Abstract
BackgroundMost smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Further, the use of proven, tobacco treatments is lower among minorities than among Whites. The primary objectives of this study are to: (1) Assess the effect of a proactive care intervention (PRO) on population-level smoking abstinence rates (i.e., abstinence among all smokers including those who use and do not utilize treatment) and on utilization of tobacco treatment compared to reactive/usual care (UC) among a diverse population of smokers, (2) Compare the effect of PRO on population-level smoking abstinence rates and utilization of tobacco treatments between African American and White smokers, and (3) Determine the cost-effectiveness of the proactive care intervention.Methods/DesignThis prospective randomized controlled trial identifies a population-based sample of current smokers from the Department of Veterans Affairs (VA) electronic medical record health factor dataset. The proactive care intervention combines: (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or face-to-face). Proactive outreach includes mailed invitation materials followed by an outreach call that encourages smokers to seek treatment with choice of services. Proactive care participants who choose telephone care receive VA telephone counseling and access to pharmacotherapy. Proactive care participants who choose face-to-face care are referred to their VA facility's smoking cessation clinic. Usual care participants have access to standard smoking cessation services from their VA facility (e.g., pharmacotherapy, smoking cessation clinic) and from their state telephone quitline. Baseline data is collected from VA administrative databases and participant surveys. Outcomes from both groups are collected 12 months post-randomization from participant surveys and from VA administrative databases. The primary outcome is self-reported smoking abstinence, which is assessed at the population-level (i.e., among those who utilize and those who do not utilize tobacco treatment). Primary analyses will follow intention-to-treat methodology.DiscussionThis randomized trial is testing proactive outreach strategies offering choice of smoking cessation services, an innovation that if proven effective and cost-effective, will transform the way tobacco treatment is delivered. National dissemination of proactive treatment strategies could dramatically reduce tobacco-related morbidity, mortality, and health care costs.Clinical trials registrationClinicalTrials.gov: NCT00608426.
Highlights
Most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy
The population impact of tobacco treatment relies on exposure to treatment and is defined as the product of the rate of utilization of treatment and the efficacy of treatment [2]
We describe the study design and methods of a prospective randomized controlled trial to determine the effects of a theory-driven intervention combining 1) proactive outreach with 2) choice of telephone care or face-to-face care for treatment of tobacco dependence compared to reactive care
Summary
Population-based interventions lead to higher utilization rates but may have lower efficacy because they are less intensive (e.g., mass mailings of self-help materials) whereas individual-level interventions might have higher efficacy but lower utilization rates. The proposed study extends this research because all smokers are being identified from the electronic medical record, not just those smokers who have already received pharmacologic treatment, and the proactive care interventions offers a choice of telephone or faceto-face smoking cessation services. The strength of this project is the use of a populationbased approach to evaluate the effectiveness of proactive outreach and choice of care on population-level quit rates. If proven to be effective and acceptably low-cost, national dissemination of proactive treatment approaches would have potential to dramatically reduce tobacco-related morbidity, mortality, and health care costs for the nation
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