Clinical trial NCT00756704: The Effectiveness of Smoking Cessation Guidelines in the Emergency Department
Official title: The Effectiveness of Smoking Cessation Guidelines in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Smoking Cessation
Emergency Medicine
Emergency Nursing
Effectiveness Trial
Implementation
Relapse prevention
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-09-22
Enrollment: 789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Presentation to the Emergency Department by private vehicle or on a walk-in basis
* Current cigarette smoker (5 or more cigarettes per day)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Performance of smoking cessation guideline-recommended actions by ED staff
timeFrame: Assessed within two weeks after discharge from ED
Secondary outcomes:
measure: 7-day point-prevalence smoking abstinence
timeFrame: 3 and 6 months post enrollment
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Iowa City
country: United States
facility: The University of Iowa Hospitals and Clinics Emergency Treatment Center
state: Iowa
Study officials:
affiliation: The Univesity of Iowa College of Medicine
name: David A Katz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Katz 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.