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

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.

Study Overview

• Status: Recruiting
• Conditions: Urologic Diseases; Spine Disease
• Intervention / Treatment: Other: active informed consent

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Boriani, MD; Phone Number: 0516366233; Email: luca.boriani@ior.it
• Study Contact Backup: Name: Bruna Maccaferri, MD; Phone Number: 0516366163; Email: bruna.maccaferri@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Cristiana Griffoni, PhD; Phone Number: +39-0516366971; Email: cgriffoni@hotmail.com
    • Sub-Investigator: Alessandro Gasbarrini, MD
    • Sub-Investigator: Stefano Bandiera, MD
    • Sub-Investigator: Riccardo Ghermandi, MD
    • Sub-Investigator: Giuseppe Tedesco, MD
    • Sub-Investigator: Gisberto Evangelisti, MD
    • Sub-Investigator: Giovanni Barbanti Brodano, MD
    • Principal Investigator: Silvia Terzi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active informed consent; 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.	Other: active informed consent; new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for vertebral or urological surgery.
No Intervention: Traditional informed consent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire	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).	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehension Questionnaire	procedure-specific assessment tool designed ad-hoc to evaluate a patient's knowledge and understanding of the planned procedure and associated risks/alternatives.	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Depression Anxiety Stress Scales (DASS-21)	is a 21-item self-report questionnaire designed to assess the severity of depression, anxiety, and stress symptoms over the past week	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Numeric Rating Scale (NRS)	is a simple self-report measure in which patients rate their current pain intensity on an scale from 0 ("no pain") to 10 ("worst imaginable pain").	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Oswestry Disability Index (ODI)	self-administered questionnaire that assesses the degree of disability and functional impairment across ten daily-activity domains.	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
International Prostate Symptom Score (IPSS)	Only for Urology patients: 7-item questionnaire that evaluates the severity of lower urinary tract symptoms and their impact on quality of life.	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)	Only for Urology patients: short, patient-completed questionnaire that measures the frequency, severity, and impact of urinary incontinence on quality of life.	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
International Index of Erectile Function (IIEF-5 )	Only for Urology patients: brief, 5-item self-report measure used to assess erectile function and screen for erectile dysfunction severity	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)
Rate of Patients Declining Spine Surgery (Opt-Out Rate)	The proportion of patients in spine surgery population, who, after receiving full information, choose not to proceed with the planned surgery.	baseline (T0)
Medico-Legal Outcomes	For each group, we will track through hospital records the number of medicolegal complaints or claims filed by patients, specifically those alleging inadequate informed consent or unexpected outcomes, related to their surgery within the follow-up period. The outcome will be reported as the count (or proportion of patients) with such complaints in each arm.	baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3).

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Glaser J, Nouri S, Fernandez A, Sudore RL, Schillinger D, Klein-Fedyshin M, Schenker Y. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review. Med Decis Making. 2020 Feb;40(2):119-143. doi: 10.1177/0272989X19896348. Epub 2020 Jan 16.
• Nathe JM, Krakow EF. The Challenges of Informed Consent in High-Stakes, Randomized Oncology Trials: A Systematic Review. MDM Policy Pract. 2019 Mar 28;4(1):2381468319840322. doi: 10.1177/2381468319840322. eCollection 2019 Jan-Jun.
• Luhnen J, Muhlhauser I, Steckelberg A. The Quality of Informed Consent Forms-a Systematic Review and Critical Analysis. Dtsch Arztebl Int. 2018 Jun 1;115(22):377-383. doi: 10.3238/arztebl.2018.0377.
• Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AG. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev. 2013 Jul 6;2013(7):CD009445. doi: 10.1002/14651858.CD009445.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Diseases; Spinal Diseases
• Other Study ID Numbers: CIA21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No