Evaluating Simplified Layered Consent for Clinical Trials
This study, called SIMPLY-SNAP, is looking at the best way to explain clinical trials to people. It's comparing a new, simpler consent form with a more traditional, longer one. The main aim is to see if the simpler form helps more people understand the trial and if it makes them more willing to join. It also checks if people are happier with the new way of getting information. Participants with a specific blood infection will randomly receive one of the two forms. Afterwards, they'll answer questions about how well they understood and how they felt about the process.
At a glance
What is this study about?
Imagine you're asked to join a medical study. Before you agree, it's really important that you understand what it's all about. This study, called SIMPLY-SNAP, is looking into the best way to give you that information.
Currently, when you're asked to join a clinical trial, you get a detailed form with a lot of information. This new study is comparing that standard form with a new, simpler form. This simpler form is designed to be easier to read and understand, and it might even include links to videos or extra information if you want to learn more.
The main goal is to find out if this simpler approach helps more people understand what they are signing up for, makes them feel better about the process, and encourages more people to take part in important medical research like the SNAP trial, which is looking at treatments for a serious blood infection called Staphylococcus aureus bacteremia. Ultimately, this research aims to make joining clinical trials a clearer and more comfortable experience for patients.
Key takeaways
- The study compares two ways of explaining clinical trials: a standard form and a new, simpler form.
- It aims to see if the simpler form helps people understand better and feel more satisfied.
- Participation involves reviewing information and answering a questionnaire, not receiving new treatments.
- Your involvement could help improve future patient information for medical research.
- You can withdraw from the study at any time without affecting your medical care.
Who may be eligible?
To be able to take part in this study, you would need to meet certain requirements. Firstly, you must have a specific type of blood infection called Staphylococcus aureus in your bloodstream, and be a patient in one of the hospitals taking part in the study.
It's also important that you can understand and speak English or French well enough to follow the information given in those languages, as the simpler consent forms and any extra materials are only available in English or French at the moment.
There are also some reasons why you wouldn't be able to join. For example, if your infection was found more than three days ago, or if you have other serious infections at the same time. Also, if your doctors believe joining the study isn't right for your health, or if you're under 18 and the hospital doesn't have approval for younger patients to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do you have a Staphylococcus aureus blood infection?
- Are you currently an inpatient at a hospital taking part in this study?
- Can you understand and speak English or French well enough to follow study information?
- Have you been diagnosed with this infection within the last 72 hours (3 days)?
What does participation involve?
If you decide to take part in this study, here's what would happen: you'd be given either the standard, full-length consent form or the new, simplified consent form. A member of the research team would use this form to explain the bigger SNAP trial, which is about treating a specific blood infection. There are no medicines or new treatments given in this SIMPLY-SNAP study itself.
After you have had the SNAP trial explained to you and have given your consent, you would then be asked to complete a questionnaire. This questionnaire will help the researchers understand how well you understood the information and how satisfied you were with the way it was explained to you. The total duration of your involvement in the SIMPLY-SNAP study would be just for this consent process and the questionnaire completion.
Potential risks and benefits
Locations (6)
- University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health CampusVerified postcodeCalgary, Canada· Recruiting
- Hamilton General HospitalVerified postcodeHamilton, Canada· Recruiting
- The Ottawa HospitalVerified postcodeOttawa, Canada· Recruiting
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada· Recruiting
- Montreal General HospitalVerified postcodeMontreal, Canada· Recruiting
- Royal Victoria HospitalVerified postcodeQuébec, Canada· Recruiting
Common questions
What is the main goal of this study?
To find out if a simpler way of explaining clinical trials helps patients understand better and encourages more people to join medical research.
Will I receive any new treatments in this study?
No, this study is about how information is given, not about new treatments. You would only be asked to review information and answer questions.
What is a 'simplified layered consent form'?
It's a shorter, easier-to-read information form, which might also include links to extra details or videos if you want to learn more.
How long will my participation last?
Your participation would be brief, just for the explanation of the trial, review of the consent form, and completing a short questionnaire.
Will my regular medical care be affected by joining?
No, taking part in this study will not affect the medical care you receive for your health condition.
How to find out more
Sean WX Ong, MBBS
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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