Clinical trial NCT04487548: Perioperative Smoking Cessation BUndle in a Tertiary Care Hospital - Can Turning Virtual Improve Outcomes?
Official title: Perioperative Smoking Cessation BUndle in a Tertiary Care Hospital - Can Turning Virtual Improve Outcomes? A Pilot Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Surgical Complications
Keywords: Smoking
Surgery
Anesthesia
Complications
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: Royal Columbian Hospital Foundation
First posted: 2020-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Design This pilot randomized controlled trial with two parallel arms will be undertaken with current smokers who are scheduled for elective surgery at RCH. Participants will be randomized to a smoking cessation bundle (video, electronic or mailed brochure, referral to QuitNow.ca Smokers' Helpline and pharmacological smoking cessation therapy) or standard care (advice to quit and inconsistent recommendation of resources).

All current adult smokers being scheduled for elective surgery at RCH will be invited to participate. The investigators plan on recruiting 30 participants with 15 participants per group. Every eligible patient will be invited to participate.
Primary purpose: PREVENTION

Brief summary: Smoking continues to be a burden to the healthcare system in Canada. It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. A quality improvement project at Royal Columbian Hospital recently showed that it is possible to implement a smoking cessation bundle for all current smokers during their preadmission clinic visit. However, due to the COVID-19 pandemic, much of the bundle was abandoned as it relied heavily on in-person interactions. The investigators wish to study the effect of a structured smoking cessation bundle, delivered remotely, on smoking cessation and postoperative complications. The aim is to determine the feasibility of giving the remotely delivered bundle to elective surgical patients before or around the time of a preadmission clinic visit, and whether it can reduce smoking rates and postoperative complications versus the standard uncoordinated advice.

Detailed description: Introduction and Background Smoking continues to be a burden to the healthcare system in Canada. As of 2019, 3.7 million Canadians (12% of the population over age 15) reported being a current smoker. British Columbia's smoking rate is lower, but 10.2% of adults still regularly smoke cigarettes1. It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. Pulmonary complications, cardiovascular complications, and surgical site infections are mediators of smoking-associated mortality at 6-months and 1-year after elective surgery.

Although there have been a handful of studies that have demonstrated dramatic reductions in postoperative complications with well-timed smoking cessation interventions in the preoperative period, these results have not translated into widespread clinical practice in delaying surgery for the purpose of achieving smoking cessation. In addition, most of these studies took place in Europe, where smokers may behave differently than in the Canadian setting.

A systematic review recommended at least 4 weeks of smoking cessation in order to reduce postoperative complications6. Several European studies have shown dramatic reductions in complications (up to 30% absolute risk reductions) when smoking cessation interventions have been implemented 4-8 weeks preoperatively. One Canadian editorial even suggested new policies be put into place to delay elective surgeries in smokers until a trial of cessation for 6 weeks had taken place.

Implementation of smoking cessation programs preoperatively have the potential to reduce morbidity and mortality. A Cochrane systematic review has shown that preoperative smoking cessation therapy improves both short and long-term smoking cessation. In fact, a surgical encounter with the healthcare system has been described as a "teachable moment" that provides motivation for patients to permanently stop smoking. Despite this information, most anesthesiologists do not routinely offer smoking cessation advice to their patients and advice, counselling, and pharmacotherapy for smoking cessation is not routine in pre-admission clinics across Canada and the United States.

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%. Prior work by one of the co-investigators showed that a simple intervention in the pre-admission clinic was able to increase the abstinence rate from 3.6% to 14.3% on the day of surgery. Smoking cessation initiated in the perioperative period can also promote long-term smoking cessation.

Despite these successes, since the COVID-19 pandemic, standard care at Royal Columbian Hospital (RCH) has not routinely included specific preoperative smoking cessation pharmacotherapy or counselling. However, hospital leaders and the RCH Department of Anesthesia have identified preoperative preparation, including smoking cessation, as a key area of interest for development. Therefore, this is the ideal time to study the feasibility of the perioperative smoking cessation bundle given to patients without the requirement for an in-person visit. Advantages of this remote model are expected to continue after the pandemic restrictions end, since smoking cessation bundles will be able to be started earlier (and thus have more potential to prevent surgical complications), compared to waiting for a preadmission clinic visit, which can often occur only a few days preoperatively. The perioperative smoking cessation bundle will include: an emailed link to a quitnow.ca preoperative smoking cessation video and referral to quit coach, free nicotine replacement therapy (NRT) delivered by an online pharmacy, an emailed or post-mailed RCH smoking cessation brochure, and brief telephone advice. This bundle will be offered to those regular smokers of cigarettes randomized to the intervention group following their surgical consultation, at the time of preadmission clinic appointment booking, or following their preadmission telephone consultation. The control group will receive the standard of care which sometimes includes brief advice and informing patients about availability of further aids.

Once the simple smoking cessation intervention has been implemented for the intervention group, the investigators wish to compare rates of resource access, smoking cessation, and postoperative complications between the group receiving the smoking cessation bundle and those receiving standard care. Due to the COVID-19 pandemic, in-person preadmission clinic visits are no longer scheduled. Instead, high-risk surgical patients are phoned prior to surgery to mitigate surgical risk factors and better prepare them for surgery. Self-identification as a regular smoker is one risk factor that would warrant recruitment into the study.

The investigators estimated that a definitive randomized controlled trial would require a sample size of 214 participants. However, relatively low rates of smoking in British Columbia and the cancellation of in-person preadmission clinic visits present a unique challenge to patient recruitment. It is therefore imperative to establish the recruitment rate for progression to a full randomized controlled trial.

Additionally, a preliminary analysis of rates of smoking and reduction of postoperative complications in elective surgical patients when the smoking cessation bundle is given to patients immediately following their preadmission clinic telephone consultation will be conducted. The investigators plan to carry out a pilot randomized controlled trial where patients who identify as smokers will be randomized to receive the remotely delivered smoking cessation bundle versus standard care.

Purpose and Justification Most randomized studies showing improved smoking cessation rates after preoperative interventions have strict inclusion and exclusion criteria, and required ongoing consent for research experimentation, which limits their external generalizability. The BuTT Out Pilot Study is of utmost importance since it has the potential to demonstrate reductions in surgical site infections and lengths-of-stay using a low-cost intervention (a bundle of emailed video, brochure, helpline referral and government funded smoking-cessation therapy). A 2020 survey of the BC Smoking Cessation Program reported that 66% of respondents found the program helpful, with a quit rate of 37%. Providing the program as a part of a structured bundle will improve the accessibility of smoking cessation aids. If this hypothesis is confirmed as suspected since it is based on prior research in other countries, widespread implementation could translate into tremendous advantages for the patient, in terms of reduced complications, and providers, in terms of cost savings. Conducting a pilot study will help mitigate the challenge of recruiting an adequate sample size by establishing a recruitment rate and consequently improve the feasibility of a definitive randomized controlled trial. Since this study will examine remotely-delivered interventions, its potential for widespread use will be much greater than other previously studied in-person study designs.

Research Question For patients who smoke undergoing elective surgery, what is the effect of an evidence-based remotely-delivered smoking cessation bundle administered preoperatively on patients' outcomes (smoking rates, complication rates and hospital length of stay) compared with standard practice which sometimes includes brief advice and informing patients about availability of further aids?

Research Objectives To establish the recruitment rate, optimal recruitment pathway, and rate of accessing of available resources as criteria for progression to a definitive randomized controlled trial.

To determine whether smoking rates, surgical complications, and postoperative complications can be documented in elective surgical patients when the remotely-delivered smoking cessation bundle is administered preoperatively vs. standard care.

Research Hypothesis The hypothesis for this pilot RCT is that at least 8 patients will be screened per week, at least 25% will give informed consent, and \>80% will adhere to the study protocol.

The overarching research hypothesis is that in patients who smoke, receiving the remotely-delivered perioperative smoking cessation bundle prior to elective surgery for the purpose of quitting smoking will result in reduced smoking rates on the day of surgery, lower 30-day complications, and shorter lengths of stay. Definitive estimation of effect size is not expected from this pilot study, but confidence intervals will give rise to sample size estimation for a future full-size trial.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 years and over.
2. Current smoker (self-identified from pre-surgical package).
3. Surgery date over 1 week away or not yet booked.

Exclusion criteria

1. Emergency surgery.
2. Smokers who only consume non-cigarette forms of tobacco (pipe, smokeless tobacco).
3. Smokers who only consume marijuana or vaping.
4. Patients who are pregnant or breastfeeding.
5. Inability to provide informed consent.
6. Currently enrolled in any other research study involving smoking cessation.

Primary outcomes:
measure: Uptake of smoking cessation resources
timeFrame: Day of surgery
measure: Uptake of smoking cessation resources
timeFrame: 30 days postoperatively
measure: Uptake of smoking cessation resources
timeFrame: 8 weeks post-randomization
measure: Uptake of smoking cessation resources
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Recruitment rate
timeFrame: Enrollment
measure: Recruitment timing
timeFrame: Enrollment
measure: Participant satisfaction with smoking cessation bundle assessed by study questionnaire
timeFrame: 8 weeks post-randomization
measure: Change in smoking status from baseline
timeFrame: Day of surgery, 30 days postoperatively, 8 weeks post-randomization and 6 months postoperatively
measure: Hospital Length of Stay
timeFrame: First 30 days
measure: Postop complications (day 3 POMS)
timeFrame: Postop Day 3
measure: Cost of nicotine replacement therapy
timeFrame: 6 months
measure: Number of nicotine replacement therapy refills
timeFrame: 6 months
measure: Number of nicotine replacement therapy pharmacy deliveries
timeFrame: 6 months
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health Authority
name: Susan M Lee, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Fraser Health Authority
name: Michelle Mozel, MSc
role: STUDY_CHAIR
References: