Evaluating Simplified Layered Consent for Clinical Trials
NCT ID: NCT06168474
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
346 participants
INTERVENTIONAL
2023-11-28
2026-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Simplified layered consent process
For participants randomized to the SIMPLY-SNAP experimental group, a simplified layered consent process will be used to explain information for the SNAP trial. The research staff member obtaining consent will provide a standardized explanation, providing summarized information in simple English or French contained in a 4-page concise participant information sheet. Throughout the consent process, the research staff member will answer any questions that the participant has, to reflect routine consent discussion practice.
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.
Full-length consent form
For participants randomized to the control group, the existing consent process will be used including going through the currently approved full-length informed consent form. The research staff member will provide an explanation using the full-length informed consent form as per standard clinical trial procedures. Similarly, throughout the consent process, the research staff member will answer any participant questions as per normal procedures.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Admitted to a participating hospital at the time of eligibility assessment
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
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
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Sean Ong
Research Associate, Evaluative Clinical Sciences
Principal Investigators
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Sean WX Ong, MBBS
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus
Calgary, Alberta, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Royal Victoria Hospital
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Ranjani Somayaji
Role: primary
Dominik Mertz, MD
Role: primary
Derek McFadden, MD
Role: primary
Todd Lee, MD
Role: primary
Todd Lee, MD
Role: primary
References
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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 randomised clinical trial (SIMPLY-SNAP trial). BMJ Open. 2024 Jan 18;14(1):e083239. doi: 10.1136/bmjopen-2023-083239.
Other Identifiers
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496741
Identifier Type: -
Identifier Source: org_study_id
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