Smoking Cessation Clinical Trial
Official title:
Centralized Telephone Outreach to Assist Smoking Cessation Among Veterans
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco use and provision of brief and/or intensive smoking cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to counseling and medications to assist smoking cessation. From the standpoint of health systems, TO provides the opportunity for centralized oversight and quality assurance, economy of scale, and dissemination strategies that are practical to implement. At the provider level, TO addresses barriers to delivery of services such as limited time and skills. From the standpoint of the smoker, attractions of TO include accessibility, convenience, and privacy.
Background:
Smoking cessation interventions including behavioral and pharmacological components have
been demonstrated to be both effective and cost-effective. Although there is a high
prevalence of smoking and smoking-related disorders among veterans who use VA medical
centers for health care, rates of identification of tobacco use and provision of brief
and/or intensive smoking cessation services are suboptimal. Telephone outreach (TO) may
serve to increase access to counseling and medications to assist smoking cessation. From the
standpoint of health systems, TO provides the opportunity for centralized oversight and
quality assurance, economy of scale, and dissemination strategies that are practical to
implement. At the provider level, TO addresses barriers to delivery of services such as
limited time and skills. From the standpoint of the smoker, attractions of TO include
accessibility, convenience, and privacy.
Objectives:
The objectives of the study are to: 1) determine if TO increases successful quitting among
veterans who smoke, compared to the distribution of written self-help materials; and 2)
determine the cost-effectiveness of TO for smoking cessation for veterans who smoke.
Methods:
The study involved a population-based sample of veterans in VISN 13 who use one of the five
Network VAMCs for primary care. 838 smokers were recruited, enrolled and randomly assigned
to 1) written self-help materials + TO, or 2) written self-help materials alone. The
behavioral intervention protocol included follow-up calls scheduled in a relapse-sensitive
fashion. Use of nicotine replacement therapy (NRT) was encouraged, and prescriptions
facilitated. Data was collected at baseline, 3 months, and 12 months by telephone.
Information on demographic characteristics, medical and mental health histories, smoking
history, intervention, and use of clinical services for smoking cessation was included. Cost
data will be calculated from administrative databases, and will include 1) written
materials, 2) counseling (personnel time, equipment, space), and 3) medications. The primary
outcome was 6 months of prolonged abstinence from smoking, measured 12 months following
intervention. Secondary analyses evaluated 3 month and 12 month point prevalent abstinence
from smoking, quit attempts, and a formal cost-effectiveness analysis that will include
total costs, total and marginal effects and cost-effectiveness ratios (average cost/quit and
average cost/marginal quit) for TO and SH interventions.
Status:
Data collection and main outcome analyses have been completed. The main manuscript will be
submitted to JAMA in October 2004. We are starting cost-effectiveness analyses.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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