Improving patient understanding of complex surgical procedures
Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
This study tests a new way to help patients better understand complex spinal and urological surgeries using multimedia tools before their operations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06059599 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate a new method for preoperative information using multimedia tools to enhance patient understanding of complex surgical procedures, specifically for spinal and urological surgeries. It is a randomized controlled trial that will objectively assess how well patients comprehend the information provided to them before surgery. The study will involve multiple centers and will focus on patients who are on the waiting list for these specific surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are on the waiting list for planned spinal or urological surgeries and can understand Italian.
Not a fit: Patients under 18, those unable to self-determine, or those requiring urgent/emergency interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better informed patients and improved surgical outcomes.
How similar studies have performed: While the specific approach of using multimedia tools for informed consent is relatively novel, similar studies have shown that improved communication methods can enhance patient understanding.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Luca Boriani, MD
- Email: luca.boriani@ior.it
- Phone: 0516366233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.