Smoking Cessation, Smoking (Tobacco) Addiction
Conditions
Brief summary
PREVENT is a multicentre, 2x2 factorial, randomized clinical trial that aims to determine the effect of cytisine versus placebo, as well as the effect of video messaging to support smoking cessation versus standard of care in perioperative patients. This trial aims to investigate the effects of cytisine and text messaging on 6-month continuous abstinence rates. PREVENT will also assess secondary outcomes at 30 days, 56 days and 6 months post-randomization: 7-day point prevalence abstinence, urge to smoke, time to first lapse, time to relapse, number of cigarettes smoking if still smoking, pulmonary complications, vascular complications, wound and infectious complications, stroke, time in hospital and acute hospital care.
Interventions
DRUGCytisine
Listed as a natural health product in Canada, cytisine is utilized to aid in smoking cessation
BEHAVIORALVideo Messaging
Supportive messaging utilizing a video messaging platform to encourage patients to abstain from smoking throughout the treatment period.
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
2x2 factorial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. are ≥18 years of age 2. are scheduled to undergo surgery within 28 days 3. are a current smoker and not currently using any smoking cessation treatment and, 4. have a smart mobile phone with an active, up to date data plan and with internet access 5. provide informed consent to participate.
Exclusion criteria
1. are pregnant or breastfeeding or expecting to become pregnant during the study follow-up period 2. are deemed unreliable for study procedures or follow-up 3. have a documented allergic reaction to cytisine, or its components (non-medicinal ingredients) or to the non-medicinal ingredients of the placebo. 4. had myocardial infarction, unstable angina, or stroke/transient ischemic attack within the preceding 2 weeks. 5. will have surgery with expected nil intake by mouth for 2 or more days 6. have previously participated in PREVENT 7. have a known diagnosis of untreated pheochromocytoma; Schizophrenia/bipolar psychiatric illness and currently psychotic; currently having suicidal ideation or risk of suicide as determined by the site physician, known history of moderate to severe depression; currently uncontrolled severe hypertension (≥180/120 mmHg) despite treatment; known history of uncontrolled hyperthyroidism (thyrotoxicosis), severe renal impairment i.e., creatinine clearance of less than 30 ml per minute (Cockcroft- Gault equation) or receiving long-term dialysis, or known diagnosis of severe liver disease as determined by the site physician or documented in the clinical history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation | 6 months | complete abstinence (smoking not more than 5 cigarettes) beginning on day 5 post randomization and lasting until the assessment at 6 months post-randomization with biochemical verification for those who report abstinence, using exhaled breath carbon monoxide (cut-off \<10 parts per million \[ppm\]) measured with a carbon monoxide (CO) monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day point-prevalence abstinence at 30 days | 30 days | Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 30-day follow-up |
| 7-day point-prevalence abstinence at 56 days | 56-days | Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 56-day follow-up |
| 7-day point-prevalence abstinence at 6-months | 6-months | Self-report of not smoking cigarettes \[not even a puff\] in the 7 days before the 6-month follow-up |
| Urge to smoke | baseline and 6-months | urge to smoke using the Mood and Physical Symptoms Scale \[MPSS\] at baseline and 6 months; a higher score indicates a stronger urge to smoke; To assess the effect of abstinence calculate the change from baseline (just prior to stopping smoking) to the post-abstinence follow-up point for items 1 to 7 and 10 to 12, and take the raw scores for items 8 and 9 |
| Number of cigarettes smoked daily if still smoking | 30 days, 56 days and 6 months | Number of cigarettes smoked daily if still smoking |
| Time to first lapse | 6 months | Time to first cigarette smoked after the initial quit, even a single puff |
| Time to relapse | 6 months | Time to return to regular smoking for three or more concurrent days after a period of abstinence. |
| 6 month continuous abstinence rate | 6-months | Complete abstinence (smoking not more than 5 cigarettes) beginning on the quit date and lasting until the assessment at 6 months post-randomization with biochemical verification for those who report abstinence, using exhaled breath carbon monoxide (cut-off \<10 ppm) measured with a carbon monoxide (CO) monitor. \*Cigarettes smoked within 5 days of randomization will be discounted. |
| Wound complications | 6 months | Seroma- wound drainage or repeated dressings required; Wound dehiscence or delayed wound healing |
| Length of hospital stay | time of hospital admission to time of discharge for surgical stay | Defined as time of hospital admission to time of discharge from hospital after index surgery. |
| Acute hospital care since discharge | after hospital discharge for the study surgery to 6-month follow-up | Acute-hospital care is a composite outcome of hospital re-admission (patient admission to an acute-care hospital) and emergency department visit (patient visit to an emergency department, which includes urgent-care centre visit). |
| Infectious complications | 6 months | Infection - defined as a pathologic process caused by the invasion of normally sterile tissue, fluid, or body cavity by pathogenic or potentially pathogenic organisms. Surgical site infection- An infection that occurs within 30 days after surgery and involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional). Sepsis- Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). Sepsis requires a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points due to infection. The qSOFA includes the following items and scoring system: 1. altered mental status (1 point); 2. systolic blood pressure ≤100 mm Hg (1 point); and 3. respiratory rate ≥22 breaths per minute (1 point). |
| Respiratory complications | 6 months | Pneumonia - defined as an acute infection of the pulmonary parenchyma that is associated with at least one sign or symptom of lower respiratory acute infection (e.g., cough, pleuritic chest pain) or acute systemic illness (e.g., fever, chills, confusion, hypoxemia); accompanied by the presence of an acute infiltrate/consolidation on a chest radiograph or auscultatory findings consistent with pneumonia (such as crackles and/or localized rales) for which there is no other explanation. Respiratory insufficiency requiring ventilatory support - Patient intubated or put on bilevel positive airway pressure (BiPAP). |
| Non-fatal Myocardial infarction | 6 months | according to the 4th universal definition |
| Number of Patients with Proximal venous thrombo-embolism | 6 months | The diagnosis of PE requires any one of the following: 1. A high probability ventilation/perfusion lung scan, 2. An intraluminal filling defect of a segmental or larger artery on a helical computerized tomography (CT) scan, 3. An intraluminal filling defect on pulmonary angiography, or 4. A positive diagnostic test for deep venous thrombosis A. Non-diagnostic ventilation/perfusion lung scan B. Non-diagnostic helical CT scan. The diagnosis of proximal DVT (leg or arm) requires: 1. Thrombosis involving the popliteal vein or more proximal veins for leg DVT and axillary or more proximal veins for arm DVT, AND 2. Evidence of vein thrombosis by any one of the following: 1\. A persistent intraluminal filling defect on contrast venography, 2. Non-compressibility of one or more venous segments on B mode compression ultrasonography, or 3. A clearly defined intraluminal filling defect on contrast enhanced computed tomography. |
| Stroke | 6 months | Stroke is defined as either: 1. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting ≥24 hours or leading to death; or 2. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting \<24 hours with positive neuroimaging consistent with a stroke. |
| Non-fatal cardiac arrest | 6 months | Nonfatal cardiac arrest is defined as successful resuscitation from either documented or presumed ventricular fibrillation, sustained ventricular tachycardia, asystole, or pulseless electrical activity requiring cardiopulmonary resuscitation, pharmacological therapy, or cardiac defibrillation. |
| Death | 6 months | The definition of death is all cause mortality. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health services utilization-related costs | 6-months | Data on hospital re-admission, healthcare utilization, and costs of health service utilization will be obtained from the Institute for Clinical Evaluative Sciences data repository. Administrative databases used to describe the health service utilization include: 1. Registered Persons Database - demographics and vital statistics of all legal residents of Ontario; 2. Discharge Abstract Database - records of inpatient hospitalizations from the Canadian Institute for Health Information (CIHI); 3. Ontario Health Insurance Plan Database - physician billing claims, and the National Ambulatory Care Reporting System - information on emergency department visits from CIHI. |
| Health-related quality of life (HRQoL) | baseline and 6-months | HRQoL will be measured with the EQ-5D-5L instrument (https://euroqol.org/eq-5d-instruments/sample-demo) due to its increased sensitivity and validation in several countries including Canada. The EQ-5D-5L is also recommended in Canada to calculate the Quality Adjusted Life Years (QALYs) when conducting cost-effectiveness analyses. |
Countries
Canada
Outcome results
None listed