Development and Evaluation of a Virtual Smoking Cessation Program - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Trial feasibility - Retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Trial feasibility - Retention
时间窗: Surgery: 30 days after surgery; Fracture Clinic: 30 days
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.
Trial feasibility - Acceptability of the email message program component
时间窗: Surgery: 30 Days after surgery; Fracture Clinic: 30 days after study recruitment
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
时间窗: Surgery: Before surgery; Fracture Clinic: Day 7 after study recruitment
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 - Recruitment
时间窗: Surgery: 30 days after surgery; Fracture Clinic: 30 days
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 - EPIC patient portal usage
时间窗: 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
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.
次要结局
- Readmission(Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment)
- 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)
- Self or assisted quit attempt(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(Surgery: 30 days after surgery; Fracture Clinic: 30 days after study recruitment)
研究者
Jean Wong
Staff Anesthesiologist
University Health Network, Toronto