# STRATIFIED CLUSTER RANDOMIZED TRIAL (SCRT) OF A CLINICAL DECISION RULE (CDR) FOR ABUSIVE HEAD TRAUMA (AHT)

> **NIH NIH P50** · PENNSYLVANIA STATE UNIVERSITY, THE · 2021 · $90,790

## Abstract

Abusive head trauma (AHT) is the leading cause of traumatic death and disability in early childhood, affecting 
at least 690,000 children annually in the United States. AHT is missed or unrecognized in 30% of head-injured 
children and more than 25% of children with unrecognized AHT suffered additional inflicted injuries. Ten 
percent of children with unrecognized AHT subsequently died or were killed—80% of whom could have been 
saved by earlier recognition of abuse.8 A flawed decision to launch an abuse evaluation can increase parental 
stress, expose the child to additional risks, prolong hospital stays, and increase health care costs.9,10 Doctors 
who care for young victims of trauma must make important decisions to launch or forgo child-abuse 
evaluations when presented with head-injured children. These decisions can be difficult, and the stakes are 
high. Unfortunately, doctors routinely struggle to define a “reasonable suspicion” of abuse and have 
demonstrated inherent biases related to child age, race, marital status, and socioeconomic status. The 
principal investigator (Hymel) conceptualized, designed, and directed sequential multicenter studies to derive 
and validate an effective AHT screening tool in the form of a clinical decision rule (CDR)—an evidence-based 
tool developed specifically to guide a discrete decision in the continuum of AHT care. Though the CDR has 
shown promise in preliminary studies, it has not yet been subjected to a formal randomized trial, which is the 
purpose of this project. The proposed CDR trial will demonstrate the CDR's impact on AHT screening 
accuracy, hypothesizing that CDR application will increase AHT detection and reduce unnecessary abuse 
evaluations. We will conduct a stratified cluster randomized trial (SCRT) at eight US pediatric intensive care 
units (PICUs) randomly assigned to intervention (n = 4) or control (n = 4) conditions. The SCRT will compare 
AHT screening accuracy after the deployment of active multifaceted implementation strategies designed to 
promote CDR acceptance, utilization, and accuracy at the intervention sites (Aim 1). In addition, the SCRT will 
determine what—if any—site-, provider-, and patient-specific factors predict CDR application in PICU settings 
(Aim 2). Once the SCRT has concluded, we will conduct a 12-month sustainability trial at intervention sites, 
systematically repealing the implementation strategies one by one to discern their relative importance to 
sustainability (Exploratory Aim 3). We anticipate that this simple, inexpensive, and reliable CDR will decrease 
the negative impacts of physicians' inherent biases and practice disparities, significantly increase AHT 
detection, decrease unnecessary abuse evaluations (and their associated risks), and reduce AHT-associated 
healthcare costs. Most importantly, the CDR will save lives—the lives of children who will otherwise suffer 
additional fatal inflicted injuries if/when their AHT is missed or unrecognized...

## Key facts

- **NIH application ID:** 10187609
- **Project number:** 5P50HD089922-05
- **Recipient organization:** PENNSYLVANIA STATE UNIVERSITY, THE
- **Principal Investigator:** Kent P Hymel
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $90,790
- **Award type:** 5
- **Project period:** 2017-04-20 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10187609

## Citation

> US National Institutes of Health, RePORTER application 10187609, STRATIFIED CLUSTER RANDOMIZED TRIAL (SCRT) OF A CLINICAL DECISION RULE (CDR) FOR ABUSIVE HEAD TRAUMA (AHT) (5P50HD089922-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10187609. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
