Trial Information

Telephone and Web-based Teen Tobacco Cessation in HMOs

Health maintenance organizations have the mission, incentive, communication tools, and
credibility with patients to reach out to teen members who use tobacco. The overall aim of
this project is to refine and test both the potential reach and the efficacy of tobacco
cessation support using a proactive telephone quitline combined with an interactive
Web-based program for teens within a managed care environment. As part of a
clinician-directed outreach effort, we will work closely with pediatric clinicians to
maximize the program's reach into the teen smoker population as identified through the
electronic data base of a large HMO. We will use letters and proactive outreach calls to
assess current smoking status and recruit 600 15- to 18-year-old teen smokers who are
interested in quitting and would be willing to receive cessation support via telephone and
the Web. A second aim will be to randomly assign interested teen smokers to receive a
proactive telephone- and Web-based tobacco cessation program or access to a website with
cessation materials (control condition) to test the efficacy of the program on long-term
cessation rates at 6- and 12-months. We will use several process measures to assess our
ability to implement and consistently deliver both the telephone and Web components of the
intervention. We will measure mediating variables to determine they support the
hypothesized linkages between the theoretical constructs described by our cognitive
behavioral model of action. An effective managed care partnership with clinicians to assess,
recruit, and intervene with teen smokers would be of great interest to clinicians and health
plan managers, highly exportable, and would be given high priority for implementation at the
population level.

Our specific aims are as follows:

1. Compare the population-based recruitment yields and costs of three proactive outreach
approaches: 1) outreach calls only to those teen smokers who are seen, advised, and
referred to us by their clinician; 2) outreach calls to a random sample of teens shown
as being smokers in the EMR; and 3) outreach calls to a sample of all teens

2. Assess efficacy/effectiveness in a randomized trial with 600 teen smokers to evaluate
the hypothesis that proactive telephone-based counseling integrated with an interactive
website will increase 6- and 12-month abstinence rates (30-day point prevalence)
relative to a control condition receiving mailed cessation materials alone

3. Assess the hypothesis that the telephone and web-based intervention will improve
longer-term maintenance of abstinence at an 12-month follow-up point compared to the
control condition

4. Describe use patterns for key intervention process measures (e.g., calls completed, use
of website) and determine if intervention affects outcome through theoretical mediators
(e.g., pros/cons, stage, efficacy)

5. Determine the total costs of the telephone and web-based program from the perspective
of the HMO and replication costs in other settings, and report costs as incremental
costs per member per month, per program participant, and per quit.