Feasibility of a Virtual Smoking Cessation Program

Study Overview
=================
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.

Official Title
-----------------
Development and Evaluation Of A Virtual Smoking Cessation Program - A Pilot Study

Conditions
-----------------
Smoking, Smoking Cessation, Smoking Reduction, Perioperative/Postoperative Complications, Fractures, Bone

Intervention / Treatment
-----------------
* Behavioral: Virtual Smoking Cessation Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm: Virtual Group<br>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<br>* 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.<br>|
| No Intervention: Control Arm: Standard Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At time of recruitment, and after module completion (Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment) | 
| Cigarettes smoked | The number of cigarettes smoked per day. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 
| 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 | 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 | 
| 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. | Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment | 
| Readmission | The number of readmissions to the hospital will be obtained from the patient's electronic health record. | Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking, Smoking Cessation, Electronic Mail, Virtual Program, Fracture, Surgery, Perioperative