Feasibility of a Virtual Smoking Cessation Program

NCT05594199 | Completed

• 1 other identifier: 22-5475
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study of a clinical trial is to learn about the acceptability and feasibility of a virtual smoking cessation program in both the perioperative and fracture clinic settings. The main questions this study aims to answer are:

• The number of people that participate in the virtual smoking cessation program
• The acceptability of the number, length, content, and delivery of the email messages provided by the program. Participants will be asked to subscribe to our virtual intervention which will include:
• A smoking cessation e-learning module component to provide education on the risks of smoking in the surgical or fracture clinic setting, and
• An emailing program component that will provide tailored email messages over a 30-45 day period depending on a patient's Fagerstrom test for nicotine dependence score and motivation to quit smoking. Researchers will also compare the virtual smoking cessation program to standard care to see if there are any differences shown between both groups in the Fagerstrom test for nicotine dependence scores, number of cigarettes smoked, number of quit attempts, complication rates, and re-admission rates at the 7 day and 30 day time points.

Conditions

Smoking; Smoking Cessation; Smoking Reduction; Perioperative/Postoperative Complications; Fractures, Bone

Keywords

Smoking; Smoking Cessation; Electronic Mail; Virtual Program; Fracture; Surgery; Perioperative

Outcome Measures

Primary Outcomes (5)

• Trial feasibility - Recruitment

  Feasibility as assessed by recruitment rate. This will be assessed as the proportion of participants who agree to participate compared to the number of patients who had met the inclusion/exclusion criteria and were approached to participate in the study. The demographics of those who declined to participate or dropped out of the virtual program will be assessed for trends within the population who do not wish to participate in the virtual smoking cessation program

  Surgery: 30 days after surgery; Fracture Clinic: 30 days

• Trial feasibility - Acceptability of the email message program component

  Patients will be asked to evaluate the email program and messages provided during their participation in the virtual program through a questionnaire that will evaluate the frequency, length, content, delivery, and duration of the email message component using a 5-point Likert scale.

  Surgery: 30 Days after surgery; Fracture Clinic: 30 days after study recruitment

• Trial feasibility - Acceptability of e-learning module program component

  Patients will be asked to evaluate the e-learning module once they completed it. A survey will be administered to evaluate the content and comprehension of the e-learning module using a 5-point Likert scale.

  Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment

• Trial feasibility - EPIC patient portal usage

  The feasibility of delivering this virtual program through the patient portal will be assessed by the proportion of study participants who have self-reported patient portal use compared to the total number of study participants.

  Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up

• Trial feasibility - Retention

  Feasibility as assessed by the retention rates. This will be defined as the proportion of program participants completing the study at the final follow-up compared to the participants enrolled. Reasons for withdrawal will also be recorded to assess any trends that occur among participants who drop out.

  Surgery: 30 days after surgery; Fracture Clinic: 30 days

Secondary Outcomes (8)

• Module Education

  At time of recruitment, and after module completion (Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment)

• Cigarettes smoked

  Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up

• Quit attempts

  Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up

• Nicotine Dependence

  Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up

• Stage of change

  Surgery: (i)Day of recruitment, (ii)Day of Surgery, (iii) 7 day follow-up, (iv) 30 day follow-up; Fracture Clinic: (i)Day of recruitment, (ii)7 day follow-up, (iii) 14 day follow-up, (iv) 30 day follow-up

Study Arms (2)

Intervention Arm: Virtual Group

EXPERIMENTAL

The intervention will involve participating in the study's virtual smoking cessation program. This program consists of 2 components: an e-learning module and a tailored email messaging program based on the participant's motivation to quit smoking and their Fagerstrom test for nicotine dependence score.

Behavioral: Virtual Smoking Cessation Program

Control Arm: Standard Care

NO INTERVENTION

This arm will receive standard care which may or may not include brief advice to quit smoking from any of the healthcare providers. Providing smoking cessation intervention is not mandatory in standard care and may not be provided.

Interventions

Virtual Smoking Cessation Program BEHAVIORAL

This program consists of an e-learning smoking cessation education module and a tailored email messaging program. The e-learning module addresses the potential health benefits to quitting smoking regarding surgery or recovering from a fracture. In addition, it provides information on getting support through the process of quitting smoking based on the individual's level of smoking dependence. Email frequency and content will vary based on the participant's score and level of motivation. Information will include the risks associated with smoking before surgery or how quitting smoking can improve recovery from a fracture injury. Additional information includes the benefits of quitting smoking and developing coping strategies during a quit attempt. Motivational emails and references to free resources for additional smoking cessation support will also be provided.

Intervention Arm: Virtual Group

Eligibility Criteria

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

You may qualify if:

• + years of age
• Daily or non-daily smoker
• Self-reported smokers who have smoked cigarettes within the past 30 days
• Must be a patient at Toronto Western Hospital or Women's College Hospital who is:
• Scheduled for an elective surgical procedure that will occur at least 48 hours after recruitment OR
• Visiting the fracture clinic (UHN) within and including 14 days from the initial date of injury or operation
• Must have a working e-mail address

You may not qualify if:

• Patients who have already quit smoking for more than 30 days,
• Patients who cannot read and understand English,
• Patients who have any form of cognitive impairment,
• Patients who do not have a telephone (for follow-up).
• Currently on pharmacological therapy for smoking cessation
• Drug or alcohol abuse or dependence within the past year

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (5)

• Graham AL, Carpenter KM, Cha S, Cole S, Jacobs MA, Raskob M, Cole-Lewis H. Systematic review and meta-analysis of Internet interventions for smoking cessation among adults. Subst Abuse Rehabil. 2016 May 18;7:55-69. doi: 10.2147/SAR.S101660. eCollection 2016.

  PMID: 27274333 BACKGROUND

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

  PMID: 1932883 BACKGROUND

• Andersen T, Christensen FB, Laursen M, Hoy K, Hansen ES, Bunger C. Smoking as a predictor of negative outcome in lumbar spinal fusion. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2623-8. doi: 10.1097/00007632-200112010-00018.

  PMID: 11725245 BACKGROUND

• Mills E, Eyawo O, Lockhart I, Kelly S, Wu P, Ebbert JO. Smoking cessation reduces postoperative complications: a systematic review and meta-analysis. Am J Med. 2011 Feb;124(2):144-154.e8. doi: 10.1016/j.amjmed.2010.09.013.

  PMID: 21295194 BACKGROUND

• Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications: a systematic review and meta-analysis. Arch Intern Med. 2011 Jun 13;171(11):983-9. doi: 10.1001/archinternmed.2011.97. Epub 2011 Mar 14.

  PMID: 21403009 BACKGROUND

MeSH Terms

Conditions

Smoking; Smoking Cessation; Smoking Reduction; Postoperative Complications; Fractures, Bone

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Jean Wong, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: December 1, 2022
• Primary Completion: August 11, 2024
• Study Completion: September 11, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CA (1)