Trial Information

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

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.

All patients will be asked for voluntary, verbal informed consent. Should consent not be
given, or should consent not be able to be obtained, a patient will not be included in this
study. Given that no harm could come from this intervention in the ED, and given that the
"intervention" is simply a verbal discussion on the motivation to quit smoking and a
telephone conversation with a 1-800-QUIT-NOW professional, we believe that verbal consent
would be acceptable. Patients who consent to the study will be given a letter that briefly
explains the purpose of the clinical trial (see Appendix B).

Basic demographic data related to age, gender, race, smoking history, and contact
information of the patient will be collected and stored on a secure electronic device as
described below. Upon conclusion of enrollment, data analysis will begin using statistical
software such as SPSS available through the Department of Emergency Medicine, Division of
Research.

Although our investigative team does not have experience in smoking cessation research,
plenty of evidence exists within the medical literature to suggest that studies on smoking
cessation are simple in design, context, and data acquisition and that patients respond
positively to preventive health interventions. Our investigative team will be working under
the Division of Research, Department of Emergency Medicine, Vanderbilt University Medical
Center. This department has plentiful resources to conduct this simple investigation,
including biostatistical support, dedicated clinical trials associates, and a culture of
rigorous and supportive academic investigation within the clinical wings of the department.

We expect no negative impact of this investigating on clinical care, the timeliness of care,
or the disposition and treatment of the patients enrolled.

A literature search has been conducted and is included. Per our review, we do not believe
that research into the utilization of the 1-800-QUIT-NOW line has occurred in an Adult ED
population. Should our research prove our hypothesis, this would provide a simple
intervention that would have large-scale positive public health ramifications for the ED
smoking population.