Comparing Simplified layered consent form with Full-length consent form for staphylococcus aureus bacteremia
Official title: Evaluating Simplified Layered Consent for Clinical Trials
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
- 2 groups
- Sites in Calgary, Hamilton and 4 more cities
- Recruiting
Interventions
- Other intervention
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 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.
- Other intervention
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.
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus
Calgary, Alberta
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
- Recruiting
Montreal General Hospital
Montreal, Quebec
- Recruiting
Royal Victoria Hospital
Québec, Quebec
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +All inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → from the larger SNAP trial:
- +S. aureus complex grown from ≥1 blood culture
- +Admitted to a participating hospital at the time of eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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
- −All exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → assessment
- −Treating team deems enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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 recruitingRecruitingThe study is currently looking for participants.Read more → siteTrial siteA hospital or clinic where a study is actually run.Read more →
- −Specific additional exclusion criteria for SIMPLY-SNAP: None
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is looking at how care is delivered and organised, rather than at a treatment itself.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Simplified layered consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Registry label: A: Simplified layered consent process
Group B, the comparison group, receives Full-length consent form.
Registry label: B: Full-length consent form
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 346 people.
The study is currently expected to finish around June 2026.
The main measurement is taken over: 1 day.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of patients recruited to SNAP — measured over 1 day.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06168474 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Simplified layered consent formOther
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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Full-length consent formOther
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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 day.
The study as a whole is currently expected to finish around 2026-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 346 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Calgary, Alberta, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.