Clinical trial NCT05108376: Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team
Official title: Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deterioration, Clinical
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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 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

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

Primary outcomes:
measure: Evaluate technical feasibility of collecting greater than 80% of continuous data
timeFrame: Upon study completion, 10 months after study initiation
measure: Evaluate technical feasibility of feeding greater then 80% of continuous data to the predictive tool
timeFrame: Upon study completion, 10 months after study initiation
measure: Evaluate technical feasibility of updating the predictive tool on a regular basis greater than 80% of the time
timeFrame: Upon study completion, 10 months after study initiation
measure: Evaluate technical feasibility of reporting greater then 80% of triggers to the RACE team
timeFrame: Upon study completion, 10 months after study initiation
measure: Evaluate clinical feasibility by assessing MD opinions of the VSI
timeFrame: Upon study completion, 10 months after study initiation
measure: Evaluate clinical feasibility by assessing RN opinions of the VSI
timeFrame: Upon study completion, 10 months after study initiation
measure: Evaluate clinical feasibility by assessing RT opinions of the VSI
timeFrame: Upon study completion, 10 months after study initiation
measure: Evaluate financial feasibility of implementing the VSI system
timeFrame: Upon study completion, 10 months after study initiation
Secondary outcomes:
measure: Evaluate potential clinical impact of the VSI
timeFrame: Upon study completion, 10 months after study initiation
measure: Evaluate potential financial impact of the VSI
timeFrame: Upon study completion, 10 months after study initiation
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Andrew JE Seely, MD, PhD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: