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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytisine and Video Messaging | Experimental | Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support through video messaging. |
|
| Placebo and Video Messaging | Placebo Comparator | Administration of placebo (inactive drug) to patients on a set dose schedule with behavioural support through video messaging. |
|
| Cytisine and No Video Messaging | Active Comparator | Administration of cytisine (pharmaceutical support) to patients on a set dose schedule with behavioural support according to standard care such as a phone number for a self-help line. |
|
| Placebo and No Video Messaging | No Intervention | Administration of placebo (inactive drug) to patients on a set dose schedule behavioural support according to standard care such as a phone number for a self-help line. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytisine | Drug | Listed as a natural health product in Canada, cytisine is utilized to aid in smoking cessation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day point-prevalence abstinence at 30 days | Self-report of not smoking cigarettes [not even a puff] in the 7 days before the 30-day follow-up | 30 days |
| 7-day point-prevalence abstinence at 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Health services utilization-related costs | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Ofori, Dr. | Population Health Research Institute | Principal Investigator |
| Flavia Kessler Borges, Dr. | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada | ||
| Juravinski Cancer Centre |
The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritizes access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee.
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016739 | Behavior, Addictive |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| C004712 | cytisine |
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2x2 factorial
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| Video Messaging | Behavioral | Supportive messaging utilizing a video messaging platform to encourage patients to abstain from smoking throughout the treatment period. |
|
Self-report of not smoking cigarettes [not even a puff] in the 7 days before the 56-day follow-up
| 56-days |
| 7-day point-prevalence abstinence at 6-months | Self-report of not smoking cigarettes [not even a puff] in the 7 days before the 6-month follow-up | 6-months |
| Urge to smoke | 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 | baseline and 6-months |
| Number of cigarettes smoked daily if still smoking | Number of cigarettes smoked daily if still smoking | 30 days, 56 days and 6 months |
| Time to first lapse | Time to first cigarette smoked after the initial quit, even a single puff | 6 months |
| Time to relapse | Time to return to regular smoking for three or more concurrent days after a period of abstinence. | 6 months |
| 6 month continuous abstinence rate | 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. | 6-months |
| Wound complications | Seroma- wound drainage or repeated dressings required; Wound dehiscence or delayed wound healing | 6 months |
| Infectious complications | 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). | 6 months |
| Respiratory complications | 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). | 6 months |
| Non-fatal Myocardial infarction | according to the 4th universal definition | 6 months |
| Number of Patients with Proximal venous thrombo-embolism | The diagnosis of PE requires any one of the following:
The diagnosis of proximal DVT (leg or arm) requires:
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. | 6 months |
| Stroke | 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. | 6 months |
| Non-fatal cardiac arrest | 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. | 6 months |
| Death | The definition of death is all cause mortality. | 6 months |
| Length of hospital stay | Defined as time of hospital admission to time of discharge from hospital after index surgery. | time of hospital admission to time of discharge for surgical stay |
| Acute hospital care since discharge | 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). | after hospital discharge for the study surgery to 6-month follow-up |
| 6-months |
| Health-related quality of life (HRQoL) | 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. | baseline and 6-months |
| Hamilton |
| Ontario |
| L8V 5C2 |
| Canada |
| Kingston Health Science Centre with its research institute Kingston General Health Research Institute | Kingston | Ontario | K7L 3N6 | Canada |
| Lawson Health Research Institute: London Health Sciences Centre Research Inc. and the Lawson Research Institute | London | Ontario | N6C 2R5 | Canada |