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Clinical Trials/NCT01328431
NCT01328431
Completed
Not Applicable

Treating Low-Income Smokers in the Hospital Emergency Department

Yale University1 site in 1 country780 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Use Cessation
Sponsor
Yale University
Enrollment
780
Locations
1
Primary Endpoint
Biochemical Verification of Tobacco Abstinence
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
January 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven Bernstein

Principal Investigator

Yale University

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

Outcomes

Primary Outcomes

Biochemical Verification of Tobacco Abstinence

Time Frame: 3 months after enrollment

Biochemical verification means a breathalyzer reading for carbon monoxide.

Self-report of Tobacco Abstinence or Reduction

Time Frame: 3 months

Questionnaires to assess self reported tobacco abstinence

Secondary Outcomes

  • Health Care Service Utilization(12 months post enrollment)
  • Self-reported Tobacco Reduction or Abstinence(12 months post enrollment)

Study Sites (1)

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