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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• All inclusion criteria from the larger SNAP trial:
‣ S. aureus complex grown from ≥1 blood culture
⁃ Admitted to a participating hospital at the time of eligibility assessment
• Specific additional inclusion criteria for SIMPLY-SNAP:
‣ 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)
Locations
Other Locations
Canada
University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus
RECRUITING
Calgary
Hamilton General Hospital
RECRUITING
Hamilton
Montreal General Hospital
RECRUITING
Montreal
The Ottawa Hospital
RECRUITING
Ottawa
Royal Victoria Hospital
RECRUITING
Québec
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Sean WX Ong, MBBS
s.ong@mail.utoronto.ca
4164806100
Time Frame
Start Date:2023-11-28
Estimated Completion Date:2026-06
Participants
Target number of participants:346
Treatments
Experimental: Simplified layered consent process
For participants randomized to the SIMPLY-SNAP experimental group, a simplified layered consent process will be used to explain information for the SNAP trial. The research staff member obtaining consent will provide a standardized explanation, providing summarized information in simple English or French contained in a 4-page concise participant information sheet. Throughout the consent process, the research staff member will answer any questions that the participant has, to reflect routine consent discussion practice.
Active_comparator: Full-length consent form
For participants randomized to the control group, the existing consent process will be used including going through the currently approved full-length informed consent form. The research staff member will provide an explanation using the full-length informed consent form as per standard clinical trial procedures. Similarly, throughout the consent process, the research staff member will answer any participant questions as per normal procedures.