A Comparative Effectiveness RCT of Optimized Cessation Treatments

优化戒烟治疗的比较有效性随机对照试验

基本信息

批准号：
9335281
负责人：
Megan E Piper
金额：
$ 7.26万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9335281
关键词：
Abstinence Address Adherence Annual Reports Cessation of life Chronic Care Chronic Disease Clinic Clinical Clinical Practice Guideline Clinical Treatment Counseling Disease Effectiveness Engineering Fostering Goals Guidelines Health Care Visit Healthcare Healthcare Systems Human Intervention Knowledge Lead Malignant Neoplasms Methodology Methods Outcome Patient Care Patients Persons Phase Phonation Preparation Preventable cancer cause Price Primary Health Care Randomized Randomized Clinical Trials Recovery Relapse Research Research Methodology Research Project Grants Science Smoker Smoking Telephone Testing Time Tobacco Tobacco Dependence Tobacco use Translating Treatment Cost United States Public Health Service Visit Withholding Treatment Work base cancer type chronic care model comparative effectiveness cost cost effective cost effectiveness design economic cost effective therapy effectiveness trial experimental study improved incremental cost-effectiveness innovation method development nicotine gum nicotine patch premature prevent programs reduce tobacco use relative effectiveness screening secondary analysis smoking cessation smoking intervention success theories therapy development treatment as usual trial comparing

项目摘要

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.

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机构，提供无与伦比的干预机会。然而，大多数吸烟者确实在就诊期间未接受高效的吸烟治疗。为了提高效率医疗保健中的吸烟治疗，该项目将进行一项效果比较随机临床一项试验比较了两种有希望的实验性戒烟治疗方法平时的护理。这两种实验治疗方法均基于创新方法：其成分均具有在之前的实验中产生了强烈的附加或交互作用，它们被设计为慢性的一部分解决吸烟治疗阶段特定挑战的护理方法（在准备时遇到）戒烟、戒烟和保持节制），它们是为医疗保健而设计并进行测试的设置。来自初级保健诊所、想要戒烟的吸烟者 (N=1200) 将被随机分配到接受三种治疗之一： 1) 戒烟优化治疗（以最大限度地提高戒烟成功率）：戒烟前尼古丁口香糖、26 周尼古丁贴片 + 尼古丁口香糖组合、密集的面对面咨询、以及长期电话咨询； 2) 成本优化治疗（以总成本最大化戒断率） < 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，以及长期电话咨询；或 3) 常规护理（根据 2008 年公共卫生服务戒烟指南治疗）：8 周的尼古丁贴片，1 次面对面咨询和 2 次电话咨询。治疗将是比较关键临床（例如，复发潜伏期）和医疗保健系统（例如，净货币效益）结果，以及被认为产生其影响的机制。这项研究将首次评估系统开发的吸烟治疗方法将确定其比较现实环境中的有效性和成本效益。结果将用于构建长期护理吸烟的治疗。拟议的研究可能会将治疗烟草使用的范式转变为慢性治疗通过验证新的治疗开发方法，护理模式和推进干预科学。