Telephone and Web-based Teen Tobacco Cessation in HMOs (QWIThelper)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311948
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : September 28, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kaiser Permanente

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Use Behavioral: Telephone counseling + interactive website = more abstinence Behavioral: Behavioral: interactive website Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Telephone and Web-based Teen Tobacco Cessation in HMOs
Study Start Date : March 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Active Comparator: Telephone counseling + interactive website
Teen has access to interactive website and receives tailored telephone counseling
Behavioral: Telephone counseling + interactive website = more abstinence
Control with interactive website
Teen only has access to interactive website.
Behavioral: Behavioral: interactive website

Primary Outcome Measures :
  1. Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up. [ Time Frame: 6 months and 12 months ]
    self report of smoking in last 30 days

  2. 12-month measure to determine long-term assessment [ Time Frame: 12-months ]
    Self report smoking or not smoking.

Secondary Outcome Measures :
  1. A six-month assessment to determine short-term effects [ Time Frame: 6 months ]
  2. Assess the prevalence of smoking on 25 or more days per month [ Time Frame: 1 month ]
  3. Assess sustained abstinence (e.g., three and six months) at each follow-up, [ Time Frame: 3 months and 6 months ]
    No smoking - yes or no at 3 month timeframe and 6 months timeframe

  4. Assess change in stage of change [ Time Frame: 6 months and 12 months ]
  5. Assess amount smoked, and use of other tobacco products (including smokeless tobacco) in the last week, 30 days, three months, and six months prior to the follow-up assessment. [ Time Frame: 30 days, 6 months, 12 months ]
  6. Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach [ Time Frame: 1 day ]
  7. Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 15-18 years old
  • both males and females
  • smoking cigarettes at least four days a month
  • some interest in quitting (will take all teen regardless of stage of readiness
  • no evidence of treatment for depression, alcohol, or drugs in last year
  • must consent
  • have physician's approval for outreach to their panel
  • have (or able to get) Internet access and phone access
  • willingness to participate in study and follow-up procedures.

Exclusion Criteria:

  • <15 years old
  • >18 years old
  • treated within 1 year for depression, alcohol, or drugs
  • No internet access or phone access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311948

United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
United States, Washington
Free & Clear, Inc.
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Kaiser Permanente
National Cancer Institute (NCI)
Principal Investigator: Jack F Hollis, Ph.D. Kaiser Permanente

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Responsible Party: Kaiser Permanente Identifier: NCT00311948     History of Changes
Other Study ID Numbers: 5R01CA098685-02 ( U.S. NIH Grant/Contract )
1R01CA098685-01A2 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2006

Keywords provided by Kaiser Permanente:
Teen smokers
Tobacco Website
Website Intervention
Tobacco counseling
Tobacco abstinence