Implementation of the Pittsburgh Infant Brain Injury Score

NCT ID: NCT05034718

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1989 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2023-12-31

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.

Conditions

Brain Injury; Clinical Decision Support; Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control Arm

Completion of nurse powerform and data collection only.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

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

Intervention Arm

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

Group Type: EXPERIMENTAL

PIBIS clinical decision support

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Standard of care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 364 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Beckwith Institute

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Rachel Berger MD, MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Berger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY21010197

Identifier Type: -

Identifier Source: org_study_id