Study Type
Interventional - Drug and behavioural support through mobile technology
ongoing
Around 60 million smokers undergo surgery annually. Smoking is the leading cause of preventable death. During the surgical period, smoking increases cardiopulmonary and infectious complications, and delays wound healing. Many smokers return to smoking after surgery and few use smoking cessation therapy around the time of surgery.
The PREVENT trial uses a 2×2 factorial randomized controlled trial design to explore:
- The effect of a smoking-cessation drug (Cytisine) compared to placebo, and
- Video messaging for behavioural counseling support compared to standard care.
The primary outcome of the vanguard phase is to determine feasibility of recruitment (target: 2 patients/centre/month) and complete follow-up on >90% of trial participants.
For the full trial, the primary objective is to determine, in adults undergoing surgery, the effect of cytisine versus placebo and personalized video messaging to provide behavioural counselling support compared to standard care, on biochemically verified 6-month continuous abstinence at the 6-month post randomization visit.
PREVENT overview (PDF)Study Design
Multicentre 2x2 factorial RCT
NO. of Countries
1 (vanguard); 9 (full trial)
NO. of Sites
7 (vanguard); 35 (full)
NO. of Participants
100 (vanguard); 1720 (full)
Study Period
2022 - 2025
Sponsor
PHRI
Sandra Ofori
Investigator
Sandra Ofori
Investigator
Sandra Ofori is an Investigator in the Perioperative and Surgery research group at PHRI, an Assistant Professor in McMaster University’s Department of Medicine (cardiology), and a PhD candidate in the Health Research Methodology program under the supervision of PJ Devereaux. Her research interests are in the areas of perioperative care and cardiovascular disease prevention.
Her current research program is focused on perioperative smoking cessation and strategies to improve long-term health in patients undergoing noncardiac surgery. Ofori is actively involved in the conduct of large international perioperative clinical trials coordinated from PHRI and was the project officer of the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) Trial.
Ofori completed her residency training in Internal Medicine and Cardiology at the University of Port Harcourt, Nigeria, where she was an Assistant Professor and Consultant Cardiologist in the College of Health Sciences and its affiliated teaching hospital. She also has a Master’s degree in Preventive Cardiology from the Imperial College, London UK, and was in the third cohort of the World Heart Federation Salim Yusuf Emerging Leaders Program that was focused on the reduction of the global burden of hypertension.
Flavia Kessler Borges
Scientist
Flavia Kessler Borges
Scientist
Flavia Borges is a Scientist in the perioperative and surgery research group at PHRI, and internist, and an Assistant Professor, Department of Medicine (perioperative care; general internal medicine), McMaster University. Her research is focused on perioperative cardiac biomarkers, and perioperative strategies to improve clinical outcomes in patients undergoing noncardiac surgery.
She undertook her Masters in Health Sciences and her PhD in Cardiovascular Sciences in Brazil, and a research and clinical perioperative vascular fellowship under the direction of PJ Devereaux at McMaster. She holds an Early Career Research Award from McMaster.
Jessica Vincent
Program Director
Jessica Vincent
Program Director
Jessica Vincent has more than 15 years’ experience in coordinating and managing large, international clinical trials. As Associate Program Manager, she oversees interventional trials, registries, and observational research studies in the areas of perioperative medicine, cardiac surgery, and digital health.
She holds an Honours Bachelor of Science Degree from Queens University, and a Master of Clinical Epidemiology Degree from the University of Newcastle.
Emily Di Sante
Senior Research Coordinator
Emily Di Sante
Senior Research Coordinator
With over 14 years experience in health research coordination, Emily is passionate about building exceptional teams that make a positive impact on global health. She has an Honours Bachelor’s of Arts degree (University of Guelph), Master’s of Political Science degree (McMaster University) and a certificate in Project Management (University of Toronto).
Her research interests include tobacco control, public and patient involvement, long-term care, evaluation and knowledge translation. At PHRI, she supports the perioperative and surgery studies, B-Free, FARGO, FAST, PREVENT and STRATUS.
