Comparing simplified and full-length consent forms for a clinical trial

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

This study is testing if a simpler consent form helps people understand and feel better about joining a clinical trial for treating Staphylococcus aureus bloodstream infections compared to a longer, traditional form.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 346 (estimated)
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (other)
• Locations: 6 sites (Calgary, Alberta and 5 other locations)
• Trial ID: NCT06168474 on ClinicalTrials.gov

What this trial studies

This clinical trial, known as SIMPLY-SNAP, aims to evaluate the effectiveness of a simplified layered consent form compared to a traditional full-length consent form in the informed consent process for a larger trial focused on treating Staphylococcus aureus bloodstream infections. Participants will be randomly assigned to one of the two consent forms, and their understanding of the trial and satisfaction with the consent process will be assessed afterward. The study seeks to determine if the simplified form can improve recruitment rates and participant comprehension.

Who should consider this trial

Good fit: Ideal candidates are patients admitted to participating hospitals with Staphylococcus aureus bacteremia who can communicate in English or French.

Not a fit: Patients with polymicrobial bacteremia or those who do not meet the eligibility criteria for the larger SNAP trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the informed consent process, leading to better participant recruitment and understanding in clinical trials.

How similar studies have performed: While the approach of using simplified consent forms has been explored in other studies, the specific methodology and focus on Staphylococcus aureus bacteremia in this context may be novel.

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

Where this trial is running

Calgary, Alberta and 5 other locations

• University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus — Calgary, Alberta, Canada (RECRUITING)
• Hamilton General Hospital — Hamilton, Ontario, Canada (RECRUITING)
• The Ottawa Hospital — Ottawa, Ontario, Canada (RECRUITING)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
• Montreal General Hospital — Montreal, Quebec, Canada (RECRUITING)
• Royal Victoria Hospital — Québec, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Sean WX Ong, MBBS — University of Toronto
• Study coordinator: Sean WX Ong, MBBS

Conditions: Staphylococcus Aureus Bacteremia, informed consent, research ethics, clinical trials, Staphylococcus aureus bacteremia, equity, diversity and inclusion