Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
Istituto Ortopedico Rizzoli
300 participants
Jun 19, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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.
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Interventions
new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for vertebral or urological surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06059599