Peri Operative Smoking Cessation Program

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053155
• Other study ID #: 6/11/2013
• Status: Completed
• Phase: N/A
• First received: January 31, 2014
• Last updated: December 3, 2015
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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.

Other known NCT identifiers

• NCT01904370

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Computer based patient education

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Womens College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit rate	we will do urine cotinine analysis to confirm the abstinence	6 month	No
Secondary	Surgical outcome	we will do a chart review to find out the intraoperative and post operative complications	1 month	No