Emergency Department Smoking Cessation Study

Tobacco Use Cessation Clinical Trial

Official title:

Emergency Department Tobacco Cessation Counseling: Implementation and Evaluation of a Community-Based Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454375
• Other study ID #: H10-01625
• Status: Completed
• Phase: N/A
• First received: October 15, 2011
• Last updated: October 2, 2014
• Start date: November 2011
• Est. completion date: February 2013

Study information

• Verified date: October 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1301
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

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

Locations

Country	Name	City	State
Canada	Vancouver General Hospital Emergency Department, University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation rates between intervention and control arms	Smoking cessation rate between intervention and control arms at 12 months	12 months	No
Secondary	Smoking cessation rates between intervention and control arms		1 month	No
Secondary	Smoking cessation rates between intervention and control arms		3 months	No
Secondary	Smoking cessation rates between intervention and control arms		6 months	No
Secondary	No of cigarettes smoked daily between intervention and control arms		1, 3, 6, and 12 months	No
Secondary	Differences in readiness for change between the intervention and control arms		1, 3, 6, and 12 months	No
Secondary	Differences in knowledge and attitudes concerning smoking between the intervention and control arms		1, 3, 6, and 12 months	No
Secondary	Differences in use of nicotine replacement therapies between the intervention and control arms		1, 3, 6, and 12 months	No
Secondary	Differences in number of quit attempts between the intervention and control arms		1,3,6,12 months	No

External Links

•   QuitNow Services website