Strategies to Help Adult ED Patients Quit Smoking

NCT ID: NCT00297466

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-05-31

Brief Summary

The purpose of this study is to determine whether a brief, focused intervention in the hospital emergency department is effective in helping adults quit smoking.

Detailed Description

In urban communities, the prevalence of tobacco use among adults visiting a hospital emergency department (ED) nears 40%, well in excess of the 25% smoking prevalence rate of the general population. Many of these patients lack easy access to primary care, suggesting the ED may be an attractive locus to initiate tobacco cessation efforts. With over 100 million annual visits to U.S. EDs, it may be possible to engage millions of smokers in tobacco cessation efforts. The major purpose of this study is to examine whether a multicomponent intervention delivered in the ED by a Lay Educator to adult smokers interested in quitting is more likely to result in cessation than usual care. A secondary goal is to test whether patients who present to the ED with a tobacco-related illness (as indicated by ICD9 code) are more likely to quit than ED smokers with a non-tobacco-related condition. This will allow us to test the validity of the "teachable moment" as an opportune time to engage patients in considering a behavioral change. The proposed study is a randomized trial of a motivational interview, provision of six weeks' worth of nicotine patches, literature, and post-visit follow-up (Enhanced Care) vs. referral to a cessation clinic (Minimal Care) for ED patients who smoke. Eligibility criteria: age > 21 years, contemplation or preparation stage of change, not admitted to hospital. All patients will undergo a standardized stage of change assessment, and measurements of nicotine dependence and exhaled carbon monoxide. All will receive a cessation fact sheet and referral card to the smoking cessation clinic; the cards of those in the Enhanced Care group will have a specific appointment date and time. The Enhanced Care group will receive a language-appropriate pamphlet discussing smoking cessation. We will record the ICD9 codes associated with each visit. Major outcome measure: cessation within 3 months of the ED visit, stratified by treatment group. Secondary outcome measure: cessation within 3 months of the ED visit, stratified by whether the visit was smoking-related. If smokers receiving Enhanced Care are more likely to quit, then the ED could be considered a new, effective locus for tobacco control, potentially reaching several million smokers. If patients with a smoking-related diagnosis for the ED visit are more likely to quit than those with non-smoking-related ICD9, then this supports the construct of the teachable moment.

Conditions

Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

transdermal nicotine patches

Intervention Type: DRUG

Motivational interview

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• >= 10 cigarettes smoked daily
• being discharged from the ED
• contemplation or preparation stage of change
• speaks English or Spanish

Exclusion Criteria

• being admitted to hospital
• too ill to consent

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Principal Investigators

Steven L. Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

Bernstein SL, Bijur P, Cooperman N, Jearld S, Arnsten JH, Moadel A, Gallagher EJ. A randomized trial of a multicomponent cessation strategy for emergency department smokers. Acad Emerg Med. 2011 Jun;18(6):575-83. doi: 10.1111/j.1553-2712.2011.01097.x.

Reference Type: DERIVED

PMID: 21676054 (View on PubMed)

Bernstein SL, Cooperman N, Jearld S, Moadel A, Bijur P, Gallagher EJ. Predictors of in-person follow-up among subjects in an ED-based smoking cessation trial. Am J Emerg Med. 2012 Nov;30(9):2067-9. doi: 10.1016/j.ajem.2012.06.011. Epub 2012 Sep 20. No abstract available.

Reference Type: DERIVED

PMID: 23000321 (View on PubMed)

Other Identifiers

DA017812

Identifier Type: -

Identifier Source: org_study_id