Tobacco UseNCT00297466
Strategies to Help Adult ED Patients Quit Smoking
A study testing transdermal nicotine patches and Motivational interview in people with Tobacco Use, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Use
- What is being tested?
- transdermal nicotine patches and Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 10 cigarettes smoked daily
- being discharged from the ED
- contemplation or preparation stage of change
- speaks English or Spanish
Who cannot join
- being admitted to hospital
- too ill to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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.
Read the 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
- Being tested
- transdermal nicotine patches, Motivational interview
- Keywords
- tobacco use, smoking cessation, emergency department
- Medical subject headings
- Tobacco Use, Smoking Cessation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdermal nicotine patchesDrug
Motivational interviewBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month cessation rate
Secondary outcomes (3)
3-month quit attempts,
daily cigarette consumption,
stage of change assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Steven L. Bernstein, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297466
- Sponsor's protocol ID
- DA017812
- Status last verified
- Feb 2006
- First submitted
- 24 Feb 2006
- Last updated
- 11 Jan 2017
- Results posted
- No
Publications
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.
PubMed 23000321Bernstein 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.
PubMed 21676054
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Help Adult ED Patients Quit Smoking
- ClinicalTrials.gov ID
- NCT00297466
- Acronym / sponsor ID
- DA017812
- Conditions
- Tobacco Use
- Keywords
- tobacco use, smoking cessation, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jan 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 10 cigarettes smoked daily
- being discharged from the ED
- contemplation or preparation stage of change
- speaks English or Spanish
Key exclusion criteria (2 listed)
- being admitted to hospital
- too ill to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transdermal nicotine patches | Drug | – |
| Motivational interview | Behavioural | – |
Primary outcome
3-month cessation rate
3 secondary outcomes
3-month quit attempts,
daily cigarette consumption,
stage of change assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 23000321Bernstein 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.
- Derived from this study: PubMed 21676054Bernstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven L. Bernstein, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transdermal nicotine patches and Motivational interview in people with Tobacco Use, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month cessation rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.