Smoking Cessation Invention in the Emergency Department (ED)
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|ClinicalTrials.gov Identifier: NCT01173653|
Recruitment Status : Completed
First Posted : August 2, 2010
Results First Posted : November 19, 2012
Last Update Posted : December 27, 2012
|First Submitted Date ICMJE||July 29, 2010|
|First Posted Date ICMJE||August 2, 2010|
|Results First Submitted Date||January 9, 2012|
|Results First Posted Date||November 19, 2012|
|Last Update Posted Date||December 27, 2012|
|Study Start Date ICMJE||July 2010|
|Actual Primary Completion Date||October 2010 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Smoking Status at Follow up [ Time Frame: 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
|Original Primary Outcome Measures ICMJE
||To determine if the ED is an effective location within the domestic health system to provide preventative medical care, including counseling on smoking cessation [ Time Frame: 1 year ]
This is a simple intervention where ED patients who are motivated to quit smoking are put in direct phone contact with a trained smoking cessation counselor, during their ED stay, to see if there is a realizable benefit in rates of smoking cessation beyond the placebo rate of cessation.
|Change History||Complete list of historical versions of study NCT01173653 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Smoking Cessation Invention in the Emergency Department (ED)|
|Official Title ICMJE||A Randomized Controlled Trial of Directed Smoking Cessation Intervention in the Emergency Care Population|
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.
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:
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date||January 2011|
|Actual Primary Completion Date||October 2010 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01173653|
|Other Study ID Numbers ICMJE||100411|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Ben Heavrin, Vanderbilt University|
|Study Sponsor ICMJE||Vanderbilt University|
|Collaborators ICMJE||Not Provided|
|PRS Account||Vanderbilt University|
|Verification Date||December 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP