Smoking Cessation Invention in the Emergency Department (ED)
A Randomized Controlled Trial of Directed Smoking Cessation Intervention in the Emergency Care Population
1 other identifier
interventional
199
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 29, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
November 19, 2012
CompletedDecember 27, 2012
December 1, 2012
3 months
July 29, 2010
January 9, 2012
December 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Standard EM Smoking Cessation Info
PLACEBO COMPARATORPatients discharged from ER receive pamphlet re: smoking cessation
Patients contact 1-800-QUIT-NOW before leaving ED
ACTIVE COMPARATORPrior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
Interventions
Randomly introducing patients to a Department of Health program to help them quit smoking.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center - Emergency Medicine
Nashville, Tennessee, 37232-4700, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This is a preliminary study with a convenience sample of patients at a single academic medical center. A larger multicenter trial targeting consecutive ED patients who smoke will be essential to validate the applicability of our findings.
Results Point of Contact
- Title
- Benjamin Heavrin, MD
- Organization
- Vanderbilt University Emergency Medicine Department
Study Officials
- PRINCIPAL INVESTIGATOR
Ben Heavrin, MD
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Benjamin S. Heavrin, MD, MBA
Study Record Dates
First Submitted
July 29, 2010
First Posted
August 2, 2010
Study Start
July 1, 2010
Primary Completion
October 1, 2010
Study Completion
January 1, 2011
Last Updated
December 27, 2012
Results First Posted
November 19, 2012
Record last verified: 2012-12