<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04487548</url>
  </required_header>
  <id_info>
    <org_study_id>FHREB 2017-099</org_study_id>
    <nct_id>NCT04487548</nct_id>
  </id_info>
  <brief_title>Perioperative Smoking Cessation BUndle in a Tertiary Care Hospital - Can Turning Virtual Improve Outcomes?</brief_title>
  <acronym>BuTT-Out</acronym>
  <official_title>Perioperative Smoking Cessation BUndle in a Tertiary Care Hospital - Can Turning Virtual Improve Outcomes? A Pilot Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fraser Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Columbian Hospital Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fraser Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Smoking continues to be a burden to the healthcare system in Canada. It is well-known that&#xD;
      smokers suffer more complications and higher risk of mortality after surgery than&#xD;
      non-smokers. A quality improvement project at Royal Columbian Hospital recently showed that&#xD;
      it is possible to implement a smoking cessation bundle for all current smokers during their&#xD;
      preadmission clinic visit. However, due to the COVID-19 pandemic, much of the bundle was&#xD;
      abandoned as it relied heavily on in-person interactions. The investigators wish to study the&#xD;
      effect of a structured smoking cessation bundle, delivered remotely, on smoking cessation and&#xD;
      postoperative complications. The aim is to determine the feasibility of giving the remotely&#xD;
      delivered bundle to elective surgical patients before or around the time of a preadmission&#xD;
      clinic visit, and whether it can reduce smoking rates and postoperative complications versus&#xD;
      the standard uncoordinated advice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction and Background Smoking continues to be a burden to the healthcare system in&#xD;
      Canada. As of 2019, 3.7 million Canadians (12% of the population over age 15) reported being&#xD;
      a current smoker. British Columbia's smoking rate is lower, but 10.2% of adults still&#xD;
      regularly smoke cigarettes1. It is well-known that smokers suffer more complications and&#xD;
      higher risk of mortality after surgery than non-smokers. Pulmonary complications,&#xD;
      cardiovascular complications, and surgical site infections are mediators of&#xD;
      smoking-associated mortality at 6-months and 1-year after elective surgery.&#xD;
&#xD;
      Although there have been a handful of studies that have demonstrated dramatic reductions in&#xD;
      postoperative complications with well-timed smoking cessation interventions in the&#xD;
      preoperative period, these results have not translated into widespread clinical practice in&#xD;
      delaying surgery for the purpose of achieving smoking cessation. In addition, most of these&#xD;
      studies took place in Europe, where smokers may behave differently than in the Canadian&#xD;
      setting.&#xD;
&#xD;
      A systematic review recommended at least 4 weeks of smoking cessation in order to reduce&#xD;
      postoperative complications6. Several European studies have shown dramatic reductions in&#xD;
      complications (up to 30% absolute risk reductions) when smoking cessation interventions have&#xD;
      been implemented 4-8 weeks preoperatively. One Canadian editorial even suggested new policies&#xD;
      be put into place to delay elective surgeries in smokers until a trial of cessation for 6&#xD;
      weeks had taken place.&#xD;
&#xD;
      Implementation of smoking cessation programs preoperatively have the potential to reduce&#xD;
      morbidity and mortality. A Cochrane systematic review has shown that preoperative smoking&#xD;
      cessation therapy improves both short and long-term smoking cessation. In fact, a surgical&#xD;
      encounter with the healthcare system has been described as a &quot;teachable moment&quot; that provides&#xD;
      motivation for patients to permanently stop smoking. Despite this information, most&#xD;
      anesthesiologists do not routinely offer smoking cessation advice to their patients and&#xD;
      advice, counselling, and pharmacotherapy for smoking cessation is not routine in&#xD;
      pre-admission clinics across Canada and the United States.&#xD;
&#xD;
      Several small trials have shown that smoking cessation interventions can increase smoking&#xD;
      cessation and reduce postoperative complications, particularly wound-healing complications,&#xD;
      which can have an absolute risk reduction of up to 25%. Prior work by one of the&#xD;
      co-investigators showed that a simple intervention in the pre-admission clinic was able to&#xD;
      increase the abstinence rate from 3.6% to 14.3% on the day of surgery. Smoking cessation&#xD;
      initiated in the perioperative period can also promote long-term smoking cessation.&#xD;
&#xD;
      Despite these successes, since the COVID-19 pandemic, standard care at Royal Columbian&#xD;
      Hospital (RCH) has not routinely included specific preoperative smoking cessation&#xD;
      pharmacotherapy or counselling. However, hospital leaders and the RCH Department of&#xD;
      Anesthesia have identified preoperative preparation, including smoking cessation, as a key&#xD;
      area of interest for development. Therefore, this is the ideal time to study the feasibility&#xD;
      of the perioperative smoking cessation bundle given to patients without the requirement for&#xD;
      an in-person visit. Advantages of this remote model are expected to continue after the&#xD;
      pandemic restrictions end, since smoking cessation bundles will be able to be started earlier&#xD;
      (and thus have more potential to prevent surgical complications), compared to waiting for a&#xD;
      preadmission clinic visit, which can often occur only a few days preoperatively. The&#xD;
      perioperative smoking cessation bundle will include: an emailed link to a quitnow.ca&#xD;
      preoperative smoking cessation video and referral to quit coach, free nicotine replacement&#xD;
      therapy (NRT) delivered by an online pharmacy, an emailed or post-mailed RCH smoking&#xD;
      cessation brochure, and brief telephone advice. This bundle will be offered to those regular&#xD;
      smokers of cigarettes randomized to the intervention group following their surgical&#xD;
      consultation, at the time of preadmission clinic appointment booking, or following their&#xD;
      preadmission telephone consultation. The control group will receive the standard of care&#xD;
      which sometimes includes brief advice and informing patients about availability of further&#xD;
      aids.&#xD;
&#xD;
      Once the simple smoking cessation intervention has been implemented for the intervention&#xD;
      group, the investigators wish to compare rates of resource access, smoking cessation, and&#xD;
      postoperative complications between the group receiving the smoking cessation bundle and&#xD;
      those receiving standard care. Due to the COVID-19 pandemic, in-person preadmission clinic&#xD;
      visits are no longer scheduled. Instead, high-risk surgical patients are phoned prior to&#xD;
      surgery to mitigate surgical risk factors and better prepare them for surgery.&#xD;
      Self-identification as a regular smoker is one risk factor that would warrant recruitment&#xD;
      into the study.&#xD;
&#xD;
      The investigators estimated that a definitive randomized controlled trial would require a&#xD;
      sample size of 214 participants. However, relatively low rates of smoking in British Columbia&#xD;
      and the cancellation of in-person preadmission clinic visits present a unique challenge to&#xD;
      patient recruitment. It is therefore imperative to establish the recruitment rate for&#xD;
      progression to a full randomized controlled trial.&#xD;
&#xD;
      Additionally, a preliminary analysis of rates of smoking and reduction of postoperative&#xD;
      complications in elective surgical patients when the smoking cessation bundle is given to&#xD;
      patients immediately following their preadmission clinic telephone consultation will be&#xD;
      conducted. The investigators plan to carry out a pilot randomized controlled trial where&#xD;
      patients who identify as smokers will be randomized to receive the remotely delivered smoking&#xD;
      cessation bundle versus standard care.&#xD;
&#xD;
      Purpose and Justification Most randomized studies showing improved smoking cessation rates&#xD;
      after preoperative interventions have strict inclusion and exclusion criteria, and required&#xD;
      ongoing consent for research experimentation, which limits their external generalizability.&#xD;
      The BuTT Out Pilot Study is of utmost importance since it has the potential to demonstrate&#xD;
      reductions in surgical site infections and lengths-of-stay using a low-cost intervention (a&#xD;
      bundle of emailed video, brochure, helpline referral and government funded smoking-cessation&#xD;
      therapy). A 2020 survey of the BC Smoking Cessation Program reported that 66% of respondents&#xD;
      found the program helpful, with a quit rate of 37%. Providing the program as a part of a&#xD;
      structured bundle will improve the accessibility of smoking cessation aids. If this&#xD;
      hypothesis is confirmed as suspected since it is based on prior research in other countries,&#xD;
      widespread implementation could translate into tremendous advantages for the patient, in&#xD;
      terms of reduced complications, and providers, in terms of cost savings. Conducting a pilot&#xD;
      study will help mitigate the challenge of recruiting an adequate sample size by establishing&#xD;
      a recruitment rate and consequently improve the feasibility of a definitive randomized&#xD;
      controlled trial. Since this study will examine remotely-delivered interventions, its&#xD;
      potential for widespread use will be much greater than other previously studied in-person&#xD;
      study designs.&#xD;
&#xD;
      Research Question For patients who smoke undergoing elective surgery, what is the effect of&#xD;
      an evidence-based remotely-delivered smoking cessation bundle administered preoperatively on&#xD;
      patients' outcomes (smoking rates, complication rates and hospital length of stay) compared&#xD;
      with standard practice which sometimes includes brief advice and informing patients about&#xD;
      availability of further aids?&#xD;
&#xD;
      Research Objectives To establish the recruitment rate, optimal recruitment pathway, and rate&#xD;
      of accessing of available resources as criteria for progression to a definitive randomized&#xD;
      controlled trial.&#xD;
&#xD;
      To determine whether smoking rates, surgical complications, and postoperative complications&#xD;
      can be documented in elective surgical patients when the remotely-delivered smoking cessation&#xD;
      bundle is administered preoperatively vs. standard care.&#xD;
&#xD;
      Research Hypothesis The hypothesis for this pilot RCT is that at least 8 patients will be&#xD;
      screened per week, at least 25% will give informed consent, and &gt;80% will adhere to the study&#xD;
      protocol.&#xD;
&#xD;
      The overarching research hypothesis is that in patients who smoke, receiving the&#xD;
      remotely-delivered perioperative smoking cessation bundle prior to elective surgery for the&#xD;
      purpose of quitting smoking will result in reduced smoking rates on the day of surgery, lower&#xD;
      30-day complications, and shorter lengths of stay. Definitive estimation of effect size is&#xD;
      not expected from this pilot study, but confidence intervals will give rise to sample size&#xD;
      estimation for a future full-size trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 24, 2022</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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).&#xD;
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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Blinding of study participants is not possible. Blinding of staff may not always be possible, although staff will not be informed which group the participant has been randomized to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Uptake of smoking cessation resources</measure>
    <time_frame>Day of surgery</time_frame>
    <description>The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uptake of smoking cessation resources</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uptake of smoking cessation resources</measure>
    <time_frame>8 weeks post-randomization</time_frame>
    <description>The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uptake of smoking cessation resources</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>Enrollment</time_frame>
    <description>Number of eligible patients consented out of all eligible patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment timing</measure>
    <time_frame>Enrollment</time_frame>
    <description>Duration between enrollment and day of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction with smoking cessation bundle assessed by study questionnaire</measure>
    <time_frame>8 weeks post-randomization</time_frame>
    <description>Open-ended questions asking how satisfied participants were with the smoking cessation bundle, which parts of the bundle were most and least helpful</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in smoking status from baseline</measure>
    <time_frame>Day of surgery, 30 days postoperatively, 8 weeks post-randomization and 6 months postoperatively</time_frame>
    <description>Self-report of smoking status at each time point compared to baseline (defined as number of cigarettes smoked in the last 24 hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>First 30 days</time_frame>
    <description>Length of time the participant is admitted to the hospital for their surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postop complications (day 3 POMS)</measure>
    <time_frame>Postop Day 3</time_frame>
    <description>Day 3 Postoperative Morbidity Survey (POMS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of nicotine replacement therapy</measure>
    <time_frame>6 months</time_frame>
    <description>Total cost of NRT prescriptions supplied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of nicotine replacement therapy refills</measure>
    <time_frame>6 months</time_frame>
    <description>For those using NRT, how many times did they refill their NRT prescription</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of nicotine replacement therapy pharmacy deliveries</measure>
    <time_frame>6 months</time_frame>
    <description>For those using NRT, how many pharmacy deliveries of NRT did they get</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Surgical Complications</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will have their preadmission clinic telephone call as normal and may be given advice to quit smoking and information about available smoking cessation resources over the phone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will be emailed (or postal mailed) the smoking cessation bundle with educational video, brochure, referral to the Smokers' Helpline and direct referral to an online pharmacy for nicotine replacement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Remote smoking cessation bundle</intervention_name>
    <description>The bundle is a remote version of what has previously been described in prior literature, which includes:&#xD;
A brief (&lt;5 minutes) advice&#xD;
Preoperative smoking cessation video prepared by QuitNow&#xD;
Patients will be provided brochures on smoking cessation&#xD;
A referral will be faxed (or internet-registered) to the Quitnow.ca Smokers' Helpline&#xD;
All patients will be requested to participate in the provincial Smoking Cessation program that provides a free 12-week supply of NRT once per year.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults aged 18 years and over.&#xD;
&#xD;
          2. Current smoker (self-identified from pre-surgical package).&#xD;
&#xD;
          3. Surgery date over 1 week away or not yet booked.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Emergency surgery.&#xD;
&#xD;
          2. Smokers who only consume non-cigarette forms of tobacco (pipe, smokeless tobacco).&#xD;
&#xD;
          3. Smokers who only consume marijuana or vaping.&#xD;
&#xD;
          4. Patients who are pregnant or breastfeeding.&#xD;
&#xD;
          5. Inability to provide informed consent.&#xD;
&#xD;
          6. Currently enrolled in any other research study involving smoking cessation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan M Lee, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fraser Health Authority</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michelle Mozel, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Fraser Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Columbian Hospital</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <zip>V3L 3W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>March 16, 2018</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fraser Health</investigator_affiliation>
    <investigator_full_name>Susan Lee</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Surgery</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Complications</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487548
org study id: FHREB 2017-099
nct id: NCT04487548
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Double (Care Provider, Outcomes Assessor)
masking description: Blinding of study participants is not possible. Blinding of staff may not always be possible, although staff will not be informed which group the participant has been randomized to.
measure: Uptake of smoking cessation resources
time frame: Day of surgery
description: The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.
measure: Uptake of smoking cessation resources
time frame: 30 days postoperatively
description: The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.
measure: Uptake of smoking cessation resources
time frame: 8 weeks post-randomization
description: The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.
measure: Uptake of smoking cessation resources
time frame: 6 months postoperatively
description: The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.
measure: Recruitment rate
time frame: Enrollment
description: Number of eligible patients consented out of all eligible patients
measure: Recruitment timing
time frame: Enrollment
description: Duration between enrollment and day of surgery
measure: Participant satisfaction with smoking cessation bundle assessed by study questionnaire
time frame: 8 weeks post-randomization
description: Open-ended questions asking how satisfied participants were with the smoking cessation bundle, which parts of the bundle were most and least helpful
measure: Change in smoking status from baseline
time frame: Day of surgery, 30 days postoperatively, 8 weeks post-randomization and 6 months postoperatively
description: Self-report of smoking status at each time point compared to baseline (defined as number of cigarettes smoked in the last 24 hours)
measure: Hospital Length of Stay
time frame: First 30 days
description: Length of time the participant is admitted to the hospital for their surgical procedure.
measure: Postop complications (day 3 POMS)
time frame: Postop Day 3
description: Day 3 Postoperative Morbidity Survey (POMS).
measure: Cost of nicotine replacement therapy
time frame: 6 months
description: Total cost of NRT prescriptions supplied
measure: Number of nicotine replacement therapy refills
time frame: 6 months
description: For those using NRT, how many times did they refill their NRT prescription
measure: Number of nicotine replacement therapy pharmacy deliveries
time frame: 6 months
description: For those using NRT, how many pharmacy deliveries of NRT did they get
arm group label: Control group
arm group type: No Intervention
description: The control group will have their preadmission clinic telephone call as normal and may be given advice to quit smoking and information about available smoking cessation resources over the phone.
arm group label: Intervention group
arm group type: Experimental
description: The intervention group will be emailed (or postal mailed) the smoking cessation bundle with educational video, brochure, referral to the Smokers' Helpline and direct referral to an online pharmacy for nicotine replacement.
intervention type: Other
intervention name: Remote smoking cessation bundle
description: The bundle is a remote version of what has previously been described in prior literature, which includes:
A brief (<5 minutes) advice
Preoperative smoking cessation video prepared by QuitNow
Patients will be provided brochures on smoking cessation
A referral will be faxed (or internet-registered) to the Quitnow.ca Smokers' Helpline
All patients will be requested to participate in the provincial Smoking Cessation program that provides a free 12-week supply of NRT once per year.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan M Lee, MD, FRCPC
role: Principal Investigator
affiliation: Fraser Health Authority
last name: Michelle Mozel, MSc
role: Study Chair
affiliation: Fraser Health Authority
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Fraser Health
investigator full name: Susan Lee
investigator title: Physician
sharing ipd: No