The CDR Implementation Trial



Status:Enrolling by invitation
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any - 3
Updated:8/24/2018
Start Date:August 1, 2017
End Date:January 31, 2021

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Implementation Trial of a Validated Clinical Decision Rule for Pediatric Abusive Head Trauma (NIH Grant Number P50HD089922)

To increase the accuracy of doctors' decisions to launch or forgo child abuse evaluations in
their young, acutely head-injured patients, investigators have derived and validated a
clinical decision rule (CDR) that detects abusive head trauma (AHT) with 96% sensitivity in
pediatric intensive care unit (PICU) settings. This "CDR Implementation Trial" across eight
PICU sites will assess the CDR's actual impact on AHT screening accuracy, identify factors
associated with maximal physician acceptance and application of this novel AHT screening
tool, and assess the sustainability of active CDR implementation strategies.

Investigators' long-term goal is to increase the accuracy of doctors' decisions to launch or
forgo child abuse evaluations in their young, acutely head-injured patients. To this end,
PediBIRN investigators have derived and validated a 4-variable clinical decision rule (CDR)
that detects abusive head trauma (AHT) with 96% sensitivity in PICU settings. Applied at PICU
admission, the CDR categorizes young, acutely head-injured patients as high risk vs. low
risk, and recommends thorough abuse evaluations for all high risk patients.

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 high risk patients evaluated thoroughly for
abuse, and lower percentages of low 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 high risk patients thoroughly evaluated for abuse, whereas patients of
minority race or ethnicity will be predictive of higher percentages of low 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.

Inclusion Criteria:

- Children under 3 years of age admitted to a PICU for management of symptomatic, acute,
closed, traumatic, cranial, or intracranial injuries confirmed by computed tomography
(CT) or magnetic resonance imaging (MRI).

Exclusion Criteria:

- Patients admitted to a PICU with acute head injuries resulting from a collision
involving a motor vehicle.

- Patients admitted to a PICU with acute head injuries and clear evidence on
neuroimaging of pre-existing brain malformation, disease, infection, or
hypoxia-ischemia.
We found this trial at
8
sites
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Houston, TX
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Omaha, NE
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1000 East Broad Street
Richmond, Virginia 23298
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Richmond, VA
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Salt Lake City, Utah 84143
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San Antonio, TX
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Wichita, Kansas 67214
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Wichita, KS
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