NCT06168474 Evaluating Simplified Layered Consent for Clinical Trials
| NCT ID | NCT06168474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Staphylococcus Aureus Bacteremia |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2023-11-28 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 346 participants in total. It began in 2023-11-28 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * All inclusion criteria from the larger SNAP trial: 1. S. aureus complex grown from ≥1 blood culture 2. Admitted to a participating hospital at the time of eligibility assessment * Specific additional inclusion criteria for SIMPLY-SNAP: 1. Admitted to participating hospital of SIMPLY-SNAP 2. Self-reported proficiency in English or French adequate to be able to participate in consent process carried out solely in English or French (as the supplementary consent materials required in the simplified consent process are currently only available in these two languages) Exclusion Criteria: * All exclusion criteria from larger SNAP trial: 1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture 2. Polymicrobial bacteremia, defined as more than one organism in the index blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician 3. Patient currently being treated with a systemic antibacterial agent that cannot be ceased 4. Known previous participation in SNAP 5. Known positive blood culture for S. aureus between 72 hours and 180 days prior to the time of eligibility assessment 6. Treating team deems enrolment in the study is not in the best interest of the patient 7. Treating team believes that death is imminent and inevitable 8. Patient is for end-of-life care and antibiotic treatment is considered inappropriate 9. Patient \<18 years of age and paediatric recruitment not approved at recruiting site * Specific additional exclusion criteria for SIMPLY-SNAP: None
Contact & Investigator
Sean WX Ong, MBBS
PRINCIPAL INVESTIGATOR
University of Toronto
Frequently Asked Questions
Who can join the NCT06168474 clinical trial?
This trial is open to participants of all sexes, studying Staphylococcus Aureus Bacteremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06168474 currently recruiting?
Yes, NCT06168474 is actively recruiting participants. Contact the research team at s.ong@mail.utoronto.ca for enrollment information.
Where is the NCT06168474 trial being conducted?
This trial is being conducted at Calgary, Canada, Hamilton, Canada, Ottawa, Canada, Toronto, Canada and 2 additional locations.
Who is sponsoring the NCT06168474 clinical trial?
NCT06168474 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Sean WX Ong, MBBS at University of Toronto. The trial plans to enroll 346 participants.