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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spine Disease, Urologic Diseases

Intervention / Treatment
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* Other: active informed consent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active informed consent<br>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<br>* new preoperative information method, based on multimedia tools and on the objective control of understanding by the patient candidate for vertebral or urological surgery.<br>|
| No Intervention: Traditional informed consent<br>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?
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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). | at baseline (day 0) |