Brain InjuryPIBISNCT05034718
Implementation of the Pittsburgh Infant Brain Injury Score
A study testing PIBIS clinical decision support in people with Brain Injury and Clinical Decision Support, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 30 to 364 days
- Conditions the study is for
- Brain Injury, Clinical Decision Support, Infant
- What is being tested?
- PIBIS clinical decision support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,989 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 364 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
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.
Read the 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
- Being tested
- PIBIS clinical decision support, Standard of care
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIBIS clinical decision supportOther
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 careOther
Standard of care, absent the PIBIS powerform and alert for providers.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Completion of nurse powerform and data collection only. Receives: Other: Standard of care |
| Intervention Arm | Experimental | Completion of nurse powerform, data collection and physician alert/powerform with score calculation and recommendations. Receives: Other: PIBIS clinical decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
The proportion of children eligible for PIBIS who undergo neuroimaging (head CT or brain MRI) during the control and intervention periods
Measured: 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
Measured: 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
Measured: 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.
Measured: From enrollment to 6 months following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,989 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Beckwith Institute
- Responsible party
- Principal investigator, Rachel Berger MD, MPH, University of Pittsburgh
- Investigators
- Rachel Berger, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034718
- Sponsor's protocol ID
- STUDY21010197
- Acronym
- PIBIS
- Status last verified
- Jun 2024
- First submitted
- 29 Jul 2021
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Pittsburgh Infant Brain Injury Score
- ClinicalTrials.gov ID
- NCT05034718
- Acronym / sponsor ID
- PIBIS / STUDY21010197
- Conditions
- Brain Injury, Clinical Decision Support, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,989 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Beckwith Institute
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Standard of careCompletion of nurse powerform and data collection only. |
| Intervention Arm | Experimental | Other: PIBIS clinical decision supportCompletion of nurse powerform, data collection and physician alert/powerform with score calculation and recommendations. |
Who may qualify
- Ages
- 30 to 364 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIBIS clinical decision supportThe 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. | Other | Intervention Arm |
| Standard of careStandard of care, absent the PIBIS powerform and alert for providers. | Other | Control Arm |
Primary outcome
Eligibility confirmation
Time frame: From enrollment to hospital discharge, up to one month
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
Time frame: From enrollment to hospital discharge, up to one month
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).
4 secondary outcomes
Proportion of children 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
Proportion of neuroimaging which demonstrates an abnormality during the control and intervention periods
Time frame: 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
Time frame: 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.
Time frame: From enrollment to 6 months following hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Berger, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIBIS clinical decision support in people with Brain Injury and Clinical Decision Support, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility confirmation (time frame: From enrollment to hospital discharge, up to one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.