Clinical trial NCT03162354: The CDR Implementation Trial
Official title: Implementation Trial of a Validated Clinical Decision Rule for Pediatric Abusive Head Trauma (NIH Grant Number P50HD089922)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Abusive Head Trauma
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-05-22
Enrollment: 420
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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 higher risk vs. lower risk, and recommends thorough abuse evaluations for all higher 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites
timeFrame: To be measured 32 months after the start of the clinical trial
measure: The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites
timeFrame: To be measured 32 months after the start of the clinical trial
measure: Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites
timeFrame: To be measured 32 months after the start of the clinical trial
Secondary outcomes:
measure: The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites
timeFrame: To be measured 32 months after the start of the clinical trial
measure: The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield)
timeFrame: To be measured 32 months after the start of the clinical trial
measure: The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites
timeFrame: To be measured 32 months after the start of the clinical trial
measure: The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites
timeFrame: To be measured 32 months after the start of the clinical trial
measure: Estimated Prevalence of AHT at Intervention vs. Control Sites
timeFrame: To be measured 32 months after the start of the clinical trial
Other outcomes:
measure: The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention Sites
timeFrame: To be measured 32 months after the start of the clinical trial
measure: The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Number of Potential Cases of Missed AHT at Intervention Sites
timeFrame: To be measured 32 months after the start of the clinical trial
measure: The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Estimated Rate (Percentage) of Missed AHT at Intervention Sites
timeFrame: To be measured 32 months after the start of the clinical trial
measure: The Number of AHT Patients (Among All Patients With AHT) That the CDR Would Have Stratified as Higher Risk if the CDR Had Been Applied Accurately and Consistently (Aka the Clinical Decision Rule's Potential AHT Screening Sensitivity)
timeFrame: To be measured 32 months after the start of the clinical trial
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Wichita
country: United States
facility: Wesley Hospital
state: Kansas
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Cneter and Children's Hospital of Omaha
state: Nebraska
city: Houston
country: United States
facility: Texas Children's Hospital, Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: University of Texas health Sciences Center at San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Richmond
country: United States
facility: Children's Hospital of Richmond, Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Kent P. Hymel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.