Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding… (NCT06059599) | Clinical Trial Compass
RecruitingNot Applicable
Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
Italy300 participantsStarted 2024-06-19
Plain-language summary
This is an interventional, non-pharmacological, randomized controlled superiority study (RCT), multicenter, open label, parallel group.
The aim is to evaluate the effectiveness of a new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for spinal or urological surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged ≥ 18 years (with full legal capacity to consent).
* Scheduled for elective surgery in one of the two domains: spinal surgery or radical prostatectomy in the waiting list of our centers.
* Ability to comprehend Italian language.
* Basic computer or internet access skills. Patients (or their family members) should have the ability to access multimedia content.
Exclusion Criteria:
* Patients under age: minors.
* Inability to provide informed consent or self-determination (significant cognitive impairment, severe mental illness, or decisional incapacity that would prevent them from understanding the consent materials or participating in the decision-making).
* Urgent or emergency surgery cases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.