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AzTrials

Spine DiseaseNCT06059599

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

A study testing active informed consent in people with Spine Disease and Urologic Diseases, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spine Disease, Urologic Diseases
What is being tested?
active informed consent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteItaly
Study dates
19 Jun 2024to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

Other trials in Italy

About this study

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.

Being tested
active informed consent
Medical subject headings
Spinal Diseases, Urologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06059599
Study groupRoleWhat they receive
active informed consentExperimentalThe 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.
Receives: Other: active informed consent
Traditional informed consentNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (9)

  1. 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.

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

  2. 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

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

  3. 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").

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

  4. Oswestry Disability Index (ODI)

    self-administered questionnaire that assesses the degree of disability and functional impairment across ten daily-activity domains.

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

  5. 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.

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

  6. 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.

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

  7. 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

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

  8. 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.

    Measured: baseline (T0)

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start19 Jun 2024
  3. Primary completion1 Jul 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06059599
Sponsor's protocol ID
CIA21
Status last verified
Oct 2026
First submitted
22 Sep 2023
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23832767

  • 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.

    PubMed 31948345

  • 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.

    PubMed 30944886

  • 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.

    PubMed 29932049

  • 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.

    PubMed 41806994

Questions about this trial

What is this clinical trial studying?

A study testing active informed consent in people with Spine Disease and Urologic Diseases, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Client Satisfaction Questionnaire (time frame: baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06059599, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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