The CDR Implementation Trial

Pediatric Abusive Head Trauma Clinical Trial

Official title:

Implementation Trial of a Validated Clinical Decision Rule for Pediatric Abusive Head Trauma (NIH Grant Number P50HD089922)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162354
• Other study ID #: STUDY00005613
• Secondary ID: P50HD089922
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: November 2020
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Pediatric Abusive Head Trauma

Intervention

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.

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Texas Children's Hospital, Baylor College of Medicine	Houston	Texas
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Nebraska Medical Cneter and Children's Hospital of Omaha	Omaha	Nebraska
United States	Children's Hospital of Richmond, Virginia Commonwealth University	Richmond	Virginia
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	University of Texas health Sciences Center at San Antonio	San Antonio	Texas
United States	Wesley Hospital	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	This outcome measure facilitates a comparison of the percentage of higher risk patients evaluated thoroughly for abuse (with skeletal survey AND retinal examination) at intervention sites in prior strictly observational PediBIRN studies vs. the current cluster randomized trial. It was calculated using precisely equivalent methods and data captured prospectively between 2010 and 2013 in comparable patient cohorts at the same four intervention sites.	To be measured 32 months after the start of the clinical trial
Other	The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Number of Potential Cases of Missed AHT at Intervention Sites	This outcome measure facilitates a comparison of the percentage of potential cases of missed AHT (among all eligible patients) at intervention sites in prior strictly observational PediBIRN studies vs. the current cluster randomized trial. It was calculated using precisely equivalent methods and data captured prospectively between 2010 and 2013 in comparable patient cohorts at the same four intervention sites.	To be measured 32 months after the start of the clinical trial
Other	The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Estimated Rate (Percentage) of Missed AHT at Intervention Sites	This outcome measure facilitates a comparison of the estimated rate (percentage) of missed AHT (among all patients with AHT) at intervention sites in prior strictly observational PediBIRN studies vs. the current cluster randomized trial. It was calculated using precisely equivalent methods and data captured prospectively between 2010 and 2013 in comparable patient cohorts at the same four intervention sites.	To be measured 32 months after the start of the clinical trial
Other	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)	This outcome measure facilitates estimation of the clinical decision rule's potential AHT screening sensitivity IF it had been applied accurately and consistently across all eight participating sites. It was calculated based on the following assumptions: (1) All higher risk patients were evaluated thoroughly for abuse with skeletal survey AND retinal exam by an ophthalmologist; Therefore, all cases of AHT among higher risk patients were recognized, and (2) Abuse evaluations were deferred in all lower risk patients; Therefore, all cases of AHT among lower risk patients were missed or unrecognized.	To be measured 32 months after the start of the clinical trial
Primary	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.	To be measured 32 months after the start of the clinical trial
Primary	The Number of Lower Risk Patients Evaluated Even Partially 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 lower risk who were nevertheless evaluated at least partially for abuse (with skeletal survey and/or retinal examination) at intervention vs. control sites. We hypothesized that (partial or complete) abuse evaluations of lower risk patients would be significantly lower at intervention sites.	To be measured 32 months after the start of the clinical trial
Primary	Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites	This outcome measures and compares estimated rates (percentages) of missed AHT (among all patients with AHT) at intervention vs. control sites. Using secondary outcome measures, it was calculated as [estimated cases of missed AHT] / [estimated cases of missed AHT + patients with corroborating findings of abuse]. We hypothesized that the estimated rate of missed AHT would be significantly lower at intervention sites. This outcome measure is best interpreted in the following contexts: (1) Applied accurately and consistently, the clinical decision rule's potential sensitivity for AHT is 96% (see references). That is, it should "miss" (categorize as lower risk) only 4% of AHT patients, and (2) We estimate that intervention and control site physicians "missed" 15% and 11% of their AHT patients, respectively, in prior PediBIRN studies (see the Post-Hoc Outcome "The Estimated Rate of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies").	To be measured 32 months after the start of the clinical trial
Secondary	The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites	This outcome measure facilitates a comparison of the percentage of patients evaluated at least partially for abuse (with skeletal survey and/or retinal examination) at intervention vs. control sites. Thus, it facilitates a broad-based comparison of AHT evaluation practices at intervention vs. control sites.	To be measured 32 months after the start of the clinical trial
Secondary	The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield)	This outcome measure facilitates a comparison of the percentage of patients whose completed skeletal surveys and/or retinal exams revealed findings considered moderately or highly specific for abuse at intervention vs. control sites. Thus, it is also a measure of the overall diagnostic yield of patients' completed skeletal surveys and retinal examinations.	To be measured 32 months after the start of the clinical trial
Secondary	The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites	This outcome measure facilitates a comparison of the percentage of eligible patients who might be potential cases of missed AHT (that is, patients lacking skeletal survey and/or retinal exam, whose abuse evaluation is therefore incomplete) at intervention vs. control sites.	To be measured 32 months after the start of the clinical trial
Secondary	The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites	This outcome measure facilitates a comparison of the estimated percentage of patients with missed AHT (among potential cases of missed AHT) at intervention vs. control sites. It was calculated as [potential cases of missed AHT] x [their mean estimate of abuse probability]. The patient-specific estimates of abuse probability used to calculate the mean estimates were accessed by applying the 4-variable rule as a clinical prediction tool (rather than a directive decision rule).	To be measured 32 months after the start of the clinical trial
Secondary	Estimated Prevalence of AHT at Intervention vs. Control Sites	This outcome measure facilitates a comparison of the estimated prevalence of AHT (among all eligible patients) at intervention vs. control sites. It was calculated as [patients with corroborating findings of abuse + estimated cases of missed AHT] / [all eligible patients in each arm of the trial].	To be measured 32 months after the start of the clinical trial

External Links

•   Website for "The CDR Implementation Trial"