Evaluating Simplified Layered Consent for Clinical Trials
Staphylococcus Aureus BacteremiaThe 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
0 and up
Participation 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
Study Location
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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Montreal General Hospital
Montreal General HospitalMontreal, Quebec
Canada
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Todd Lee, MD
The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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Derek McFadden, MD
Toronto General Hospital
Toronto General HospitalToronto, Ontario
Canada
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Bryan Coburn, MD
Michael Garron Hospital
Michael Garron HospitalToronto, Ontario
Canada
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Christopher Kandel, MD
Royal Victoria Hospital
Royal Victoria HospitalQuébec, Quebec
Canada
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Todd Lee, MD
Hamilton General Hospital
Hamilton General HospitalHamilton, Ontario
Canada
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Dominik Mertz, MD
Mount Sinai Hospital
Mount Sinai HospitalToronto, Ontario
Canada
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Jennie Johnstone, PhD
- Study Sponsored By
- Sunnybrook Health Sciences Centre
- Participants Required
- More Information
- Study ID:
NCT06168474