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：
9300893
负责人：
Steven L Bernstein
金额：
$ 75.04万
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/9300893
关键词：
Abstinence Accident and Emergency department Acute Adult Affect Aftercare American Behavioral Biochemical 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 Industrialization Injury Intervention Investigation Laceration Lead Litigation Low income Mentally Ill Persons Methodology Methods Modeling Pamphlets Patients Pharmaceutical Preparations Phonation Pilot Projects Policies Population Prevalence 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 Text Time Tobacco Tobacco Dependence Tobacco use Treatment Efficacy United States United States National Institutes of Health Visit Work Wound Healing addiction arm base behavioral pharmacology clinical efficacy cohort cost cost effective cost effectiveness design drug development efficacy testing experience experimental study 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 screening, brief intervention, referral, and treatment smoking cessation symposium therapy design tobacco abstinence trial design

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.

抽象的烟草使用仍然是美国可预防死亡的主要原因。吸烟的人越来越多一种医疗服务不足人群的疾病，包括社会经济地位较低的个人和那些患有行为或物质使用障碍。急诊室 (ED)，美国人向其支付了 130 2013 年就诊人数达 100 万人次，是识别吸烟者、开始治疗和转诊的绝佳临床环境。善后护理。我们之前的工作已经证明了多成分干预在促进戒烟3个月。干预措施包括一整套循证治疗，包括在急诊室开始尼古丁替代疗法、提供 6 周的贴片和口香糖、简短的说明动机访谈、主动转介州吸烟者戒烟热线以及包含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措施的可行性和潜在功效其中包括向受调查者的手机发送短信以促进戒烟。尽管虽然有效，但尚不清楚干预措施的哪些组成部分产生了最大的影响，以及哪些组合治疗可能效果最好，或者适用于所有急诊室。为了设计一个干预措施临床上有效、成本效益高且实用，我们建议理清这些成分的作用并制定一项干预措施，在考虑到成本的情况下，最大限度地提高临床疗效、可行性和可接受性有效性约束和定性分析的结果。我们建议使用的方法是多重优化策略 (MOST)，一种临床试验设计，采用工业界改编的原理工程。我们在 1056 名成年吸烟者的队列中提出了一种创新的 16 臂全因子设计城市急诊科，测试四个关键组成部分的功效：动机访谈、尼古丁启动替代药物、戒烟热线转诊和短信。所有受试者都会收到戒烟手册。在试验完成后，我们将使用一种新颖的混合方法来识别在拟议的成本限制内有效，以及受试者的可行性和可接受性。我们将将临床上有效、具有成本效益且可行/可接受的组件组装成用于在未来随机临床试验中进行测试的多组分包。研究目标 (1) 是进行析因实验；目标（2）是分析试验结果以确定有效成分，目标（3）是奠定为后续临床试验测试这种多成分干预措施与对照的基础健康）状况。多成分干预措施一旦传播和实施，就可以改变对患者的护理前往美国急诊室就诊的数千万烟民我们的团队包括一批杰出的专家在试验设计方面拥有丰富的经验，包括 MOST 的开发人员、基于急诊科的调查、烟草依赖治疗、短信、健康经济学和定性方法。