Actively Recruiting

Phase Not Applicable
All Genders
ID06168474

Evaluating the Impact of a Simplified Layered Consent Process on Recruitment for the Staphylococcus Aureus Network Adaptive Platform Trial

Led by Sunnybrook Health Sciences Centre · Updated on 2025-05-15

346

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Sunnybrook Health Sciences Centre

Lead Sponsor

M

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare a simplified layered consent form with a full-length consent form during the informed consent process for a larger clinical trial treating Staphylococcus aureus bloodstream infection. The trial focuses on whether the simplified form improves recruitment rates, participant understanding, and satisfaction with the consent process. It also evaluates staff satisfaction and the time taken for consent. Participants are randomly assigned to either the simplified layered consent group, where a concise 4-page summary with links to extra information and videos is provided on electronic tablets, or to the control group, which uses the full-length consent form without embedded links. Research staff explain the trial using the assigned form and answer any participant questions as usual. During the study, participants complete questionnaires within three days after consenting to assess their understanding and satisfaction. Researchers also measure recruitment rates, staff satisfaction, and the duration of the consent process. The trial will continue until June 2026, with outcomes focused on improving the informed consent experience for potential participants in the larger SNAP trial.

CONDITIONS

Brief Title

Evaluating Simplified Layered Consent for Clinical Trials

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Positive blood culture for Staphylococcus aureus complex from at least one blood sample
  • Admitted to a participating hospital at the time of eligibility assessment
  • Admitted to a participating hospital involved in the SIMPLY-SNAP trial
  • Able to understand and participate in the consent process in English or French
Not Eligible

You will not qualify if you...

  • Entry time greater than 72 hours after the blood culture collection
  • Presence of polymicrobial bacteremia, except organisms deemed contaminants
  • Currently receiving systemic antibacterial treatment that cannot be stopped
  • Previous participation in the SNAP trial
  • Positive blood culture for Staphylococcus aureus within 72 hours to 180 days before eligibility assessment
  • Treating team considers study participation not in patient's best interest
  • Treating team believes death is imminent and inevitable
  • Patient is receiving end-of-life care and antibiotics are inappropriate
  • Under 18 years old if pediatric recruitment not approved at the site (no pediatric recruitment at some sites)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Consent Process

Duration - 1 day

Participants undergo the consent process using either a simplified layered consent form or a full-length consent form, with research staff providing explanations and answering questions.

1 visit (in-person)

Follow-up

Duration - Within 3 days after the consent process

Participants complete assessments regarding their understanding and satisfaction with the consent process within 3 days after consenting.

1 follow-up visit (in-person or remote)

Trial Site Locations

Total: 6 locations

1

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

Calgary, Alberta, Canada

Actively Recruiting

2

Hamilton General Hospital

Hamilton, Ontario, Canada

Actively Recruiting

3

The Ottawa Hospital

Ottawa, Ontario, Canada

Actively Recruiting

4

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N3M5

Actively Recruiting

5

Montreal General Hospital

Montreal, Quebec, Canada

Actively Recruiting

6

Royal Victoria Hospital

Québec, Quebec, Canada

Actively Recruiting

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Research Team

S

Sean WX Ong, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

Evaluating the impact of a SIMPlified LaYered consent process on recruitment of potential participants to the Staphylococcus aureus Network Adaptive Platform trial: study protocol for a multicentre pragmatic nested randomised clinical trial (SIMPLY-SNAP trial).

Sean W X Ong, Todd C Lee, Robert A Fowler...

https://pubmed.ncbi.nlm.nih.gov/38238170