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Treating Low-Income Smokers in the Hospital Emergency Department

Treating Low-Income Smokers in the Hospital Emergency Department

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01328431
Enrollment
780
Registered
2011-04-04
Start date
2010-10-31
Completion date
2014-01-31
Last updated
2014-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Smoking Cessation, Tobacco Use Cessation, Tobacco Use Disorder

Keywords

Tobacco Use Cessation, Smoking Cessation, Nicotine Replacement Therapy, Brief Intervention

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.

Interventions

OTHERBrief 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemical Verification of Tobacco Abstinence3 months after enrollmentBiochemical verification means a breathalyzer reading for carbon monoxide.
Self-report of Tobacco Abstinence or Reduction3 monthsQuestionnaires to assess self reported tobacco abstinence

Secondary

MeasureTime frameDescription
Self-reported Tobacco Reduction or Abstinence1 month post enrollmentself-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.
Health Care Service Utilization1 month post enrollmentA 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard Care
Subjects receive a brochure for the state's Smokers' Quitline only.
390
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. 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.
388
Total778

Withdrawals & dropouts

PeriodReasonFG000FG001
12 Month (12M)Death26
12 Month (12M)Lost to Follow-up8291
1 Month (1M)Lost to Follow-up5558
3 Month (3M)Death22
3 Month (3M)Lost to Follow-up7570
BaselineProtocol Violation02

Baseline characteristics

CharacteristicStandard CareSBIRT+NRTTotal
Age, Categorical
<=18 years
4 Participants2 Participants6 Participants
Age, Categorical
>=65 years
2 Participants10 Participants12 Participants
Age, Categorical
Between 18 and 65 years
384 Participants376 Participants760 Participants
Sex: Female, Male
Female
189 Participants218 Participants407 Participants
Sex: Female, Male
Male
201 Participants170 Participants371 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 3900 / 388
serious
Total, serious adverse events
0 / 3900 / 388

Outcome results

Primary

Biochemical Verification of Tobacco Abstinence

Biochemical verification means a breathalyzer reading for carbon monoxide.

Time frame: 3 months after enrollment

Population: This is the # of participants in each group.

ArmMeasureValue (NUMBER)
Standard CareBiochemical Verification of Tobacco Abstinence19 participants
SBIRT+NRTBiochemical Verification of Tobacco Abstinence47 participants
Primary

Self-report of Tobacco Abstinence or Reduction

Questionnaires to assess self reported tobacco abstinence

Time frame: 3 months

Population: This is the # of participants in each group.

ArmMeasureValue (NUMBER)
Standard CareSelf-report of Tobacco Abstinence or Reduction34 participants
SBIRT+NRTSelf-report of Tobacco Abstinence or Reduction63 participants
Secondary

Health Care Service Utilization

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.

Time frame: 1 month post enrollment

Secondary

Health Care Service Utilization

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.

Time frame: 3 months post enrollment

Secondary

Health Care Service Utilization

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.

Time frame: 12 months post enrollment

Secondary

Self-reported Tobacco Reduction or Abstinence

self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.

Time frame: 1 month post enrollment

Secondary

Self-reported Tobacco Reduction or Abstinence

self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.

Time frame: 12 months post enrollment

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026