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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • active informed consent

    Other intervention

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: active informed consentExperimental treatment 1 intervention
Group B: Traditional informed consentNo intervention 0 interventions

Trial outcomes

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).

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

Secondary outcomes

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.

Time frame
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

Time frame
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").

Time frame
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.

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

Other outcomes

Sponsors and contacts

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