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 每年访问医疗保健机构，提供无与伦比的干预机会。然而，大多数吸烟者都这样做 在就诊期间没有接受高效的吸烟治疗。提高……的有效性 吸烟在医疗保健中的治疗，本项目将进行随机对照临床疗效研究 这项试验将两种有希望的实验性戒烟疗法相互比较，并与 照常照看。这两种实验疗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相加或交互效应，它们被设计为慢性 应对吸烟治疗阶段特定挑战的护理方法(在准备过程中遇到 戒烟、戒烟和保持禁欲)，它们是为医疗保健设计的，并在医疗保健中进行了测试 设置。来自初级保健诊所的想要戒烟的吸烟者(N=1200)将被随机分配到 接受以下三种治疗方法之一：1)禁欲优化治疗(以最大限度地提高戒烟成功率)： 戒烟前的尼古丁口香糖，26周的尼古丁贴片+尼古丁口香糖，密集的面对面咨询， 和长期电话咨询；2)成本优化治疗(以总成本最大限度地提高禁酒率 500美元)：8周的尼古丁贴片+尼古丁口香糖，密集的面对面咨询，以及长期的 电话咨询；或3)常规护理(基于2008年公共卫生服务戒烟指南 治疗)：8周的尼古丁贴片，一次面对面和两次电话咨询。治疗将是 比较关键临床(例如，复发的潜伏期)和医疗保健系统(例如，净货币收益) 结果，以及被认为产生其影响的机制。这项研究将第一次评估 吸烟的治疗方法是系统地开发的，并将确定它们的比较 在现实世界环境中的有效性和成本效益。结果将被用来构建慢性护理 对吸烟的治疗。这项拟议的研究可能会将治疗烟草使用的范式转变为慢性 通过验证新的治疗开发方法，建立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.