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Feasibility of a Virtual Smoking Cessation Program

Primary Purpose

Smoking, Smoking Cessation, Smoking Reduction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Smoking Cessation Program
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Smoking focused on measuring Smoking, Smoking Cessation, Electronic Mail, Virtual Program, Fracture, Surgery, Perioperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Arm: Virtual Group

    Control Arm: Standard Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Module Education
    The effectiveness of the virtual program's e-learning module component will be assessed by a survey that will evaluate the patient's understanding of the risks of smoking before/after surgery and while recovering from a fracture using a 5-point Likert scale.
    Cigarettes smoked
    The number of cigarettes smoked per day.
    Quit attempts
    The number of quit attempts made since study recruitment. A quit attempt will be defined by a patient making a serious, conscious attempt to completely abstain from cigarette smoking and has abstained from smoking for at least 24 hours.
    Nicotine Dependence
    Nicotine dependence will be assessed using the Fagerström test for nicotine dependence, which is a standard instrument for assessing the intensity of physical addiction to nicotine.
    Stage of change
    Stage of Change will be assessed using Prochaska and DiClemente's Stages of Change Model, a transtheoretical model of change that proposes a series of stages through which smokers move as they successfully change their smoking habit.
    Self or assisted quit attempt
    Participants will be asked to report whether they are currently going through a self-quit attempt or a quit attempt assisted by a health care professional
    Complications/Adverse Events
    Complications/adverse events regarding the patient's surgery or recovery from fracture will be obtained from the patient's electronic health record.
    Readmission
    The number of readmissions to the hospital will be obtained from the patient's electronic health record.

    Full Information

    First Posted
    October 21, 2022
    Last Updated
    October 25, 2022
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05594199
    Brief Title
    Feasibility of a Virtual Smoking Cessation Program
    Official Title
    Development and Evaluation Of A Virtual Smoking Cessation Program - A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking, Smoking Cessation, Smoking Reduction, Perioperative/Postoperative Complications, Fractures, Bone
    Keywords
    Smoking, Smoking Cessation, Electronic Mail, Virtual Program, Fracture, Surgery, Perioperative

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Arm: Virtual Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Arm: Standard Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual Smoking Cessation Program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Trial feasibility - Recruitment
    Description
    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
    Time Frame
    Surgery: 30 days after surgery; Fracture Clinic: 30 days
    Title
    Trial feasibility - Acceptability of the email message program component
    Description
    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.
    Time Frame
    Surgery: 30 Days after surgery; Fracture Clinic: 30 days after study recruitment
    Title
    Trial feasibility - Acceptability of e-learning module program component
    Description
    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.
    Time Frame
    Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment
    Title
    Trial feasibility - EPIC patient portal usage
    Description
    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.
    Time Frame
    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
    Title
    Trial feasibility - Retention
    Description
    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.
    Time Frame
    Surgery: 30 days after surgery; Fracture Clinic: 30 days
    Secondary Outcome Measure Information:
    Title
    Module Education
    Description
    The effectiveness of the virtual program's e-learning module component will be assessed by a survey that will evaluate the patient's understanding of the risks of smoking before/after surgery and while recovering from a fracture using a 5-point Likert scale.
    Time Frame
    At time of recruitment, and after module completion (Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment)
    Title
    Cigarettes smoked
    Description
    The number of cigarettes smoked per day.
    Time Frame
    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
    Title
    Quit attempts
    Description
    The number of quit attempts made since study recruitment. A quit attempt will be defined by a patient making a serious, conscious attempt to completely abstain from cigarette smoking and has abstained from smoking for at least 24 hours.
    Time Frame
    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
    Title
    Nicotine Dependence
    Description
    Nicotine dependence will be assessed using the Fagerström test for nicotine dependence, which is a standard instrument for assessing the intensity of physical addiction to nicotine.
    Time Frame
    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
    Title
    Stage of change
    Description
    Stage of Change will be assessed using Prochaska and DiClemente's Stages of Change Model, a transtheoretical model of change that proposes a series of stages through which smokers move as they successfully change their smoking habit.
    Time Frame
    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
    Title
    Self or assisted quit attempt
    Description
    Participants will be asked to report whether they are currently going through a self-quit attempt or a quit attempt assisted by a health care professional
    Time Frame
    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
    Title
    Complications/Adverse Events
    Description
    Complications/adverse events regarding the patient's surgery or recovery from fracture will be obtained from the patient's electronic health record.
    Time Frame
    Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment
    Title
    Readmission
    Description
    The number of readmissions to the hospital will be obtained from the patient's electronic health record.
    Time Frame
    Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jean Wong, MD
    Phone
    416-603-5800
    Ext
    3635
    Email
    jean.wong@uhn.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean Wong, MD
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27274333
    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.
    Results Reference
    background
    PubMed Identifier
    1932883
    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.
    Results Reference
    background
    PubMed Identifier
    11725245
    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.
    Results Reference
    background
    PubMed Identifier
    21295194
    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.
    Results Reference
    background
    PubMed Identifier
    21403009
    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.
    Results Reference
    background

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    Feasibility of a Virtual Smoking Cessation Program

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