此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Treating Low-Income Smokers in the Hospital Emergency Department

2014年7月8日 更新者:Steven Bernstein、Yale University

This study will test the effectiveness of an Emergency Department (ED) initiated tobacco intervention which includes counseling and medication. Our proposed intervention combines a Brief Negotiated Interview (BNI) with initiation of nicotine patch and gum in the ED, as well as a faxed referral to the state's Smokers' Quitline. A 6 week supply of nicotine patches and nicotine gum are provided to subjects in the intervention arm. Subjects randomized to the control arm will receive a brochure from the state's Smokers' Quitline only.

The primary hypothesis is that the intervention will be superior to the control condition in reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months.

研究概览

详细说明

Of the nation's 45 million adult smokers, nearly 20 million visit hospital emergency departments (EDs) each year. ED patients, particularly smokers, are disproportionately low-income, with limited access to traditional primary care settings. Patients presenting to the ED with a tobacco-related trigger event, like an asthma attack, may be experiencing a "teachable moment." Thus, the ED may be an ideal location in which to identify smokers and initiate treatment for tobacco dependence. Initial pilot research by our group has demonstrated the feasibility of ED-based brief interventions for smokers. Based on our feasibility studies, the Institute of Medicine 2006 report on tobacco and the 2008 US Public Health Service guidelines now list EDs as appropriate loci for tobacco control efforts. This study aims to test the efficacy of an ED-initiated tobacco intervention which includes counseling and medication. The intervention-Screening, Brief Intervention, and Referral to Treatment (SBIRT)-uses a form of motivational interviewing known as the Brief Negotiation Interview (BNI). Our proposed intervention combines a BNI with initiation of nicotine replacement therapy (NRT) and a fax referral to the state Smokers' Quitline during the ED visit. A 6-week starter kit of NRT (patch and/or gum, tailored to level of addiction and patient preference) will be provided with written materials. The initial dose of NRT will be given in the ED. A trained nurse will administer the booster intervention via telephone 3 days post-visit. The SBIRT+NRT arm will be compared to standard care (SC), which consists of written materials only, in a controlled trial of 778 smokers age 18 years or older randomized in a 1:1 fashion.

The primary hypothesis is that SBIRT+NRT will be superior to SC in reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months. Secondary hypotheses include: (1) Patients with a tobacco related diagnosis for the ED visit will have a higher cessation rate than patients without a tobacco related diagnosis, and (2) Patients who believe their ED visit is smoking-related will have a higher quit rate than others. The investigators will conduct a cost benefit analysis of the interventions. Follow-up assessments at 1, 3 and 12 months will combine self-report with in-person carbon monoxide testing at 3 months for smokers who assert abstinence via phone. Expansions of the proposed project as compared to earlier studies include: 1) initiation of NRT during the ED visit; 2) provision of multiple forms of NRT; 3) a proactive referral made to the Quitline; 4)a credible control condition with minimal baseline assessment, to avoid the assessment reactivity seen in similar ED studies; and 5) an economic analysis of the tested interventions.

研究类型

介入性

注册 (实际的)

780

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age > 18 years
  • Speaks English
  • Willing and able to give informed consent
  • >100 cigarettes lifetime
  • Current daily or some day smoker
  • Smokes > 5 cigarettes/day
  • Medicaid or self-pay insurance

Exclusion Criteria:

  • Too ill or unable to consent
  • Not interested in study participation
  • Not interested in quitting
  • Pregnant, nursing, or trying to conceive
  • Current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette)
  • Actively psychotic or mentally ill
  • Leaving ED against medical advice
  • Investigator discretion
  • Lives outside of New Haven County
  • Does not have phone with CT area code
  • In police custody
  • History of allergic reaction to nicotine replacement products
  • Currently receiving formal tobacco dependence tx
  • Currently taking Zyban, Wellbutrin (bupropion) or Chantix(varenicline)
  • Resides in an extended care facility

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
无干预:Standard Care
Subjects receive a brochure for the state's Smokers' Quitline only.
实验性的:SBIRT+NRT
Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Biochemical Verification of Tobacco Abstinence
大体时间:3 months after enrollment
Biochemical verification means a breathalyzer reading for carbon monoxide.
3 months after enrollment
Self-report of Tobacco Abstinence or Reduction
大体时间:3 months
Questionnaires to assess self reported tobacco abstinence
3 months

次要结果测量

结果测量
措施说明
大体时间
Self-reported Tobacco Reduction or Abstinence
大体时间:1 month post enrollment
self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.
1 month post enrollment
Health Care Service Utilization
大体时间:1 month post enrollment
A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
1 month post enrollment
Self-reported Tobacco Reduction or Abstinence
大体时间:12 months post enrollment
self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.
12 months post enrollment
Health Care Service Utilization
大体时间:3 months post enrollment
A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
3 months post enrollment
Health Care Service Utilization
大体时间:12 months post enrollment
A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
12 months post enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Steven L. Bernstein, MD、Yale University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年10月1日

初级完成 (实际的)

2013年4月1日

研究完成 (实际的)

2014年1月1日

研究注册日期

首次提交

2011年3月30日

首先提交符合 QC 标准的

2011年3月31日

首次发布 (估计)

2011年4月4日

研究记录更新

最后更新发布 (估计)

2014年8月4日

上次提交的符合 QC 标准的更新

2014年7月8日

最后验证

2014年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 0907005437
  • R01CA141479 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅