Optimizing Tobacco Dependence Treatment in the Emergency Department

优化急诊科的烟草依赖治疗

• 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
• 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

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.

摘要 烟草使用仍然是美国可预防死亡的主要原因。吸烟越来越多 一种医疗服务不足人群的疾病，包括社会经济地位较低的人和那些 行为或物质使用障碍急诊室（ED），美国人支付130美元 在2013年的100万次访问中，是识别吸烟者，开始治疗和转诊的绝佳临床环境。 善后我们以前的工作已经证明了多组分干预在促进 戒烟3个月干预措施包括一整套循证治疗， 包括在艾德开始尼古丁替代治疗，提供6周的贴剂和口香糖， 动机访谈，积极转介到国家吸烟者戒烟热线，以及一本关于健康信息的小册子 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 其中包括向受试者的手机发送短信，以促进戒烟。而 有效，目前尚不清楚干预措施的哪些组成部分产生了最大的影响，哪些组合 治疗可能效果最好，或可推广到所有ED。为了设计一种干预措施， 临床有效，成本效益，和实用，我们建议解开这些组件的影响 并在给定成本的情况下，组合一种最大化临床疗效、可行性和可接受性的干预措施- 有效性限制和定性分析结果。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，使用工业应用中的原则 工程.我们提出了一个创新的16臂全因子设计，在一个队列中的1056名成年吸烟者， 城市艾德，以测试四个关键组成部分的功效：动机访谈，开始尼古丁 替代药物戒烟热线和短信所有受试者都将收到戒烟手册。在 试验完成后，我们将使用一种新的混合方法来确定 在建议的成本限制内有效，沿着受试者的可行性和可接受性。我们将 将临床上有效、成本效益高且可行/可接受的组件组装成 多组分包装，用于未来随机临床试验的测试。研究目的（1）是进行 析因实验，目的（2）是分析试验结果，以确定有效成分，目的（3）是奠定 为随后的临床试验测试这种多组分干预，与对照的基础 条件多方面的干预措施一旦得到传播和实施， 去美国急诊室的数千万烟民我们的团队包括一批杰出的专家， 在试验设计方面有丰富的经验，包括MOST的开发者，基于应急部门的调查， 烟草依赖治疗，短信，卫生经济学和定性方法。