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. 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. The study involves a population-based sample of veterans in VISN 13 who use one of the five Network VAMCs for primary care. Eight hundred smokers will be recruited and randomly assigned to 1) written self-help materials + TO, or 2) written self-help materials alone. The structured TO intervention protocol is based on the California Smokers’ Helpline, which has been extensively evaluated by Dr. Shu-Hong Zhu, a co-investigator on this project. The behavioral intervention protocol includes follow-up calls scheduled in a relapse-sensitive fashion. Use of nicotine replacement therapy (NRT) is encouraged, and prescriptions facilitated.

Data will be 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 will be 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 will be continuous abstinence from smoking since the subject’s initial quit date, measured 12 months following intervention. Secondary analyses will evaluate 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.

Condition	Treatment or Intervention	Phase
Smoking Smoking cessation	Procedure: Telephone Care	Phase IV

Genders Eligible for Study:  Both

Criteria

Subjects must be smokers who have a phone and who speak English. They are excluded for psychiatric instability.

Minnesota
      VA Medical Center, Minneapolis,  Minnesota,  55417,  United States; Recruiting

Study ID Numbers:  SUI 99-101
Record last reviewed:  January 2003
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00012948
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09