Medico-economical Evaluation of Patient-hotel in Urology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- ICER = Incremental Cost-Effectiveness Ratio of Costs and QALY(quality-adjusted life year) (unit of measure = cost(€)/QALY)
研究概览
简要总结
This is a medico-economic study of outpatient surgery paired with a night stay in a patient-hotel, compared with a conventional hospitalization for three types of urological surgeries.
The aim is to show that those two strategies are not different in term of adverse effects or rehospitalization, and that the patient-hotel provide a better quality of life at a reduced cost, in order to generate savings for the paying agent: the Healthcare insurance.
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
- •Age > 18 years
- •Healthcare insurance affiliation
- •Surgeries : sacral nerve neurostimulation, urinary artificial sphincter, or prosthetic penile implant
- •ASA (American Society of Anesthesiology) score between I and III
- •Patients that can be accompanied by a person with a car
- •Prior Informed Consent procedure form signed
- •Hospitalisation in Lyon Sud Hospital
排除标准
- •Refusal of participation or signing the consent form, guardianship or curatorship patients
- •Inability to understand the procedure
- •History of cognitive or psychiatric disorders
- •Non eligibility to out patient
- •Pregnant or breastfeeding patients
- •No affiliation to Healthcare insurance
结局指标
主要结局
ICER = Incremental Cost-Effectiveness Ratio of Costs and QALY(quality-adjusted life year) (unit of measure = cost(€)/QALY)
时间窗: at 3 months
Efficacity (QALY) is a composite measure of quality of life and adverse events occurence: * Quality of life is a composite score of : EQS5D questionnaire converted in utility, Other questionnaires : SF-12 ; International Continence Society short form, Post-Operative Patient, Global Impression of Improvement (PGI-I), l'Incontinence Impact Questionnaire-Short Form (IIQ-SF) et l'Urogenital Distress Index (UDI-SF). * Adverse events occurrence : urinary retention, postoperative infection, rehospitalization Costs : according to " micro-costing " method. Rehospitalizations will be priced from ENC rate.
次要结局
- Change in specific quality of life measured by Global Impression of Improvement (PGI-I) questionnaire(at Baseline and at 3 months)
- Change in general quality of life postoperatively measured by EQ5D questionnaire(at Baseline and after surgery at day one)
- Change in general quality of life at 3 months after surgery measured by EQ5D questionnaire(at Baseline and at 3 moths)
- Change in general quality of life at 3 months after surgery measured by SF12 questionnaire(at Baseline and at 3 moths)
- Change in specific quality of life measured by questionnaires International Continence Society short form(at Baseline and after surgery at day one)
- Change in specific quality of life measured by Post-Operative Patient questionnaire(at Baseline and at 3 months)
- Change in specific quality of life measured by Incontinence Impact Questionnaire-Short Form (IIQ-SF)(at Baseline and at 3 months)
- postoperative complications(at 3 months)
- Change in general quality of life postoperatively measured by SF12 questionnaire(at Baseline and after surgery at day one)
- Change in specific quality of life measured by Urogenital Distress Index (UDI-SF) questionnaire(at Baseline and at 3 months)
- Change in specific quality of life measured by International Continence Society short form(at Baseline and at 3 months)