Treating Low-Income Smokers in the Hospital Emergency Department

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01328431
• Collaborator: National Cancer Institute (NCI) (NIH), National Institutes of Health (NIH) (NIH)
• Enrollment: 780
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Cessation; Smoking Cessation; Smoking; Tobacco Use Disorder	Other: Brief Intervention with NRT Initiation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 780 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Treating Low-Income Smokers in the Hospital Emergency Department
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Biochemical Verification of Tobacco Abstinence [3 months after enrollment]

   Biochemical verification means a breathalyzer reading for carbon monoxide.

2. Self-report of Tobacco Abstinence or Reduction [3 months]

   Questionnaires to assess self reported tobacco abstinence

Secondary Outcome Measures

1. Self-reported Tobacco Reduction or Abstinence [1 month post enrollment]

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

2. Health Care Service Utilization [1 month post enrollment]

   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.

3. Self-reported Tobacco Reduction or Abstinence [12 months post enrollment]

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

4. Health Care Service Utilization [3 months post enrollment]

   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.

5. Health Care Service Utilization [12 months post enrollment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University
• National Cancer Institute (NCI)
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Steven L. Bernstein, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Steven Bernstein, Principal Investigator, Yale University
• ClinicalTrials.gov Identifier: NCT01328431
• Other Study ID Numbers: 0907005437; R01CA141479
• First Posted: Apr 4, 2011
• Last Update Posted: Aug 4, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Steven Bernstein, Principal Investigator, Yale University: Tobacco Use Cessation; Smoking Cessation; Nicotine Replacement Therapy; Brief Intervention
• Additional relevant MeSH terms: Emergencies; Tobacco Use Disorder

Study Results

Participant Flow

Arm/Group Title	Standard Care	SBIRT+NRT
Arm/Group Description	Subjects receive a brochure for the state's Smokers' Quitline only.	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.
Period Title: Baseline
STARTED	390	390
COMPLETED	390	388
NOT COMPLETED	0	2
Period Title: Baseline
STARTED	390	388
COMPLETED	335	330
NOT COMPLETED	55	58
Period Title: Baseline
STARTED	390	388
COMPLETED	313	316
NOT COMPLETED	77	72
Period Title: Baseline
STARTED	388	386
COMPLETED	304	289
NOT COMPLETED	84	97

Baseline Characteristics

Arm/Group Title	Standard Care	SBIRT+NRT	Total
Arm/Group Description	Subjects receive a brochure for the state's Smokers' Quitline only.	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.	Total of all reporting groups
Overall Participants	390	388	778
Age (Count of Participants)
<=18 years	4 1%	2 0.5%	6 0.8%
Between 18 and 65 years	384 98.5%	376 96.9%	760 97.7%
>=65 years	2 0.5%	10 2.6%	12 1.5%
Sex: Female, Male (Count of Participants)
Female	189 48.5%	218 56.2%	407 52.3%
Male	201 51.5%	170 43.8%	371 47.7%

Outcome Measures

1. Primary Outcome

Title	Biochemical Verification of Tobacco Abstinence
Description	Biochemical verification means a breathalyzer reading for carbon monoxide.
Time Frame	3 months after enrollment

Outcome Measure Data

Analysis Population Description

This is the # of participants in each group.

Arm/Group Title	Standard Care	SBIRT+NRT
Arm/Group Description	Subjects receive a brochure for the state's Smokers' Quitline only.	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.
Measure Participants	388	386
Number [participants]	19 4.9%	47 12.1%

2. Primary Outcome

Title	Self-report of Tobacco Abstinence or Reduction
Description	Questionnaires to assess self reported tobacco abstinence
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

This is the # of participants in each group.

Arm/Group Title	Standard Care	SBIRT+NRT
Arm/Group Description	Subjects receive a brochure for the state's Smokers' Quitline only.	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.
Measure Participants	388	386
Number [participants]	34 8.7%	63 16.2%

3. Secondary Outcome

Title	Self-reported Tobacco Reduction or Abstinence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Health Care Service Utilization
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Self-reported Tobacco Reduction or Abstinence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Health Care Service Utilization
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Health Care Service Utilization
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	No adverse events reported during the course of the study
Arm/Group Title	Standard Care		SBIRT+NRT
Arm/Group Description	Subjects receive a brochure for the state's Smokers' Quitline only.		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.
All Cause Mortality
	Standard Care		SBIRT+NRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Care		SBIRT+NRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/390 (0%)		0/388 (0%)
Other (Not Including Serious) Adverse Events
	Standard Care		SBIRT+NRT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/390 (0%)		0/388 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.