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The CDR Implementation Trial

NCT03162354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2020-12-16

Study results available
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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.

Conditions

  • Pediatric Abusive Head Trauma

Interventions

OTHER

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Kent P. Hymel, MD · Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03162354 on ClinicalTrials.gov