Clinical trial NCT05594199: Feasibility of a Virtual Smoking Cessation Program
Official title: Development and Evaluation Of A Virtual Smoking Cessation Program - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Smoking Reduction
Perioperative/Postoperative Complications
Fractures, Bone
Keywords: Smoking
Smoking Cessation
Electronic Mail
Virtual Program
Fracture
Surgery
Perioperative
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Smoking is the most preventable cause of disease and premature death in Canada. In this pilot study our aim is to determine whether a virtual perioperative program, using automated emails, for smoking cessation is feasible and acceptable for increasing abstinence from smoking, compared to the usual care in patients undergoing surgery or with an acute traumatic fracture. Patients that present to the preoperative clinic or fracture clinic will be recruited for this trial. This feasibility study will be followed by the proposed randomized control trial to identify whether our planned study procedures are acceptable to surgical patients.

Both components of the virtual smoking cessation program (Smoking cessation e-learning modules and Virtual Program Evaluation) will be more personalized to the patient as the patient's nicotine dependence will determine the tailored information that will be provided in the e-learning module and the email messages. Study procedures and components of the virtual smoking cessation program will be modified for clinical use and future research based on the feedback from this pilot study.

Eligibility criteria: Inclusion Criteria:

* 18+ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Trial feasibility - Recruitment
timeFrame: Surgery: 30 days after surgery; Fracture Clinic: 30 days
measure: Trial feasibility - Acceptability of the email message program component
timeFrame: Surgery: 30 Days after surgery; Fracture Clinic: 30 days after study recruitment
measure: Trial feasibility - Acceptability of e-learning module program component
timeFrame: Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment
measure: Trial feasibility - EPIC patient portal usage
timeFrame: 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
measure: Trial feasibility - Retention
timeFrame: Surgery: 30 days after surgery; Fracture Clinic: 30 days
Secondary outcomes:
measure: Module Education
timeFrame: At time of recruitment, and after module completion (Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment)
measure: Cigarettes smoked
timeFrame: 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
measure: Quit attempts
timeFrame: 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
measure: Nicotine Dependence
timeFrame: 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
measure: Stage of change
timeFrame: 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
measure: Self or assisted quit attempt
timeFrame: 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
measure: Complications/Adverse Events
timeFrame: Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment
measure: Readmission
timeFrame: Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jean Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.