Implementation of the Pittsburgh Infant Brain Injury Score

Brain Injury Clinical Trial

— PIBIS  

Official title:

Implementation of the Pittsburgh Infant Brain Injury Score

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05034718
• Other study ID #: STUDY21010197
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 609
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Days to 364 Days

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Clinical Decision Support
• Infant
• Wounds and Injuries

Intervention

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.
• Standard of care
Standard of care, absent the PIBIS powerform and alert for providers.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	The Beckwith Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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