Evaluating Simplified Layered Consent for Clinical Trials

• Simplified layered consent form (Other): 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 (Other): 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.

Primary outcomes

• 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.

Secondary outcomes

• Participant understanding of the clinical trial [Within 3 days after the consent process]: 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).
• Participant satisfaction with the consent process [Within 3 days after the consent process]: Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).
• Research staff satisfaction with the consent process [1 day]: Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).
• Time taken for entire consent process [1 day]: In minutes

Other outcomes

• Diversity of enrolled trial population [End of the entire SIMPLY-SNAP study]: 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.

Sex: All

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

• Results publication: Ong SWX, Lee TC, Fowler RA, Mahar R, Pinto RL, Rishu A, Petrella L, Whiteway L, Cheng M, McDonald E, Johnstone J, Mertz D, Kandel C, Somayaji R, Davis JS, Tong SYC, Daneman N. Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to the Staphylococcus aureus Network Adaptive Platform trial: study protocol for a multicentre pragmatic nested randomised clinical trial (SIMPLY-SNAP trial). BMJ Open. 2024 Jan 18;14(1):e083239. doi: 10.1136/bmjopen-2023-083239. PMID 38238170

• Sean WX Ong, MBBS, Principal investigator, University of Toronto