Randomized Controlled Trial of Predicting Intensive Care Transfers and Other UnfoReseen Events (PICTURE)-Pediatric

NCT ID: NCT07304050

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-01-31

Brief Summary

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.

Conditions

Clinical Deterioration

Keywords

Artificial Intelligence model; Usability; Acceptability; Questionnaire; Real-time alerts; Workflow compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PICTURE-Pediatric scores and alerts

This arm will happen for two four-week periods.

Group Type: EXPERIMENTAL

PICTURE-Pediatric scores and alerts

Intervention Type: DEVICE

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 can be wrenched into the patient lists, in a patient summary report and as a vital and/or a flowsheet. The scores for patients with an alert (scores that have surpassed the corresponding alert thresholds) will be colored accordingly (yellow or red) in the electronic medical record. Various staff on the clinical team will use this data to help determine intervention and or escalation depending on the alerts.

Control Arm

During the control arm, the PICTURE scores and alerts will not be shown. This arm will happen for two four-week periods.

Group Type: OTHER

Control Arm - Scores and alerts hidden

Intervention Type: OTHER

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.

Interventions

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 can be wrenched into the patient lists, in a patient summary report and as a vital and/or a flowsheet. The scores for patients with an alert (scores that have surpassed the corresponding alert thresholds) will be colored accordingly (yellow or red) in the electronic medical record. Various staff on the clinical team will use this data to help determine intervention and or escalation depending on the alerts.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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:

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

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Rodney Daniels

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodney Daniels

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Central Contacts

Jay Semerad

Role: CONTACT

Phone: 734-647-4751

Email: jsemerad@umich.edu

Facility Contacts

Jay Semerad

Role: primary

Other Identifiers

HUM00274862

Identifier Type: -

Identifier Source: org_study_id