Clinical trial NCT05034718: Implementation of the Pittsburgh Infant Brain Injury Score
Official title: Implementation of the Pittsburgh Infant Brain Injury Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Clinical Decision Support
Infant
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Beckwith Institute
First posted: 2021-09-05
Enrollment: 1989
Sex: ALL
Minimum age (years): 30
Maximum age (years): 364
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is an implementation study of the Pittsburgh Infant Brain Injury Score (PIBIS) into the UPMC Children's Hospital of Pittsburgh emergency department. Children less than 1 year of age presenting to the CHP ED for symptoms which place them at increased risk for AHT as defined in the PIBIS validation study will be potentially eligible.

Detailed description: Abusive head trauma is the leading cause of death due to physical abuse. Missing the diagnosis of abusive head trauma (AHT), particularly when it less severe is common and contributes to increased morbidity and mortality. Over the past 10 years, the investigators have derived and subsequently prospectively validated the Pittsburgh Infant Brain Injury Score (PIBIS), a point of care clinical decision rule to help physicians determine when it is appropriate to obtain neuroimaging in infants who present to the ED for evaluation of soft neurologic signs such as vomiting and fussiness. The results of the NIH multi-center prospective validation were published in 2016 in Pediatrics.

The next step in evaluating PIBIS as a clinical prediction rule is to perform an implementation study. Children less than 1 year of age presenting to the CHP ED for symptoms which place them at increased risk for AHT as defined in the PIBIS validation study will be potentially eligible.

Discrete fields in the electronic health record - including patient age, Emergency Severity Index (ESI), Glasgow Coma Scale (GCS) score, temperature and chief complaint - will be used to identify potentially eligible children in a systematic and efficient manner. Children who are potentially eligible based on this initial screen will trigger an alert to the nurse who will then complete a brief powerform to ensure eligibility and assess for inclusion/exclusion criteria. Due to the nature of the research, the investigators will seek a waiver of informed consent as has been done in similar studies at our institution and others. At this point, eligible children will be considered enrolled.

For children enrolled during the intervention period, providers will be presented with a detailed decision support strategy which encourages - but does not require - use of the PIBIS to make clinical decision re: the need for neuroimaging. For children enrolled during the control period, no other clinical decision support will occur. The duration of this evaluation period will be 24 months.

Eligibility criteria: Inclusion Criteria:

* Age 30 days to less than 1 year
* Chief complaint of Apnea, BRUE, Fussiness or Irritability, Lethargy, Neurologic complaint, Poor Feeding-Acute, Seizures/Spells, or Vomiting Alone
* First temperature in the ED less than or equal to 38.3C
* Acuity level/ESI of 3, 4, or 5

Exclusion Criteria:

* History of trauma related to this ED encounter
* Parent reported temperature of greater than 38.3C in the prior 24 hours
* Prior abnormal neuroimaging
* Previously enrolled in this study within preceding 28 days
* Provider preference for any reason

Primary outcomes:
measure: Eligibility confirmation
timeFrame: From enrollment to hospital discharge, up to one month
measure: Proportion of children with PIBIS calculation and recommendations
timeFrame: From enrollment to hospital discharge, up to one month
Secondary outcomes:
measure: Proportion of children who undergo neuroimaging (head CT or brain MRI) during the control and intervention periods
timeFrame: From enrollment to hospital discharge, up to one month
measure: Proportion of neuroimaging which demonstrates an abnormality during the control and intervention periods
timeFrame: From enrollment to hospital discharge, up to one month
measure: Proportion of all children with each PIBIS score who are ultimately diagnosed with physical abuse by the CHP Child Protection Team
timeFrame: From enrollment to hospital discharge, up to one month
measure: The number of enrolled children who return to the ED within 6 months of enrollment and undergo neuroimaging.
timeFrame: From enrollment to 6 months following hospital discharge
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rachel Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: