Evaluating Simplified Layered Consent for Clinical Trials

NCT06168474 | Recruiting

• 1 other identifier: 496741
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 6

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.

Conditions

Staphylococcus Aureus Bacteremia

Keywords

informed consent; research ethics; clinical trials; Staphylococcus aureus bacteremia; equity, diversity and inclusion

Outcome Measures

Primary Outcomes (1)

• Proportion of patients recruited to SNAP

  The number of patients who consented and were randomized in the SNAP trial, divided by the total number of patient eligible for the SNAP trial and randomized in SIMPLY-SNAP.

  1 day

Secondary Outcomes (4)

• Participant understanding of the clinical trial

  Within 3 days after the consent process

• Participant satisfaction with the consent process

  Within 3 days after the consent process

• Research staff satisfaction with the consent process

  1 day

• Time taken for entire consent process

  1 day

Other Outcomes (1)

• Diversity of enrolled trial population

  End of the entire SIMPLY-SNAP study

Study Arms (2)

Simplified layered consent process

EXPERIMENTAL

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.

Other: Simplified layered consent form

Full-length consent form

ACTIVE COMPARATOR

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.

Other: Full-length consent form

Interventions

Simplified layered consent form OTHER

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.

Simplified layered consent process

Full-length consent form OTHER

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.

Full-length consent form

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• S. aureus complex grown from ≥1 blood culture
• Admitted to a participating hospital at the time of eligibility assessment
• Admitted to participating hospital of SIMPLY-SNAP
• 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)

You may not qualify if:

• 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 eligibility assessment
• Treating team deems enrolment 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 recruiting site

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (6)

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, M4N3M5, Canada

RECRUITING

Montreal General Hospital

Montreal, Quebec, Canada

RECRUITING

Royal Victoria Hospital

Québec, Quebec, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 38238170 DERIVED

Study Officials

• Sean WX Ong, MBBS

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean WX Ong, MBBS

CONTACT

4164806100; s.ong@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neither study subjects nor research staff administering consent will be masked to intervention allocation, as masking of the two different consent processes is not feasible. However, to minimize bias in measurement of outcomes, the assessor of the secondary outcomes of participant satisfaction and understanding will not be directly involved in the consent process and will be masked to the intervention allocation. Analysis of outcome results will also be performed masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate, Evaluative Clinical Sciences

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 13, 2023
• Study Start: November 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)