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临床试验/NCT01173653
NCT01173653已完成不适用

A Randomized Controlled Trial of Directed Smoking Cessation Intervention in the Emergency Care Population

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
199
试验地点
2
主要终点
Smoking Status at Follow up

研究概览

简要总结

The emergency department (ED) serves a vital and growing role in the US health care system, responsible for both the delivery of emergent medical care and for safety-net care for populations without traditional access to health services. Uninsured populations rely significantly on the safety-net services of the ED. Between 2000-2005 the number of uninsured Americans increased from 39.6 million to 46.1 million, and this growth is expected to continue. Many health policy analysts consider the ED to be an effective place to provide preventative care. Prophylactic tetanus immunization, for example, has been a successful preventive health intervention that has become a standard of care in the ED setting. Brief smoking cessation interventions have been introduced in the ED but have not had great success based on lack of follow-up and continuity.

Our study is novel in that it introduces a brief smoking intervention through use of an established, federally-funded and federally-sponsored cessation counseling resource, the National Smoking Cessation Quit Line, also available at smokefree.gov. This is a joint initiative between the Tobacco Control Research Branch of the National Cancer Institute and the Centers for Disease Control and Prevention. Since ED patients who smoke often lack the ability to use self-help cessation resources, we hypothesize that by introducing this population to the counselors on the National Smoking Cessation Quit Line (also called the 1-800-QUIT-NOW line) during the ED visit via phone, that this new brief intervention would have a realizable and significant effect on smoking cessation among the this population.

详细描述

Smoking is a public health epidemic. Over 20% of adults in the USA smoke according to the American Heart Association. Benefits of smoking cessation are realizable and readily apparent: reductions in the risk of heart, kidney, and lung disease, reduction in the risk of stroke and certain cancers, blood pressure improvement, increased life expectancy, economic benefits, and the positive externality in secondhand smoke reduction are some of the more common benefits cited by public health experts. Smoking remains the leading preventable cause of chronic illness in our country, and, despite the well-publicized benefits, quitting smoking remains difficult. Many smokers do not wish to undergo the negative physiological effects of detoxification from nicotine dependence. Others lack the resources, support and motivation to make this lifestyle change. Providers, moreover, struggle to find a simple, effective intervention that will help their smoking population kick the habit.

Given this background, our research proposal has the following specific aims:

  1. The ED is an effective location within the domestic health system to provide preventive medical care, including counseling on smoking cessation.
  2. A simple intervention where ED patients who were motivated to quit smoking were put in direct phone contact with a trained smoking cessation counselor, during their ED stay, will have a realizable benefit in rates of smoking cessation beyond the placebo rate of cessation.
  3. We hypothesize that smokers who are motivated to quit will react positively to the national quit line and will have a higher rate of cessation at two months time compared to other motivated smokers in the ED department who are not put in immediate contact with a smoking cessation counselor.

A background statistical analysis and literature review has already been conducted. A literature review has been attached for reference (see Appendix A). We have discussed this topic with our biostatistical liaison and we believe such a study can show statistical significance with appropriate power based on a target enrollment of 150 patients.

Following anticipated IRB approval, we expect this study to be ready for enrollment. Mr. Pelster will be the lead enrollee within the Adult Emergency Department and has the full support of the ED faculty and staff for this work. He will be supervised directly by Dr. Benjamin Heavrin, Assistant Professor of Emergency Medicine, who will function as his faculty sponsor through the VUSM emphasis program. All patients presenting to the Adult Emergency Department are asked about smoking status through the triage note. Mr. Pelster will have access to this triage note and will approach patients who meet inclusion criteria. Our inclusion criteria includes: verbally consenting patients of the Adult ED who actively smoke, have normal vital signs, and are not emergency will based on triage criteria. Exclusion criteria includes patients unable to provide consent, unable to verbally communicate, patients with emergent illness defined by ESI triage protocols, patients with unstable vitals, and patients under the age of 18. Mr. Pelster will then approach these patients for possible enrollment. Prior to the beginning of this study, Mr. Pelster will become well read on current smoking statistics and on the medical and health related benefits of smoking cessation, should patient questions arise. He will be supervised in these verbal patient discussions by Dr. Heavrin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years of age and older
  • Patients who are active smokers who present to the Adult ED at VUMC
  • Patients who are able to give informed verbal consent
  • Patients with stable vital signs

排除标准

  • Patients who are unable to provide consent
  • Patients who are unable to communicate verbally as determined by the treating attending physician and/or triage nurse. This includes patients with alterations in mental status, who are cognitively impaired, or are intoxicated or on drugs
  • Patients with abnormal vital signs, and triage ratings (ES1 score 1) suggesting immediate life threatening illness

结局指标

主要结局

Smoking Status at Follow up

时间窗: 6 weeks

Patients enrolled in this study were contacted via phone to assess smoking status. Smoking status was a self-report from each subject. Primary outcome measure is the smoking status of the enrollee at the time of follow-up contact. We calculated the percentage of participants who had stopped smoking at the 6 week follow-up period in each arm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ben Heavrin

Benjamin S. Heavrin, MD, MBA

Vanderbilt University

研究点 (2)

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