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

Summary

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.

Conditions

• Surgery
• Perioperative Complication
• COVID

Interventions

OTHER

Virtual Care and Remote Automated Monitoring

Patients will measure daily vitals (blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, weight) with remote monitoring technology and complete recovery surveys daily in home after discharge from hospital. Patients will interact with a virtual nurse daily on days 1-15 and every other day from days 16-30. 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, the virtual nurse will escalate care to a pre-assigned and available physician. Physicians will add or modify treatments as needed, and if required, they will have the patient come to an outpatient facility for evaluation or management. Via secure video or text messaging, patients will also have access to a virtual nurse at night, for any urgent issues.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation

  collaborator OTHER

• McMaster University

  collaborator OTHER

• Population Health Research Institute

  lead OTHER

Principal Investigators

• Michael McGillion, PhD · McMaster University, Population Health Research Institute

• PJ Devereaux, PhD · McMaster University, Population Health Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-23

Primary Completion

2020-10-28

Completion

2021-06-02

Countries

• Canada

Study Locations