Proactive Tobacco Treatment for Veterans
Condition: Smoking Cessation; Smoking Tobacco
Study type: Interventional

Summary: 
      Tobacco use is the leading cause of premature death in the United States and
      disproportionately affects Veterans and certain racial/ethnic minority groups. Most smokers
      are interested in quitting; however, current tobacco use treatment approaches are reactive
      and require smokers to initiate treatment or depend on the provider to initiate smoking
      cessation care. As a result, most smokers do not receive comprehensive, evidence-based
      treatment for tobacco use that includes intensive behavioral counseling along with
      pharmacotherapy. Proactive tobacco treatment integrates population-based treatment (i.e.,
      proactive outreach) and individual-level treatment (i.e., smoking cessation counseling and
      pharmacotherapy) to address both patient and provider barriers to comprehensive care.
    

Detailed description: 
      1. BACKGROUND/RATIONALE Tobacco use remains the number one cause of premature death and
           morbidity in the United States. Most cigarette smokers want to quit smoking, and about
           50% make a quit attempt each year, but only 6% achieve long-term cessation. This
           randomized controlled trial - the Veterans Victory over Tobacco Study - compared the
           effects of a proactive tobacco cessation care model versus a traditional cessation care
           model on the use of tobacco treatment and subsequent population-level smoking cessation
           rates. Veterans from four VAMCs were recruited from 10/09 to 9/10 and were randomized to
           either usual care (i.e., reactive care) or the proactive care intervention. Veterans in
           the usual care group (n=2,604) received access to tobacco treatment services from their
           VAMC. Veterans in the proactive care intervention group (n=2,519) received proactive
           outreach (mailed invitation materials followed by telephone outreach); and were offered
           a choice of smoking cessation services (telephone care or in-person care). The primary
           outcome was six-month prolonged smoking abstinence one year after randomization.
           Investigators also analyzed baseline demographics, clinical characteristics (i.e.,
           distance to VAMC, comorbid psychiatric conditions), and smoking history.

        2. OBJECTIVES The primary objectives of this study were to (1) Assess the effect of a
           proactive care intervention on population-level smoking abstinence rates (i.e.,
           abstinence among all smokers including those who use and do not use treatment) and on
           use of evidence-based tobacco treatments compared to reactive/usual care among a diverse
           population of Veteran smokers, (2) Compare the effect of proactive care on
           population-level smoking abstinence rates and use of tobacco treatments between African
           American and White smokers, and (3) Determine the cost-effectiveness of the proactive
           care intervention.

        3. METHODS In this prospective randomized controlled trial, we identified a
           population-based registry of current smokers (N=6400) from four Department of Veterans
           Affairs (VA) Medical Centers facilities using the VA electronic medical record, who were
           randomized to proactive care or usual care. The proactive care intervention combines:
           (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone
           or face-to-face). Proactive outreach included mailed invitations followed by telephone
           outreach with motivational enhancement (up to 6 call attempts) to encourage smokers to
           seek treatment with choice of services. Proactive care participants who chose telephone
           care received VA telephone counseling and access to pharmacotherapy. Proactive care
           participants who chose face-to-face care were referred to their VA facility's smoking
           cessation clinic. Usual care group participants had access to standard smoking cessation
           services provided by their VA facility and their VA primary care provider. Usual care
           participants could also call their local state telephone quitline. Because this study
           was testing proactive outreach, smokers were randomized prior to contact and a baseline
           survey was administered after randomization using a multiple-wave mailed questionnaire
           protocol. Additional baseline data were extracted from VA administrative databases.
           Outcomes from both groups were collected 12 months post-randomization from participant
           surveys and from VA administrative databases. The primary outcome was population-level
           cessation at one year using a self-reported, 6-month prolonged smoking abstinence
           measure.

        4. STATUS We have successfully conducted a multi-site population-based randomized
           controlled trial. Our primary outcomes paper was published by the JAMA Internal Medicine
           online in March 2014 and we are currently working on a second manuscript.

        5. CLINICAL SIGNIFICANCE In this study, we tested a proactive care intervention that
           harnesses the power of the electronic medical record to identify populations of smokers
           in a health care system and capitalize on the availability of validated telephone care
           protocols to efficiently deliver intensive behavioral counseling and facilitate access
           to pharmacotherapy.
    

Intervention name(s): Proactive Outreach with choice of telephone or in-person smoking cessation services
Intervention type(s): Behavioral
Intervention description(s): This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: African Americans; telephone counseling; community health planning; ethnic groups