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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Perioperative Complication
• Intervention / Treatment: Combination product: Virtual care with remote automated monitoring

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Harrison; Phone Number: 905-594-0564; Email: stephanie.harrison@phri.ca
• Study Contact Backup: Name: Valerie Harvey; Phone Number: 905-594-0563; Email: valerie.harvey@phri.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • Hamilton General Hospital
      • Contact: Krysten Gregus; Email: gregusk@hhsc.ca
      • Contact: John Harlock, M.D
    • Hamilton, Ontario, Canada
      • Recruiting
      • Juravinski Hospital
      • Contact: Kelly Lawrence; Email: lawrenceke@hhsc.ca
      • Contact: Ameen Patel, M.D
      • Contact: Flavia Borges, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. are ≥40 years of age;
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:

1. planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute-hospital care	Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.	45 days post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days in hospital	Total number of days in hospital from randomization to 45 days post-randomization, including index hospital stay and any hospital readmission (s). A day in hospital is counted if a participant spends 1 minute of any day admitted to hospital.	45 days post randomization
Index length of hospital stay	Length of hospital stay calculated from time of surgery completion (i.e., time of surgical wound closure) until discharge from the index hospitalization (measured in days and hours).	45 days post randomization
Hospital readmission	Patient admission to an acute-care hospital.	45 days post randomization
Emergency department visit	Patient visit to an emergency department.	45 days post randomization
Medication error detection	Medication errors include mistakes in medication prescribing, transcribing, dispensing, administering, or monitoring due to preventable events or actions taken by a patient, caregiver, or healthcare worker. Medication errors include: drug omission (i.e., patient did not take a drug they were supposed to take), drug commission (i.e., patient taking a drug they were not supposed to take), duration error, dosing error, frequency error, route error, and timing error. We will record all drug errors identified and also report whether they resulted in harm.	45 days post randomization
Medication error correction	Any medication error that is corrected.	45 days post randomization
Surgical site infection	Surgical site infection is an infection that occurs within 30 days after randomization and involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional).	45 days post randomization
Pain of any severity	Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).The BPI-SF includes four 11-point numeric rating scales (NRS) of pain intensity, which measure "average", "least", and "worst" pain intensity in the past 24 hours (hrs.), respectively, as well as pain intensity "now" (0= no pain, 10= pain as bad as you can imagine).	15 and 45 days post randomization
Moderate to severe pain	Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).The BPI-SF includes four 11-point numeric rating scales (NRS) of pain intensity, which measure "average", "least", and "worst" pain intensity in the past 24 hours (hrs.), respectively, as well as pain intensity "now" (0= no pain, 10= pain as bad as you can imagine). Pain is of moderate or greater severity is defined by a score of ≥4/10 on a standard numeric rating scale (NRS) for pain.	15 and 45 days post randomization
Optimal pharmacological management for patients with atherosclerotic disease	Among patients with atherosclerotic disease, we will also assess optimal pharmacological management based upon whether patients are taking 0, 1, 2, or 3 of the following classes of efficacious medications at 45 days (i.e., an antiplatelet or anticoagulant drug; an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker; and a statin).	45 days post randomization
Optimal pharmacological management self-reported current smokers	Among patient who self-report to be current smokers at baseline, we will assess if patients are receiving pharmacological smoking cessation interventions at 45 days after randomization.	45 days post randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	All cause mortality.	30 days post randomization
Infection	Infection is defined as a pathologic process caused by the invasion of normally sterile tissue, fluid, or body cavity by pathogenic or potentially pathogenic organisms.	45 days post randomization
Re-operation	Re-operation refers to any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection).	45 days post randomization
Myocardial Infarction	4th Universal definition of myocardial infarction.	45 days post randomization
Acute Heart Failure	The definition of acute heart failure requires at least one of the following clinical signs (i.e., elevated jugular venous pressure, respiratory rales or crackles, crepitations, or presence of S3) with at least one of the following: radiographic findings of vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema, OR; heart failure treatment with a diuretic and documented clinical improvement.	45 days post randomization
Arrhythmia that results in patient presenting to an emergency department or being admitted to hospital	Any arrhythmia that results in patient presenting to an emergency department, which includes an urgent care centre, or being admitted to hospital.	45 days post randomization
Health services utilization-related costs	Costs associated with hospital re-admission, length of stay, and healthcare utilization will be obtained from administrative datasets.	45 days post randomization
Health-related quality of life (HRQL)	HRQL will be measured with the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument (https://euroqol.org/eq-5d-instruments/sample-demo) due to its increased sensitivity and validation in several countries including Canada. The EQ-5D-5L is also recommended in Canada to calculate the Quality Adjusted Life Years (QALYs) when conducting cost-effectiveness analyses. The EQ-5D-5L questionnaire consists of descriptive questions regarding 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with a 5-level scale for participants to indicate the most accurate response (ranging from no problems to extreme problems).	45 days post randomization

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: Michael McGillion, PhD, McMaster University, Population Health Research Institute; Principal Investigator: PJ Devereaux, M.D, PhD, McMaster University, Population Health Research Institute; Principal Investigator: Sandra Ofori, M.D., PhD, Hamilton Health Sciences, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Remote monitoring; Virtual care; Acute hospital care
• Other Study ID Numbers: 1.0.2021.04.30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No