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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 346
- Locations
- 6
- Primary Endpoint
- Proportion of patients recruited to SNAP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Simplified layered consent form (Other)
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.
Intervention: Full-length consent form (Other)
Outcomes
Primary Outcomes
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
- Time taken for entire consent process(1 day)
- Participant satisfaction with the consent process(Within 3 days after the consent process)
- Research staff satisfaction with the consent process(1 day)
- Participant understanding of the clinical trial(Within 3 days after the consent process)
Investigators
Sean Ong
Research Associate, Evaluative Clinical Sciences
Sunnybrook Health Sciences Centre