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

NCT04876950 | Recruiting DMC

• 1 other identifier: 1.0.2021.04.30
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Virtual care; Remote monitoring; Acute hospital care

Outcome Measures

Primary Outcomes (1)

• Acute-hospital care

  Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.

  45 days post randomization

Secondary Outcomes (11)

• Days in hospital

  45 days post randomization

• Index length of hospital stay

  45 days post randomization

• Hospital readmission

  45 days post randomization

• Emergency department visit

  45 days post randomization

• Medication error detection

  45 days post randomization

Other Outcomes (8)

• Infection

  45 days post randomization

• Re-operation

  45 days post randomization

• Myocardial Infarction

  45 days post randomization

Study Arms (2)

Virtual Care with Remote Automated Monitoring

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Patients randomized to standard care will receive post discharge care as per the standard of care at the hospital where they undergo surgery.

Interventions

Virtual care with remote automated monitoring COMBINATION_PRODUCT

Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.

Virtual Care with Remote Automated Monitoring

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are ≥40 years of age;
• will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and
• provide informed consent to participate.

You may not qualify if:

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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (2)

Hamilton General Hospital

Hamilton, Ontario, Canada

RECRUITING

Juravinski Hospital

Hamilton, Ontario, Canada

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Harrison

CONTACT

905-594-0564; stephanie.harrison@phri.ca

Valerie Harvey

CONTACT

905-594-0563; valerie.harvey@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: October 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)