Treating Low-Income Smokers in the Hospital Emergency Department
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| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06510 |
| Conditions: |
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Tobacco Use Cessation - Smoking Cessation - Smoking - Tobacco Use Disorder |
| Purpose: |
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This study will test the effectiveness of an Emergency Department (ED) initiated tobacco
intervention which includes counseling and medication. Our proposed intervention combines a
Brief Negotiated Interview (BNI) with initiation of nicotine patch and gum in the ED, as
well as a faxed referral to the state's Smokers' Quitline. A 6 week supply of nicotine
patches and nicotine gum are provided to subjects in the intervention arm. Subjects
randomized to the control arm will receive a brochure from the state's Smokers' Quitline
only.
The primary hypothesis is that the intervention will be superior to the control condition in
reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months.
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| Study Summary: |
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Of the nation's 45 million adult smokers, nearly 20 million visit hospital emergency
departments (EDs) each year. ED patients, particularly smokers, are disproportionately
low-income, with limited access to traditional primary care settings. Patients presenting to
the ED with a tobacco-related trigger event, like an asthma attack, may be experiencing a
"teachable moment." Thus, the ED may be an ideal location in which to identify smokers and
initiate treatment for tobacco dependence. Initial pilot research by our group has
demonstrated the feasibility of ED-based brief interventions for smokers. Based on our
feasibility studies, the Institute of Medicine 2006 report on tobacco and the 2008 US Public
Health Service guidelines now list EDs as appropriate loci for tobacco control efforts. This
study aims to test the efficacy of an ED-initiated tobacco intervention which includes
counseling and medication. The intervention—Screening, Brief Intervention, and Referral to
Treatment (SBIRT)—uses a form of motivational interviewing known as the Brief Negotiation
Interview (BNI). Our proposed intervention combines a BNI with initiation of nicotine
replacement therapy (NRT) and a fax referral to the state Smokers' Quitline during the ED
visit. A 6-week starter kit of NRT (patch and/or gum, tailored to level of addiction and
patient preference) will be provided with written materials. The initial dose of NRT will be
given in the ED. A trained nurse will administer the booster intervention via telephone 3
days post-visit. The SBIRT+NRT arm will be compared to standard care (SC), which consists of
written materials only, in a controlled trial of 778 smokers age 18 years or older
randomized in a 1:1 fashion.
The primary hypothesis is that SBIRT+NRT will be superior to SC in reducing self-reported
and biochemically verified 7-day tobacco abstinence at 3 months. Secondary hypotheses
include: (1) Patients with a tobacco related diagnosis for the ED visit will have a higher
cessation rate than patients without a tobacco related diagnosis, and (2) Patients who
believe their ED visit is smoking-related will have a higher quit rate than others. The
investigators will conduct a cost benefit analysis of the interventions. Follow-up
assessments at 1, 3 and 12 months will combine self-report with in-person carbon monoxide
testing at 3 months for smokers who assert abstinence via phone. Expansions of the proposed
project as compared to earlier studies include: 1) initiation of NRT during the ED visit; 2)
provision of multiple forms of NRT; 3) a proactive referral made to the Quitline; 4)a
credible control condition with minimal baseline assessment, to avoid the assessment
reactivity seen in similar ED studies; and 5) an economic analysis of the tested
interventions.
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| Criteria: |
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Inclusion Criteria:
- Age > 18 years
- Speaks English
- Willing and able to give informed consent
- >100 cigarettes lifetime
- Current daily or some day smoker
- Smokes > 5 cigarettes/day
- Medicaid or self-pay insurance
Exclusion Criteria:
- Too ill or unable to consent
- Not interested in study participation
- Not interested in quitting
- Pregnant, nursing, or trying to conceive
- Current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge,
e-cigarette)
- Actively psychotic or mentally ill
- Leaving ED against medical advice
- Investigator discretion
- Lives outside of New Haven County
- Does not have phone with CT area code
- In police custody
- History of allergic reaction to nicotine replacement products
- Currently receiving formal tobacco dependence tx
- Currently taking Zyban, Wellbutrin (bupropion) or Chantix(varenicline)
- Resides in an extended care facility
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| NCT ID: |
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NCT01328431 |
| Primary Contact: |
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Principal Investigator
Steven L. Bernstein, MD
Yale University
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Haven, Connecticut 06510
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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