Spine Disease, Urologic Diseases
Conditions
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.
Interventions
OTHERactive 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.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comprehension Questionnaire | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) | procedure-specific assessment tool designed ad-hoc to evaluate a patient's knowledge and understanding of the planned procedure and associated risks/alternatives. |
| Depression Anxiety Stress Scales (DASS-21) | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) | is a 21-item self-report questionnaire designed to assess the severity of depression, anxiety, and stress symptoms over the past week |
| Numeric Rating Scale (NRS) | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) | 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"). |
| Oswestry Disability Index (ODI) | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) | self-administered questionnaire that assesses the degree of disability and functional impairment across ten daily-activity domains. |
| International Prostate Symptom Score (IPSS) | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) | Only for Urology patients: 7-item questionnaire that evaluates the severity of lower urinary tract symptoms and their impact on quality of life. |
| International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) | Only for Urology patients: short, patient-completed questionnaire that measures the frequency, severity, and impact of urinary incontinence on quality of life. |
| International Index of Erectile Function (IIEF-5 ) | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3) | Only for Urology patients: brief, 5-item self-report measure used to assess erectile function and screen for erectile dysfunction severity |
| Rate of Patients Declining Spine Surgery (Opt-Out Rate) | baseline (T0) | The proportion of patients in spine surgery population, who, after receiving full information, choose not to proceed with the planned surgery. |
| Medico-Legal Outcomes | baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3). | 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. |
Countries
Italy
Contacts
CONTACTLuca Boriani, MD
CONTACTBruna Maccaferri, MD
Outcome results
None listed