Smoking Cessation Clinical Trial
Official title:
A Randomized Controlled Trial of Directed Smoking Cessation Intervention in the Emergency Care Population
Verified date | December 2012 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 199 |
Est. completion date | January 2011 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center - Emergency Medicine | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Status at Follow up | 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 | 6 weeks | No |
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