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

NCT05108376 | Recruiting

• 1 other identifier: 3199
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Deterioration, Clinical

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Evaluate potential clinical impact of the VSI

  Upon study completion, 10 months after study initiation

• Evaluate potential financial impact of the VSI

  Upon study completion, 10 months after study initiation

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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

Device: Visensia Safety Index (VSI)

Interventions

Visensia Safety Index (VSI) DEVICE

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.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• 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 and Category 2 status - Full Care except CPR) 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 the clinical team

You may not qualify if:

• 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 III (Full Care except Respiratory or Hemodynamic Life Support, or CPR) or IV status (Comfort Care)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Related Publications (1)

• Tran A, Ramchandani R, Brehaut J, Hudek N, Haines J, Watpool I, Porteous R, Kusevic D, Bucciero K, Kyeremanteng K, Hartwick M, Thavorn K, Hooper J, Kubelik D, Herry C, Scales N, Hryciw B, Abou-Khalil J, Perry J, Bredeson C, Seely A. Assessing Clinical Impressions of Early Warning Score Integration With the Rapid Response Team: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Jul 31;14:e65360. doi: 10.2196/65360.

  PMID: 40742731 DERIVED

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew JE Seely, MD, PhD, FRCSC

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew JE Seely, MD, PhD, FRCSC

CONTACT

613-737-8899; aseely@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 4, 2021
• Study Start: September 19, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)