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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07304050
Status
Recruiting

Conditions

  • Clinical Deterioration

Eligibility Criteria

Sex
ALL
Age
30 Days - 25 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 9, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Jay Semerad
734-647-4751
Rodney Daniels, MD, FAAP (PRINCIPAL_INVESTIGATOR)

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