Cigarette SmokingNCT00756704
The Effectiveness of Smoking Cessation Guidelines in the Emergency Department
A study testing Smoking cessation guideline implementation in people with Cigarette Smoking, run by University of Iowa at 2 sites in United States.
Trial summary
Although 78% of smokers report that a health professional has previously advised them to quit smoking, most smokers are not advised to stop smoking or offered assistance with smoking cessation during a given ED visit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Smoking cessation guideline implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 789 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Jun 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presentation to the Emergency Department by private vehicle or on a walk-in basis
- Current cigarette smoker (5 or more cigarettes per day)
Who cannot join
- Acute medical decompensation (e.g., acute respiratory failure requiring intubation, cardiac arrest, cardiogenic or septic shock)
- Life-threatening trauma
- Altered mental status
- Dementia
- Language barrier
- Incarceration
Show all 12Show fewer
- Transfer to another ED
- Departure from the ED prior to evaluation
- Inability to be contacted by telephone
- ED presentation for sexual assault
- ED presentation for acute psychiatric crisis (e.g., suicidal ideation)
- Participation in a smoking cessation program in the past 3 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Iowa Methodist Medical Center
Des Moines, Iowa, 50316
The University of Iowa Hospitals and Clinics Emergency Treatment Center
Iowa City, Iowa, 52242
About this study
Although 78% of smokers report that a health professional has previously advised them to quit smoking, most smokers are not advised to stop smoking or offered assistance with smoking cessation during a given ED visit. There are multiple barriers to routine implementation of smoking cessation guidelines by emergency clinicians, however, and rigorously performed clinical trials are needed to demonstrate that routine screening and counseling of ED patients results in increased quit rates. To determine the feasibility of implementing the Agency for Healthcare Research and Quality (AHRQ) Smoking Cessation Guideline in the ED, we will conduct a clinical trial in 974 ambulatory adult smokers who present to 2 emergency departments, using a pre-post design. During the 3-month baseline period, clinicians will perform their usual duties but will not receive training in use of the AHRQ Guideline. Based on the Chronic Care Model, the 3-month intervention period will include: 1) a tutorial on brief cessation counseling for ED nurses and physicians, 2) use of an ED algorithm that includes recommended tobacco counseling items, 3) fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy, and 4) group and individual feedback to ED staff. We will conduct exit interviews of ED patients to assess performance of guideline-recommended actions by ED staff and 3- and 6-month telephone follow-up to determine 7-day point-prevalence abstinence (with biochemical confirmation of self-reported quitters at 6 months). Our main analyses will examine the contrast between the intervention and control periods in the performance of guideline-recommended actions and in 6-month quit rates, using hierarchical logistic regression to adjust for baseline differences in potentially confounding patient variables. In secondary analyses, we will assess the change in attitudes of ED nurses and physicians toward smoking cessation counseling. This feasibility study will determine the receptivity of patients and ED staff to the guideline-based intervention and will provide estimates of effect size in planning a full scale multi-site clinical trial of the study intervention in community hospital EDs.
- Conditions
- Cigarette Smoking
- Being tested
- Smoking cessation guideline implementation
- Keywords
- Smoking Cessation, Emergency Medicine, Emergency Nursing, Effectiveness Trial, Implementation, Relapse prevention
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation guideline implementationBehavioural
- a tutorial on brief cessation counseling for ED nurses and physicians
- use of an ED algorithm that includes recommended tobacco counseling items
- fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy
- group feedback to ED staff
| Study group | Role | What they receive |
|---|---|---|
| Baseline Period | No intervention | Not described |
| Intervention Period | Experimental | Not described Receives: Behavioral: Smoking cessation guideline implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of smoking cessation guideline-recommended actions by ED staff
Measured: Assessed within two weeks after discharge from ED
Secondary outcomes (1)
7-day point-prevalence smoking abstinence
Measured: 3 and 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- David A Katz, MD, MSc, Principal investigator, The Univesity of Iowa College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756704
- Sponsor's protocol ID
- R21DA021607
- Other IDs
- R21DA021607
- Status last verified
- Nov 2011
- First submitted
- 19 Sep 2008
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Katz D, Vander Weg M, Nugent A, Kim R, Graham M, Holman J, Hillis S, Titler M. Adherence to smoking cessation guidelines in the emergency department. J Gen Intern Med 2009; 24 (Suppl 1): S15.
Katz DA, Paez MW, Reisinger HS, Gillette MT, Weg MW, Titler MG, Nugent AS, Baker LJ, Holman JE, Ono SS. Implementation of smoking cessation guidelines in the emergency department: a qualitative study of staff perceptions. Addict Sci Clin Pract. 2014 Jan 24;9(1):1. doi: 10.1186/1940-0640-9-1.
PubMed 24460974Katz DA, Holman JE, Nugent AS, Baker LJ, Johnson SR, Hillis SL, Tinkelman DG, Titler MG, Vander Weg MW. The emergency department action in smoking cessation (EDASC) trial: impact on cessation outcomes. Nicotine Tob Res. 2013 Jun;15(6):1032-43. doi: 10.1093/ntr/nts219. Epub 2012 Nov 2.
PubMed 23125437
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Smoking Cessation Guidelines in the Emergency Department
- ClinicalTrials.gov ID
- NCT00756704
- Acronym / sponsor ID
- R21DA021607
- Conditions
- Cigarette Smoking
- Keywords
- Smoking Cessation, Emergency Medicine, Emergency Nursing, Effectiveness Trial, Implementation, Relapse prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Sep 2008 (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.
Although 78% of smokers report that a health professional has previously advised them to quit smoking, most smokers are not advised to stop smoking or offered assistance with smoking cessation during a given ED visit. There are multiple barriers to routine implementation of smoking cessation guidelines by emergency clinicians, however, and rigorously performed clinical trials are needed to demonstrate that routine screening and counseling of ED patients results in increased quit rates. To determine the feasibility of implementing the Agency for Healthcare Research and Quality (AHRQ) Smoking Cessation Guideline in the ED, we will conduct a clinical trial in 974 ambulatory adult smokers who present to 2 emergency departments, using a pre-post design. During the 3-month baseline period, clinicians will perform their usual duties but will not receive training in use of the AHRQ Guideline. Based on the Chronic Care Model, the 3-month intervention period will include: 1) a tutorial on brief cessation counseling for ED nurses and physicians, 2) use of an ED algorithm that includes recommended tobacco counseling items, 3) fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy, and 4) group and individual feedback to ED staff. We will conduct exit interviews of ED patients to assess performance of guideline-recommended actions by ED staff and 3- and 6-month telephone follow-up to determine 7-day point-prevalence abstinence (with biochemical confirmation of self-reported quitters at 6 months). Our main analyses will examine the contrast between the intervention and control periods in the performance of guideline-recommended actions and in 6-month quit rates, using hierarchical logistic regression to adjust for baseline differences in potentially confounding patient variables. In secondary analyses, we will assess the change in attitudes of ED nurses and physicians toward smoking cessation counseling. This feasibility study will determine the receptivity of patients and ED staff to the guideline-based intervention and will provide estimates of effect size in planning a full scale multi-site clinical trial of the study intervention in community hospital EDs.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Period | No intervention | – |
| Intervention Period | Experimental | Behavioral: Smoking cessation guideline implementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presentation to the Emergency Department by private vehicle or on a walk-in basis
- Current cigarette smoker (5 or more cigarettes per day)
Key exclusion criteria (12 listed)
- Acute medical decompensation (e.g., acute respiratory failure requiring intubation, cardiac arrest, cardiogenic or septic shock)
- Life-threatening trauma
- Altered mental status
- Dementia
- Language barrier
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 |
|---|---|---|
| Smoking cessation guideline implementation1. a tutorial on brief cessation counseling for ED nurses and physicians 2. use of an ED algorithm that includes recommended tobacco counseling items 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy 4. group feedback to ED staff | Behavioural | Intervention Period |
Primary outcome
Performance of smoking cessation guideline-recommended actions by ED staff
Time frame: Assessed within two weeks after discharge from ED
1 secondary outcome
7-day point-prevalence smoking abstinence
Time frame: 3 and 6 months post enrollment
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 4 Nov 2011.
- Results publicationKatz D, Vander Weg M, Nugent A, Kim R, Graham M, Holman J, Hillis S, Titler M. Adherence to smoking cessation guidelines in the emergency department. J Gen Intern Med 2009; 24 (Suppl 1): S15.
- Derived from this study: PubMed 24460974Katz DA, Paez MW, Reisinger HS, Gillette MT, Weg MW, Titler MG, Nugent AS, Baker LJ, Holman JE, Ono SS. Implementation of smoking cessation guidelines in the emergency department: a qualitative study of staff perceptions. Addict Sci Clin Pract. 2014 Jan 24;9(1):1. doi: 10.1186/1940-0640-9-1.
- Derived from this study: PubMed 23125437Katz DA, Holman JE, Nugent AS, Baker LJ, Johnson SR, Hillis SL, Tinkelman DG, Titler MG, Vander Weg MW. The emergency department action in smoking cessation (EDASC) trial: impact on cessation outcomes. Nicotine Tob Res. 2013 Jun;15(6):1032-43. doi: 10.1093/ntr/nts219. Epub 2012 Nov 2.
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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.
David A Katz, MD, MSc principal investigator
The Univesity of Iowa College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation guideline implementation in people with Cigarette Smoking, run by University of Iowa at 2 sites 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 2 inclusion and 12 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 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Performance of smoking cessation guideline-recommended actions by ED staff (time frame: Assessed within two weeks after discharge from ED). 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 NCT00756704, which also lists 3 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 4 Nov 2011.