Published
May 9, 2024

SIMPLY SNAP

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SIMPLY SNAP

SIMPLY-SNAP: Evaluating the impact of a SIMPlified Layered consent process versus a conventional informed consent form on recruitment of potential participants to a large platform clinical trial: a pragmatic nested randomized controlled trial

We are enrolling potential SNAP trial participants to this sub-study to test out different consent processes and their impact on recruitment, participant understanding, and participant satisfaction.

  • Existing clinical trial consent forms are long and complicated, and patients can be overwhelmed with too much information. This can lead to counter-productive effects such as deterring patients from participating in a clinical trial, or unintentionally discriminating against patients with less privileged educational or socio-economic backgrounds.
  • In this study, we are evaluating the use of a novel simplified layered consent process, where summarized information is provided in a 4-page concise participant information sheet, with links to additional information that can be accessed separately for participants who wish to read more.
  • We are comparing this to the conventional informed consent form where all information is provided upfront, and assessing if there is any difference in recruitment, participant satisfaction, and participant understanding of the clinical trial with these two different consent methods.

This sub study is being conducted in Canada.

Lead Investigators: Dr Sean Ong, Prof Nick Daneman, Prof Steven Tong, Prof Joshua Davis, Dr Rob Mahar, A/Prof Todd Lee, Dr Emily McDonald

What will the sub-study involve – more information

There are no additional blood tests, interventions, or follow-up required as part of this sub-study.

There will be additional survey questions assessing your understanding of the SNAP trial to determine how well you understood the information conveyed during the consent process.

Risks and benefits of taking part in the sub study

There are no anticipated risks of participating in this sub-study.

Where will my sub study information be collected and stored?

All additional data collected as part of this sub-study will be de-identified and stored on the same secured database as the primary SNAP trial.

What if I withdraw from this sub study?

You can withdraw from the sub study at any time, just notify a member ofthe SNAP study team.

If you withdraw, we will keep any information wehave collected about you up until you withdraw.

Sub Study Contacts

Name: Dr Sean Ong (lead investigator)

Email: s.ong@mail.utoronto.ca

Substudies in Progress

SNAP Trial

SABSI

Profiling the genetic and epigenetic determinants that predispose to severe manifestations of Staphylococcus aureus bacteremia

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All Interested
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Substudy in Progress

cfDNA

Cell-free DNA is a Versatile Analyte to Monitor Complications and Guide Treatment Duration in Staphylococcus aureus Bacteremia

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Any interested
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Substudy in Progress

SABSI-Outcomes

Derivation and Validation of Phenotypes of Staphylococcus aureus bloodstream infection, with Correlation with Outcome.

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Any Interested
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Substudy in Progress

SNAP-SEQ

Pilot study for real-time sequencing of Staphylococcus aureus bloodstream isolates

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Any Interested
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Substudy in Progress

PENFAST

Using a validated penicillin allergy risk prediction tool (Pen-FAST) in patients with a low risk penicillin allergy 

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Any Interested
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Substudy in Progress

Pharmacogenomics

 Immunopathogenesis and pharmacogenomics of severe antibiotic hypersensitivity 

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Australia
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Substudy in Progress
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