Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial
NCT ID: NCT04876950
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2024-10-04
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Virtual Care with Remote Automated Monitoring
Patients randomized to the PVC-RAM-2 intervention will take biophysical measurements with the RAM technology and complete a daily recovery survey for 14 days after index hospital discharge, and nurses will review these results daily. Through scheduled video visits, patients will virtually interact with a nurse on days 1, 3, 7 and 14, and a physician on days 1 and 14. Patients will take a photograph of their wound daily for the first 7 days on the program, and nurses will review these pictures. 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, they will escalate care to a pre-assigned and available physician. Two 7-day extensions to the intervention will be possible, based on the patient's need for continued support. This decision will be based on standardized criteria.
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.
Standard Care
Patients randomized to standard care will receive post discharge care as per the standard of care at the hospital where they undergo surgery.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and
3. provide informed consent to participate.
Exclusion Criteria
2. 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
3. reside in an area without cellular network coverage.
40 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Michael McGillion, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University, Population Health Research Institute
PJ Devereaux, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University, Population Health Research Institute
Sandra Ofori, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences, Population Health Research Institute
Locations
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Hamilton General Hospital
Hamilton, Ontario, Canada
Juravinski Hospital
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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John Harlock, M.D
Role: backup
Ameen Patel, M.D
Role: backup
Flavia Borges, M.D
Role: backup
Other Identifiers
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1.0.2021.04.30
Identifier Type: -
Identifier Source: org_study_id
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