Emergency Department Smoking Cessation Study

October 2, 2014 updated by: University of British Columbia

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

1301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital Emergency Department, University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
QuitNow Services is a telephone counseling program supported by the Ministry of Health Living and Sport that counsels individuals to stop smoking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking cessation rates between intervention and control arms
Time Frame: 12 months
Smoking cessation rate between intervention and control arms at 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Smoking cessation rates between intervention and control arms
Time Frame: 1 month
1 month
Smoking cessation rates between intervention and control arms
Time Frame: 3 months
3 months
Smoking cessation rates between intervention and control arms
Time Frame: 6 months
6 months
No of cigarettes smoked daily between intervention and control arms
Time Frame: 1, 3, 6, and 12 months
1, 3, 6, and 12 months
Differences in readiness for change between the intervention and control arms
Time Frame: 1, 3, 6, and 12 months
1, 3, 6, and 12 months
Differences in knowledge and attitudes concerning smoking between the intervention and control arms
Time Frame: 1, 3, 6, and 12 months
1, 3, 6, and 12 months
Differences in use of nicotine replacement therapies between the intervention and control arms
Time Frame: 1, 3, 6, and 12 months
1, 3, 6, and 12 months
Differences in number of quit attempts between the intervention and control arms
Time Frame: 1,3,6,12 months
1,3,6,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ka Wai Cheung, MD, MPH, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 15, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-01625

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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