Clinical trial NCT06168474: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Staphylococcus Aureus Bacteremia
Keywords: informed consent
research ethics
clinical trials
Staphylococcus aureus bacteremia
equity, diversity and inclusion
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2023-12-13
Enrollment: 346
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 criteria: 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 outcomes:
measure: Proportion of patients recruited to SNAP
timeFrame: 1 day
Secondary outcomes:
measure: Participant understanding of the clinical trial
timeFrame: Within 3 days after the consent process
measure: Participant satisfaction with the consent process
timeFrame: Within 3 days after the consent process
measure: Research staff satisfaction with the consent process
timeFrame: 1 day
measure: Time taken for entire consent process
timeFrame: 1 day
Other outcomes:
measure: Diversity of enrolled trial population
timeFrame: End of the entire SIMPLY-SNAP study
Locations:
city: Calgary
country: Canada
facility: University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Québec
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: University of Toronto
name: Sean WX Ong, MBBS
role: PRINCIPAL_INVESTIGATOR
References: