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

NCT07304050 | Recruiting FDA Device

• 1 other identifier: HUM00274862
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Deterioration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Compliance with the model workflow as measured by a pop-up questionnaire after each model alert aggregated as a proportion -clinicians

  Responses to the questions measure compliance with the workflow. Compliance will be measured as binary outcomes (i.e., compliant and noncompliant) and aggregated as a proportion.

  within 30 minutes after each alert during a patient's admission

Secondary Outcomes (3)

• Acceptability of Intervention Measure (AIM)-clinicians

  At the end of the study (approximately 4 months after the start of the enrollment)

• Intervention Appropriateness Measure (IAM)-clinicians

  At the end of the study (approximately 4 months after the start of the enrollment)

• Feasibility of Intervention Measure (FIM)-clinicians

  At the end of the study (approximately 4 months after the start of the enrollment)

Study Arms (2)

PICTURE-Pediatric scores and alerts

EXPERIMENTAL

This arm will happen for two four-week periods.

Device: PICTURE-Pediatric scores and alerts

Control Arm

OTHER

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

Other: Control Arm - Scores and alerts hidden

Interventions

PICTURE-Pediatric scores and alerts 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.

PICTURE-Pediatric scores and alerts

Control Arm - Scores and alerts hidden 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.

Control Arm

Eligibility Criteria

• Age: 30 Days - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

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

Study Officials

• Rodney Daniels

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jay Semerad

CONTACT

734-647-4751; jsemerad@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: This study will not be randomization at the patient level. This randomized clinical trial (RCT) will use an on-off design, alternating sequentially between the treatment and control arms on the entire study population. In this design, the model scores and alerts will be available to the care teams for 4 weeks (treatment arm), then the scores will not be available for the following 4 weeks, on for another 4 weeks and so on. Randomization of the first period will be used to minimize bias.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: December 26, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)