Smoking Cessation Clinical Trial
Official title:
Proactive Tobacco Treatment for Diverse Veteran Smokers
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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