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

Not Applicable

Recruiting

• Conditions: Urologic Diseases; Spine Disease

• Registration Number: NCT06059599
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Study Start: 2024-06-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2026-09
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age ≥ 18 years
• Presence on waiting list for planned spinal (instrumented vertebral arthrodesis) and urological (radical prostatectomy) surgeries
• Understanding of the Italian language (in fact, it is believed that the percentage of non
• Italian mother-tongue patients is minimal and therefore not impacting the study)
• Ability to access computer tools -

Exclusion Criteria

• Age < 18 years
• Inability to self-determine
• Urgency/emergency of intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire	at baseline (day 0)	The primary outcome of the study will be measured: - by means of the Client Satisfaction Questionnaire, which provides a patient satisfaction score with a range from a minimum of 8 points (completely dissatisfied) to a maximum of 32 points (completely satisfied).

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy