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

NCT04876950 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2024-11-15

No results posted yet for this study

Summary

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.

Conditions

  • Surgery
  • Perioperative Complication

Interventions

COMBINATION_PRODUCT

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.

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

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

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

  • Sandra Ofori, M.D., PhD · Hamilton Health Sciences, 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
2024-10-04
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04876950 on ClinicalTrials.gov