Treating Low-Income Smokers in the Hospital Emergency Department

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Steven Bernstein, Yale University
ClinicalTrials.gov Identifier:
NCT01328431
First received: March 30, 2011
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Tobacco Use Cessation
Smoking Cessation
Smoking
Tobacco Use Disorder
Other: Brief Intervention with NRT Initiation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Treating Low-Income Smokers in the Hospital Emergency Department

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Biochemical verification of tobacco abstinence [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    Biochemical verification means a breathalyzer reading for carbon monoxide.

  • Self-report of tobacco abstinence or reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    A series of questionnaires are completed over the phone to assess self-reported reduction in cigarette use or abstinence from cigarette use.


Secondary Outcome Measures:
  • Self-reported tobacco reduction or abstinence [ Time Frame: 1 month post enrollment ] [ Designated as safety issue: No ]
    self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.

  • Health care service utilization [ Time Frame: 1 month post enrollment ] [ Designated as safety issue: No ]
    A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.

  • Self-reported tobacco reduction or abstinence [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: No ]
    self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.

  • Health care service utilization [ Time Frame: 3 months post enrollment ] [ Designated as safety issue: No ]
    A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.

  • Health care service utilization [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: No ]
    A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.


Enrollment: 778
Study Start Date: October 2010
Estimated Study Completion Date: January 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
Subjects receive a brochure for the state's Smokers' Quitline only.
Experimental: SBIRT+NRT
Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
Other: Brief Intervention with NRT Initiation
Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328431

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Steven L. Bernstein, MD Yale University
  More Information

No publications provided

Responsible Party: Steven Bernstein, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01328431     History of Changes
Other Study ID Numbers: 0907005437, R01CA141479
Study First Received: March 30, 2011
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Yale University:
Tobacco Use Cessation
Smoking Cessation
Nicotine Replacement Therapy
Brief Intervention

Additional relevant MeSH terms:
Emergencies
Smoking
Tobacco Use Disorder
Disease Attributes
Pathologic Processes
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014