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

Deterioration, Clinical Clinical Trial

— VSI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05108376
• Other study ID #: 3199
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: January 2024

Study information

• Verified date: September 2022
• Source: Ottawa Hospital Research Institute
• Contact: Andrew JE Seely, MD, PhD, FRCSC
• Phone: 613-737-8899
• Email: aseely[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Clinical Deterioration
• Deterioration, Clinical

Intervention

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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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