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Emergency Department Smoking Cessation Study

Primary Purpose

Tobacco Use Cessation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Referral to QuitNow Services
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Use Cessation focused on measuring Smoking

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General Hospital Emergency Department, University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Arm

Referral fo QuitNow Services

Arm Description

No change in current practice

Behavioural - referral to QuitNow Services, smoking cessation counseling telephone line supported by the Ministry of Healthy Living and Sport

Outcomes

Primary Outcome Measures

Smoking cessation rates between intervention and control arms
Smoking cessation rate between intervention and control arms at 12 months

Secondary Outcome Measures

Smoking cessation rates between intervention and control arms
Smoking cessation rates between intervention and control arms
Smoking cessation rates between intervention and control arms
No of cigarettes smoked daily between intervention and control arms
Differences in readiness for change between the intervention and control arms
Differences in knowledge and attitudes concerning smoking between the intervention and control arms
Differences in use of nicotine replacement therapies between the intervention and control arms
Differences in number of quit attempts between the intervention and control arms

Full Information

First Posted
October 15, 2011
Last Updated
October 2, 2014
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01454375
Brief Title
Emergency Department Smoking Cessation Study
Official Title
Emergency Department Tobacco Cessation Counseling: Implementation and Evaluation of a Community-Based Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation
Keywords
Smoking

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
No change in current practice
Arm Title
Referral fo QuitNow Services
Arm Type
Experimental
Arm Description
Behavioural - referral to QuitNow Services, smoking cessation counseling telephone line supported by the Ministry of Healthy Living and Sport
Intervention Type
Behavioral
Intervention Name(s)
Referral to QuitNow Services
Intervention Description
QuitNow Services is a telephone counseling program supported by the Ministry of Health Living and Sport that counsels individuals to stop smoking
Primary Outcome Measure Information:
Title
Smoking cessation rates between intervention and control arms
Description
Smoking cessation rate between intervention and control arms at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Smoking cessation rates between intervention and control arms
Time Frame
1 month
Title
Smoking cessation rates between intervention and control arms
Time Frame
3 months
Title
Smoking cessation rates between intervention and control arms
Time Frame
6 months
Title
No of cigarettes smoked daily between intervention and control arms
Time Frame
1, 3, 6, and 12 months
Title
Differences in readiness for change between the intervention and control arms
Time Frame
1, 3, 6, and 12 months
Title
Differences in knowledge and attitudes concerning smoking between the intervention and control arms
Time Frame
1, 3, 6, and 12 months
Title
Differences in use of nicotine replacement therapies between the intervention and control arms
Time Frame
1, 3, 6, and 12 months
Title
Differences in number of quit attempts between the intervention and control arms
Time Frame
1,3,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Wai Cheung, MD, MPH
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital Emergency Department, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27748218
Citation
Tsai APY, Tsai JP, Stewart L, Brubacher J, Cheung KW. Prevalence of potential smoking-related conditions among tobacco users in the emergency department and their perception that their visit may be smoking-related. CJEM. 2017 May;19(3):207-212. doi: 10.1017/cem.2016.381. Epub 2016 Oct 17. Erratum In: CJEM. 2017 May;19(3):246.
Results Reference
derived
Links:
URL
http://www.quitnow.ca/index.php
Description
QuitNow Services website

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Emergency Department Smoking Cessation Study

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