Grant: Project Grant

In this study, we plan to test out a new way to explain clinical trials to potential participants. Obtaining patients' consent to participate in trials is difficult, as patients often find consent forms daunting with too much information. These forms are very long, and many patients do not read them. Even among those that do, they may not fully understand them. This can put off patients with different educational or cultural backgrounds, depriving them the chance to benefit from a clinical trial. Patients, when ill in the hospital, may also be unable to read long forms, which may cause more discomfort to them. We will test out a new simplified consent process where the patient takes the lead in directing how much information they want to read. There will be a simplified form with the most important information needed to make a decision safely. For patients keen to know more, there are links to extra information and videos on a website. This is much simpler than the current forms used, which can be up to 20 pages and filled with complex information. We will study patients invited to participate in a large clinical trial for blood infection, the SNAP trial, and compare this new method to the current long form by randomly allocating patients to either the new form or the current form. We will then look at how the different forms affects patients' willingness to participate in the trial, their overall satisfaction with the consent process, and their understanding of the trial. We hope that this method will increase patient participation in trials and provide patients a more positive experience with research. If the results are positive, this approach can be extended to all future clinical trials.