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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
346
The simplified consent form includes all essential elements of trial consent including an explanation of the trial procedures, data and sample collection, and follow-up information. The form also outlines important ethical considerations for patients, such as confidentiality, regulatory and safety requirements, the ability to drop out, and the necessary process and contact numbers for grievances or feedback. In addition to the text, the form includes links to additional written information and videos that can be accessed on top of the simplified informed consent form (i.e., the additional layers in the layered consent process). These materials are hosted on the main SNAP trial website (https://www.snaptrial.com.au/patients) and are available in English and French. Participants will be able to access these directly through embedded hyperlinks using provided electronic tablets.
The full-length informed consent form contains all information upfront. Links to additional information will not be provided on the form but are freely available on the Internet should the participant wish to access them.
University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus
Calgary, Alberta, Canada
RECRUITINGHamilton General Hospital
Hamilton, Ontario, Canada
RECRUITINGThe Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGMontreal General Hospital
Montreal, Quebec, Canada
RECRUITINGRoyal Victoria Hospital
Québec, Quebec, Canada
RECRUITINGProportion of patients recruited to SNAP
The number of patients who consented and were randomized in the SNAP trial, divided by the total number of patient eligible for the SNAP trial and randomized in SIMPLY-SNAP.
Time frame: 1 day
Participant understanding of the clinical trial
Understanding of the clinical trial will be measured by a modified Consent Understanding Evaluation (CUE) tool. This is a questionnaire that comprises a list of open and closed-ended questions designed to evaluate a participant's understanding of the clinical trial they just enrolled in. It is adapted from previous similar trials evaluating adjunctive consent interventions but modified to the context of SNAP. The score ranges from 0 (worst understanding) to 15 (best understanding).
Time frame: Within 3 days after the consent process
Participant satisfaction with the consent process
Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).
Time frame: Within 3 days after the consent process
Research staff satisfaction with the consent process
Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).
Time frame: 1 day
Time taken for entire consent process
In minutes
Time frame: 1 day
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