Recruiting

PICTURE

Sponsor:

University of Michigan

Code:

NCT07304050

Conditions

Clinical Deterioration

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Interventions

PICTURE-Pediatric scores and alerts

Control Arm - Scores and alerts hidden

Study Details

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

Study ID

NCT07304050

Start date

Feb 9, 2026

Status verified date

Mar, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

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:

1. 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

Study Design

Enrollment

375 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PICTURE-Pediatric scores and alerts

This arm will happen for two four-week periods.

other: Control Arm

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

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jay Semerad

734-647-4751jsemerad@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jay Semerad

734-647-4751jsemerad@umich.edu

Principal Investigator:

Rodney Daniels, MD, FAAP

More Information

Sponsor

University of Michigan

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-03-05.