A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU : A Stepped Wedge Cluster-randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 256
- 主要终点
- All-cause mortality
研究概览
简要总结
Admission to the intensive care unit (ICU) is a common event in patients treated for solid tumors or hematologic malignancies. A volume-outcome relationship has been shown in these patients, with a mortality rate decreasing from 70% in low-volume centres to 30-40% in high-volume centres.
We hypothesize that providing the low-volume centres with assistance from experts working in high-volume centres for the management of critically-ill cancer patients can bring down mortality to the values seen in high-volume centres.
The main objective of this study is to evaluate whether combining three knowledge-transfer methods (videoconference-based forum, educational sessions, and dissemination of published work) increases the survival of cancer patients managed in low-volume centres to the values seen in high-volume centres.
The main endpoint is all-cause mortality at hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (> 18 years old)
- •Active malignancy;
- •ICUs seeking for an advice must admit fewer than 30 patients with active cancer per year;
- •Patients has been urgently admitted in the ICU for a life threatening complication of the malignancy or its treatments.
排除标准
- •Isolated HIV infection or AIDS;
- •ICU admission complicating scheduled surgery,
- •Treatment-limitation decisions at admission;
- •No coverage by the French statutory health insurance system,
- •Pregnant or breastfeeding
研究组 & 干预措施
Comparator Arm
Classic expertise (as routinely performed in the participating ICU)
干预措施: Standard of care arm (Other)
Telemedicine-based intervention
Telemedicine-based expert advice.
干预措施: Telemedicine-based intervention (Other)
结局指标
主要结局
All-cause mortality
时间窗: at hospital discharge (up to 28 days)
次要结局
- Number of blood transfusions(at 28 days)
- Number of changes based on expert opinion(at 28 days)
- Number of invasive diagnostic tests used(at 28 days)
- Number of non-invasive diagnostic tests used(at 28 days)
- Proportion of patients with non-invasive ventilation and/or high flow oxygen(at 28 days)
- Number of chemotherapy(at 28 days)
- Proportion of patients with antibiotic de-escalation(at 28 days)
- Satisfaction of patients, intensivists, primary physicians, and expert.(at 28 days)
- Number of days without life-supporting interventions(at 28 days)
- Duration of antibiotic therapy(up to 28 days)
- Proportion of patients in whom the cause for ICU admission remained undetermined(at 28 days)
- Number of anti-microbial agents(at 28 days)
- Length of ICU stay(at hospital discharge (up to 28 days))
- Proportion of ICU-acquired events(at 28 days)