Evaluating Simplified Layered Consent for Clinical Trials

NCT06168474 · tracked via the Priya Life Science Canada tracker

Sponsor

Sunnybrook Health Sciences Centre

Phase

Not applicable

Started

2023-11-28

Last updated

2025-05-15

Condition(s) studied

Staphylococcus Aureus Bacteremia

Investigational drug(s) / intervention(s)

Simplified layered consent formFull-length consent form

Simplified layered consent form: 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.

Full-length consent form: 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.

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Proportion of patients recruited to SNAP — 1 day
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.

Trial sites (6)

Facility	City	Region	Status
University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus	Calgary	Alberta	Recruiting
Hamilton General Hospital	Hamilton	Ontario	Recruiting
The Ottawa Hospital	Ottawa	Ontario	Recruiting
Sunnybrook Health Sciences Centre	Toronto	Ontario	Recruiting
Montreal General Hospital	Montreal	Quebec	Recruiting
Royal Victoria Hospital	Québec	Quebec	Recruiting

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Other trials for the same condition

Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia Recruiting

Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia Recruiting

Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia Recruiting

Adjunctive Fosfomycin for Treatment of Staphylococcus Aureus Bacteraemia Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06168474 on ClinicalTrials.gov ↗ ← All trials in Canada