Abstract
BackgroundThere is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations. Effective, evidenced-based smoking cessation treatments are available, but low-income smokers are less likely than higher-income smokers to use these treatments, especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling.Methods/DesignThe primary objectives of this randomized controlled trial are to compare the effects of a proactive tobacco treatment intervention compared to usual care on population-level smoking abstinence rates and tobacco treatment utilization rates among a diverse population of low-income smokers, and to determine the cost-effectiveness of proactive tobacco treatment intervention. The proactive care intervention systematically offers low-income smokers free and easy access to evidence-based treatments and has two primary components: (1) proactive outreach to current smokers in the form of mailed invitation materials and telephone calls containing targeted health messages, and (2) facilitated access to free, comprehensive, evidence-based tobacco cessation treatments in the form of NRT and intensive, telephone-based behavioral counseling. The study aims to include a population-based sample (N = 2500) of adult smokers enrolled in the Minnesota Health Care Programs (MHCP), a state-funded health insurance plan for low-income persons. Baseline data is obtained from MHCP administrative databases and a participant survey that is conducted prior to randomization. Outcome data is collected from a follow-up survey conducted 12 months after randomization and MHCP administrative data. The primary outcome is six-month prolonged smoking abstinence at one year and is assessed at the population level. All randomized individuals are asked to complete the follow-up survey, regardless of whether they participated in tobacco treatment. Data analysis of the primary aims will follow intent-to-treat methodology.DiscussionThere is a critical need to increase access to effective tobacco dependence treatments. This randomized trial evaluates the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment. If proven to be effective and cost-effective, national dissemination of proactive treatment approaches would reduce tobacco-related morbidity, mortality, and health care costs for low income Americans.Clinical trials registrationClinicalTrials.gov: NCT01123967
Highlights
There is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations
There is a critical need to increase access to effective tobacco dependence treatments. This randomized trial evaluates the effects of proactive outreach coupled with free nicotine replacement therapy (NRT) and telephone counseling on the population impact of tobacco dependence treatment
We describe the study design and methods of a prospective randomized controlled trial testing a proactive tobacco intervention that is hypothesized to have greater population impact because it will 1) achieve wide reach and increase utilization of treatment and 2) increase the effectiveness of treatment
Summary
There is clear evidence that low-income smokers are less likely than higher-income smokers to use tobacco dependence treatments, especially the most comprehensive form that includes a combination of pharmacotherapy and intensive behavioral counseling. Continue to be under-used and do not consistently provide comprehensive care (medications with counseling). In this randomized controlled trial, we are testing an innovative intervention that integrates population-based and individual approaches to address both patient and provider barriers to treatment that low-income smokers face. This trial will provide evidence regarding the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment. All authors provided critical review of the study protocol and approved the final manuscript
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