Emergency Department Smoking Cessation Study

This study is currently recruiting participants.
Verified December 2011 by University of British Columbia
Sponsor:
Collaborator:
Vancouver Coastal Health Research Institute
Information provided by (Responsible Party):
Ka Wai Cheung, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01454375
First received: October 15, 2011
Last updated: December 1, 2011
Last verified: December 2011

October 15, 2011
December 1, 2011
November 2011
June 2013   (final data collection date for primary outcome measure)
Smoking cessation rates between intervention and control arms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Smoking cessation rate between intervention and control arms at 12 months
Same as current
Complete list of historical versions of study NCT01454375 on ClinicalTrials.gov Archive Site
  • Smoking cessation rates between intervention and control arms [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Smoking cessation rates between intervention and control arms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Smoking cessation rates between intervention and control arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • No of cigarettes smoked daily between intervention and control arms [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Differences in readiness for change between the intervention and control arms [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Differences in knowledge and attitudes concerning smoking between the intervention and control arms [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Differences in use of nicotine replacement therapies between the intervention and control arms [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Differences in number of quit attempts between the intervention and control arms [ Time Frame: 1,3,6,12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Emergency Department Smoking Cessation Study
Emergency Department Tobacco Cessation Counseling: Implementation and Evaluation of a Community-Based Program

Tobacco smoke claims approximately 6000 lives annually in BC. In this study, the investigators will determine whether referring smoking patients from the Vancouver General Hospital Emergency Department to the investigators provincial QuitNow smoking cessation service will lead to improved patient outcomes, including number of cigarettes smoked, any quit attempts, and actual smoking cessation.

Participants in the usual care arm will receive standard care. Participants in the intervention arm will be eligible for referral to QuitNow Services, where telephone counseling will be offered. Further follow-up on all enrolled patients will be conducted at 1, 3, 6, and 12 months to re-assess smoking status.

The investigators hypothesis is that the intervention arm will have a higher quit rate that the control arm.

As the leading cause of preventable deaths in British Columbia (BC), tobacco smoke claims approximately 6000 lives annually in BC. Although 16% of British Columbians smoke, the prevalence of smoking may be as high as 48% in the Emergency Department (ED) patient population. In this study, the investigators will determine whether referring stable adult smoking patients from the Vancouver General Hospital ED directly to the investigators provincial QuitNow smoking cessation service will lead to improved patient outcomes, including number of cigarettes smoked, any quit attempts, and actual smoking cessation. This will be the first ever randomized controlled trial to determine whether smokers referred from the ED to a web and phone based community resource will receive benefit.

Currently, EDs in British Columbia, including VGH, are not routinely counseling patients to stop smoking. However, up to 44% of ED patients do not have a family practitioner and rely solely on EDs for their health care. Therefore, the ED serves as a critical venue where smoking cessation can be initiated or reinforced. The BC Ministry of Health has recently funded a program called QuitNow, which in collaboration with the BC Lung Association, offers smoking cessation advice through an internet resource and a 24-hour telephone quit line. This year, a meta-analysis of randomized controlled trials showed that web-based and computer-based smoking cessation programs led to a significant increase in patients who stopped smoking, with effects that were sustained at 12 months. However, these studies did not include ED patients.

In this trial, participants assigned to the usual care arm will receive standard care, with no additional study-related smoking cessation counseling. Participants assigned to the intervention arm will be eligible for referral to the QuitNow service. In the intervention arm, individuals will receive telephone follow-up from QuitNow at their earliest convenience. For all participants, data will be collected on demographic information, chief complaint, past medical history, smoking history, medications including nicotine replacement therapies, and final diagnosis. The smoking history will include the patient's number of daily cigarettes smoked, years of smoking, any previous quit attempts, and desire to quit. Further telephone follow-up on all enrolled patients will be conducted at 1, 3, 6, and 12 months to re-assess smoking status.

Data analysis will be performed using individual growth curve analyses with a multi-level regression model. P values of <0.05 will be considered statistically significant. If results are found to be significant, a Benjamini-Hochberg adjustment for multiple comparisons will be done. The expected time commitment for each patient will be 15 minutes in the ED and 20 minutes total for 4 follow-up telephone phone calls.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Tobacco Use Cessation
Behavioral: Referral to QuitNow Services
QuitNow Services is a telephone counseling program supported by the Ministry of Health Living and Sport that counsels individuals to stop smoking
  • No Intervention: Control Arm
    No change in current practice
  • Experimental: Referral fo QuitNow Services
    Behavioural - referral to QuitNow Services, smoking cessation counseling telephone line supported by the Ministry of Healthy Living and Sport
    Intervention: Behavioral: Referral to QuitNow Services
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
924
January 2014
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 19 years of age or older
  • stable (vital signs within normal limits not requiring immediate physician intervention)
  • used a tobacco product in the last 30 days
  • presenting to the Vancouver General Hospital Emergency Department
  • can provide informed consent in English

Exclusion Criteria:

  • cannot provide informed consent
  • sexual assault patients
  • not a resident of British Columbia
  • unable to provide telephone number of email address for follow-up
Both
19 Years and older
Yes
Contact: Ka Wai Cheung, MD, MPH 778-999-5370 tokwcheung@gmail.com
Canada
 
NCT01454375
H10-01625
No
Ka Wai Cheung, University of British Columbia
University of British Columbia
Vancouver Coastal Health Research Institute
Principal Investigator: Ka Wai Cheung, MD, MPH University of British Columbia
University of British Columbia
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP