Emergency Department Smoking Cessation Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of British Columbia
Sponsor:
Collaborator:
Vancouver Coastal Health Research Institute
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01454375
First received: October 15, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Tobacco Use Cessation
Behavioral: Referral to QuitNow Services

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Emergency Department Tobacco Cessation Counseling: Implementation and Evaluation of a Community-Based Program

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 924
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

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. We will also determine whether participants were enrolled in or completed the QuitNow Services program. For our initial pilot study, we made 5 calls to each participant at each follow-up period. For this full randomized controlled trial, participants will be called a maximum of 15 times at 12 months.

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. An intention-to-treat analysis will be performed. 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01454375

Contacts
Contact: Ka Wai Cheung, MD, MPH 778-999-5370 tokwcheung@gmail.com

Locations
Canada, British Columbia
Vancouver General Hospital Emergency Department, University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Ka Wai Cheung, MD, MPH    778-999-5370      
Sub-Investigator: Jeffrey Brubacher, MD         
Sub-Investigator: Riyad Abu-Laban, MD         
Sub-Investigator: Michael Schulzer, PhD         
Sub-Investigator: Monique McLaughlin, RN         
Principal Investigator: Ka Wai Cheung, MD, MPH         
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Investigators
Principal Investigator: Ka Wai Cheung, MD, MPH University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01454375     History of Changes
Other Study ID Numbers: H10-01625
Study First Received: October 15, 2011
Last Updated: March 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of British Columbia:
Smoking

ClinicalTrials.gov processed this record on September 18, 2014