Clinical DeteriorationNCT07304050
Predicting ICU Transfers and Other Unforeseen Events (PICTURE)-Pediatric
A study testing PICTURE-Pediatric scores and alerts in people with Clinical Deterioration, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days to 25 years
- Conditions the study is for
- Clinical Deterioration
- What is being tested?
- PICTURE-Pediatric scores and alerts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Patients that do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Jay Semerad, 734-647-4751, jsemerad@umich.edu
Rodney Daniels, MD, FAAP
About this study
Official title: Pilot Randomized Controlled Trial of PICTURE-Pediatric
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.
Read more
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.
Read the 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
- Being tested
- PICTURE-Pediatric scores and alerts, Control Arm - Scores and alerts hidden
- Keywords
- Artificial Intelligence model, Usability, Acceptability, Questionnaire, Real-time alerts, Workflow compliance
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICTURE-Pediatric scores and alertsDevice
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 hiddenOther
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 group | Role | What they receive |
|---|---|---|
| PICTURE-Pediatric scores and alerts | Experimental | This arm will happen for two four-week periods. Receives: 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. Receives: Other: Control Arm - Scores and alerts hidden |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 minutes after each alert during a patient's admission
Secondary outcomes (3)
Acceptability of Intervention Measure (AIM)-clinicians
There are 4 questions that the clinicians will answer about intervention with options from completely agree (5) to completely disagree (1). The range of scores are 4-20 with a higher score indicating greater acceptability.
Measured: At the end of the study (approximately 4 months after the start of the enrollment)
Intervention Appropriateness Measure (IAM)-clinicians
There are 4 questions that the clinicians will answer about intervention with options from completely agree (5) to completely disagree (1). The range of scores are 4-20 with a higher score indicating greater appropriateness.
Measured: At the end of the study (approximately 4 months after the start of the enrollment)
Feasibility of Intervention Measure (FIM)-clinicians
There are 4 questions that the clinicians will answer about intervention with options from completely agree (5) to completely disagree (1). The range of scores are 4-20 with a higher score indicating greater feasibility.
Measured: At the end of the study (approximately 4 months after the start of the enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start9 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical DeteriorationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodney Daniels, University of Michigan
- Investigators
- Rodney Daniels, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304050
- Sponsor's protocol ID
- HUM00274862
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of PICTURE-Pediatric
- ClinicalTrials.gov ID
- NCT07304050
- Acronym / sponsor ID
- HUM00274862
- Conditions
- Clinical Deterioration
- Keywords
- Artificial Intelligence model, Usability, Acceptability, Questionnaire, Real-time alerts, Workflow compliance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PICTURE-Pediatric scores and alerts | Experimental | Device: PICTURE-Pediatric scores and alertsThis arm will happen for two four-week periods. |
| Control Arm | Other | Other: Control Arm - Scores and alerts hiddenDuring the control arm, the PICTURE scores and alerts will not be shown. This arm will happen for two four-week periods. |
Who may qualify
- Ages
- 30 days to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (1 listed)
- Patients that do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICTURE-Pediatric scores and alertsPatients 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. | Device | PICTURE-Pediatric scores and alerts |
| Control Arm - Scores and alerts hiddenThe 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. | Other | Control Arm |
Primary outcome
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.
3 secondary outcomes
Acceptability of Intervention Measure (AIM)-clinicians
Time frame: At the end of the study (approximately 4 months after the start of the enrollment)
Intervention Appropriateness Measure (IAM)-clinicians
Time frame: At the end of the study (approximately 4 months after the start of the enrollment)
Feasibility of Intervention Measure (FIM)-clinicians
Time frame: At the end of the study (approximately 4 months after the start of the enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodney Daniels principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICTURE-Pediatric scores and alerts in people with Clinical Deterioration, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Semerad (734-647-4751, jsemerad@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.