NCT00756704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
789

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 4, 2011

Status Verified

November 1, 2011

Enrollment Period

2.7 years

First QC Date

September 19, 2008

Last Update Submit

November 2, 2011

Conditions

Keywords

Smoking CessationEmergency MedicineEmergency NursingEffectiveness TrialImplementationRelapse prevention

Outcome Measures

Primary Outcomes (1)

  • Performance of smoking cessation guideline-recommended actions by ED staff

    Assessed within two weeks after discharge from ED

Secondary Outcomes (1)

  • 7-day point-prevalence smoking abstinence

    3 and 6 months post enrollment

Study Arms (2)

Baseline Period

NO INTERVENTION

Intervention Period

EXPERIMENTAL
Behavioral: Smoking cessation guideline implementation

Interventions

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

Intervention Period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Iowa Methodist Medical Center

Des Moines, Iowa, 50316, United States

Location

The University of Iowa Hospitals and Clinics Emergency Treatment Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

  • 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.

    RESULT
  • 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.

  • 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.

MeSH Terms

Conditions

Cigarette SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Study Officials

  • David A Katz, MD, MSc

    The Univesity of Iowa College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

September 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 4, 2011

Record last verified: 2011-11

Locations