The END Perioperative Smoking Pilot Study

Study Overview
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Brief Summary
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The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes and telephone counselling (compared to transdermal nicotine replacement and telephone counselling) as a harm-reduction tool that may lead to increased smoking cessation in the perioperative setting in smokers presenting for elective surgery at the San Francisco Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit, hospital length-of-stay, postoperative complications within the first 30-days, and smoking status 8-weeks after randomization. This pilot study is designed to provide the preliminary data necessary to plan and fund a larger-scale randomized clinical trial that will assess the utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking cessation, specifically in the perioperative setting where the risks of continued smoking are great and the motivation to stop is high.

Detailed Description
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It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. Despite this knowledge, it is unclear what clinicians can do to minimize this risk. Surgery represents a 'teachable moment' that might encourage smokers to engage in permanent cessation. Several small trials have shown that smoking cessation interventions can increase smoking cessation and reduce postoperative complications, particularly wound-healing complications, which can have an absolute risk reduction of up to 25%. Smoking cessation initiated in the perioperative period can also promote long-term smoking cessation. Despite the benefits of comprehensive smoking cessation interventions including nicotine replacement therapy, current standard of care at the SFVAMC does not routinely include specific preoperative smoking cessation pharmacotherapy or counselling. Although there is an urgent need for more data, e-cigarettes have been proposed as an alternative to nicotine replacement therapy that are at least as effective for smoking cessation, and may be more acceptable to some patients. The main hypothesis of this pilot study is that the use of e-cigarettes and telephone counselling, compared to telephone counselling and transdermal nicotine replacement, in the perioperative period results in increased smoking cessation on the day of surgery and at 8-weeks after randomization in smokers presenting for elective surgery. As secondary hypotheses, the study will also assess the acceptability of e-cigarettes versus nicotine patches, postoperative complications within the first 30-days, length-of-stay in the PACU and hospital length-of-stay. The investigators will examine the above hypotheses through the following aims:  Aim 1) To determine how e-cigarettes plus counselling compare to transdermal nicotine replacement plus counselling for the achievement of smoking cessation, when introduced prior to elective surgery in veterans. The investigators plan to carry-out a pilot randomized controlled trial with parallel design comparing e-cigarettes and telephone counselling with transdermal nicotine replacement and telephone counselling. Our primary outcome is smoking cessation on the day of surgery, as confirmed biochemically by exhaled carbon monoxide. Smoking reduction (self-reported cigarettes per day) of 50% or more and bedside spirometry readings will be assessed as secondary outcomes.  Aim 2) To determine the acceptability of e-cigarettes amongst veterans as an aid for smoking cessation and to determine the feasibility of recruitment, randomization, and follow-up procedures in preparation for large-scale trial. Through implementation of this pilot trial, the investigators will determine the feasibility and acceptability of e-cigarettes for smoking cessation perioperatively in the veteran population and obtain the preliminary data necessary to run a larger trial on the effectiveness of e-cigarettes as a perioperative smoking cessation aid.  Aim 3) To determine the safety of e-cigarettes as a harm reduction strategy to achieve short-term perioperative smoking cessation. The investigators plan to improve the overall knowledge of the safety of short-term e-cigarettes use through careful surveillance for adverse events and side effects.  Aim 4) To determine if e-cigarette use preoperatively is associated with a lower risk of complications postoperatively. The investigators plan to measure the following secondary outcomes: postoperative complications and mortality within the first 30 days, post-anesthesia care unit (PACU) length-of-stay, and hospital length-of-stay. This will help us understand if e-cigarettes have the potential to be used for harm-reduction perioperatively.

Official Title
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A Pilot Randomized Controlled Clinical Trial - Electronic Nicotine Delivery Device (E-cigarette) for Perioperative Smoking Cessation in Veterans

Conditions
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Smoking, Nicotine Addiction, Surgery

Intervention / Treatment
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* Behavioral: ENDD (NJOY)
* Drug: NRT (NicoDerm CQ)
* Behavioral: telephone counseling
* Behavioral: brief advice
* Behavioral: brochure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults (age >18) any gender scheduled to undergo elective surgery at the San Francisco Veterans Affairs Medical Center (SFVAMC) daily smoker, based on self-report of at least 2 cigarettes/day and having smoked in the last 7 days presenting to the anesthesia preoperative (APO) clinic at least 3 days preoperatively Exclusion Criteria: emergency surgery (booked <24 hours preoperatively) consumers of non-cigarette forms of tobacco only (pipe, smokeless tobacco) or marijuana only already enrolled in a smoking cessation trial current smoking cessation pharmacotherapy daily user of e-cigarettes previous adverse reaction to e-cigarette or transdermal nicotine poor proficiency of English language¸as indicated by need for an interpreter (including family members) at the preadmission visit lacking capacity for consent (e.g. due to mental illness or dementia), as indicated by consent for surgery and other medical procedures being obtained from a substitute decision maker pregnant or breastfeeding unstable cardiac condition (unstable angina, unstable arrhythmia)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENDD<br>6-week supply of disposable NJOY ENDDs (e-cigarettes) the number of e-cigarettes will be determined by equating the number of e-cigarettes to the number of cigarettes smoked per day (1 pack per day = 2 e-cigarettes per day = 14 e-cigarettes/week) veterans will be given detailed instructions for use and also instructed to start with the high nicotine content (4.5%) strength for three weeks, then decrease to the low nicotine content (2.4%) for two weeks, then switch to nicotine-free for the final week Both groups will receive: i) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery | Behavioral: ENDD (NJOY)<br>* As described above.<br>* Other names: NJOY e-cigarettes;Behavioral: telephone counseling<br>* Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.<br>Behavioral: brief advice<br>* Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible.<br>Behavioral: brochure<br>* A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery. Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf<br>|
| Active Comparator: NRT (NicoDerm CQ)<br>A prescription for 6 weeks of transdermal nicotine replacement (on-formulary at the VA) in the following doses: For smokers of 10 cigarettes per day or more, a 3-week supply of 21 mg/d, 1-week supply of 14 mg/d, 1-week supply of 7 mg/d, and 1-week of 0mg/d. Smokers of <10 cigarettes per day, 3 weeks of 14 mg/d patches 2 weeks of 7 mg/d patches, and 1-week of 0mg/d. Both groups will receive: i) referral to the California Smokers' Helpline, ii) brief advice lasting less than 2 minutes, iii) a brochure from the ASA about quitting smoking before surgery | Drug: NRT (NicoDerm CQ)<br>* As described above.<br>* Other names: nicotine patch;Behavioral: telephone counseling<br>* Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.<br>Behavioral: brief advice<br>* Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible.<br>Behavioral: brochure<br>* A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery. Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO) | Confirmed abstinent. Abstinence confirmed with exhaled carbon monoxoide <10ppm. Time Frame depends on date of preadmission clinic visit | day of surgery (expected average around 1-2 weeks after enrollment/randomization) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Use of Product - Number Reporting Use Daily or Most Days | how often product (e-cigarette or patch) was used (everyday except while hospitalized, most days, a few times a week, once a week, less than once a week, not at all) Result reported is those that used the product daily or most days | 8-weeks | 
| Report of How Helpful the Product Was for Quitting | 7-point likert scale (strongly disagree to strongly agree) strongly disagree disagree disagree somewhat neither agree nor disagree agree somewhat agree strongly agree | 8-weeks | 
| How Satisfied the Patient Was With the Product (E-cigarette or Patch) | 7-point likert scale (strongly disagree to strongly agree) strongly disagree disagree disagree somewhat neither agree nor disagree agree somewhat agree strongly agree | 8-weeks | 
| How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others | 7-point likert scale (strongly disagree to strongly agree) strongly disagree disagree disagree somewhat neither agree nor disagree agree somewhat agree strongly agree | 8-weeks | 
| Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO) | by self-report and confirmed by exhaled CO<10ppm - confirmed abstinent | 8-weeks | 
| Smoking Reduction | 50% or less regular cigarette use compared to baseline as determined by asking participants to self-report daily cigarette use in cigarettes per day at each time point. | on day of surgery and 8-weeks after randomization | 
| Number of Participants With Dual Use | use of both regular and e-cigarettes concurrently | on day of surgery and 8-weeks after randomization | 
| Spirometry - FEV1/FVC Change | Change in FEV1/FVC from baseline to day of surgery / 8-weeks. FEV1/FVC is expressed in percent. For example, if FEV1/FVC was 75%, 80%, and 85% at baseline, day of surgery and 8-weeks, result is reported as change in FEV1/FVC being +5% and +10% for day of surgery and 8-weeks respectively. | day of surgery and 8-weeks | 
| Spirometry - FEV1 | change in FEV1 (mL) compared to baseline | day of surgery and 8-weeks | 
| Cotinine Level (Change in) | salivary | day of surgery and 8-weeks | 
| Number of Participants With Postoperative Complications (Composite) | by chart review - research assistant or investigator examined notes and investigations postoperatively for complications by telephone self-report - patients were asked open-ended question about whether they experienced any postoperative complications | 30-days postop | 
| Long-term Smoking Status - Use of Conventional Cigarettes | by self-report (7-day point prevalence) | 6 months | 
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | all patients will be asked about adverse events each time they are contacted (day of surgery, 30-days postoperatively, and 8-weeks after randomization), and they will also be able to call to report adverse events to the study team any time during the study. | 8 weeks | 
| Number of Participants Postoperative Complications (Composite) | by telephone self-report | 30-days postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic cigarette, nicotine replacement therapy, smoking cessation, perioperative