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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Simplified layered consent form
Other interventionThe 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.
Full-length consent form
Other interventionThe 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.
Treatment groups
346 Participants
are divided into 2 treatment groupsGroup A: Simplified layered consent processExperimental treatment 1 intervention
Group B: Full-length consent formActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion 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 daySecondary outcomes
1
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 process2
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 process3
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 day4
Time taken for entire consent process
In minutes
Time frame
1 dayOther outcomes
1
Diversity of enrolled trial population
As an exploratory outcome, we will also evaluate diversity of the enrolled trial population across five self-reported socio-demographic characteristics: gender, ethnicity, primary spoken language, socioeconomic status (measured by income level, or last-income level before retirement), and highest formal educational level attained. We will separately evaluate diversity of the patient group enrolled in SNAP via the simplified consent process versus the patient group enrolled via the full-length consent form. Diversity will be measured using the Simpson's Diversity Index (SDI). SDI will be calculated for each of five socio-demographic variables for the group recruited via simplified consent and the group recruited via conventional consent. A composite diversity score for each group combining the SDIs of all five variables will also be calculated.
Time frame
End of the entire SIMPLY-SNAP studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sunnybrook Health Sciences Centre
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov