One billion people will die from tobacco-related illnesses this century. Most health care providers, however, fail to treat tobacco dependence. This may in part be due to the treatment default. Current treatment guidelines recommend that providers a) ask patients if they are willing to quit and b) provide cessation-focused medications and counseling only to smokers who state they are willing to quit. For other health conditions-diabetes, hypertension, asthma, and even substance abuse-the treatment default is to a) identify the health condition and b) initiate evidence-based treatment. For example, when a patient is newly diagnosed with hypertension, they aren't asked if they are `ready' to start treatment. The physician simply begins with a prescription or discussion of treatment options. As with any healthcare treatment option, patients are free to decline-they can opt out if they wish to refuse care. If patients do nothing, they will receive care. For tobacco users, however, the default is that they have to opt in to receive cessation assistance: providers ask smokers if they are willing to quit, and only offer medications and cessation support to those who say yes. This drastically limits the reach of cessation services because, at any given encounter, only 1 in 3 smokers say they are ready to quit. As a result, few receive medications or cessation counseling. Recent studies suggest that, when provided with cessation medications and counseling, unmotivated smokers are as likely to quit as motivated smokers. Hence, there is a critical need to examine the impact of changing the treatment default on utilization and quitting. The objective of this application is to determine the impact of providing all smokers wit tobacco treatment unless they refuse it (OPT OUT) versus current practice-screening for readiness and only offering treatment to smokers who say they are ready to quit (OPT IN). The study employs an individually-randomized design, and is conducted in a tertiary care hospital. We will conduct the trial among 1,000 randomly-selected hospitalized smokers to determine the population impact of changing the treatment default, identify mediators of outcome, and determine the cost-effectiveness of this new, highly proactive approach. This is a population-based study that targets an endpoint of vital interest; applies minimal eligibility criteria to broaden generalizability; and utilizes hospital staff for interventions to ensure long-term sustainability. The study employs an innovative Baysian adaptive design to evaluate a major shift in our approach to care. If effective, this change would expand the reach of tobacco treatment from 30% to 100% of smokers.

Public Health Relevance

Even though tobacco dependence remains the top preventable cause of death in the U.S., most health care providers fail to treat tobacco dependence. This study tests the effects of proactively providing tobacco treatment to all smokers, versus only offering active cessation treatment-medications and counseling-to smokers who say they are ready to quit. If effective, proactively providing tobacco treatment could expand access to care from 30% to 100% of smokers.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project (R01)
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Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Nicastro, Holly L
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University of Kansas
Public Health & Prev Medicine
Schools of Medicine
Kansas City
United States
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Warlick, Craig; Richter, Kimber P; Catley, Delwyn et al. (2018) Two brief valid measures of therapeutic alliance in counseling for tobacco dependence. J Subst Abuse Treat 86:60-64
Faseru, Babalola; Ellerbeck, Edward F; Catley, Delwyn et al. (2017) Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial. Trials 18:379