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

Primary Purpose

Deterioration, Clinical

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Visensia Safety Index (VSI)
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Deterioration, Clinical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

The Visensia Safety Index (VSI) will be used to alert RACE staff of patient deterioration.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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

Secondary Outcome Measures

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.
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

Full Information

First Posted
October 7, 2021
Last Updated
September 22, 2022
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05108376
Brief Title
Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team
Acronym
VSI
Official Title
Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deterioration, Clinical

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
The Visensia Safety Index (VSI) will be used to alert RACE staff of patient deterioration.
Intervention Type
Device
Intervention Name(s)
Visensia Safety Index (VSI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate technical feasibility of collecting greater than 80% of continuous data
Description
Feasibility of continuous data collection will be evaluated by determining if greater than 80% of continuous data can be collected
Time Frame
Upon study completion, 10 months after study initiation
Title
Evaluate technical feasibility of feeding greater then 80% of continuous data to the predictive tool
Description
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
Time Frame
Upon study completion, 10 months after study initiation
Title
Evaluate technical feasibility of updating the predictive tool on a regular basis greater than 80% of the time
Description
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
Time Frame
Upon study completion, 10 months after study initiation
Title
Evaluate technical feasibility of reporting greater then 80% of triggers to the RACE team
Description
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
Time Frame
Upon study completion, 10 months after study initiation
Title
Evaluate clinical feasibility by assessing MD opinions of the VSI
Description
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
Time Frame
Upon study completion, 10 months after study initiation
Title
Evaluate clinical feasibility by assessing RN opinions of the VSI
Description
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
Time Frame
Upon study completion, 10 months after study initiation
Title
Evaluate clinical feasibility by assessing RT opinions of the VSI
Description
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
Time Frame
Upon study completion, 10 months after study initiation
Title
Evaluate financial feasibility of implementing the VSI system
Description
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
Time Frame
Upon study completion, 10 months after study initiation
Secondary Outcome Measure Information:
Title
Evaluate potential clinical impact of the VSI
Description
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.
Time Frame
Upon study completion, 10 months after study initiation
Title
Evaluate potential financial impact of the VSI
Description
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
Time Frame
Upon study completion, 10 months after study initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew JE Seely, MD, PhD, FRCSC
Phone
613-737-8899
Ext
74052
Email
aseely@toh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew JE Seely, MD, PhD, FRCSC
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew JE Seely, MD, PhD, FRCSC
Phone
613-737-8899
Ext
74052
Email
aseely@toh.ca
First Name & Middle Initial & Last Name & Degree
Alexandre Tran, MD, MSc, FRCSC
First Name & Middle Initial & Last Name & Degree
Jamie Brehaut, PhD
First Name & Middle Initial & Last Name & Degree
Natasha Hudek, PhD
First Name & Middle Initial & Last Name & Degree
Kwadwo Kyeremanteng
First Name & Middle Initial & Last Name & Degree
Michael Hartwick
First Name & Middle Initial & Last Name & Degree
Kednapa Thavorn, PhD, MPharm, BPharm
First Name & Middle Initial & Last Name & Degree
Jonathan Hooper
First Name & Middle Initial & Last Name & Degree
Christophe Herry, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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