NCT06059599

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2024Oct 2026

First Submitted

Initial submission to the registry

September 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

June 19, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

September 22, 2023

Last Update Submit

January 29, 2026

Conditions

Spine DiseaseUrologic Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Comprehension Questionnaire

    baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

  • Depression Anxiety Stress Scales (DASS-21)

    baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

  • Numeric Rating Scale (NRS)

    baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

  • Oswestry Disability Index (ODI)

    baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

  • International Prostate Symptom Score (IPSS)

    baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)

  • +4 more secondary outcomes

Study Arms (2)

active informed consent

EXPERIMENTAL

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

Traditional informed consent

NO INTERVENTION

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.

Interventions

active informed consentOTHER

new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for vertebral or urological surgery.

active informed consent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23832767RESULT

  • 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.

    PMID: 31948345RESULT

  • 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.

    PMID: 30944886RESULT

  • 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.

    PMID: 29932049RESULT

  • Boriani L, Quattrini I, Maccaferri B, Lima C, Benuzzi A, Salvador M, Schiavina R, Brunocilla E, Deiure F, Maselli V, De Stefano R, Vommaro F, Gasbarrini A. Protocol RCT for active informed consent in spine and urologic surgery in the metropolitan city of Bologna: does an increased patient engagement improve satisfaction of complex surgical procedures? BMJ Open. 2026 Mar 10;16(3):e108286. doi: 10.1136/bmjopen-2025-108286.

    PMID: 41806994DERIVED

MeSH Terms

Conditions

Spinal DiseasesUrologic Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Luca Boriani, MD

CONTACT

0516366233luca.boriani@ior.it

Bruna Maccaferri, MD

CONTACT

0516366163bruna.maccaferri@ior.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2023

First Posted

September 28, 2023

Study Start

June 19, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)