Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)

The automated IVR uses algorithms and sophisticated speech recognition (computerized) to engage smokers on the telephone; gather information, provide reinforcing messages and triage them to a study nurse for call-back within 2 working days if either the smoker or nurse identify help is required. The technology recognizes the smoker's verbal responses, documents them and thereby assists in guiding further follow-up. IVR is a low-cost, high-yield way of contacting smokers when they would not ordinarily be contacted.

When prospective subjects call to register, a voice message will ask them to leave their name, telephone number, and register their choice of session date they would like to attend (the telephone message will list the 3 choices of session dates - as outlined on the poster).

Each session is a combined Information, Screening, and Recruitment session, which will be held once a week at St. Paul's Hospital (for a period of 3 weeks). The sessions will begin with a presentation by the participating physician, and will be group-based. The sessions will include information about smoking, smoking cessation, varenicline (Champix), eligibility for the study, and the relevance of the questionnaire about demographics, motivation, stress, and smoking, and the consent form (see questionnaire attachment). (The consent forms will be distributed to the group so they may view them while their relevance is discussed). Potential subjects will be given an information package including the Canadian Cancer Society booklets "For Smokers Who Don't Want to Quit" and "For Smokers Who Want To Quit" (see booklet attachments in 9.8).

Potential subjects will then be asked to read the consent form. If they think they meet the inclusion and exclusion criteria and are interested in proceeding they will meet with the physician in private (in a conference room across the hall) after the session. The physician will determine their eligibility (as per inclusion and exclusion criteria). A Healthy Heart volunteer will then witness their signing of the consent form. They will be asked to sign a second consent form that will be marked "copy" and given to them.

There is no time limit to sign the consent form. If potential subjects would like to make an appointment with the study nurse to come in to sign the consent at a future date, they may do so. In this situation, the following study procedures would be completed at this later date.