Manage,Intensive Treatment Experimental Treatment 5 Interventions

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Group IV: No Incentive,Tailored,No Care Manage,Standard Treatment Experimental Treatment 3 Interventions

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Group V: No Incentive,Tailored,No Care Manage,Intensive Treatment Experimental Treatment 4 Interventions

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Group VI: No Incentive,Tailored,Care Manage,Standard Treatment Experimental Treatment 4 Interventions

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Group VII: No Incentive,Tailored,Care Manage,Intensive Treatment Experimental Treatment 5 Interventions

Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Group VIII: Incentive,Untailored,No Care Manage,Standard Treatment Experimental Treatment 4 Interventions

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Group IX: Incentive,Untailored,No Care Manage,Intensive Treatment Experimental Treatment 5 Interventions

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Group X: Incentive,Untailored,Care Manage,Standard Treatment Experimental Treatment 5 Interventions

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Group XI: Incentive,Untailored,Care Manage,Intensive Treatment Experimental Treatment 6 Interventions

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Group XII: Incentive,Tailored,No Care Manage,Standard Treatment Experimental Treatment 4 Interventions

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Group XIII: Incentive,Tailored,No Care Manage,Intensive Treatment Experimental Treatment 5 Interventions

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Group XIV: Incentive,Tailored,Care Manage,Standard Treatment Experimental Treatment 5 Interventions

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Group XV: Incentive,Tailored,Care Manage,Intensive Treatment Experimental Treatment 6 Interventions

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Group XVI: No Incentive,Untailored,No Care Manage,Standard Treatment Active Control 3 Interventions

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UW Center for Tobacco Research and Intervention Madison, WI

Who Is Running the Clinical Trial?

University of Wisconsin, Madison Lead Sponsor

National Cancer Institute (NCI) Collaborator

References