Evaluating Simplified Layered Consent for Clinical Trials

Official title

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

Overview

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.

Interventions

• Other 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 v
• Other 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.

Primary outcome measures

• Proportion of patients recruited to SNAP [Time frame: 1 day]

Secondary outcome measures (4)

• Participant understanding of the clinical trial [Time frame: Within 3 days after the consent process]
• Participant satisfaction with the consent process [Time frame: Within 3 days after the consent process]
• Research staff satisfaction with the consent process [Time frame: 1 day]
• Time taken for entire consent process [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

• All inclusion criteria from the larger SNAP trial:

• S. aureus complex grown from ≥1 blood culture
• Admitted to a participating hospital at the time of eligibility assessment
• Specific additional inclusion criteria for SIMPLY-SNAP:

• 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 criteria

• All exclusion criteria from larger SNAP trial:

• 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
• Specific additional exclusion criteria for SIMPLY-SNAP: None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Canada · 6 centers

• University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital — Calgary
• Hamilton General Hospital — Hamilton
• The Ottawa Hospital — Ottawa
• Sunnybrook Health Sciences Centre — Toronto
• Montreal General Hospital — Montreal
• Royal Victoria Hospital — Québec

Publications

• 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 randomise PMID 38238170

Identifiers

NCT: NCT06168474 · 496741

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗