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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vancouver Coastal Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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