Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team (VSI)

Rapid response teams (RRTs) have been adopted by hospitals to provide urgent critical care to hospitalized patients who require quick intervention to prevent further deterioration. Early warning scores (EWS) serve as a method to identify patients requiring RRT assessment by analyzing routinely collected data such as vital signs and laboratory results. The Visensia Safety Index (VSI) is an EWS that uses continuous vital sign monitoring and machine learning to identify the likelihood of deterioration and can be integrated with existing hospital data infrastructure. Initial studies of the VSI have both validated the system and found that patients monitored using VSI had a shorter duration of any instability and fewer episodes of serious and persistent instability. The investigators' recent retrospective analysis at The Ottawa Hospital (TOH) identified that implementation of an EWS could have detected earlier deterioration in over half of the patients identified, potentially preventing subsequent ICU admission, severity of illness, and/or mortality. Thus, this study aims to determine the feasibility and potential impact of implementing a portable continuous monitoring system with a VSI trigger at TOH to identify patients at high risk of deterioration.

Study Overview

• Status: Not yet recruiting
• Conditions: Deterioration, Clinical
• Intervention / Treatment: Device: Visensia Safety Index (VSI)

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew JE Seely, MD, PhD, FRCSC; Phone Number: 74052 613-737-8899; Email: aseely@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
      • Contact: Andrew JE Seely, MD, PhD, FRCSC; Phone Number: 74052 613-737-8899; Email: aseely@toh.ca
      • Sub-Investigator: Jamie Brehaut, PhD
      • Sub-Investigator: Christophe Herry, PhD
      • Principal Investigator: Alexandre Tran, MD, MSc, FRCSC
      • Sub-Investigator: Natasha Hudek, PhD
      • Sub-Investigator: Kwadwo Kyeremanteng
      • Sub-Investigator: Michael Hartwick
      • Sub-Investigator: Kednapa Thavorn, PhD, MPharm, BPharm
      • Sub-Investigator: Jonathan Hooper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Adult patient (greater than or equal to 18 years of age) designated for the most aggressive levels of potential intervention (Category 1 status - Full Care) who belong to one of the following groups:

• Patients who have undergone high risk elective surgery (Whipple procedures, high risk vascular surgery, high risk general surgery, among others)
• Malignant haematology or oncology patients at high risk for deterioration
• Patients with infection admitted from the Emergency Department (ED) to the ward
• Other high-risk patients determined at the discretion of RACE physician with agreement from the patient's most responsible physicians (MRP)

Exclusion Criteria:

• Patients admitted to a unit with higher level monitoring (Neurological Acute Assessment Unit, Acute Monitoring Area, Trauma Step-Down, Intensive Care Unit)
• Patients with Category II (Full Care except CPR), III (Full Care except Respiratory or Hemodynamic Life Support, or CPR) or IV status (Comfort Care)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; The Visensia Safety Index (VSI) will be used to alert RACE staff of patient deterioration.	Device: Visensia Safety Index (VSI); Enrolled patients will undergo continuous vital sign monitoring, to be used by the Visensia Safety Index (VSI) to identify early deterioration. If early deterioration is identified, the VSI will produce an alert to notify the RACE team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate technical feasibility of collecting greater than 80% of continuous data	Feasibility of continuous data collection will be evaluated by determining if greater than 80% of continuous data can be collected	Upon study completion, 10 months after study initiation
Evaluate technical feasibility of feeding greater then 80% of continuous data to the predictive tool	Feasibility of feeding continuous data to the predictive tool will evaluated by determining if greater than 80% of continuous data can be fed to the predictive tool	Upon study completion, 10 months after study initiation
Evaluate technical feasibility of updating the predictive tool on a regular basis greater than 80% of the time	Feasibility of updating the predictive tool on a regular basis will be evaluated by determining if greater than 80% of the time the predictive tool can be updated on a regular basis	Upon study completion, 10 months after study initiation
Evaluate technical feasibility of reporting greater then 80% of triggers to the RACE team	Feasibility of reporting triggers to the RACE team will be evaluated by determining if greater than 80% of triggers are reported to the RACE team	Upon study completion, 10 months after study initiation
Evaluate clinical feasibility by assessing MD opinions of the VSI	Clinical feasibility will be evaluated by assessing MD opinions regarding understanding of the predictive tool, ease of use, perceived strengths and limitations, and perceived enablers and barriers to effective usage through post-encounter surveys and interviews	Upon study completion, 10 months after study initiation
Evaluate clinical feasibility by assessing RN opinions of the VSI	Clinical feasibility will be evaluated by assessing RN opinions regarding understanding of the predictive tool, ease of use, perceived strengths and limitations, and perceived enablers and barriers to effective usage through post-encounter surveys and interviews	Upon study completion, 10 months after study initiation
Evaluate clinical feasibility by assessing RT opinions of the VSI	Clinical feasibility will be evaluated by assessing RT opinions regarding understanding of the predictive tool, ease of use, perceived strengths and limitations, and perceived enablers and barriers to effective usage through post-encounter surveys and interviews	Upon study completion, 10 months after study initiation
Evaluate financial feasibility of implementing the VSI system	Financial feasibility of implementing the VSI system will be evaluated by identifying the costs related to implementation and maintenance of the portable continuous monitoring system through health economic evaluation	Upon study completion, 10 months after study initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate potential clinical impact of the VSI	The potential clinical impact of the VSI will be evaluated by comparing the prognostic accuracy of the VSI trigger to clinical gestalt using statistical analysis of performance measures including sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve.	Upon study completion, 10 months after study initiation
Evaluate potential financial impact of the VSI	The potential financial impact of the VSI will be evaluated by estimating the potential cost savings related to earlier detection of potential deterioration with comparison to historical RACE cohort	Upon study completion, 10 months after study initiation

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Andrew JE Seely, MD, PhD, FRCSC, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: 3199

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