Study Results
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View full resultsBasic Information
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COMPLETED
NA
420 participants
INTERVENTIONAL
2017-08-01
2020-03-31
Brief Summary
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Detailed Description
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The "CDR Implementation Trial" across eight PICUs will assess the CDR's actual impact on AHT screening accuracy. The stratified cluster randomized trial design will facilitate direct comparison of child abuse evaluations at four, randomly selected, control sites to four matched intervention sites, where investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application. These strategies will include physician training with onsite visits, monthly "booster training emails," access to an "AHT probability calculator," audit and site-specific feedback, and local "information sharing sessions" designed to address local barriers to CDR acceptance and application.
PediBIRN investigators will conduct the CDR Implementation Trial with three Specific Aims. Aim 1 is to assess the CDR's actual impact on AHT screening accuracy. Investigators hypothesize that deployment of CDR implementation strategies at the four intervention sites will be associated with higher percentages of higher risk patients evaluated thoroughly for abuse, and lower percentages of lower risk patients evaluated (even partially) for abuse. Aim 2 is to identify factors that impact CDR application in PICU settings. Investigators hypothesize that PICUs with higher patient volumes, providers with child abuse expertise, and providers with more intense exposure to CDR implementation strategies will be predictive of higher percentages of higher risk patients thoroughly evaluated for abuse, whereas patients of minority race or ethnicity will be predictive of higher percentages of lower risk patients evaluated for abuse. Investigators' third Exploratory Aim is to measure the sustained impacts of CDR implementation strategies. Investigators hypothesize that CDR utilization at intervention sites will be sustained twelve months after CDR implementation strategies have been discontinued.
Based on strong Preliminary Studies, investigators predict that CDR adoption as an AHT screening tool will increase AHT detection; reduce overall abuse evaluations and their associated risks; reduce unwarranted variation in current AHT screening practices; minimize the adverse impacts of doctors' inherent biases, uncertainty, and practice disparities; reduce AHT-associated acute health care costs in PICU settings; and save the lives of children who will be reinjured and killed if their AHT is missed or unrecognized.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Intervention Sites
At the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. These strategies will include physician training with onsite visits, monthly "booster training emails," access to an "AHT probability calculator," audit and site-specific feedback, and local "information sharing sessions" designed to address local barriers to CDR acceptance and application.
Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool
The Clinical Decision Rule (CDR) for AHT reads as follows:
Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered "high risk" and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture.
Control Sites
At the four matched control sites, physicians will engage in "AHT screening as usual."
No interventions assigned to this group
Interventions
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Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool
The Clinical Decision Rule (CDR) for AHT reads as follows:
Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered "high risk" and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients admitted to a PICU with acute head injuries and clear evidence on neuroimaging of pre-existing brain malformation, disease, infection, or hypoxia-ischemia.
3 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Kent Hymel
Child Abuse Pediatrician, Professor of Pediatrics
Principal Investigators
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Kent P. Hymel, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Connecticut Children's Medical Center
Hartford, Connecticut, United States
Wesley Hospital
Wichita, Kansas, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of Nebraska Medical Cneter and Children's Hospital of Omaha
Omaha, Nebraska, United States
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, United States
University of Texas health Sciences Center at San Antonio
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Hospital of Richmond, Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Hymel KP, Willson DF, Boos SC, Pullin DA, Homa K, Lorenz DJ, Herman BE, Graf JM, Isaac R, Armijo-Garcia V, Narang SK; Pediatric Brain Injury Research Network (PediBIRN) Investigators. Derivation of a clinical prediction rule for pediatric abusive head trauma. Pediatr Crit Care Med. 2013 Feb;14(2):210-20. doi: 10.1097/PCC.0b013e3182712b09.
Hymel KP, Armijo-Garcia V, Foster R, Frazier TN, Stoiko M, Christie LM, Harper NS, Weeks K, Carroll CL, Hyden P, Sirotnak A, Truemper E, Ornstein AE, Wang M; Pediatric Brain Injury Research Network (PediBIRN) Investigators. Validation of a clinical prediction rule for pediatric abusive head trauma. Pediatrics. 2014 Dec;134(6):e1537-44. doi: 10.1542/peds.2014-1329. Epub 2014 Nov 17.
Hymel KP, Herman BE, Narang SK, Graf JM, Frazier TN, Stoiko M, Christie LM, Harper NS, Carroll CL, Boos SC, Dias M, Pullin DA, Wang M; Pediatric Brain Injury Research Network (PediBIRN) Investigators; Pediatric Brain Injury Research Network PediBIRN Investigators. Potential Impact of a Validated Screening Tool for Pediatric Abusive Head Trauma. J Pediatr. 2015 Dec;167(6):1375-81.e1. doi: 10.1016/j.jpeds.2015.09.018. Epub 2015 Oct 23.
Hymel KP, Armijo-Garcia V, Musick M, Marinello M, Herman BE, Weeks K, Haney SB, Frazier TN, Carroll CL, Kissoon NN, Isaac R, Foster R, Campbell KA, Tieves KS, Livingston N, Bucher A, Woosley MC, Escamilla-Padilla D, Jaimon N, Kustka L, Wang M, Chinchilli VM, Dias MS, Noll J; Pediatric Brain Injury Research Network (PediBIRN) Investigators. A Cluster Randomized Trial to Reduce Missed Abusive Head Trauma in Pediatric Intensive Care Settings. J Pediatr. 2021 Sep;236:260-268.e3. doi: 10.1016/j.jpeds.2021.03.055. Epub 2021 Mar 31.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Website for "The CDR Implementation Trial"
Other Identifiers
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STUDY00005613
Identifier Type: -
Identifier Source: org_study_id