Perioperative Smoking Cessation BUndle in a Tertiary Care Hospital - Can Turning Virtual Improve Outcomes?

NCT04487548 | Completed

• 1 other identifier: FHREB 2017-099
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking continues to be a burden to the healthcare system in Canada. It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. A quality improvement project at Royal Columbian Hospital recently showed that it is possible to implement a smoking cessation bundle for all current smokers during their preadmission clinic visit. However, due to the COVID-19 pandemic, much of the bundle was abandoned as it relied heavily on in-person interactions. The investigators wish to study the effect of a structured smoking cessation bundle, delivered remotely, on smoking cessation and postoperative complications. The aim is to determine the feasibility of giving the remotely delivered bundle to elective surgical patients before or around the time of a preadmission clinic visit, and whether it can reduce smoking rates and postoperative complications versus the standard uncoordinated advice.

Conditions

Smoking Cessation; Surgical Complications

Keywords

Smoking; Surgery; Anesthesia; Complications

Outcome Measures

Primary Outcomes (4)

• Uptake of smoking cessation resources

  The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.

  Day of surgery

• Uptake of smoking cessation resources

  The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.

  30 days postoperatively

• Uptake of smoking cessation resources

  The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.

  8 weeks post-randomization

• Uptake of smoking cessation resources

  The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.

  6 months postoperatively

Secondary Outcomes (9)

• Recruitment rate

  Enrollment

• Recruitment timing

  Enrollment

• Participant satisfaction with smoking cessation bundle assessed by study questionnaire

  8 weeks post-randomization

• Change in smoking status from baseline

  Day of surgery, 30 days postoperatively, 8 weeks post-randomization and 6 months postoperatively

• Hospital Length of Stay

  First 30 days

Study Arms (2)

Control group

NO INTERVENTION

The control group will have their preadmission clinic telephone call as normal and may be given advice to quit smoking and information about available smoking cessation resources over the phone.

Intervention group

EXPERIMENTAL

The intervention group will be emailed (or postal mailed) the smoking cessation bundle with educational video, brochure, referral to the Smokers' Helpline and direct referral to an online pharmacy for nicotine replacement.

Other: Remote smoking cessation bundle

Interventions

Remote smoking cessation bundle OTHER

The bundle is a remote version of what has previously been described in prior literature, which includes: 1. A brief (\<5 minutes) advice 2. Preoperative smoking cessation video prepared by QuitNow 3. Patients will be provided brochures on smoking cessation 4. A referral will be faxed (or internet-registered) to the Quitnow.ca Smokers' Helpline 5. All patients will be requested to participate in the provincial Smoking Cessation program that provides a free 12-week supply of NRT once per year.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and over.
• Current smoker (self-identified from pre-surgical package).
• Surgery date over 1 week away or not yet booked.

You may not qualify if:

• Emergency surgery.
• Smokers who only consume non-cigarette forms of tobacco (pipe, smokeless tobacco).
• Smokers who only consume marijuana or vaping.
• Patients who are pregnant or breastfeeding.
• Inability to provide informed consent.
• Currently enrolled in any other research study involving smoking cessation.

Sponsors & Collaborators

• Fraser Health: lead
• Royal Columbian Hospital Foundation: collaborator

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Related Publications (1)

• Pillar M, Sara R, Burditt D, Rai RK, Monteiro L, Lertnamvongwan R, Mozel M, Merchant R, Lee SM. A pilot randomized trial of a virtual perioperative smoking cessation bundle in a tertiary care hospital. Can J Surg. 2025 Nov 13;68(6):E460-E468. doi: 10.1503/cjs.016224. Print 2025 Nov-Dec.

  PMID: 41233153 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Susan M Lee, MD, FRCPC

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

• Michelle Mozel, MSc

  Fraser Health Authority

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Blinding of study participants is not possible. Blinding of staff may not always be possible, although staff will not be informed which group the participant has been randomized to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Study Design This pilot randomized controlled trial with two parallel arms will be undertaken with current smokers who are scheduled for elective surgery at RCH. Participants will be randomized to a smoking cessation bundle (video, electronic or mailed brochure, referral to QuitNow.ca Smokers' Helpline and pharmacological smoking cessation therapy) or standard care (advice to quit and inconsistent recommendation of resources). All current adult smokers being scheduled for elective surgery at RCH will be invited to participate. The investigators plan on recruiting 30 participants with 15 participants per group. Every eligible patient will be invited to participate.

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: July 27, 2020
• Study Start: February 24, 2022
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: August 14, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)