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

Population Health Research Institute (PHRI) logo

Population Health Research Institute (PHRI)

Status

Completed

Conditions

Perioperative Complication
COVID
Surgery

Treatments

Other: Virtual Care and Remote Automated Monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT04344665
v5.0, 2020.09.12

Details and patient eligibility

About

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.

Enrollment

905 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. are ≥40 years of age;
  2. 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
  3. provide informed consent to participate.

Exclusion criteria

  1. 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;
  2. went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;
  3. 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
  4. reside in an area without cellular network coverage and no home Wi-Fi.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

905 participants in 2 patient groups

Virtual Care and Remote Automated Monitoring
Experimental group
Treatment:
Other: Virtual Care and Remote Automated Monitoring
Standard Care
No Intervention group

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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