Evaluating Simplified Layered Consent for Clinical Trials
ConditionStaphylococcus Aureus Bacteremia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSunnybrook Health Sciences Centre
About this trial
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
Qualifiers
S. aureus complex grown from ≥1 blood culture
Admitted to a participating hospital at the time of eligibility assessment
Admitted to participating hospital of SIMPLY-SNAP
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)
Disqualifiers
Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture
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
Patient currently being treated with a systemic antibacterial agent that cannot be ceased
Known previous participation in SNAP
Trial design
Treatments tested in this trial
- Simplified layered consent form
- Full-length consent form
Treatment groups
346 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sunnybrook Health Sciences Centre
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov