Smoking Cessation Clinical Trial
Official title:
Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET
The adverse impact of tobacco use on disease prevalence and health care costs is well documented. Hence, finding effective ways to reduce tobacco dependence is an essential component of improving the outcomes, quality and efficiency of VHA care. The U.S. Public Health Service (PHS) Smoking Cessation Clinical Practice Guideline provides specific recommendations for treating tobacco dependence. Despite their strong evidence base, however, these recommendations have not been fully integrated into clinical practice within the VHA. Recent data suggest that logistical difficulties associated with identifying and linking smokers with appropriate treatments may explain why the PHS Smoking Cessation Guideline has not been more broadly implemented.
Background:
The adverse impact of tobacco use on disease prevalence and health care costs is well
documented. Hence, finding effective ways to reduce tobacco dependence is an essential
component of improving the outcomes, quality and efficiency of VHA care. The U.S. Public
Health Service (PHS) Smoking Cessation Clinical Practice Guideline provides specific
recommendations for treating tobacco dependence. Despite their strong evidence base,
however, these recommendations have not been fully integrated into clinical practice within
the VHA. Recent data suggest that logistical difficulties associated with identifying and
linking smokers with appropriate treatments may explain why the PHS Smoking Cessation
Guideline has not been more broadly implemented.
Objectives:
The primary objective of this study is to assess the effectiveness of an intervention for
increasing the rate of tobacco dependence treatment in a population of smokers identified
through the VA Pharmacy Benefits Management database. Secondary objectives of this study
include (1) assessing the effect of the intervention on smoking cessation rates, and (2)
developing options for overcoming potential barriers to broad implementation of the
strategies.
Methods:
The effectiveness of the intervention will be evaluated using a multi-center, randomized,
controlled trial. Veterans receiving a prescription for transdermal nicotine, nicotine gum,
or bupropion for smoking cessation in the past year at one of the participating VHA
facilities (as determined from Pharmacy Benefits Management records) will be eligible for
the study. A total of 1,900 eligible veterans selected from five test sites will be randomly
assigned to one of two groups: (1) patient phone call and tailored, computerized prompt to
providers (intervention), or (2) usual care (control). The primary outcome is the proportion
of patients receiving pharmacological or other smoking cessation treatment in the six month
follow-up period, as assessed from VA pharmacy and outpatient data files. All patients will
be recruited to a brief phone interview six months post-intervention to gather secondary
outcome measure data related to smoking status, quit history, and use of smoking cessation
assistance.
Status:
Data preparation and analysis.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind
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