RecruitingNot ApplicableNCT06168474

Evaluating Simplified Layered Consent for Clinical Trials

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

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

346 participants

Start Date

Nov 28, 2023

Study Type

INTERVENTIONAL

Conditions

Staphylococcus Aureus Bacteremia

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

Inclusion Criteria4

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)

Exclusion Criteria9

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
Known positive blood culture for S. aureus between 72 hours and 180 days prior to the time of eligibility assessment
Treating team deems enrolment in the study is not in the best interest of the patient
Treating team believes that death is imminent and inevitable
Patient is for end-of-life care and antibiotic treatment is considered inappropriate
Patient \<18 years of age and paediatric recruitment not approved at recruiting site

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Interventions

OTHERSimplified 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.

OTHERFull-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.