Implementation of the Pittsburgh Infant Brain Injury Score

NCT05034718 | Completed

• 1 other identifier: STUDY21010197
• Study Type: interventional
• Target: 1,989
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury; Clinical Decision Support; Infant

Outcome Measures

Primary Outcomes (2)

• 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 1. have a PIBIS score calculated and 2. 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 Outcomes (4)

• Proportion of children 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

  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

  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.

  From enrollment to 6 months following hospital discharge

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Completion of nurse powerform and data collection only.

Other: Standard of care

Intervention Arm

EXPERIMENTAL

Completion of nurse powerform, data collection and physician alert/powerform with score calculation and recommendations.

Other: PIBIS clinical decision support

Interventions

PIBIS clinical decision support OTHER

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.

Intervention Arm

Standard of care OTHER

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

Control Arm

Eligibility Criteria

• Age: 30 Days - 364 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Beckwith Institute: collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rachel Berger, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 5, 2021
• Study Start: July 5, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)