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NCT Number: NCT06168474

Evaluating Simplified Layered Consent for Clinical Trials

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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Key information

Conditions

Staphylococcus Aureus Bacteremia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All inclusion criteria from the larger SNAP trial:
  • S. aureus complex grown from ≥1 blood culture
  • Admitted to a participating hospital at the time of eligibility 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 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:
  • 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
  • Specific additional exclusion criteria for SIMPLY-SNAP: None

Treatment and study plan

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.

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.

Primary outcomes

  1. Proportion of patients recruited to SNAP

    Time frame: 1 day

    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.

Secondary outcomes

  1. Participant understanding of the clinical trial

    Time frame: Within 3 days after the consent process

    Understanding of the clinical trial will be measured by a modified Consent Understanding Evaluation (CUE) tool. This is a questionnaire that comprises a list of open and closed-ended questions designed to evaluate a participant's understanding of the clinical trial they just enrolled in. It is adapted from previous similar trials evaluating adjunctive consent interventions but modified to the context of SNAP. The score ranges from 0 (worst understanding) to 15 (best understanding).

  2. Participant satisfaction with the consent process

    Time frame: Within 3 days after the consent process

    Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).

  3. Research staff satisfaction with the consent process

    Time frame: 1 day

    Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).

  4. Time taken for entire consent process

    Time frame: 1 day

    In minutes

Other outcomes

  1. Diversity of enrolled trial population

    Time frame: End of the entire SIMPLY-SNAP study

    As an exploratory outcome, we will also evaluate diversity of the enrolled trial population across five self-reported socio-demographic characteristics: gender, ethnicity, primary spoken language, socioeconomic status (measured by income level, or last-income level before retirement), and highest formal educational level attained.

    We will separately evaluate diversity of the patient group enrolled in SNAP via the simplified consent process versus the patient group enrolled via the full-length consent form. Diversity will be measured using the Simpson's Diversity Index (SDI). SDI will be calculated for each of five socio-demographic variables for the group recruited via simplified consent and the group recruited via conventional consent. A composite diversity score for each group combining the SDIs of all five variables will also be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Sean WX Ong, MBBS

CONTACT

[email protected]

4164806100 ext. 2791

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

Registry information

Official study title

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

Acronym: SIMPLY-SNAP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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