The Effectiveness of Smoking Cessation Guidelines in the Emergency Department

Cigarette Smoking Clinical Trial

Official title:

The Effectiveness of Smoking Cessation Guidelines in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756704
• Other study ID #: R21DA021607
• Secondary ID: R21DA021607
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: November 2, 2011
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cigarette Smoking
• Emergencies

Intervention

Behavioral:
• Smoking cessation guideline implementation
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

Locations

Country	Name	City	State
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	The University of Iowa Hospitals and Clinics Emergency Treatment Center	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of smoking cessation guideline-recommended actions by ED staff		Assessed within two weeks after discharge from ED	No
Secondary	7-day point-prevalence smoking abstinence		3 and 6 months post enrollment	No