Actively Recruiting
Evaluating Simplified Layered Consent for Clinical Trials
Led by Sunnybrook Health Sciences Centre · Updated on 2025-05-15
346
Participants Needed
6
Research Sites
130 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of Staphylococcus aureus bloodstream infection (the SNAP trial). The main questions it aims to answer are: * Does use of a simplified layered consent form lead to an increased recruitment rate to the SNAP trial? * Does use of a simplified layer consent form lead to increased participant understanding of the SNAP trial and increased participant satisfaction with the informed consent process? Participants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. Research staff will use the assigned form to explain the SNAP trial to participants. After consent, participants will be evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire.
CONDITIONS
Official Title
Evaluating Simplified Layered Consent for Clinical Trials
Who Can Participate
Eligibility Criteria
You may qualify if you...
- S. aureus complex grown from at least 1 blood culture
- Admitted to a participating hospital at the time of eligibility assessment
- Admitted to a participating hospital of SIMPLY-SNAP
- Self-reported proficiency in English or French adequate to participate in consent process in English or French
You will not qualify if you...
- Anticipated platform entry more than 72 hours after blood culture collection
- Polymicrobial bacteremia with more than one organism in blood cultures (except contaminants)
- Currently treated with systemic antibacterial agent that cannot be stopped
- Previous participation in SNAP trial
- Positive blood culture for S. aureus between 72 hours and 180 days before eligibility assessment
- Treating team believes enrollment is not in patient's best interest
- Treating team believes death is imminent and inevitable
- Patient is for end-of-life care and antibiotic treatment is inappropriate
- Patient is under 18 years and pediatric recruitment is not approved at site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus
Calgary, Alberta, Canada
Actively Recruiting
2
Hamilton General Hospital
Hamilton, Ontario, Canada
Actively Recruiting
3
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
5
Montreal General Hospital
Montreal, Quebec, Canada
Actively Recruiting
6
Royal Victoria Hospital
Québec, Quebec, Canada
Actively Recruiting
Research Team
S
Sean WX Ong, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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