N/A
N=420
The CDR Implementation Trial
Pediatric Abusive Head Trauma
Bottom Line
View on ClinicalTrials.gov: NCT03162354 ↗Enrolled (actual)
420
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites — 128; 128 Participants — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites |
128; 128 | 0.11 |
| PRIMARY The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites |
17; 37 | 0.49 |
| PRIMARY Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites |
6; 14 | 0.22 |
| SECONDARY The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites |
163; 189 | 0.01 sig |
| SECONDARY The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield) |
75; 93 | 0.84 |
| SECONDARY The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites |
38; 75 | 0.05 |
| SECONDARY The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites |
6; 14 | 0.71 |
| SECONDARY Estimated Prevalence of AHT at Intervention vs. Control Sites |
81; 107 | 0.86 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03162354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.