Telephone and Web-based Teen Tobacco Cessation in HMOs (QWIThelper)
研究概览
地位
条件
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:
- 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
- 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
- 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
- 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)
- 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
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Oregon
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Eugene、Oregon、美国、97403
- Oregon Research Institute
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Portland、Oregon、美国、97227
- Kaiser Permanente Center for Health Research
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Washington
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Seattle、Washington、美国、98104
- Free & Clear, Inc.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
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其他:Control with interactive website
Teen only has access to interactive website.
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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
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self report of smoking in last 30 days
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6 months and 12 months
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12-month measure to determine long-term assessment
大体时间:12-months
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Self report smoking or not smoking.
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12-months
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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
|
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Assess the prevalence of smoking on 25 or more days per month
大体时间:1 month
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1 month
|
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Assess sustained abstinence (e.g., three and six months) at each follow-up,
大体时间:3 months and 6 months
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No smoking - yes or no at 3 month timeframe and 6 months timeframe
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3 months and 6 months
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Assess change in stage of change
大体时间:6 months and 12 months
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6 months and 12 months
|
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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
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30 days, 6 months, 12 months
|
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Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach
大体时间:1 day
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1 day
|
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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
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
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研究记录日期
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初级完成 (实际的)
研究完成 (实际的)
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首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
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其他研究编号
- 5R01CA098685-02 (美国 NIH 拨款/合同)
- 1R01CA098685-01A2 (美国 NIH 拨款/合同)
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