Clinical trial NCT01328431: Treating Low-Income Smokers in the Hospital Emergency Department
Official title: Treating Low-Income Smokers in the Hospital Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Smoking Cessation
Smoking
Tobacco Use Disorder
Keywords: Tobacco Use Cessation
Smoking Cessation
Nicotine Replacement Therapy
Brief Intervention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2011-04-04
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemical Verification of Tobacco Abstinence
timeFrame: 3 months after enrollment
measure: Self-report of Tobacco Abstinence or Reduction
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported Tobacco Reduction or Abstinence
timeFrame: 1 month post enrollment
measure: Health Care Service Utilization
timeFrame: 1 month post enrollment
measure: Self-reported Tobacco Reduction or Abstinence
timeFrame: 12 months post enrollment
measure: Health Care Service Utilization
timeFrame: 3 months post enrollment
measure: Health Care Service Utilization
timeFrame: 12 months post enrollment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Steven L. Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References: