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

February 2, 2024 updated by: Population Health Research Institute
The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) 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 days alive at home during the 30-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. It will also determine, during the first 30 days, the effect of virtual care with RAM technology on several secondary outcomes, including: 1. hospital re-admission; 2. emergency department visit; 3. urgent-care centre visit; 4. acute-hospital care (i.e., a composite of hospital re-admission and emergency department or urgent-care centre visit) 5. brief acute-hospital care (i.e., acute-hospital care that lasts <24 hours); 6. all-cause hospital days; 7. medication error detection; 8. medication error correction; and 9. death. An additional secondary objective is to determine the effect of virtual care with RAM technology on pain at 7, 15, and 30 days and 6 months after randomization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
905

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Hamilton, Canada
        • Hamilton General Hospital
      • Hamilton, Canada
        • Juravinski Hospital
      • Hamilton, Canada
        • St. Joseph's Healthcare Hamilton
      • Kingston, Canada
        • Kingston Health Sciences Centre
      • London, Canada
        • London Health Sciences Centre
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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. have undergone same-day or inpatient semi-urgent, urgent, or emergency surgery and are being discharged home or are within 24 hours after discharge home, as long as they have not had acute-hospital care since their discharge; and
  3. provide informed consent to participate.

Exclusion Criteria:

  1. underwent same-day surgery and the surgeon or anesthesiologist believe the case reflects a traditional same-day surgery case with a low likelihood of needing acute-hospital care;
  2. went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;
  3. are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a cognitive, language, visual, or hearing impairment; or
  4. reside in an area without cellular network coverage and no home Wi-Fi.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Care
Experimental: Virtual Care and Remote Automated Monitoring
Other: Virtual Care and Remote Automated Monitoring
Patients will measure daily vitals (blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, weight) with remote monitoring technology and complete recovery surveys daily in home after discharge from hospital. Patients will interact with a virtual nurse daily on days 1-15 and every other day from days 16-30. 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, the virtual nurse will escalate care to a pre-assigned and available physician. Physicians will add or modify treatments as needed, and if required, they will have the patient come to an outpatient facility for evaluation or management. Via secure video or text messaging, patients will also have access to a virtual nurse at night, for any urgent issues.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Days alive at home
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Days alive at home are the number of days patients spend at their usual residence - be it a house or apartment, a group home or shelter, a seniors residence, or a nursing home - or at a community residence of a relative, friend, or acquaintance without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Thus, patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.
30 Days (after randomization); 6 months (after randomization)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital re-admission
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Emergency Department visit
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Urgent Care centre visit
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Brief acute hospital care
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Medication error detection
Time Frame: Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
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.
Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Medication error correction
Time Frame: Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Any medication error that is corrected.
Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Death
Time Frame: 30 Days (after randomization); 6 months (after randomization)
All cause mortality
30 Days (after randomization); 6 months (after randomization)
Participant Pain
Time Frame: 7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization)
Assessed using the Brief Pain Inventory Short Form (BPI-SF)
7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization)
Acute hospital care
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Composite of hospital re-admission and emergency department or urgent-care centre visit
30 Days (after randomization); 6 months (after randomization)
All-cause hospital days
Time Frame: 30 Days (after randomization); 6 months (after randomization)
If a patient is admitted to the hospital for any reason anytime between midnight and 23:59 on a given day, this will count as a day in hospital.
30 Days (after randomization); 6 months (after randomization)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health services utilization-related costs
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Data on hospital re-admission, healthcare utilization, and costs of health service utilization will be obtained from the Institute for Clinical Evaluative Sciences (ICES) data repository
30 Days (after randomization); 6 months (after randomization)
Patient level cost of recovery
Time Frame: 30 Days (after randomization)
Assessment performed using the Ambulatory Home Care Record
30 Days (after randomization)
Re-operation
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection)
30 Days (after randomization); 6 months (after randomization)
Arrythmia resulting in electrical cardioversion
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Arrythmia resulting in electrical cardioversion
30 Days (after randomization); 6 months (after randomization)
Acute renal failure resulting in dialysis
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Acute renal failure resulting in dialysis
30 Days (after randomization); 6 months (after randomization)
Respiratory failure
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Patient intubated or put on bilevel positive airway pressure (BiPAP).
30 Days (after randomization); 6 months (after randomization)
Infection
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Infection
30 Days (after randomization); 6 months (after randomization)
Surgical site infection
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Life-threatening bleed
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Major bleed
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Critical organ bleed
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Ileus
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Myocardial Infarction
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Clinically important atrial fibrillation
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Symptomatic proximal venous thrombo-embolism
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Stroke
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Non-fatal cardiac arrest
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Clostridium difficile-associated diarrhea
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Indwelling device
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
COVID-19 Infection
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Delirium
Time Frame: 30 Days (after randomization); 6 months (after randomization)
Positive history of delirium in hospital health records, positive 3D-CAM assessment, or FAM-CAM assessment. Assessments performed by telephone or in person.
30 Days (after randomization); 6 months (after randomization)
Surgeon, family physician, or specialist in-person clinic visit
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Sepsis
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Acute Heart Failure
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)
Surgeon, family physician, or specialist virtual visit
Time Frame: 30 Days (after randomization); 6 months (after randomization)
30 Days (after randomization); 6 months (after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McMaster University
Hamilton Health Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: PJ Devereaux, PhD, McMaster University, Population Health Research Institute
  • Principal Investigator: Michael McGillion, PhD, McMaster University, Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • v5.0, 2020.09.12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritises access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee. Data are available to the journal for evaluation of reported analyses. Regarding the ICES data, while data sharing agreements prohibit ICES from making the data set publicly available, access can be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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