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Simplified layered consent process for Staph Bacteremia (SIMPLY-SNAP Trial)

N/A

Recruiting

Led By Sean WX Ong, MBBS

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of the entire simply-snap study

Awards & highlights

SIMPLY-SNAP Trial Summary

This trial will compare a simplified version of the consent form to a full-length version to see if understanding and satisfaction increases.

Who is the study for?

This trial is for adults with a Staphylococcus aureus blood infection, who speak English or French well enough to understand the consent process. They must be in a participating hospital and not have multiple bacteria in their blood, nor be on certain antibiotics they can't stop. Patients already enrolled in SNAP or treated for S. aureus recently cannot join.Check my eligibility

What is being tested?

The SIMPLY-SNAP trial tests if a simplified layered consent form improves recruitment rates, understanding of the study, and satisfaction compared to a full-length form during informed consent for treating Staph infections. Participants will receive either the detailed or simplified form randomly.See study design

What are the potential side effects?

Since this trial focuses on comparing different types of consent forms rather than medical treatments, there are no direct physical side effects associated with participation.

SIMPLY-SNAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 days after the consent process

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 days after the consent process

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 days after the consent process for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients recruited to SNAP

Secondary outcome measures

Participant satisfaction with the consent process

Participant understanding of the clinical trial

Research staff satisfaction with the consent process

+1 more

Other outcome measures

Diversity of enrolled trial population

SIMPLY-SNAP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Simplified layered consent processExperimental Treatment1 Intervention

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.

Group II: Full-length consent formActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,962 Total Patients Enrolled

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

446 Previous Clinical Trials

159,380 Total Patients Enrolled

Sean WX Ong, MBBSPrincipal InvestigatorUniversity of Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings to join this investigation?

"Affirmative. Clinicaltrials.gov attests to the fact that 346 individuals are being sought for this clinical trial, which was initiated on November 28th 2023 and revised most recently on December 4th of the same year. The recruitment is ongoing at 8 locations across the country."

Answered by AI

How many venues are engaged in administering this clinical experiment?

"Eight healthcare facilities are currently recruiting patients for this study. In Canada, these include Royal Victoria Hospital in Québec, Sunnybrook Health Sciences Centre in Hamilton and the Hamilton General Hospital in Ottawa; there are also several other sites open to recruitment."

Answered by AI

How many individuals are enrolled in this clinical trial?

"Indeed, clinicaltrials.gov has confirmed that enrollment for this trial is open as of December 4th 2023. The initial posting was on November 28th 2023 and the aim is to recruit 346 patients from 8 different medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating Simplified Layered Consent for Clinical Trials

Sean Ong 2023. "Evaluating Simplified Layered Consent for Clinical Trials". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06168474.