Pediatric Abusive Head Trauma
Conditions
Brief 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.
Detailed 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.
Interventions
OTHERApplication 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
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
The study statistician will remain blinded to PICU site group membership (control vs. intervention sites).
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites | To be measured 32 months after the start of the clinical trial | 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. |
| Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites | To be measured 32 months after the start of the clinical trial | 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). |
| The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites | To be measured 32 months after the start of the clinical trial | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites | To be measured 32 months after the start of the clinical trial | 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. |
| The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites | To be measured 32 months after the start of the clinical trial | 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. |
| The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield) | To be measured 32 months after the start of the clinical trial | 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. |
| The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites | To be measured 32 months after the start of the clinical trial | 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). |
| Estimated Prevalence of AHT at Intervention vs. Control Sites | To be measured 32 months after the start of the clinical trial | 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 \[patients with corroborating findings of abuse + estimated cases of missed AHT\] / \[all eligible patients in each arm of the trial\]. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Number of Potential Cases of Missed AHT at Intervention Sites | To be measured 32 months after the start of the clinical trial | 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. |
| 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) | To be measured 32 months after the start of the clinical trial | 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. |
| 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 | To be measured 32 months after the start of the clinical trial | 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. |
| The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Estimated Rate (Percentage) of Missed AHT at Intervention Sites | To be measured 32 months after the start of the clinical trial | 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. |
Countries
United States
Participant flow
Recruitment details
Participating PICUs were stratified based on projected patient volumes, matched into pairs, and allocated randomly to intervention (n=4) or control (n=4) conditions. Eligible participants were acutely head injured patients \<3 years admitted for intensive care (excluding MVA victims and patients with pre-existing brain abnormalities). Prospective data capture at all 8 participating PICUs began 1 August 2017 and ended 31 March 2020. For patients, the study was strictly observational.
Pre-assignment details
All eligible patients were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Sites At the four intervention sites, investigators will deploy active, multifaceted, implementation strategies designed to promote CDR acceptability and application as an AHT screening tool. 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.
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. | 183 |
| Control Sites At the four matched control sites, physicians will engage in AHT screening as usual. | 237 |
| Total | 420 |
Baseline characteristics
| Characteristic | Control Sites | Total | Intervention Sites |
|---|---|---|---|
| Age, Continuous | 8.7 Months STANDARD_DEVIATION 8.8 | 8.3 Months STANDARD_DEVIATION 8.1 | 7.7 Months STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 88 Participants | 109 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 269 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 22 Participants | 42 Participants | 20 Participants |
| Higher Risk | 175 participants | 333 participants | 158 participants |
| Lower Risk | 62 participants | 87 participants | 25 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 80 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 19 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 39 Participants | 25 Participants |
| Race (NIH/OMB) White | 174 Participants | 273 Participants | 99 Participants |
| Region of Enrollment United States | 237 participants | 420 participants | 183 participants |
| Sex: Female, Male Female | 87 Participants | 155 Participants | 68 Participants |
| Sex: Female, Male Male | 150 Participants | 265 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 183 | 0 / 237 |
| other Total, other adverse events | 0 / 183 | 0 / 237 |
| serious Total, serious adverse events | 0 / 183 | 0 / 237 |
Outcome results
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).
Time frame: To be measured 32 months after the start of the clinical trial
Population: From those patients deemed to be victims of AHT in each arm of the trial, this outcome estimates the proportion whose AHT may have been missed or unrecognized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites | 6 Participants |
| Control Sites | Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites | 14 Participants |
p-value: 0.2295% CI: [0.69, 5.13]Chi-squared
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.
Time frame: To be measured 32 months after the start of the clinical trial
Population: From all patients in each arm of the trial that the clinical prediction rule specified to be at higher risk for abuse, this outcome measures the proportion that were evaluated thoroughly for abuse with skeletal survey AND retinal exam by an ophthalmologist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites | 128 Participants |
| Control Sites | The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites | 128 Participants |
Comparison: We powered this hypothesis to detect a 17% increase (from 73% to 90%) in higher risk patients evaluated thoroughly for abuse at intervention sites, compared to baseline in prior PediBIRN studies. Generalized linear mixed-effects models were adopted to analyze 1,000 Monte Carlo datasets from simulation. For the target sample size of 304 higher risk patients (152 in each arm), the proportion of simulated datasets that yielded a statistically significant result for the primary hypothesis was 95.7%.p-value: 0.1195% CI: [0.37, 1.11]Chi-squared
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.
Time frame: To be measured 32 months after the start of the clinical trial
Population: From all patients in each arm of the trial that the clinical prediction rule specified to be at lower risk for abuse, this outcome measures the proportion that were (nevertheless) evaluated even partially for abuse with skeletal survey and/or retinal exam by an ophthalmologist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites | 17 Participants |
| Control Sites | The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites | 37 Participants |
p-value: 0.4995% CI: [0.24, 1.98]Chi-squared
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 \[patients with corroborating findings of abuse + estimated cases of missed AHT\] / \[all eligible patients in each arm of the trial\].
Time frame: To be measured 32 months after the start of the clinical trial
Population: From all eligible patients in each arm of the trial, this outcome estimates the proportion who were victims of AHT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | Estimated Prevalence of AHT at Intervention vs. Control Sites | 81 Participants |
| Control Sites | Estimated Prevalence of AHT at Intervention vs. Control Sites | 107 Participants |
p-value: 0.8695% CI: [0.7, 1.53]Chi-squared
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).
Time frame: To be measured 32 months after the start of the clinical trial
Population: From patients in each arm of the trial who are potential cases of missed abuse, this outcome measures the proportion of patients whose AHT may have been missed or unrecognized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites | 6 Participants |
| Control Sites | The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites | 14 Participants |
p-value: 0.7195% CI: [0.43, 3.49]Chi-squared
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.
Time frame: To be measured 32 months after the start of the clinical trial
Population: From all eligible patients in each arm of the trial, this outcome measures the proportion who were evaluated at least partially for abuse with skeletal survey and/or retinal examination by an ophthalmologist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites | 163 Participants |
| Control Sites | The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites | 189 Participants |
p-value: 0.0195% CI: [0.27, 0.85]Chi-squared
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.
Time frame: To be measured 32 months after the start of the clinical trial
Population: From all patients in each arm of the trial who underwent at least a partial evaluation for abuse, this outcome measures the proportion whose completed skeletal survey and/or retinal examination by an ophthalmologist revealed moderately or highly specific findings of abuse.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield) | 75 Participants |
| Control Sites | The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield) | 93 Participants |
p-value: 0.8495% CI: [0.46, 2.6]Chi-squared
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.
Time frame: To be measured 32 months after the start of the clinical trial
Population: From all eligible patients in each arm of the trial, this outcome measures the proportion of patients that are potential cases of missed AHT (i.e., patients not evaluated for abuse, and, patients with negative incomplete abuse evaluations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites | 38 Participants |
| Control Sites | The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites | 75 Participants |
p-value: 0.0595% CI: [1, 3.38]Chi-squared
Other Pre-specified
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.
Time frame: To be measured 32 months after the start of the clinical trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Estimated Rate (Percentage) of Missed AHT at Intervention Sites | 11 Participants |
| Control Sites | The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Estimated Rate (Percentage) of Missed AHT at Intervention Sites | 6 Participants |
p-value: 0.1495% CI: [0.16, 1.31]Chi-squared
Other Pre-specified
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.
Time frame: To be measured 32 months after the start of the clinical trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | 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 | 89 Participants |
| Control Sites | 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 | 128 Participants |
p-value: 0.0195% CI: [1.16, 3.52]Chi-squared
Other Pre-specified
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.
Time frame: To be measured 32 months after the start of the clinical trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Number of Potential Cases of Missed AHT at Intervention Sites | 68 Participants |
| Control Sites | The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Number of Potential Cases of Missed AHT at Intervention Sites | 38 Participants |
p-value: <0.00195% CI: [0.26, 0.67]Chi-squared
Post Hoc
The Estimated Rate (Percentage) of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies
This outcome facilitates comparison of the estimated rates (percentages) of missed AHT (among all patients with AHT) at intervention vs. control sites in prior strictly observational PediBIRN studies. It was calculated using precisely equivalent methods and data captured in comparable patient cohorts at the same eight sites between 2010 and 2013. The results provide context for interpreting estimated rates of missed AHT during the subsequent cluster randomized trial.
Time frame: To be measured 32 months after the start of the clinical trial.
Population: From those patients deemed to be victims of AHT, in prior PediBIRN studies, at the same PICU sites that are participating in each arm of the current trial, this outcome estimates the proportion whose AHT may have been missed or unrecognized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Estimated Rate (Percentage) of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies | 11 Participants |
| Control Sites | The Estimated Rate (Percentage) of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies | 7 Participants |
p-value: 0.5795% CI: [0.27, 2.05]Chi-squared
Other Pre-specified
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.
Time frame: To be measured 32 months after the start of the clinical trial
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | 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) | 181 Participants |
Post Hoc
The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies
This outcome measure facilitates comparison of the percentage of potential cases of missed AHT (among all eligible patients) in prior strictly observational PediBIRN studies at intervention vs. control sites. It was calculated using precisely equivalent methods and data captured in comparable patient cohorts at the same eight sites between 2010 and 2013. The results provide context for interpreting estimated rates of missed AHT during the subsequent cluster randomized trial.
Time frame: To be measured 32 months after the start of the clinical trial
Population: From all eligible patients hospitalized in prior PediBIRN studies at the same PICU sites participating in each arm of the current trial, this outcome measures the proportion who represent potential cases of missed AHT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Sites | The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies | 68 Participants |
| Control Sites | The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies | 48 Participants |
p-value: 0.0495% CI: [0.4, 0.99]Chi-squared