Smoking, CigarettePhase 4NCT04199117
Health Systems Reach Interventions Project
A Phase 4 study testing Varenicline, Combination nicotine patch and nicotine mini-lozenge treatment and Monetary incentives for initiating treatment in people with Smoking, Cigarette and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Cigarette, Smoking Cessation
- What is being tested?
- Varenicline, Combination nicotine patch and nicotine mini-lozenge treatment and Monetary incentives for initiating treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 16 Oct 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care patient who receives care at one of the host family medicine or internal medicine clinics
- >17 years old
- Report smoking 7 of the last 7 days at enrollment
- Report smoking at least five cigarettes per day for at least 6 months at enrollment
- Able to speak and read English
Who cannot join
- Opted out of Care Manager outreach at the most recent clinic visit or by phone
- Willing to quit smoking within 30 days (these patients will be referred for immediate treatment rather than enrolled in this study)
- Inability to use both C-NRT and varenicline due to a contraindication to both treatments at enrollment (allergic reactions, severe renal disease)
- Current treatment for schizophrenia or a psychotic disorder at enrollment
- History of suicide attempt in the past 10 years at enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
About this study
Official title: Centralized Health System Interventions to Enhance Reach: A Factorial Screening Experiment
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 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.
Read the detailed description
Design and Objective: This 2-year experimental study will evaluate the effectiveness, costs, and cost-effectiveness of four interventions designed to connect primary care patients who smoke with evidence-based stop-smoking treatment. The interventions to be tested are healthcare system interventions intended to better attract patients who smoke to stop-smoking treatments that work. Participants enrolled in the study will be randomized to 1 level of each of the following 4 intervention components: 1) to receive financial incentive each time they complete a first counseling telephone call in a new round of stop-smoking treatment (for up to 4 rounds of treatment) or no incentives for starting treatment; 2) to receive tailored letters encouraging use of evidence-based stop-smoking treatment every 4-6 months for 2 years, or non-tailored letters every 4-6 months for 2 years; 3) to receive calls every 4-6 months from a Tobacco Care Manager who will provide motivational counseling to patients to encourage them to use stop-smoking treatment, and will connect patients willing to quit with available treatments, or no Tobacco Care Manager calls; and 4) access to intensive treatment (standard 12-week regimens of 2 nicotine medications used together, also called combination nicotine replacement therapy, or varenicline, a non-nicotine pill), with 3 telephone counseling sessions, all of which improve stop-smoking success rates), or standard care (referral to a quitline offering telephone counseling and 2 weeks of one nicotine medication provided by the quitline, and referral to the patient's primary care provider). The objective is to identify the intervention components and combination of components that best promote use of smoking cessation treatment and tobacco abstinence.
Recruitment and Participants: Participants will be 1664 primary care patients recruited through their primary care clinics in 2 healthcare systems in central and eastern Wisconsin. At the launch of recruitment in a clinic, all patients known to smoke at that clinic will receive notice that a new tobacco specialist, a Tobacco Care Manager, is available to help them quit smoking and given information about how to contact them. At healthcare visits, patients will be asked if they smoke, and if they do, told that the clinic has a new program for smokers that will start with a phone call from a Tobacco Care Manager within the next few days. Patients will be able to opt out of receiving such calls if they do not want them. The Tobacco Care Manager will offer information to all patients who smoke about resources available to help them quit smoking, and will ask them if they are interested in a research study. For those not willing to quit within a month and interested in the study, the Tobacco Care Manager will describe this study and ask them if they want to be screened for eligibility for the study. Those who assent to and pass the screening will then be given detailed information about the study and asked to provide informed consent for participation. For those who consent to participation, the Tobacco Care Manager will administer a 10-15-minute baseline interview over the phone, randomize patients to experimental condition, and inform them of the types of stop-smoking information and resources they will receive over the course of the 2-year study. Everyone in the study will receive a letter about their randomly assigned smoking cessation resources and study information by mail after enrollment and 4 more times over the next 2 years. Follow-up assessments will occur every 6 months over 2 years to see if participants are still smoking, if they have tried to quit, and if they have used any stop-smoking treatment. One and two years after enrollment, some participants will be asked to come to their clinic for breath and urine tests to determine if they are still smoking. Patients may be asked to complete additional follow-up calls if they start stop-smoking treatment, to see if they are smoking, using treatment, experiencing withdrawal, and are still motivated and confident about quitting and treatment at 3, 12, and 26 weeks after trying to quit smoking.
Outcomes and Analyses. The primary outcome of interest in this study is whether or not participants use the stop-smoking treatments available to them. The primary research question of interest is the extent to which each intervention improves the reach of stop-smoking treatments (i.e., how many people use the treatment), and whether particular packages of interventions do this particularly well. A second important research question is whether the study interventions help more people stop smoking during the 2-year study, and which packages of interventions do this well. A third question of importance to healthcare systems that may adopt these interventions is whether the interventions are affordable and whether or not they improve treatment use rates and tobacco abstinence rates in a manner that is cost-effective. Total costs of each intervention component will be estimated and used to compute costs per reach (initiating treatment), per quit (achieving abstinence), and per quality-adjusted life-year gained, and to estimate the net monetary benefit and incremental cost effectiveness ratio for each intervention component and combination of components.
Knowledge to be Gained. This study will assess the effectiveness, costs, and cost-effectiveness of 4 promising strategies to connect more primary care patients who smoke with evidence-based treatment to help them quit smoking. Results will be used to select an optimized package of interventions that seems to work especially well. The results of this research have the potential to suggest effective and efficient ways to reduce smoking prevalence by connecting more primary care patients who smoke to evidence-based care.
- Conditions
- Smoking, Cigarette, Smoking Cessation
- Being tested
- Varenicline, Combination nicotine patch and nicotine mini-lozenge treatment, Monetary incentives for initiating treatment, Automated tailored outreach, Care management
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.
Combination nicotine patch and nicotine mini-lozenge treatmentDrug
Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.
Monetary incentives for initiating treatmentBehavioural
Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.
Automated tailored outreachBehavioural
Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.
Care managementBehavioural
Participants randomized to this intervention will receive 5 live, proactive phone calls lasting 10-15 minutes from as assigned Tobacco Care Manager who will provide manualized support and motivational encouragement, discuss available treatment options, and inform the participant how to initiate treatment when ready to quit.
Wisconsin Tobacco Quit Line referralOther
This is recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. The Wisconsin Tobacco Quit Line (WTQL) offers a single 20-minute counseling session to all Wisconsin residents ready to set a date to stop smoking in the next month, at no charge, and offers those who meet their medical eligibility criteria a 2-week supply of either nicotine patches, lozenges, or gums, at no charge. The WTQL assumes full clinical responsibility for participants' use of cessation medications dispensed by the WTQL.
Primary care provider referralOther
This is a form of recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. Participants who choose to use this intervention will be referred electronically to their primary care provider for counseling and/or medication if they express an interest in quitting in the next 30 days and agree to this referral.
Untailored outreachBehavioural
Participants randomized to this intervention will receive 5 untailored letters delivered every 4-6 months. Letter content will not be tailored or personalized. Letters will offer information about how to access available treatments.
Multiple smoking cessation coaching callsBehavioural
Participants randomized to intensive treatment access who choose to quit will receive three 15-20-minute quit coaching calls from a trained smoking cessation health counselor. Calls will be scheduled for one week pre-quit, one day after the target quit day, and one week after the target quit day.
| Study group | Role | What they receive |
|---|---|---|
| Incentive,Tailored,Care Manage,Intensive Treatment | Experimental | 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. Receives: Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Monetary incentives for initiating treatment; Behavioral: Automated tailored outreach; Behavioral: Care management; Behavioral: Multiple smoking cessation coaching calls |
| Incentive,Tailored,Care Manage,Standard Treatment | Experimental | 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. Receives: Behavioral: Monetary incentives for initiating treatment; Behavioral: Automated tailored outreach; Behavioral: Care management; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral |
| Incentive,Tailored,No Care Manage,Intensive Treatment | Experimental | 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. Receives: Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Monetary incentives for initiating treatment; Behavioral: Automated tailored outreach; Behavioral: Multiple smoking cessation coaching calls |
| Incentive,Tailored,No Care Manage,Standard Treatment | Experimental | 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. Receives: Behavioral: Monetary incentives for initiating treatment; Behavioral: Automated tailored outreach; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral |
| Incentive,Untailored,Care Manage,Intensive Treatment | Experimental | 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. Receives: Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Monetary incentives for initiating treatment; Behavioral: Care management; Behavioral: Untailored outreach; Behavioral: Multiple smoking cessation coaching calls |
| Incentive,Untailored,Care Manage,Standard Treatment | Experimental | 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. Receives: Behavioral: Monetary incentives for initiating treatment; Behavioral: Care management; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral; Behavioral: Untailored outreach |
| Incentive,Untailored,No Care Manage,Intensive Treatment | Experimental | 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. Receives: Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Monetary incentives for initiating treatment; Behavioral: Untailored outreach; Behavioral: Multiple smoking cessation coaching calls |
| Incentive,Untailored,No Care Manage,Standard Treatment | Experimental | 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. Receives: Behavioral: Monetary incentives for initiating treatment; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral; Behavioral: Untailored outreach |
| No Incentive,Tailored,Care Manage,Intensive Treatment | Experimental | 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. Receives: Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Automated tailored outreach; Behavioral: Care management; Behavioral: Multiple smoking cessation coaching calls |
| No Incentive,Tailored,Care Manage,Standard Treatment | Experimental | 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. Receives: Behavioral: Automated tailored outreach; Behavioral: Care management; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral |
| No Incentive,Tailored,No Care Manage,Intensive Treatment | Experimental | 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. Receives: Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Automated tailored outreach; Behavioral: Multiple smoking cessation coaching calls |
| No Incentive,Tailored,No Care Manage,Standard Treatment | Experimental | 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. Receives: Behavioral: Automated tailored outreach; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral |
| No Incentive,Untailored,Care Manage,Intensive Treatment | Experimental | 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. Receives: Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Care management; Behavioral: Untailored outreach; Behavioral: Multiple smoking cessation coaching calls |
| No Incentive,Untailored,Care Manage,Standard Treatment | Experimental | 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. Receives: Behavioral: Care management; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral; Behavioral: Untailored outreach |
| No Incentive,Untailored,No Care Manage,IntensiveTreatment | Experimental | 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. Receives: Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Untailored outreach; Behavioral: Multiple smoking cessation coaching calls |
| No Incentive,Untailored,No Care Manage,Standard Treatment | Active comparator | 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. Receives: Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral; Behavioral: Untailored outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Initiate Treatment Over 1 Year of Study Enrollment
The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over 1-year of study enrollment period, vs. 0=no evidence of treatment initiation).
Measured: 1 year
Number of Participants Who Initiate Treatment Over 2 Years of Study Enrollment
The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over the 2-year study enrollment period, vs. 0=no evidence of treatment initiation).
Measured: 2 years
Secondary outcomes (1)
Number of Participants Who Achieve Biochemically Verified Seven-day Point Prevalence Abstinence 2 Years Post-enrollment
All study participants randomized to experimental condition will be asked to report on any smoking in the last 7 days at a follow-up phone interview 2 years after enrollment. Those claiming complete abstinence in the past 7 days at this follow-up interview will be asked to provide a saliva sample for biochemical verification of abstinence via cotinine testing. Participants who report abstinence in the last 7 days at this visit but have a cotinine level >10ng/mL or who do not have provide a cotinine result will be considered to be smoking. Missing data will be coded as not abstinent in primary, intent-to-treat analyses.
Measured: 2 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start11 Mar 2020
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 x 2 x 2 factorial experiment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael C Fiore, MD,MPH,MBA, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199117
- Sponsor's protocol ID
- 2019-0939
- Other IDs
- 2P01CA180945-06, A534253, SMPH/MEDICINE/MEDICINE*G, 5736, UW20070, Protocol Version 10/25/2023
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2019
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available by UW-CTRI in accord with NCI data sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centralized Health System Interventions to Enhance Reach: A Factorial Screening Experiment
- ClinicalTrials.gov ID
- NCT04199117
- Acronym / sponsor ID
- 2019-0939
- Conditions
- Smoking, Cigarette, Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Detailed description
Design and Objective: This 2-year experimental study will evaluate the effectiveness, costs, and cost-effectiveness of four interventions designed to connect primary care patients who smoke with evidence-based stop-smoking treatment. The interventions to be tested are healthcare system interventions intended to better attract patients who smoke to stop-smoking treatments that work. Participants enrolled in the study will be randomized to 1 level of each of the following 4 intervention components: 1) to receive financial incentive each time they complete a first counseling telephone call in a new round of stop-smoking treatment (for up to 4 rounds of treatment) or no incentives for starting treatment; 2) to receive tailored letters encouraging use of evidence-based stop-smoking treatment every 4-6 months for 2 years, or non-tailored letters every 4-6 months for 2 years; 3) to receive calls every 4-6 months from a Tobacco Care Manager who will provide motivational counseling to patients to encourage them to use stop-smoking treatment, and will connect patients willing to quit with available treatments, or no Tobacco Care Manager calls; and 4) access to intensive treatment (standard 12-week regimens of 2 nicotine medications used together, also called combination nicotine replacement therapy, or varenicline, a non-nicotine pill), with 3 telephone counseling sessions, all of which improve stop-smoking success rates), or standard care (referral to a quitline offering telephone counseling and 2 weeks of one nicotine medication provided by the quitline, and referral to the patient's primary care provider). The objective is to identify the intervention components and combination of components that best promote use of smoking cessation treatment and tobacco abstinence.
Recruitment and Participants: Participants will be 1664 primary care patients recruited through their primary care clinics in 2 healthcare systems in central and eastern Wisconsin. At the launch of recruitment in a clinic, all patients known to smoke at that clinic will receive notice that a new tobacco specialist, a Tobacco Care Manager, is available to help them quit smoking and given information about how to contact them. At healthcare visits, patients will be asked if they smoke, and if they do, told that the clinic has a new program for smokers that will start with a phone call from a Tobacco Care Manager within the next few days. Patients will be able to opt out of receiving such calls if they do not want them. The Tobacco Care Manager will offer information to all patients who smoke about resources available to help them quit smoking, and will ask them if they are interested in a research study. For those not willing to quit within a month and interested in the study, the Tobacco Care Manager will describe this study and ask them if they want to be screened for eligibility for the study. Those who assent to and pass the screening will then be given detailed information about the study and asked to provide informed consent for participation. For those who consent to participation, the Tobacco Care Manager will administer a 10-15-minute baseline interview over the phone, randomize patients to experimental condition, and inform them of the types of stop-smoking information and resources they will receive over the course of the 2-year study. Everyone in the study will receive a letter about their randomly assigned smoking cessation resources and study information by mail after enrollment and 4 more times over the next 2 years. Follow-up assessments will occur every 6 months over 2 years to see if participants are still smoking, if they have tried to quit, and if they have used any stop-smoking treatment. One and two years after enrollment, some participants will be asked to come to their clinic for breath and urine tests to determine if they are still smoking. Patients may be asked to complete additional follow-up calls if they start stop-smoking treatment, to see if they are smoking, using treatment, experiencing withdrawal, and are still motivated and confident about quitting and treatment at 3, 12, and 26 weeks after trying to quit smoking.
Outcomes and Analyses. The primary outcome of interest in this study is whether or not participants use the stop-smoking treatments available to them. The primary research question of interest is the extent to which each intervention improves the reach of stop-smoking treatments (i.e., how many people use the treatment), and whether particular packages of interventions do this particularly well. A second important research question is whether the study interventions help more people stop smoking during the 2-year study, and which packages of interventions do this well. A third question of importance to healthcare systems that may adopt these interventions is whether the interventions are affordable and whether or not they improve treatment use rates and tobacco abstinence rates in a manner that is cost-effective. Total costs of each intervention component will be estimated and used to compute costs per reach (initiating treatment), per quit (achieving abstinence), and per quality-adjusted life-year gained, and to estimate the net monetary benefit and incremental cost effectiveness ratio for each intervention component and combination of components.
Knowledge to be Gained. This study will assess the effectiveness, costs, and cost-effectiveness of 4 promising strategies to connect more primary care patients who smoke with evidence-based treatment to help them quit smoking. Results will be used to select an optimized package of interventions that seems to work especially well. The results of this research have the potential to suggest effective and efficient ways to reduce smoking prevalence by connecting more primary care patients who smoke to evidence-based care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
- Model description
- 2 x 2 x 2 x 2 factorial experiment
| Arm | Type | Receives |
|---|---|---|
| Incentive,Tailored,Care Manage,Intensive Treatment | Experimental | Drug: Varenicline, Drug: Combination nicotine patch and nicotine mini-lozenge treatment, Behavioral: Monetary incentives for initiating treatment, Behavioral: Automated tailored outreach, Behavioral: Care management, Behavioral: Multiple smoking cessation coaching callsParticipants 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. |
| Incentive,Tailored,Care Manage,Standard Treatment | Experimental | Behavioral: Monetary incentives for initiating treatment, Behavioral: Automated tailored outreach, Behavioral: Care management, Other: Wisconsin Tobacco Quit Line referral, Other: Primary care provider referralParticipants 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. |
| Incentive,Tailored,No Care Manage,Intensive Treatment | Experimental | Drug: Varenicline, Drug: Combination nicotine patch and nicotine mini-lozenge treatment, Behavioral: Monetary incentives for initiating treatment, Behavioral: Automated tailored outreach, Behavioral: Multiple smoking cessation coaching callsParticipants 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. |
| Incentive,Tailored,No Care Manage,Standard Treatment | Experimental | Behavioral: Monetary incentives for initiating treatment, Behavioral: Automated tailored outreach, Other: Wisconsin Tobacco Quit Line referral, Other: Primary care provider referralParticipants 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. |
| Incentive,Untailored,Care Manage,Intensive Treatment | Experimental | Drug: Varenicline, Drug: Combination nicotine patch and nicotine mini-lozenge treatment, Behavioral: Monetary incentives for initiating treatment, Behavioral: Care management, Behavioral: Untailored outreach, Behavioral: Multiple smoking cessation coaching callsParticipants 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. |
| Incentive,Untailored,Care Manage,Standard Treatment | Experimental | Behavioral: Monetary incentives for initiating treatment, Behavioral: Care management, Other: Wisconsin Tobacco Quit Line referral, Other: Primary care provider referral, Behavioral: Untailored outreachParticipants 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. |
| Incentive,Untailored,No Care Manage,Intensive Treatment | Experimental | Drug: Varenicline, Drug: Combination nicotine patch and nicotine mini-lozenge treatment, Behavioral: Monetary incentives for initiating treatment, Behavioral: Untailored outreach, Behavioral: Multiple smoking cessation coaching callsParticipants 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. |
| Incentive,Untailored,No Care Manage,Standard Treatment | Experimental | Behavioral: Monetary incentives for initiating treatment, Other: Wisconsin Tobacco Quit Line referral, Other: Primary care provider referral, Behavioral: Untailored outreachParticipants 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. |
| No Incentive,Tailored,Care Manage,Intensive Treatment | Experimental | Drug: Varenicline, Drug: Combination nicotine patch and nicotine mini-lozenge treatment, Behavioral: Automated tailored outreach, Behavioral: Care management, Behavioral: Multiple smoking cessation coaching callsParticipants 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. |
| No Incentive,Tailored,Care Manage,Standard Treatment | Experimental | Behavioral: Automated tailored outreach, Behavioral: Care management, Other: Wisconsin Tobacco Quit Line referral, Other: Primary care provider referralParticipants 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. |
| No Incentive,Tailored,No Care Manage,Intensive Treatment | Experimental | Drug: Varenicline, Drug: Combination nicotine patch and nicotine mini-lozenge treatment, Behavioral: Automated tailored outreach, Behavioral: Multiple smoking cessation coaching callsParticipants 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. |
| No Incentive,Tailored,No Care Manage,Standard Treatment | Experimental | Behavioral: Automated tailored outreach, Other: Wisconsin Tobacco Quit Line referral, Other: Primary care provider referralParticipants 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. |
| No Incentive,Untailored,Care Manage,Intensive Treatment | Experimental | Drug: Varenicline, Drug: Combination nicotine patch and nicotine mini-lozenge treatment, Behavioral: Care management, Behavioral: Untailored outreach, Behavioral: Multiple smoking cessation coaching callsParticipants 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. |
| No Incentive,Untailored,Care Manage,Standard Treatment | Experimental | Behavioral: Care management, Other: Wisconsin Tobacco Quit Line referral, Other: Primary care provider referral, Behavioral: Untailored outreachParticipants 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. |
| No Incentive,Untailored,No Care Manage,IntensiveTreatment | Experimental | Drug: Varenicline, Drug: Combination nicotine patch and nicotine mini-lozenge treatment, Behavioral: Untailored outreach, Behavioral: Multiple smoking cessation coaching callsParticipants 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. |
| No Incentive,Untailored,No Care Manage,Standard Treatment | Active comparator | Other: Wisconsin Tobacco Quit Line referral, Other: Primary care provider referral, Behavioral: Untailored outreachParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary care patient who receives care at one of the host family medicine or internal medicine clinics
- >17 years old
- Report smoking 7 of the last 7 days at enrollment
- Report smoking at least five cigarettes per day for at least 6 months at enrollment
- Able to speak and read English
Key exclusion criteria (5 listed)
- Opted out of Care Manager outreach at the most recent clinic visit or by phone
- Willing to quit smoking within 30 days (these patients will be referred for immediate treatment rather than enrolled in this study)
- Inability to use both C-NRT and varenicline due to a contraindication to both treatments at enrollment (allergic reactions, severe renal disease)
- Current treatment for schizophrenia or a psychotic disorder at enrollment
- History of suicide attempt in the past 10 years at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineParticipants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy. | Drug | Incentive,Tailored,Care Manage,Intensive Treatment, Incentive,Tailored,No Care Manage,Intensive Treatment, Incentive,Untailored,Care Manage,Intensive Treatment, Incentive,Untailored,No Care Manage,Intensive Treatment, No Incentive,Tailored,Care Manage,Intensive Treatment, No Incentive,Tailored,No Care Manage,Intensive Treatment, No Incentive,Untailored,Care Manage,Intensive Treatment, No Incentive,Untailored,No Care Manage,IntensiveTreatment |
| Combination nicotine patch and nicotine mini-lozenge treatmentParticipants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline. | Drug | Incentive,Tailored,Care Manage,Intensive Treatment, Incentive,Tailored,No Care Manage,Intensive Treatment, Incentive,Untailored,Care Manage,Intensive Treatment, Incentive,Untailored,No Care Manage,Intensive Treatment, No Incentive,Tailored,Care Manage,Intensive Treatment, No Incentive,Tailored,No Care Manage,Intensive Treatment, No Incentive,Untailored,Care Manage,Intensive Treatment, No Incentive,Untailored,No Care Manage,IntensiveTreatment |
| Monetary incentives for initiating treatmentParticipants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment. | Behavioural | Incentive,Tailored,Care Manage,Intensive Treatment, Incentive,Tailored,Care Manage,Standard Treatment, Incentive,Tailored,No Care Manage,Intensive Treatment, Incentive,Tailored,No Care Manage,Standard Treatment, Incentive,Untailored,Care Manage,Intensive Treatment, Incentive,Untailored,Care Manage,Standard Treatment, Incentive,Untailored,No Care Manage,Intensive Treatment, Incentive,Untailored,No Care Manage,Standard Treatment |
| Automated tailored outreachParticipants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments. | Behavioural | Incentive,Tailored,Care Manage,Intensive Treatment, Incentive,Tailored,Care Manage,Standard Treatment, Incentive,Tailored,No Care Manage,Intensive Treatment, Incentive,Tailored,No Care Manage,Standard Treatment, No Incentive,Tailored,Care Manage,Intensive Treatment, No Incentive,Tailored,Care Manage,Standard Treatment, No Incentive,Tailored,No Care Manage,Intensive Treatment, No Incentive,Tailored,No Care Manage,Standard Treatment |
| Care managementParticipants randomized to this intervention will receive 5 live, proactive phone calls lasting 10-15 minutes from as assigned Tobacco Care Manager who will provide manualized support and motivational encouragement, discuss available treatment options, and inform the participant how to initiate treatment when ready to quit. | Behavioural | Incentive,Tailored,Care Manage,Intensive Treatment, Incentive,Tailored,Care Manage,Standard Treatment, Incentive,Untailored,Care Manage,Intensive Treatment, Incentive,Untailored,Care Manage,Standard Treatment, No Incentive,Tailored,Care Manage,Intensive Treatment, No Incentive,Tailored,Care Manage,Standard Treatment, No Incentive,Untailored,Care Manage,Intensive Treatment, No Incentive,Untailored,Care Manage,Standard Treatment |
| Wisconsin Tobacco Quit Line referralThis is recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. The Wisconsin Tobacco Quit Line (WTQL) offers a single 20-minute counseling session to all Wisconsin residents ready to set a date to stop smoking in the next month, at no charge, and offers those who meet their medical eligibility criteria a 2-week supply of either nicotine patches, lozenges, or gums, at no charge. The WTQL assumes full clinical responsibility for participants' use of cessation medications dispensed by the WTQL. | Other | Incentive,Tailored,Care Manage,Standard Treatment, Incentive,Tailored,No Care Manage,Standard Treatment, Incentive,Untailored,Care Manage,Standard Treatment, Incentive,Untailored,No Care Manage,Standard Treatment, No Incentive,Tailored,Care Manage,Standard Treatment, No Incentive,Tailored,No Care Manage,Standard Treatment, No Incentive,Untailored,Care Manage,Standard Treatment, No Incentive,Untailored,No Care Manage,Standard Treatment |
| Primary care provider referralThis is a form of recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. Participants who choose to use this intervention will be referred electronically to their primary care provider for counseling and/or medication if they express an interest in quitting in the next 30 days and agree to this referral. | Other | Incentive,Tailored,Care Manage,Standard Treatment, Incentive,Tailored,No Care Manage,Standard Treatment, Incentive,Untailored,Care Manage,Standard Treatment, Incentive,Untailored,No Care Manage,Standard Treatment, No Incentive,Tailored,Care Manage,Standard Treatment, No Incentive,Tailored,No Care Manage,Standard Treatment, No Incentive,Untailored,Care Manage,Standard Treatment, No Incentive,Untailored,No Care Manage,Standard Treatment |
| Untailored outreachParticipants randomized to this intervention will receive 5 untailored letters delivered every 4-6 months. Letter content will not be tailored or personalized. Letters will offer information about how to access available treatments. | Behavioural | Incentive,Untailored,Care Manage,Intensive Treatment, Incentive,Untailored,Care Manage,Standard Treatment, Incentive,Untailored,No Care Manage,Intensive Treatment, Incentive,Untailored,No Care Manage,Standard Treatment, No Incentive,Untailored,Care Manage,Intensive Treatment, No Incentive,Untailored,Care Manage,Standard Treatment, No Incentive,Untailored,No Care Manage,IntensiveTreatment, No Incentive,Untailored,No Care Manage,Standard Treatment |
| Multiple smoking cessation coaching callsParticipants randomized to intensive treatment access who choose to quit will receive three 15-20-minute quit coaching calls from a trained smoking cessation health counselor. Calls will be scheduled for one week pre-quit, one day after the target quit day, and one week after the target quit day. | Behavioural | Incentive,Tailored,Care Manage,Intensive Treatment, Incentive,Tailored,No Care Manage,Intensive Treatment, Incentive,Untailored,Care Manage,Intensive Treatment, Incentive,Untailored,No Care Manage,Intensive Treatment, No Incentive,Tailored,Care Manage,Intensive Treatment, No Incentive,Tailored,No Care Manage,Intensive Treatment, No Incentive,Untailored,Care Manage,Intensive Treatment, No Incentive,Untailored,No Care Manage,IntensiveTreatment |
Primary outcome
Number of Participants Who Initiate Treatment Over 1 Year of Study Enrollment
Time frame: 1 year
The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over 1-year of study enrollment period, vs. 0=no evidence of treatment initiation).
Number of Participants Who Initiate Treatment Over 2 Years of Study Enrollment
Time frame: 2 years
The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over the 2-year study enrollment period, vs. 0=no evidence of treatment initiation).
1 secondary outcome
Number of Participants Who Achieve Biochemically Verified Seven-day Point Prevalence Abstinence 2 Years Post-enrollment
Time frame: 2 years from enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be made available by UW-CTRI in accord with NCI data sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Fiore, MD,MPH,MBA principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline, Combination nicotine patch and nicotine mini-lozenge treatment and Monetary incentives for initiating treatment in people with Smoking, Cigarette and Smoking Cessation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Initiate Treatment Over 1 Year of Study Enrollment (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.