Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • active informed consent

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators