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临床试验/NCT05171569
NCT05171569进行中(未招募)不适用

Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PVC-RAM-3) Trial

Population Health Research Institute2 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2021年12月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,500
试验地点
2
主要终点
Index hospital length of stay

研究概览

简要总结

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM)-3 Trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (RAM) technology compared to standard care on length of index hospital stay and use of acute hospital care (composite of hospital readmission and emergency department visit) after randomization, in adults who have undergone elective non cardiac surgery. Secondary outcomes at 30 days after randomization include: 1) hospital re-admission; 2) emergency department visit; 3) medication error detection;4) medication error correction; 5) surgical site infection; and 6) days in hospital. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 30 days after randomization. The investigators will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease and current smokers whether patients are taking classes of efficacious medications at 30 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • are ≥18 years of age;
  • are undergoing inpatient elective noncardiac surgery with an expected length of hospital stay ≤3 days after surgery; and
  • provide informed consent to participate.

排除标准

  • are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a language barrier or a cognitive, visual, or hearing impairment; or
  • reside in an area without cellular network coverage.

结局指标

主要结局

Index hospital length of stay

时间窗: 30 Days post randomization

Length of stay from randomization until discharge from the index hospitalization (measured in days and hours)

Acute hospital care (composite of hospital readmission and emergency department visit)

时间窗: 30 Days post randomization

Acute-hospital care is a composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.

次要结局

  • Hospital readmission(30 days post randomization)
  • Medication error correction(30 days post randomization)
  • Emergency department visit (includes urgent care centre visit)(30 days post randomization)
  • Medication error detection(30 days post randomization)
  • Surgical site infection(30 days post randomization)
  • Days in hospital(30 days post randomization)
  • Optimization of medications for long-term health(30 days post randomization)
  • Level of pain and pain related interference in recovery(15 and 30 days post randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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