Implementation of the Pittsburgh Infant Brain Injury Score (PIBIS)

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.

Study Overview

• Status: Completed
• Conditions: Brain Injury; Infant; Clinical Decision Support
• Intervention / Treatment: Other: Standard of care; Other: PIBIS clinical decision support

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.

• Study Type: Interventional
• Enrollment (Actual): 1989
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 11 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; Completion of nurse powerform and data collection only.	Other: Standard of care; Standard of care, absent the PIBIS powerform and alert for providers.
Experimental: Intervention Arm; Completion of nurse powerform, data collection and physician alert/powerform with score calculation and recommendations.	Other: PIBIS clinical decision support; The intervention is the presence of the PIBIS physician alert and powerform, which is clinical decision support for the treating provider if a patient meets inclusion criteria for Pittsburgh Infant Brain Injury Score (PIBIS) calculation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eligibility confirmation	Children identified as eligible by Cerner and confirmed by the nurse powerform as eligible for PIBIS will also be determined to be eligible after chart review and discussion with the clinician (which is how eligibility was determined during the validation study). The primary outcome will be the concordance between these two methods of determining eligibility. A concordance of >90% is the goal.	From enrollment to hospital discharge, up to one month
Proportion of children with PIBIS calculation and recommendations	The proportion of children eligible for PIBIS who; have a PIBIS score calculated and; in whom the provider follows the recommendation by PIBIS OR documents in the EHR the clinical reasoning why they are NOT following the recommendation (e.g. patient being admitted, in-patient team will make decision).	From enrollment to hospital discharge, up to one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children who undergo neuroimaging (head CT or brain MRI) during the control and intervention periods	The proportion of children eligible for PIBIS who undergo neuroimaging (head CT or brain MRI) during the control and intervention periods	From enrollment to hospital discharge, up to one month
Proportion of neuroimaging which demonstrates an abnormality during the control and intervention periods	Proportion of neuroimaging which demonstrates an abnormality during the control and intervention periods	From enrollment to hospital discharge, up to one month
Proportion of all children with each PIBIS score who are ultimately diagnosed with physical abuse by the CHP Child Protection Team	Proportion of all children with each PIBIS score who are ultimately diagnosed with physical abuse by the CHP Child Protection Team	From enrollment to hospital discharge, up to one month
The number of enrolled children who return to the ED within 6 months of enrollment and undergo neuroimaging.	The number of enrolled children who return to the ED within 6 months of enrollment and undergo neuroimaging.	From enrollment to 6 months following hospital discharge

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: The Beckwith Institute
• Investigators: Principal Investigator: Rachel Berger, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 29, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: STUDY21010197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No