NCT07304050 · University of Michigan
Predicting ICU Transfers and Other Unforeseen Events (PICTURE)-Pediatric
What this study is about
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.
View original scientific description
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.
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 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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations