Predicting ICU Transfers and Other Unforeseen Events (PICTURE)-Pediatric
ConditionClinical Deterioration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-25
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥30 days and ≤25 years
Patient class: not emergency b. Patient level of care: not Intensive Care unit (ICU) c. Patient locations (per protocol)
Disqualifiers
Patients that do not meet the inclusion criteria
Trial design
Design model
Factorial
Treatments tested in this trial
PICTURE-Pediatric scores and alerts
DevicePatients 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 interventionThe 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.
Treatment groups
375 Participants
are divided into 2 treatment groupsGroup A: PICTURE-Pediatric scores and alertsExperimental treatment 1 intervention
Group B: Control ArmOther 1 intervention
Trial outcomes
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.
Time frame
within 30 minutes after each alert during a patient's admissionSecondary outcomes
1
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.
Time frame
At the end of the study (approximately 4 months after the start of the enrollment)2
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.
Time frame
At the end of the study (approximately 4 months after the start of the enrollment)3
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.
Time frame
At the end of the study (approximately 4 months after the start of the enrollment)Sponsors and contacts
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Source ClinicalTrials.gov