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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00756704 |
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.
Condition | Intervention |
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Cigarette Smoking |
Behavioral: Smoking cessation guideline implementation |
Study Type: | Interventional |
Study Design: | Health Services Research, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | The Effectiveness of Smoking Cessation Guidelines in the Emergency Department |
Estimated Enrollment: | 974 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Baseline Period: No Intervention | |
Intervention Period: Experimental |
Behavioral: Smoking cessation guideline implementation
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: John E Holman, MA | 319-338-0581 ext 7507 | john.holman2@va.gov |
United States, Iowa | |
The University of Iowa Hospitals and Clinics Emergency Treatment Center | Completed |
Iowa City, Iowa, United States, 52242 | |
Iowa Methodist Medical Center | Recruiting |
Des Moines, Iowa, United States, 50316 | |
Contact: Lawrence Baker, MD 515-241-6212 |
Principal Investigator: | David A Katz, MD, MSc | The Univesity of Iowa College of Medicine |
Responsible Party: | The University of Iowa College of Medicine ( David A. Katz, MD, MSc/Associate Professor ) |
Study ID Numbers: | R21 DA021607 |
Study First Received: | September 19, 2008 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00756704 History of Changes |
Health Authority: | United States: Federal Government |
Smoking Cessation Emergency Medicine Emergency Nursing |
Effectiveness Trial Implementation Relapse prevention |
Nicotine polacrilex Smoking Nicotine Emergencies |
Habits Smoking Disease Attributes Pathologic Processes Emergencies |