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

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Spine Disease; Urologic Diseases

Treatments: Other: active informed consent

Study type: Interventional

Funder types: Other

Identifiers

NCT06059599

CIA21

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

active informed consent

Experimental group

Description:

The experimental group will be prepared for the surgery through the new information tools, a video will be administered with information about the various surgical possibilities, graphics and animations in order to direct the patient toward a more informed choice. Next, an interview with the surgeon will be arranged for the patient and care givers to be listened to and guided through the use of 3D-printed models into the best decision for the individual case (Shared Decision Making - SDM). Having decided on the surgery, patients with similar surgical programs will be guided in educational programs to reinforce information, understanding and long-term retention of the concepts learned. The course will conclude with a second interview with the surgeon and the signing of the standard informed consent.

Treatment:

Other: active informed consent

Traditional informed consent

No Intervention group

Description:

The control group of patients will be informed about the surgery according to standard practices. As per standard practice, the patient will meet with the physician before surgery for an explanatory interview and subsequent signing of informed consent.