The Effectiveness of Smoking Cessation Guidelines in the Emergency Department

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT00756704
First received: September 19, 2008
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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
Cigarette Smoking
Behavioral: Smoking cessation guideline implementation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Effectiveness of Smoking Cessation Guidelines in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Performance of smoking cessation guideline-recommended actions by ED staff [ Time Frame: Assessed within two weeks after discharge from ED ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-day point-prevalence smoking abstinence [ Time Frame: 3 and 6 months post enrollment ] [ Designated as safety issue: No ]

Enrollment: 789
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline Period
Experimental: Intervention Period Behavioral: Smoking cessation guideline implementation
  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
  4. group feedback to ED staff

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756704

Locations
United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50316
The University of Iowa Hospitals and Clinics Emergency Treatment Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: David A Katz, MD, MSc The Univesity of Iowa College of Medicine
  More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT00756704     History of Changes
Other Study ID Numbers: R21 DA021607, R21DA021607
Study First Received: September 19, 2008
Last Updated: November 2, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Iowa:
Smoking Cessation
Emergency Medicine
Emergency Nursing
Effectiveness Trial
Implementation
Relapse prevention

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014