Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial

Обзор

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.

Вмешательства

• Комбинированный продукт Virtual care with remote automated monitoring
  Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.

Первичные конечные точки

• Acute-hospital care [Срок оценки: 45 days post randomization]

Вторичные конечные точки (11)

• Days in hospital [Срок оценки: 45 days post randomization]
• Index length of hospital stay [Срок оценки: 45 days post randomization]
• Hospital readmission [Срок оценки: 45 days post randomization]
• Emergency department visit [Срок оценки: 45 days post randomization]
• Medication error detection [Срок оценки: 45 days post randomization]
• Medication error correction [Срок оценки: 45 days post randomization]
• Surgical site infection [Срок оценки: 45 days post randomization]
• Pain of any severity [Срок оценки: 15 and 45 days post randomization]
• Moderate to severe pain [Срок оценки: 15 and 45 days post randomization]
• Optimal pharmacological management for patients with atherosclerotic disease [Срок оценки: 45 days post randomization]
• Optimal pharmacological management self-reported current smokers [Срок оценки: 45 days post randomization]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Канада · 2 центра

• Hamilton General Hospital — Hamilton
• Juravinski Hospital — Hamilton

Идентификаторы

NCT: NCT04876950 · 1.0.2021.04.30

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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