Optimizing Tobacco Dependence Treatment in the Emergency Department

优化急诊科的烟草依赖治疗

• 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
• 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

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的死亡的主要原因。吸烟的人越来越多 一种医疗服务不足的人群的疾病，包括社会经济地位较低的个人和 有行为或药物使用障碍。急诊部(ED)，美国人向其支付了130 2013年的100万人次就诊，是识别吸烟者、启动治疗和参考 善后护理。我们之前的工作已经证明了多组分干预在促进 3个月后戒烟。干预措施包括一整套循证治疗， 包括在ED启动尼古丁替代疗法，提供6周的贴片和口香糖，简短的 励志访谈，主动推荐一个州吸烟者戒烟热线，以及一本关于健康信息的小册子 吸烟的风险。随后的一项初步研究证明了干预的可行性和潜在效果。 这包括向受试者手机发送短信(SMS)，以促进戒烟。而当 有效，目前还不清楚干预的哪些组成部分影响最大，哪些组合 治疗可能效果最好，或者可以推广到所有的急诊室。为了设计一种干预措施，即 从临床效果、成本效益和可行性来看，我们建议将这些成分的影响分开。 并在给定成本的情况下，组装最大限度地提高临床疗效、可行性和可接受性的干预措施- 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，其原理改编自工业 工程学。我们在1056名成年吸烟者中提出了一种创新的16臂全因子设计 城市ED，测试四个关键组成部分的有效性：励志访谈，尼古丁的启动 替代药物，戒烟转介和发短信。所有受试者都将收到一本戒烟手册。在… 试验完成后，我们将使用一种新的混合方法来识别 在拟议的成本限制内有效，以及对受试者的可行性和可接受性。我们会 将临床上有效、经济、可行/可接受的部件组装成 用于在未来的随机临床试验中测试的多组分包装。研究目的(1)是进行 析因试验；目的(2)是分析试验结果以确定有效成分，目的(3)是为了 为随后的临床试验测试这种多组分干预与对照奠定了基础 条件。多成分干预一旦传播和实施，可以改变对儿童的护理 数以千万计的烟民访问美国爱丁堡。我们的团队包括一批杰出的专家，他们 在试验设计方面有丰富的经验，包括MOST、基于急诊部门的调查的开发人员， 烟草依赖治疗、短信、健康经济学和定性方法。