Tobacco use is the leading preventable cause of premature death overall, as well as cancer death, in the US. Although healthcare settings offer great opportunities to provide effective smoking treatment, too few smokers receive such treatment in these settings. This project will work to increase the effectiveness and reach of smoking treatment in primary care.
Breathe 2 Project 3, is a 2-arm randomized controlled trial designed to evaluate whether Comprehensive Chronic Care, relative to Standard Care, increases smoking abstinence and treatment use in primary care patients who smoke.
Adult patients who smoke daily at the time of enrollment will be eligible to participate, with no obligation to quit smoking or use treatment. Approximately 1,000 patients will be recruited in 8-14 primary care clinics in 2 healthcare systems by healthcare system staff (Care Managers) using an opt-out strategy to maximize inclusion and enhance the generalizability of the results.
Participants who enter the study will be randomized to one of two treatments:
- Comprehensive Chronic Care; CCC (n=600)
- Standard Care; SC (n=400)
Those randomized to CCC will receive ongoing smoking treatment offers via the following routes: 1) Four Outreach Calls at 4, 8, 12, and 14 months post-study enrollment; and 2) Four texts and/or mailings over 14 months. These outreach contacts will offer cessation treatment for those interested in quitting (4 weeks pre-quit day + 12 weeks of post-quit day treatment) or smoking reduction treatment for those not ready to quit but willing to reduce their smoking (8 weeks of smoking reduction treatment).
All treatment will be provided by trained UW-CTRI Health Counselors. Those who enter cessation treatment will receive treatment-initiated assessment calls from UW-CTRI staff at 8- and 12-weeks following the target-quit day to evaluate smoking status. CCC participants who have an unsuccessful quit attempt will be encouraged to make a new quit attempt using cessation treatment provided by the study; those who decline additional cessation treatment will be offered reduction treatment.
Participants randomized to SC will receive one outreach call per year offering cessation treatment (8 weeks of nicotine patch and referral to Wisconsin Tobacco Quitline and/or Smokefree.txt).
All participants can elect to engage in treatment (or not) at any time up to Month 14 of the 18-month study period. Participants in both groups may engage in treatment multiple times, consistent with good clinical care. In addition to a Baseline Assessment, all participants will complete Semi-Annual Follow-Up Assessments at Months 6, 12, and 18 post-study enrollment.
Outcomes
The primary outcome is biochemically confirmed point-prevalence abstinence at 18 months post-enrollment.
Secondary outcomes are: Seven-day point-prevalence abstinence at six months and a year after enrollment, along with use of cessation treatment and cost.
