Tobacco Use CessationNCT01454375
Emergency Department Smoking Cessation Study
A study testing Referral to QuitNow Services in people with Tobacco Use Cessation, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Referral to QuitNow Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,301 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cannot provide informed consent
- sexual assault patients
- not a resident of British Columbia
- unable to provide telephone number of email address for follow-up
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital Emergency Department, University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Use Cessation
- Being tested
- Referral to QuitNow Services
- Keywords
- Smoking
- Medical subject headings
- Tobacco Use Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to QuitNow ServicesBehavioural
QuitNow Services is a telephone counseling program supported by the Ministry of Health Living and Sport that counsels individuals to stop smoking
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | No change in current practice |
| Referral fo QuitNow Services | Experimental | Behavioural - referral to QuitNow Services, smoking cessation counseling telephone line supported by the Ministry of Healthy Living and Sport Receives: Behavioral: Referral to QuitNow Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rates between intervention and control arms
Smoking cessation rate between intervention and control arms at 12 months
Measured: 12 months
Secondary outcomes (8)
Smoking cessation rates between intervention and control arms
Measured: 1 month
Smoking cessation rates between intervention and control arms
Measured: 3 months
Smoking cessation rates between intervention and control arms
Measured: 6 months
No of cigarettes smoked daily between intervention and control arms
Measured: 1, 3, 6, and 12 months
Differences in readiness for change between the intervention and control arms
Measured: 1, 3, 6, and 12 months
Differences in knowledge and attitudes concerning smoking between the intervention and control arms
Measured: 1, 3, 6, and 12 months
Differences in use of nicotine replacement therapies between the intervention and control arms
Measured: 1, 3, 6, and 12 months
Differences in number of quit attempts between the intervention and control arms
Measured: 1,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Ka Wai Cheung, MD, MPH, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454375
- Sponsor's protocol ID
- H10-01625
- Status last verified
- Oct 2014
- First submitted
- 15 Oct 2011
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27748218
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Tobacco Cessation Counseling: Implementation and Evaluation of a Community-Based Program
- ClinicalTrials.gov ID
- NCT01454375
- Acronym / sponsor ID
- H10-01625
- Conditions
- Tobacco Use Cessation
- Keywords
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,301 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –No change in current practice |
| Referral fo QuitNow Services | Experimental | Behavioral: Referral to QuitNow ServicesBehavioural - referral to QuitNow Services, smoking cessation counseling telephone line supported by the Ministry of Healthy Living and Sport |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- cannot provide informed consent
- sexual assault patients
- not a resident of British Columbia
- unable to provide telephone number of email address for follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral to QuitNow ServicesQuitNow Services is a telephone counseling program supported by the Ministry of Health Living and Sport that counsels individuals to stop smoking | Behavioural | Referral fo QuitNow Services |
Primary outcome
Smoking cessation rates between intervention and control arms
Time frame: 12 months
Smoking cessation rate between intervention and control arms at 12 months
8 secondary outcomes
Smoking cessation rates between intervention and control arms
Time frame: 1 month
Smoking cessation rates between intervention and control arms
Time frame: 3 months
Smoking cessation rates between intervention and control arms
Time frame: 6 months
No of cigarettes smoked daily between intervention and control arms
Time frame: 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
Differences in knowledge and attitudes concerning smoking between the intervention and control arms
Time frame: 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
Differences in number of quit attempts between the intervention and control arms
Time frame: 1,3,6,12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Derived from this study: PubMed 27748218Tsai 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.
- QuitNow Services websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Wai Cheung, MD, MPH principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral to QuitNow Services in people with Tobacco Use Cessation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation rates between intervention and control arms (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01454375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.