Predicting ICU Transfers and Other Unforeseen Events (PICTURE)-Pediatric

Official title

Pilot Randomized Controlled Trial of PICTURE-Pediatric

Overview

The purpose of this study is to evaluate the effectiveness and user satisfaction of the study teams early warning system, called PICTURE, which utilizes artificial intelligence (AI) techniques and algorithms to identify patient deterioration on pediatric units within Mott Children's Hospital. In this pilot study the patient care team will review the PICTURE information and alerts. Morning rounds will be partially informed by the PICTURE scores and the scores will be included in the hand off notes for the patients with a red score. The primary purpose of this study is to test the hypothesis that the combination of the PICTURE-Pediatric model, the proposed workflow and the proposed interface results in at least 80% compliance. No participants will be consented as the Institutional review board has approved a waiver of consent for THE clinicians and the patients information being reviewed. The enrollment numbers will include only the clinicians.

Detailed description

PICTURE Pediatric evaluates large amounts of patient data, labs, monitored data, and vital signs (all variables that are measured as part of routine clinical care and that are stored in the electronic health record in real-time); it does this every 15-minutes and delivers a deterioration risk index score that has been shown to outperform Pediatric Early Warning Score (PEWS), and other similar scoring systems in identifying patients at risk for clinical deterioration. Clinical implementation of PICTURE Pediatric could identify patients at high risk of deterioration early enough to intervene and decrease the need for transfer to the Pediatric Intensive Care unit (PICU), and it could also reduce morbidity and hospital length of stay. This in turn could also improve bed availability for patients awaiting admission in the emergency department and improve efficient transfer out of the PICU, all of which improves care and reduces cost for the patients, their families, and the hospital system.

This protocol also does not mandate or require clinical decisions based on alerts generated (e.g. there is no mandate to transfer to the Intensive Care unit, perform an intervention, or change therapy/clinical course based on PICTURE alerts); rather, the clinical team will decide whether additional investigation, therapy, intervention, or transfer is required after alerts are generated based on staff's clinical experience, knowledge and with consultation with an attending physician when applicable. In case of device failure, there would be no deterioration risk scores generated and the clinical teams would simply continue to follow the current workflow.

Interventions

• Device PICTURE-Pediatric scores and alerts
  Patients that satisfy the inclusion criteria will receive PICTURE-Pediatric scores and alerts. Scores are numbers that indicate the likelihood that the patient may experience deterioration in the next 24 hours, i.e., the higher the score, the higher the likelihood of deterioration. Alerts will be sent through pages or phone notifications, depending on the user's current method of receiving non-routine communications. Scores are also available through electronic medical record as a column that ca
• Other Control Arm - Scores and alerts hidden
  The morning rounds and prerounding procedures will revert back to the baseline procedures before the trial. All care teams will be notified about this transition in advance and will be directed to revert back to the standard of care.

Primary outcome measures

• Compliance with the model workflow as measured by a pop-up questionnaire after each model alert aggregated as a proportion -clinicians [Time frame: within 30 minutes after each alert during a patient's admission]

Secondary outcome measures (3)

• Acceptability of Intervention Measure (AIM)-clinicians [Time frame: At the end of the study (approximately 4 months after the start of the enrollment)]
• Intervention Appropriateness Measure (IAM)-clinicians [Time frame: At the end of the study (approximately 4 months after the start of the enrollment)]
• Feasibility of Intervention Measure (FIM)-clinicians [Time frame: At the end of the study (approximately 4 months after the start of the enrollment)]

Eligibility criteria

Inclusion Criteria - Patients:

• Age ≥30 days and ≤25 years
• Be on the general care wards of Mott Children's Hospital or boarding in the Emergency Department (ED), but admitted to a pediatric floor medical team. These will be enforced by these criteria:

• Patient class: not emergency b. Patient level of care: not Intensive Care unit (ICU) c. Patient locations (per protocol)

Exclusion Criteria - Patients:

• Patients that do not meet the inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT07304050 · HUM00274862

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗