The CDR Implementation Trial

Milton S. Hershey Medical Center420 enrolled

Overview

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 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.

Conditions

Pediatric Abusive Head Trauma

Interventions

Application of a validated Clinical Decision Rule (CDR) as an AHT screening toolOTHER

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

Sex: ALLMax age: 3 Years

Medical Language ↔ Plain English

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.

Locations (8)

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

Outcomes

Primary Outcomes

The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites

This outcome measure facilitates a comparison of the percentage of patients that the clinical decision rule stratified as higher risk who were evaluated thoroughly for abuse (with both skeletal survey and retinal exam) at intervention vs. control sites. We hypothesized that thorough evaluations of higher risk patients would be significantly higher at intervention sites.