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

Urologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06059599
• Other study ID #: CIA21
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: October 2026

Study information

• Verified date: May 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Luca Boriani, MD
• Phone: 0516366233
• Email: luca.boriani[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Diseases
• Spine Disease
• Urologic Diseases

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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): — View Citation

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 procedu — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	at baseline (day 0)