- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02053155
Peri Operative Smoking Cessation Program
Development and Implementation of a Peri Operative Smoking Cessation Program With Computer Based Patient Education.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be enrolled in the quit smoking before surgery program. Before participating in the education program, the investigators will ask patients questions about their smoking habits, and patient will complete pre-education questionnaires that should take about 5 minutes. Patients will participate in a computer-based education program about quitting smoking for about 15 minutes. It will explain the importance of quitting smoking before their surgery, how to quit and coping with quitting. If they are not familiar with using a computer, we will provide an assistant for them to complete the education program. After completing the education program, they will complete a post-education questionnaire. patients will also receive an information pamphlet.
All participants will receive the computer-based education program, brief counselling, pamphlet, Smokers' Helpline referral, and telephone follow-up.
Altogether you will be spending about 30 minutes to complete the assessment, education program and counselling.
patients will be asked for their permission to inform their family physician about their participation in this study. Their smoking status, date of surgery, quit date, and recommended medication (when appropriate) will be faxed to your family physician to assist them quitting process. If they are willing to accept the assistance from Smokers' Helpline, their name and phone number will be faxed to the Smokers' Helpline, and someone from Smokers' Helpline will call you in the next 48 hours to follow-up.
The investigators will monitor patient's smoking behavior by measuring expired carbon monoxide, a gas in the air they breathe out, during their pre-surgery visit and on the day of surgery. We also will measure urine cotinine (a by-product of nicotine) by taking urine samples and check their smoking status by asking questions about their smoking habits on the day of surgery, 1 month, 3 months and 6 months after their surgery. During the telephone interview follow-up, we will remind them to do the urine cotinine and mail it to us. (Prepaid mail with urine cotinine strip will be provided at the time of the 2nd visit on the day of surgery.) Each follow-up phone call will take about 6 -10 minutes.
A one-month,3 month and 6 month follow up will be done by the research coordinator to assess the smoking status. Brief counseling (< 5 mins) will be provided.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
-
Toronto, Ontario, Canada
- Toronto Western Hospital
-
Toronto, Ontario, Canada
- Womens College Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients> 18 years of age
- self reported smokers ( daily or non daily smokers)
- Scheduled for elective surgical procedures
Exclusion Criteria:
- patients who cannot read and understand English
- Have any form of cognitive impairment
- Do not have a telephone
- Drug or alcohol abuser dependence within the past year
- Patients whop are already on pharmacotherapy for smoking cessation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: computer based patient education
The patients will complete a pre module and post module set of questions to determine whether their knowledge about peri operative smoking cessation increase smoking has changed.
According to their willingness and eligibility, pharmacotherapy will be given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quit rate
Time Frame: 6 month
|
we will do urine cotinine analysis to confirm the abstinence
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical outcome
Time Frame: 1 month
|
we will do a chart review to find out the intraoperative and post operative complications
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean Wong, FRCPC, Associate professor, dewpartment of anesthesia. Toronto Western Hospital, University Health Network, University of Toronto, Toronto, Ontario
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 6/11/2013
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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