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Smoking CessationNCT02053155

Peri Operative Smoking Cessation Program

A study testing Computer based patient education in people with Smoking Cessation, run by University Health Network, Toronto at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Implementation of a perioperative smoking cessation program with computer based patient education increases the rate of short term (1 month) and long term (6 month) reduces the incidence of perioperative complications in elective surgical patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
Computer based patient education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
345 participants
Where
3 sitesCanada
Study dates
Jul 2013to Jun 2015
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients> 18 years of age
  • self reported smokers ( daily or non daily smokers)
  • Scheduled for elective surgical procedures

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites
  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Toronto Western Hospital

    Toronto, Ontario

  • Womens College Hospital

    Toronto, Ontario

Other trials in Canada

About this study

Official title: Development and Implementation of a Peri Operative Smoking Cessation Program With Computer Based Patient Education.

Implementation of a perioperative smoking cessation program with computer based patient education increases the rate of short term (1 month) and long term (6 month) reduces the incidence of perioperative complications in elective surgical patients.

Read the 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.

Being tested
Computer based patient education
Keywords
Smoking cessation, perioperative complication, Smokerlyzer, smokers help line
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer based patient educationBehavioural

Study groups in NCT02053155
Study groupRoleWhat they receive
computer based patient educationExperimentalThe 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.
Receives: Behavioral: Computer based patient education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quit rate

    we will do urine cotinine analysis to confirm the abstinence

    Measured: 6 month

Secondary outcomes (1)
  1. Surgical outcome

    we will do a chart review to find out the intraoperative and post operative complications

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2014 (estimated)
  2. Study startJul 2013
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02053155
Sponsor's protocol ID
6/11/2013
Status last verified
Dec 2015
First submitted
31 Jan 2014
Last updated
4 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Wong J, Raveendran R, Chuang J, Friedman Z, Singh M, Patras J, Wong DT, Chung F. Utilizing Patient E-learning in an Intervention Study on Preoperative Smoking Cessation. Anesth Analg. 2018 May;126(5):1646-1653. doi: 10.1213/ANE.0000000000002885.

    PubMed 29517567

Questions about this trial

What is this clinical trial studying?

A study testing Computer based patient education in people with Smoking Cessation, run by University Health Network, Toronto at 3 sites 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 3 inclusion and 5 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 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Quit rate (time frame: 6 month). 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 NCT02053155, 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 4 Dec 2015; AzTrials last refreshed its copy on 5 Nov 2026.

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