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临床试验/NCT00311948
NCT00311948已完成3 期

Telephone and Web-based Teen Tobacco Cessation in HMOs

Kaiser Permanente6 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
600
试验地点
6
主要终点
Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up.

时间窗: 6 months and 12 months

self report of smoking in last 30 days

12-month measure to determine long-term assessment

时间窗: 12-months

Self report smoking or not smoking.

次要结局

  • A six-month assessment to determine short-term effects(6 months)
  • Assess the prevalence of smoking on 25 or more days per month(1 month)
  • Assess sustained abstinence (e.g., three and six months) at each follow-up,(3 months and 6 months)
  • Assess change in stage of change(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.(30 days, 6 months, 12 months)
  • Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach(1 day)
  • Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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