A Comparative Effectiveness RCT of Optimized Cessation Treatments

在美国和大多数吸烟者中，烟草使用是癌症和过早死亡的主要可预防原因 每年访问一次医疗机构，提供无与伦比的干预机会。然而，大多数吸烟者 在医疗保健就诊期间没有接受高效的吸烟治疗。以进一步有效 吸烟治疗在医疗保健，本项目将进行比较有效性随机临床 一项试验，比较了两种有前途的实验性戒烟治疗方法， 常规护理这两种实验性治疗方法都是基于创新的方法：它们的成分都有 在先前的实验中产生了强烈的累加或交互作用，它们被设计成慢性疾病的一部分。 针对吸烟治疗阶段特定挑战的护理方法（准备时遇到） 戒烟，戒烟，保持禁欲），他们被设计，并在医疗保健中进行测试， 设置.来自初级保健诊所想要戒烟的吸烟者（N=1200）将被随机分配至 接受以下三种治疗之一：1）禁欲优化治疗（最大限度地提高戒烟成功率）： prequit尼古丁口香糖，26周的尼古丁贴片+尼古丁口香糖组合，密集的面对面咨询， 和长期电话咨询; 2）成本优化治疗（以最大限度地提高戒烟率的总成本 <500美元）：8周的尼古丁贴片+尼古丁口香糖组合，密集的面对面咨询， 电话咨询;或3）产后护理（根据2008年公共卫生服务指南戒烟 治疗）：8周尼古丁贴片，一次面对面和两次电话咨询。治疗将 在关键临床上进行比较（例如，复发的潜伏期）和保健系统（例如，净货币收益） 结果，并认为产生其效果的机制。这项研究将首次评估 吸烟的治疗是系统开发的，并将确定其比较 有效性和成本效益在现实世界的设置。结果将用于构建慢性护理 治疗吸烟。这项拟议中的研究可能会将治疗烟草使用的范式转变为慢性吸烟。 通过验证新的治疗开发方法，改进护理模式和先进的干预科学。

Tobacco use is the primary preventable cause of cancer and premature death in the US and most smokers visit a healthcare setting each year, providing an unequaled opportunity to intervene. Yet, most smokers do not receive highly effective smoking treatment during their healthcare visits. To improve the effectiveness of smoking treatment in healthcare, this project will conduct a comparative effectiveness randomized clinical trial that compares two promising experimental smoking cessation treatments with one another and with usual care. The two experimental treatments are based on innovative methods: their components have all produced strong additive or interactive effects in prior experiments, they are designed to be part of a chronic care approach that addresses phase-specific challenges of smoking treatment (encountered when preparing to quit, quitting, and maintaining abstinence), and they were engineered for, and tested in, healthcare settings. Smokers (N=1200) from primary care clinics, who want to quit smoking, will be randomized to receive one of three treatments: 1) Abstinence-Optimized Treatment (to maximize cessation success): prequit nicotine gum, 26 weeks of combination nicotine patch + nicotine gum, intensive in-person counseling, and long-term phone counseling; 2) Cost-Optimized Treatment (to maximize abstinence rates for a total cost < $500): 8 weeks of combination nicotine patch + nicotine gum, intensive in-person counseling, and long-term phone counseling; or 3) Usual Care (based on the 2008 Public Health Service Guideline for cessation treatment): 8 weeks of nicotine patch, one in-person and two phone counseling sessions. Treatments will be compared on key clinical (e.g., latency to relapse) and healthcare system (e.g., net monetary benefit) outcomes, and on mechanisms thought to produce their effects. This research will, for the first time, evaluate treatments for smoking that were developed systematically and will determine their comparative effectiveness and cost-effectiveness in real-world settings. Results will be used to construct a chronic care treatment for smoking. The proposed research could shift the paradigm for treating tobacco use to a chronic care model and advance intervention science by validating new treatment development methods.