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

September 27, 2012 updated by: Kaiser Permanente
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research
    • Washington
      • Seattle, Washington, United States, 98104
        • Free & Clear, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Other: Control with interactive website
Teen only has access to interactive website.
Behavioral: Behavioral: interactive website

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months and 12 months
12-month measure to determine long-term assessment
Time Frame: 12-months
Self report smoking or not smoking.
12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A six-month assessment to determine short-term effects
Time Frame: 6 months
6 months
Assess the prevalence of smoking on 25 or more days per month
Time Frame: 1 month
1 month
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
3 months and 6 months
Assess change in stage of change
Time Frame: 6 months and 12 months
6 months and 12 months
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
30 days, 6 months, 12 months
Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach
Time Frame: 1 day
1 day
Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jack F Hollis, Ph.D., Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

September 28, 2012

Last Update Submitted That Met QC Criteria

September 27, 2012

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5R01CA098685-02 (U.S. NIH Grant/Contract)
  • 1R01CA098685-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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