Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 905
- 试验地点
- 7
- 主要终点
- Days alive at home
研究概览
简要总结
The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) 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 days alive at home during the 30-day follow-up after randomization, in adults who have undergone semi-urgent (e.g., oncology), urgent (e.g., hip fracture), or emergency (e.g., ruptured abdominal aortic aneurysm) surgery. It will also determine, during the first 30 days, the effect of virtual care with RAM technology on several secondary outcomes, including: 1. hospital re-admission; 2. emergency department visit; 3. urgent-care centre visit; 4. acute-hospital care (i.e., a composite of hospital re-admission and emergency department or urgent-care centre visit) 5. brief acute-hospital care (i.e., acute-hospital care that lasts <24 hours); 6. all-cause hospital days; 7. medication error detection; 8. medication error correction; and 9. death. An additional secondary objective is to determine the effect of virtual care with RAM technology on pain at 7, 15, and 30 days and 6 months after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are ≥40 years of age;
- •have undergone same-day or inpatient semi-urgent, urgent, or emergency surgery and are being discharged home or are within 24 hours after discharge home, as long as they have not had acute-hospital care since their discharge; and
- •provide informed consent to participate.
排除标准
- •underwent same-day surgery and the surgeon or anesthesiologist believe the case reflects a traditional same-day surgery case with a low likelihood of needing acute-hospital care;
- •went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;
- •are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a cognitive, language, visual, or hearing impairment; or
- •reside in an area without cellular network coverage and no home Wi-Fi.
结局指标
主要结局
Days alive at home
时间窗: 30 Days (after randomization); 6 months (after randomization)
Days alive at home are the number of days patients spend at their usual residence - be it a house or apartment, a group home or shelter, a seniors residence, or a nursing home - or at a community residence of a relative, friend, or acquaintance without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Thus, patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.
次要结局
- Medication error detection(Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31))
- Urgent Care centre visit(30 Days (after randomization); 6 months (after randomization))
- All-cause hospital days(30 Days (after randomization); 6 months (after randomization))
- Hospital re-admission(30 Days (after randomization); 6 months (after randomization))
- Emergency Department visit(30 Days (after randomization); 6 months (after randomization))
- Brief acute hospital care(30 Days (after randomization); 6 months (after randomization))
- Death(30 Days (after randomization); 6 months (after randomization))
- Acute hospital care(30 Days (after randomization); 6 months (after randomization))
- Participant Pain(7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization))
- Medication error correction(Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31))