Active Informed Consent: a New Solution to Improve and Objectively Test the Patient Understanding of Complex Surgical Procedures Proposals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Client Satisfaction Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Traditional informed consent
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.
active informed consent
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.
干预措施: active informed consent (Other)
结局指标
主要结局
Client Satisfaction Questionnaire
时间窗: 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).
次要结局
- 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))
- International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)(baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3))
- International Index of Erectile Function (IIEF-5 )(baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3))
- Rate of Patients Declining Spine Surgery (Opt-Out Rate)(baseline (T0))
- Medico-Legal Outcomes(baseline (T0), discharge (T1), 2 months follow-up (T2) and 6 months follow-up (T3).)