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Telephone and Web-Based Teen Tobacco Cessation in HMOs
This study is currently recruiting participants.
Verified by Kaiser Permanente, September 2006
Sponsors and Collaborators: Kaiser Permanente
National Cancer Institute (NCI)
Information provided by: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00311948
  Purpose

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 Intervention Phase
Tobacco Use
Behavioral: Telephone counseling + interactive website = more abstinence
Phase III

MedlinePlus related topics: Smoking Smoking and Youth
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Telephone and Web-Based Teen Tobacco Cessation in HMOs

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Participants’ self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up.
  • 12-month measure to determine long-term assessment

Secondary Outcome Measures:
  • A six-month assessment to determine short-term effects
  • Assess the prevalence of smoking on 25 or more days per month
  • Assess sustained abstinence (e.g., three and six months) at each follow-up,
  • Assess change in stage of change
  • 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.
  • Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach
  • Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement

Estimated Enrollment: 600
Study Start Date: March 2006
Estimated Study Completion Date: July 2008
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.
  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311948

Contacts
Contact: Jack F Hollis, Ph.D. 503-335-2400 ext 6754 jack.hollis@kpchr.org
Contact: Dan Laferriere, RN, MSN 503-335-2400 ext 6715 dan.laferriere@kpchr.org

Locations
United States, Oregon
Kaiser Permanente Center for Health Research Recruiting
Portland, Oregon, United States, 97227
Contact: Jack F Hollis, Ph.D.     503-335-2400 ext 6754     jack.hollis@kpchr.org    
Principal Investigator: Jack F Hollis, Ph.D            
Sub-Investigator: Jeffrey L Fellows, Ph.D.            
Sub-Investigator: John P Mullooly, Ph.D.            
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact: Edward Lichtenstein, Ph.D.     541-484-2123     ed@ori.org    
Principal Investigator: Edward Lichtenstein, Ph.D.            
Sub-Investigator: Brian G Danaher, Ph.D.            
United States, Washington
Free & Clear, Inc. Recruiting
Seattle, Washington, United States, 98104
Contact: Tim Mcafee, MD, MPH     206-876-2551     Tim.McAfee@freeclear.com    
Contact: Mona Deprey, MS     206-876-2203     Mona.Deprey@freeclear.com    
Principal Investigator: Tim McAfee, MD, MPH            
Sub-Investigator: Terry Bush, Ph.D.            
Sub-Investigator: Susan Zbikowski, Ph.D.            
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Jack F Hollis, Ph.D. Kaiser Permanente
  More Information

Tobacco cessation website for teens  This link exits the ClinicalTrials.gov site

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Study ID Numbers: 5RO1 CA098685-02, NGA: 1RO1 CA98685-01A2
Study First Received: April 4, 2006
Last Updated: April 17, 2007
ClinicalTrials.gov Identifier: NCT00311948  
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on January 15, 2009