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The Effectiveness of Smoking Cessation Guidelines in the Emergency Department

Primary Purpose

Cigarette Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking cessation guideline implementation
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cigarette Smoking focused on measuring Smoking Cessation, Emergency Medicine, Emergency Nursing, Effectiveness Trial, Implementation, Relapse prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Iowa Methodist Medical Center
  • The University of Iowa Hospitals and Clinics Emergency Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline Period

Intervention Period

Arm Description

Outcomes

Primary Outcome Measures

Performance of smoking cessation guideline-recommended actions by ED staff

Secondary Outcome Measures

7-day point-prevalence smoking abstinence

Full Information

First Posted
September 19, 2008
Last Updated
November 2, 2011
Sponsor
University of Iowa
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00756704
Brief Title
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

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Iowa
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking
Keywords
Smoking Cessation, Emergency Medicine, Emergency Nursing, Effectiveness Trial, Implementation, Relapse prevention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
789 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline Period
Arm Type
No Intervention
Arm Title
Intervention Period
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation guideline implementation
Intervention Description
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
Primary Outcome Measure Information:
Title
Performance of smoking cessation guideline-recommended actions by ED staff
Time Frame
Assessed within two weeks after discharge from ED
Secondary Outcome Measure Information:
Title
7-day point-prevalence smoking abstinence
Time Frame
3 and 6 months post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Katz, MD, MSc
Organizational Affiliation
The Univesity of Iowa College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
The University of Iowa Hospitals and Clinics Emergency Treatment Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
result
PubMed Identifier
24460974
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.
Results Reference
derived
PubMed Identifier
23125437
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.
Results Reference
derived

Learn more about this trial

The Effectiveness of Smoking Cessation Guidelines in the Emergency Department

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