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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00311948
First received: April 4, 2006
Last updated: September 27, 2012
Last verified: September 2006
  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
Behavioral: Behavioral: interactive website
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Telephone and Web-based Teen Tobacco Cessation in HMOs

Resource links provided by NLM:


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. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    self report of smoking in last 30 days

  • 12-month measure to determine long-term assessment [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    Self report smoking or not smoking.


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

  • Assess change in stage of change [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: March 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
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
Investigators
Principal Investigator: Jack F Hollis, Ph.D. Kaiser Permanente
  More Information

Publications:
Bernard HR, Ryan GW. Text analysis: Qualitative and Quantitative Methods. In Handbook of Methods in Cultural Anthropology. Walnut Creek, CA: AltaMira Press; 1998
Burton D. Tobacco cessation programs for adolescents. In: Richmond R, editor. Interventions for Smokers, an International Perspective. Baltimore, MD: Williams & Wilkins; 1994. p. 95-105.
Cannell M. Generation Online: Internet use of teenagers. Science World 1999;55(9):5
Digiusto E. Pros and cons of cessation interventions for adolescent smokers at school. In R Richmond (ed). Interventions for smokers: An international perspective. Baltimore: MD: Williams & Wilkins;107 136, 1994.
Drummond MF, O'Brien B, Stoddart GL, Torrance GW. Methods for the Economic Evaluation of Health Care Programmes. 2nd Edition. Oxford: Oxford University Press, 1997.
Fleiss JL. Statistical methods for rates and proportions. Second Ed. New York: John Wiley & Sons; 1981.
Glasgow RE, Eakin EG. Medical office-based interventions. In: Snoek FJ, Skinner CS., Eds. Psychological Aspects of Diabetes Care. New York: John Wiley and Sons; 2000
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-Effectiveness in Health and Medicine. New York: Oxford University Press, 1996.
Hollis JF, Vogt TM, Stevens VJ, Biglan A, Severson H, Lichtenstein E. The Tobacco Reduction and Cancer Control (TRACC) Program: Team approaches to counseling in medical and dental settings. In US Department of Health and Human Services, Tobacco and the Clinician: Interventions for Medical and Dental Practice, pp. 143 185. Smoking and Tobacco Control: Monograph 5. US Department of Health and Human Services, Public Health Service, National Institutes of Health. NIH Publication No. 94 3693, January 1994.
Lynch BS, Bonnie RJ (eds). Growing Up Tobacco Free: Preventing Nicotine Addiction in Children and Youths. Committee on Preventing Nicotine Addiction in Children and Youths, Institute of Medicine; 1994.
Miller WL, Crabtree BF. Clinical research. In: Handbook of Qualitative Research. NK Denzin & YS Lincoln (eds.) Thousand Oaks, CA: Sage Publications; 1994.
Miller WR, Rollnick S. Motivational Interviewing: Preparing People to Change Addictive Behavior. New York: The Guilford Press; 1991.
Morgan DL, ed. The Focus Group Guidebook. Thousand Oaks, CA: Sage; 1998.
Nichter M, Vuckovic N, Parker S. The looking good, feeling good program: A multi-ethnic intervention for healthy body image, nutrition and physical activity. In Preventing Eating Disorders: A Handbook of Intervention and Special Challenges. E Piran, MP Levine and C Steiner-Adair, eds. Philadelphia: Brunner-Mozel; 1999, 173-93.
Oregon Youth Risk Behavior Survey. Health Division, Oregon Department of Human Resources. Portland, Oregon, Dec. 1993.
Roberts DF, Foehr UB, Rideout VJ, Brodie M. Kids, Media @ The New Millennium. A Kaiser Family Foundation Report, November; 1999.
SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine & Tobacco Research 2002; 4:149-159.

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00311948     History of Changes
Other Study ID Numbers: 5RO1 CA098685-02, 1R01CA098685-01A2
Study First Received: April 4, 2006
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014