Evaluating Simplified Layered Consent for Clinical Trials (NCT06168474)
Evaluating the Impact of a SIMPlified LaYered Consent Process on Recruitment of Potential Participants to the Staphylococcus Aureus Network Adaptive Platform Trial: a Pragmatic Nested Randomized Clinical Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus — Calgary, Alberta
🧪 Interventions in This Study
- Simplified layered consent form (OTHER)
- Full-length consent form (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus — Calgary, Alberta
- Hamilton General Hospital — Hamilton, Ontario
- The Ottawa Hospital — Ottawa, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario
- Montreal General Hospital — Montreal, Quebec
- Royal Victoria Hospital — Québec, Quebec
📞 Contact the Study Coordinator
Phone: (416) 480-6100
Email: s.ong@mail.utoronto.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Staphylococcus Aureus Bacteremia
- Adjunctive Fosfomycin for Treatment of Staphylococcus Aureus Bacteraemia — Melbourne, Victoria
- Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia — Calgary, Alberta
- Staphylococcus Aureus Network Adaptive Platform Trial — Houston, Texas
- Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia — Brighton, Colorado
Explore by condition: All Staphylococcus Aureus Bacteremia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.