Telephone and Web-based Teen Tobacco Cessation in HMOs
Condition: Tobacco Use
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to look at both the clinicians' ability to reach out to the teen
      smokers and to evaluate the efficacy of providing tobacco cessation support using a proactive
      telephone quitline combined with an interactive Web-based program for teens within a managed
      care environment.
    

Detailed description: 
      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.
    

Intervention name(s): Telephone counseling + interactive website = more abstinence; Behavioral: interactive website
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Teen smokers; Quithelper; Tobacco; Tobacco Website; Website Intervention; Tobacco counseling; Tobacco abstinence