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Clinical Trials/NCT05171569
NCT05171569
Active, not recruiting
Not Applicable

Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PVC-RAM-3) Trial

Population Health Research Institute2 sites in 1 country2,500 target enrollmentDecember 28, 2021
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Population Health Research Institute
Enrollment
2500
Locations
2
Primary Endpoint
Index hospital length of stay
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM)-3 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 length of index hospital stay and use of acute hospital care (composite of hospital readmission and emergency department visit) after randomization, in adults who have undergone elective non cardiac surgery. Secondary outcomes at 30 days after randomization include: 1) hospital re-admission; 2) emergency department visit; 3) medication error detection;4) medication error correction; 5) surgical site infection; and 6) days in hospital. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 30 days after randomization. The investigators will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease and current smokers whether patients are taking classes of efficacious medications at 30 days.

Registry
clinicaltrials.gov
Start Date
December 28, 2021
End Date
May 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • are ≥18 years of age;
  • are undergoing inpatient elective noncardiac surgery with an expected length of hospital stay ≤3 days after surgery; and
  • provide informed consent to participate.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Index hospital length of stay

Time Frame: 30 Days post randomization

Length of stay from randomization until discharge from the index hospitalization (measured in days and hours)

Acute hospital care (composite of hospital readmission and emergency department visit)

Time Frame: 30 Days post randomization

Acute-hospital care is a composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.

Secondary Outcomes

  • Hospital readmission(30 days post randomization)
  • Medication error correction(30 days post randomization)
  • Emergency department visit (includes urgent care centre visit)(30 days post randomization)
  • Medication error detection(30 days post randomization)
  • Surgical site infection(30 days post randomization)
  • Days in hospital(30 days post randomization)
  • Optimization of medications for long-term health(30 days post randomization)
  • Level of pain and pain related interference in recovery(15 and 30 days post randomization)

Study Sites (2)

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