Staphylococcus Aureus Bacteremia
Conditions
Keywords
informed consent, research ethics, clinical trials, Staphylococcus aureus bacteremia, equity, diversity and inclusion
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.
Interventions
OTHERSimplified 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.
OTHERFull-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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sunnybrook Health Sciences Centre
Study design
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
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All inclusion criteria from the larger SNAP trial: 1. S. aureus complex grown from ≥1 blood culture 2. Admitted to a participating hospital at the time of eligibility assessment * Specific additional inclusion criteria for SIMPLY-SNAP: 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
* All
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients recruited to SNAP | 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
| Measure | Time frame | Description |
|---|---|---|
| Participant understanding of the clinical trial | 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). |
| Participant satisfaction with the consent process | 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). |
| Research staff satisfaction with the consent process | 1 day | Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied). |
| Time taken for entire consent process | 1 day | In minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diversity of enrolled trial population | 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. |
Countries
Canada
Contacts
Primary ContactSean WX Ong, MBBS
Outcome results
None listed