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

2012年9月27日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

600

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 至 18年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Telephone counseling + interactive website
Teen has access to interactive website and receives tailored telephone counseling
其他:Control with interactive website
Teen only has access to interactive website.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up.
大体时间: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
大体时间:12-months
Self report smoking or not smoking.
12-months

次要结果测量

结果测量
措施说明
大体时间
A six-month assessment to determine short-term effects
大体时间:6 months
6 months
Assess the prevalence of smoking on 25 or more days per month
大体时间:1 month
1 month
Assess sustained abstinence (e.g., three and six months) at each follow-up,
大体时间: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
大体时间: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.
大体时间: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
大体时间:1 day
1 day
Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement
大体时间:12 months
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jack F Hollis, Ph.D.、Kaiser Permanente

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年3月1日

初级完成 (实际的)

2010年4月1日

研究完成 (实际的)

2010年4月1日

研究注册日期

首次提交

2006年4月4日

首先提交符合 QC 标准的

2006年4月4日

首次发布 (估计)

2006年4月6日

研究记录更新

最后更新发布 (估计)

2012年9月28日

上次提交的符合 QC 标准的更新

2012年9月27日

最后验证

2006年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 5R01CA098685-02 (美国 NIH 拨款/合同)
  • 1R01CA098685-01A2 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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