Cost-utility Analysis of the Outpatient Hospitalization Versus Conventional Hospitalization in Endovascular Treatment of Occlusive Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 13
- 主要终点
- Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms
研究概览
简要总结
The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.
详细描述
Rationale for ambulatory hospitalization is based on increased demand of hospital care, hospital budgets constraints and patients who ask for a prompt recovery. Consequently, physicians should find ways to optimize the resources' allocation, without compromising quality, safety and efficiency of patient care. Several studies and routine practice have shown that ambulatory hospitalization was safe but we are still lacking evidence to demonstrate the cost-utility of this kind of management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients limping
- •Patients with PAD requiring endovascular management
- •Patients with stabilized level 1 to 3 ASA (classification of the American Society of Anesthesiology)
- •Ability to walking
- •Endovascular indicated and compatible with an introducer 5F to 7F
- •Agreeing to participate in the study and having signed an informed consent.
- •Agreeing to lend itself to a post-operative monitoring a duration of 30 days
- •Social Insured
排除标准
- •No possibility of an outpatient management
- •Previous participation in the AMBUVASC study
- •Refusal of patient to participate in the study
- •Patient with hemostasis disorders
- •Acute Ischemia
- •Using a more 7F introducer
- •Radial or brachial puncture
- •Antegrade femoral puncture
- •Contraindication to endovascular treatment
- •Less than one month life expectancy
- •Participation in another clinical trial
研究组 & 干预措施
Outpatient hospitalisation
The intervention is the Treatment of Occlusive Arterial Disease, during an ambulatory hospitalisation, with the use of an arterial closure device (ACD).
The patients treated for PAD (Peripheral Arterial Disease) are informed and prepared in the morning of D0. The surgical endovascular procedure is performed at D0 before 1:00 p.m. The patients leave the hospital in the evening at D0 after a systematic visit.
干预措施: Treatment of Occlusive Arterial Disease (Procedure)
Conventional inpatient hospitalisation
The intervention is the Treatment of Occlusive Arterial Disease, during a conventional hospitalisation, with or without ACD (ACD will be used at the discretion of the interventionalist).
The patients treated for PAD arrive at the hospital the day before surgery (D-1). The surgical endovascular procedure takes place the next day (D0). The day after (D1), the patients leave the hospital after a systematic visit.
干预措施: Treatment of Occlusive Arterial Disease (Procedure)
结局指标
主要结局
Incremental Cost Effectiveness Ratio (ICER) comparing cost and utility in the two arms
时间窗: 3 months
The objective of the study is to perform a cost-utility analysis comparing outpatient surgery to conventional hospitalization in endovascular treatment of occlusive arterial disease. The analysis will be conducted from a society's perspective using a one-month time horizon following the date of intervention (and 2 months before intervention). A microcosting approach will be used to estimate the cost of the surgical intervention in both arms and all subsequent in-hospital and ambulatory care resources consumption will be systematically recorded during the one month follow-up period. Effectiveness will be assessed in terms of Quality-Adjusted Life-Years (QALYs) estimated from patients' answers to the Euroqol EQ-5D questionnaire and french preferences scores. Results will be presented as an incremental cost-per-QALY ratio.
次要结局
- Time period to back-to-work(1 month)
- Budget impact analysis(5 years)
- Functional improvement(1 month)
- Complication rates(1 month)