Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Acute-hospital care
研究概览
简要总结
The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology-2 (PVC-RAM-2) 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 acute-hospital care during the 45-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. Secondary outcomes at 45 days after randomization include 1) days in hospital; 2) index length of hospital stay; 3) hospital re-admission; 4) emergency department visit; 5) medication error detection; 6) medication error correction; and 7) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 45 days. We will also assess optimal management of long-term health by evaluating among self-reported current smokers and those with atherosclerotic disease, whether patients are taking classes of efficacious medications at 45 days post 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;
- •will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and
- •provide informed consent to participate.
排除标准
- •planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery;
- •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.
研究组 & 干预措施
Virtual Care with Remote Automated Monitoring
Patients randomized to the PVC-RAM-2 intervention will take biophysical measurements with the RAM technology and complete a daily recovery survey for 14 days after index hospital discharge, and nurses will review these results daily. Through scheduled video visits, patients will virtually interact with a nurse on days 1, 3, 7 and 14, and a physician on days 1 and 14. Patients will take a photograph of their wound daily for the first 7 days on the program, and nurses will review these pictures. If the patient's RAM measurements exceed predetermined thresholds, the patient reports specific symptoms (e.g., shortness of breath), a drug error is identified, or the virtual nurse has concerns about the patient's health that they cannot resolve, they will escalate care to a pre-assigned and available physician. Two 7-day extensions to the intervention will be possible, based on the patient's need for continued support. This decision will be based on standardized criteria.
干预措施: Virtual care with remote automated monitoring (Combination Product)
Standard Care
Patients randomized to standard care will receive post discharge care as per the standard of care at the hospital where they undergo surgery.
结局指标
主要结局
Acute-hospital care
时间窗: 45 days post randomization
Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.
次要结局
- Days in hospital(45 days post randomization)
- Index length of hospital stay(45 days post randomization)
- Hospital readmission(45 days post randomization)
- Medication error detection(45 days post randomization)
- Emergency department visit(45 days post randomization)
- Moderate to severe pain(15 and 45 days post randomization)
- Medication error correction(45 days post randomization)
- Optimal pharmacological management for patients with atherosclerotic disease(45 days post randomization)
- Optimal pharmacological management self-reported current smokers(45 days post randomization)
- Surgical site infection(45 days post randomization)
- Pain of any severity(15 and 45 days post randomization)