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Implementation of the Pittsburgh Infant Brain Injury Score (PIBIS)

Primary Purpose

Brain Injury, Clinical Decision Support, Infant

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PIBIS clinical decision support
Standard of care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Brain Injury

Eligibility Criteria

30 Days - 364 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Arm

Intervention Arm

Arm Description

Completion of nurse powerform and data collection only.

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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
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
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
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.

Full Information

First Posted
July 29, 2021
Last Updated
July 11, 2023
Sponsor
University of Pittsburgh
Collaborators
The Beckwith Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05034718
Brief Title
Implementation of the Pittsburgh Infant Brain Injury Score
Acronym
PIBIS
Official Title
Implementation of the Pittsburgh Infant Brain Injury Score
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
The Beckwith Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Clinical Decision Support, Infant

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
609 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Completion of nurse powerform and data collection only.
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Completion of nurse powerform, data collection and physician alert/powerform with score calculation and recommendations.
Intervention Type
Other
Intervention Name(s)
PIBIS clinical decision support
Intervention Description
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 Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care, absent the PIBIS powerform and alert for providers.
Primary Outcome Measure Information:
Title
Eligibility confirmation
Description
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.
Time Frame
From enrollment to hospital discharge, up to one month
Title
Proportion of children with PIBIS calculation and recommendations
Description
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).
Time Frame
From enrollment to hospital discharge, up to one month
Secondary Outcome Measure Information:
Title
Proportion of children who undergo neuroimaging (head CT or brain MRI) during the control and intervention periods
Description
The proportion of children eligible for PIBIS who undergo neuroimaging (head CT or brain MRI) during the control and intervention periods
Time Frame
From enrollment to hospital discharge, up to one month
Title
Proportion of neuroimaging which demonstrates an abnormality during the control and intervention periods
Description
Proportion of neuroimaging which demonstrates an abnormality during the control and intervention periods
Time Frame
From enrollment to hospital discharge, up to one month
Title
Proportion of all children with each PIBIS score who are ultimately diagnosed with physical abuse by the CHP Child Protection Team
Description
Proportion of all children with each PIBIS score who are ultimately diagnosed with physical abuse by the CHP Child Protection Team
Time Frame
From enrollment to hospital discharge, up to one month
Title
The number of enrolled children who return to the ED within 6 months of enrollment and undergo neuroimaging.
Description
The number of enrolled children who return to the ED within 6 months of enrollment and undergo neuroimaging.
Time Frame
From enrollment to 6 months following hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
364 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Berger, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Implementation of the Pittsburgh Infant Brain Injury Score

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