Strategies to Help Adult ED Patients Quit Smoking

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00297466
First received: February 24, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Tobacco Use
Drug: transdermal nicotine patches
Behavioral: Motivational interview

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strategies to Help Adult ED Patients Quit Smoking

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 3-month cessation rate

Secondary Outcome Measures:
  • 3-month quit attempts,
  • daily cigarette consumption,
  • stage of change assessment

Estimated Enrollment: 336
Study Start Date: January 2006
Estimated Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00297466

Contacts
Contact: Steven L. Bernstein, MD 718-920-2068 sbernste@montefiore.org
Contact: Deepa Prasad, MPH 718-430-2985 dprasad@aecom.yu.edu

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Sub-Investigator: Lisa Cabral, MD         
Principal Investigator: Steven L. Bernstein, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Steven L. Bernstein, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00297466     History of Changes
Other Study ID Numbers: DA017812
Study First Received: February 24, 2006
Last Updated: February 24, 2006
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute on Drug Abuse (NIDA):
tobacco use
smoking cessation
emergency department

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014