Evaluating a New Multimedia-Based Informed Consent Method to Help Patients Understand Complex Spine and Prostate Surgery Options

What this Trial Is About

Researchers are evaluating a new way to provide preoperative information to patients who are candidates for spinal or urological surgery. This study is an interventional, randomized controlled trial conducted at multiple centers. It aims to compare a new multimedia-based method that objectively checks patient understanding against the standard informed consent process to see which better supports patient decision-making about surgery. Participants in the experimental group will receive detailed information through videos with surgical options, graphics, and animations. They will also have interviews with the surgeon and caregivers using 3D-printed models to guide shared decision-making. After deciding on surgery, patients will join educational programs to reinforce understanding before a final surgeon interview and signing of informed consent. The control group will receive the usual care, including a standard explanatory interview and consent signing. Throughout the study, participants will complete questionnaires assessing satisfaction, comprehension, mental health, pain, disability, urinary and sexual function, and legal outcomes at multiple time points before surgery, at discharge, and at two and six months after surgery. The research team will monitor these measures to evaluate the impact of the new method on patient understanding and decision satisfaction over time.

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