Optimizing Tobacco Dependence Treatment in the Emergency Department

优化急诊科的烟草依赖治疗

基本信息

批准号：
9173355
负责人：
Steven L Bernstein
金额：
$ 65.47万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-07-01 至 2020-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9173355
关键词：
Abstinence Accident and Emergency department Acute Adult Affect Aftercare American Behavioral Budgets Caring Cessation of life Clinical Clinical Trials Clinical Trials Design Combined Modality Therapy Counseling Development Direct Costs Disease Education Emergency Department patient Emergency department visit Engineering Enrollment Evidence based treatment Facilities and Administrative Costs Fracture Future General Population Goals Health Healthy People 2020 Hospitals Individual Injury Intervention Investigation Laceration Lead Litigation Low income Mentally Ill Persons Methodology Methods Modeling Pamphlets Patients Pharmaceutical Preparations Pilot Projects Policies Population Primary Health Care Process Qualitative Methods Randomized Clinical Trials Regulation Reporting Research Resources Risk Science Services Site Smoke Smoker Smoking Substance Use Disorder Surgeon Telephone Testing Time Tobacco Tobacco Dependence Tobacco use Treatment Efficacy United States United States National Institutes of Health Visit Work abstracting addiction arm base clinical efficacy cohort cost cost effective cost effectiveness design drug development efficacy testing experience health economics innovation low socioeconomic status medically underserved population motivational enhancement therapy multi-component intervention nicotine gum nicotine patch nicotine replacement novel programs public health relevance quitline randomized trial research study screening, brief intervention, referral, and treatment smoking cessation symposium therapy design tobacco abstinence trial design wound

项目摘要

Abstract Tobacco use remains the leading cause of preventable death in the United States. Smoking is increasingly a disease of medically underserved populations, including individuals of lower socioeconomic status and those with behavioral or substance use disorders. Emergency departments (EDs), to which Americans paid 130 million visits in 2013, are excellent clinical settings in which to identify smokers, initiate treatment, and refer for aftercare. Our previous work has demonstrated the efficacy of a multicomponent intervention in promoting tobacco abstinence at 3 months. The intervention included a full package of evidence-based treatments, including initiation of nicotine replacement therapy in the ED, provision of 6 weeks of patches and gum, a brief motivational interview, active referral to a state smokers' quitline, and a brochure with information on the health risks of smoking. A subsequent pilot study demonstrated the feasibility and potential efficacy of an intervention that included short-message-service (SMS) texting to subject cellphones to promote tobacco abstinence. While efficacious, it is not clear which components of the intervention had the greatest impact, which combinations of therapy might work best, or which are generalizable to all EDs. In order to design an intervention that is clinically effective, cost-effective, and practicable, we propose to disentangle the effects of these components and assemble an intervention that maximizes clinical efficacy, feasibility, and acceptability, given a cost- effectiveness constraint and findings from qualitative analysis. The methodology we propose using is the Multiple Optimization Strategy (MOST), a clinical trials design that uses principles adapted from industrial engineering. We propose an innovative 16-arm full-factorial design in a cohort of 1056 adult smokers in an urban ED, to test the efficacy of four key components: motivational interviewing, initiation of nicotine replacement medication, quitline referral, and texting. All subjects will receive a smoking cessation brochure. At the trial's completion, we will use a novel mixed-methods approach to identify components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to subjects. We will assemble components found to be clinically efficacious, cost-effective, and feasible/acceptable into a multicomponent package for testing in a future randomized clinical trial. Study Aim (1) is to conduct the factorial experiment; Aim (2) is to analyze trial results to identify the effective components, and Aim (3) is to lay the groundwork for the subsequent clinical trial testing this multicomponent intervention, versus a control condition. The multicomponent intervention, once disseminated and implemented, can transform the care of the tens of millions of smokers who visit U.S. EDs. Our team includes an outstanding array of experts with deep experience in trial design, including the developer of MOST, emergency department-based investigation, tobacco dependence treatment, texting, health economics, and qualitative methods.

抽象的在美国，烟草使用仍然是可预防死亡的主要原因。吸烟越来越多一种医疗服务不足的人群，包括较低的社会经济地位的人和那些人的疾病使用行为或物质使用障碍。急诊部（ED），美国人支付了130 2013年数百万次访问是出色的临床环境，可以在其中识别吸烟者，启动治疗并参考护理。我们以前的工作证明了多组分干预措施促进的功效 3个月的烟草禁欲。干预措施包括一套完整的基于证据的治疗方法，包括在ED中启动尼古丁替代疗法，提供6周的斑块和口香糖，简短励志面试，积极地转介到州吸烟者的戒烟线以及有关健康信息的小册子吸烟的风险。随后的试点研究证明了干预的可行性和潜在功效其中包括短信服务（SMS）发短信给主题手机以促进戒烟。尽管有效，尚不清楚干预的哪些组成部分具有最大的影响，哪些组合治疗可能最有效，或者可以推广到所有ED。为了设计一种干预措施临床上有效，具有成本效益且可行，我们建议解散这些组件的影响并组装一项干预措施，以最大化临床功效，可行性和可接受性，鉴于成本定性分析的有效性约束和发现。我们建议使用的方法是多重优化策略（大多数），这是一种临床试验设计，该设计使用了工业改编的原理工程。我们在1056名成年吸烟者的队列中提出了创新的16臂全能设计城市ED，测试四个关键组成部分的功效：动机访谈，尼古丁的启动替代药物，Quitline转诊和发短信。所有受试者都将获得戒烟小册子。在试验的完成，我们将使用一种新颖的混合方法方法来识别组件在拟议的成本限制中有效，以及对受试者的可行性和可接受性。我们将组装组件发现临床上有效，具有成本效益且可行/可接受在未来的随机临床试验中进行测试的多组分软件包。研究目的（1）是进行阶乘实验；目的（2）是分析试验结果以识别有效的组件，而目标（3）则是随后的临床试验测试这种多组分干预的基础，而不是对照健康）状况。一旦传播和实施，多组分干预措施可以改变访问美国EDS的数千万吸烟者。我们的团队包括一系列出色的专家试验设计的深刻经验，包括大多数基于急诊室调查的开发人员，烟草依赖治疗，发短信，健康经济学和定性方法。