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临床试验/NCT00366977
NCT00366977已完成3 期

Efficacy and Cost of State Quitline Policies

Kaiser Permanente6 个研究点 分布在 1 个国家目标入组 4,614 人开始时间: 2000年6月最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
4,614
试验地点
6
主要终点
Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.

研究概览

简要总结

State-sponsored anti-tobacco campaigns are motivating large numbers of smokers to seek advice, assistance, and support to make their cessation efforts more successful. Like many states, Oregon has sponsored the implementation of a statewide telephone quitline to provide information, referrals, and cessation support for callers. This study will answer key policy questions about how to most effectively support smokers who call the Oregon Quitline for assistance. The specific aims are to recruit 4,500 callers to participate in a 3 x 2 randomized trial comparing the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies on the availability of nicotine patch therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking status, quit attempts, and use of health plan anc community cessation services. Costs will be assessed separately from the perspectives of the patients, health plans, the State (i.e., Oregon Quitline), and society. Cost per quit and cost per year quality-adjusted years of life saved will be calculated from each of these perspectives.

详细描述

Anti-tobacco media campaigns in many states are motivating large numbers of smokers to seek advice, assistance, and support to make their cessation efforts more successful. Like many other states, Oregon has sponsored the implementation of a statewide telephone quitline to provide information, referrals, and cessation support for callers. Two investigators on this proposal (Hollis and McAfee) have a contract with the State of Oregon to provide the Oregon Quitline (OQL) services. The purpose of the proposed research effort is to collaborate further with State representatives to answer key policy questions about how to most effectively support smokers who call the OQL for assistance.

Our overall aim is to recruit 4,500 callers to the OQL to participate in a 3 x 2 randomized trial to compare the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies regarding the availability of nicotine patch therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking status, quit attempts, and use of health plan and community cessation services. Costs will be assessed separately from the perspective of the patients, health plan, the State (i.e., OQL), and society. The specific aims are described below:

  1. Compare the efficacy of three policies for supporting OQL callers:
  • Brief counseling with referral to caller's health plan cessation services (standard service);
  • Moderate counseling, referral to health plan, and one follow-up call to reinforce use of health plan services;
  • Moderate counseling, referral, and availability a multi-session telephonic intervention.
  1. Compare the efficacy of two policies regarding the provision of nicotine replacement:
  • No offer of nicotine replacement (current policy);
  • An offer of free nicotine replacement patches.
  1. Determine the costs and cost per quit of the additional policy interventions relative to usual care (i.e., standard service) from the following perspectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Speak English or Spanish
  • Oregon resident
  • Smoke 5 or more cigarettes/day
  • Planning to quit within 30 days (or quit within in last 7 days)
  • Consent to random assignment and follow-up

排除标准

  • Health plan benefit includes free multi-session telephone counseling
  • Current or planned pregnancy or breast-feeding
  • Heart attack within the preceding month.

结局指标

主要结局

Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.

次要结局

  • Participant self-reported (at 6 and 12 months) any tobacco use by type
  • amount used per day
  • stage of change
  • number of quit attempts
  • use of health plan and community cessation resources
  • intervention total cost, cost per participant, and cost per quit
  • incremental cost effectiveness ratios for each intervention compared to baseline
  • patterns of pharmacotherapy use
  • out-of-pocket expenses for cessation activities.

研究者

申办方类型
Other

研究点 (6)

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