Evaluating Simplified Layered Consent for Clinical Trials

Staphylococcus Aureus Bacteremia Clinical Trial

— SIMPLY-SNAP  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168474
• Other study ID #: 496741
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Sean WX Ong, MBBS
• Phone: 4164806100
• Email: s.ong[@]mail.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 346
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 exclusion criteria from larger SNAP trial:

1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture

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

• Specific additional exclusion criteria for SIMPLY-SNAP: None

Related Conditions & MeSH terms

• Bacteremia
• Staphylococcal Infections
• Staphylococcus Aureus Bacteremia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Montreal General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Royal Victoria Hospital	Québec	Quebec
Canada	Michael Garron Hospital	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diversity of enrolled trial population	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.	End of the entire SIMPLY-SNAP study
Primary	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	Participant understanding of the clinical trial	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).	Within 3 days after the consent process
Secondary	Participant satisfaction with the consent process	Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).	Within 3 days after the consent process
Secondary	Research staff satisfaction with the consent process	Scored by 11-point Likert scale (0 to 10; 0 being not satisfied at all and 10 being extremely satisfied).	1 day
Secondary	Time taken for entire consent process	In minutes	1 day