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| ID | Type | Description | Link |
|---|---|---|---|
| P50HD089922 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Sites | Experimental | 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. |
|
| Control Sites | No Intervention | At the four matched control sites, physicians will engage in "AHT screening as usual." |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kent P. Hymel, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States | ||
| Wesley Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23314183 | Background | 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. | |
| 25404722 | Background | 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. |
| Label | URL |
|---|---|
| Website for "The CDR Implementation Trial" | View source |
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All eligible patients were included in the analysis.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Sites | At the four matched control sites, physicians will engage in "AHT screening as usual." |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial |
|
32 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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CDR implementation supports may not have been delivered uniformly. We relied on imperfect patient-specific estimates of AHT probability to predict the results of abuse evaluations never completed. We failed to capture prospective data that might explain absent or incomplete abuse evaluations (e.g., early death). The trial was likely underpowered. Our results are not generalizable to non-PICU settings, to PICUs in non-academic centers, or to PICUs lacking access to CAP physicians.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kent P. Hymel, MD; Professor of Pediatrics; Study PI | Penn State College of Medicine, Penn State Health Children's Hospital | 7036748989 | kphymel@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2016 | Oct 14, 2020 | Prot_SAP_000.pdf |
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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.
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The study statistician will remain blinded to PICU site group membership (control vs. intervention sites).
|
| To be measured 32 months after the start of the clinical trial |
| 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 |
| 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 |
| 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 |
| 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 |
| To be measured 32 months after the start of the clinical trial |
| 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 |
| 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 |
| 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 |
| Wichita |
| Kansas |
| 67214 |
| United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| University of Nebraska Medical Cneter and Children's Hospital of Omaha | Omaha | Nebraska | 68114 | United States |
| Texas Children's Hospital, Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas health Sciences Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Children's Hospital of Richmond, Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| 26477871 | Background | 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. |
| 33798512 | Derived | Hymel KP, Armijo-Garcia V, Musick M, Marinello M, Herman BE, Weeks K, Haney SB, Frazier TN, Carroll CL, Kissoon NN, Isaac R, Foster R, Campbell KA, Tieves KS, Livingston N, Bucher A, Woosley MC, Escamilla-Padilla D, Jaimon N, Kustka L, Wang M, Chinchilli VM, Dias MS, Noll J; Pediatric Brain Injury Research Network (PediBIRN) Investigators. A Cluster Randomized Trial to Reduce Missed Abusive Head Trauma in Pediatric Intensive Care Settings. J Pediatr. 2021 Sep;236:260-268.e3. doi: 10.1016/j.jpeds.2021.03.055. Epub 2021 Mar 31. |
| BG001 | Control Sites | At the four matched control sites, physicians will engage in "AHT screening as usual." |
| BG002 | Total | Total of all reporting groups |
| Months |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Higher Risk | To reduce cases of missed or unrecognized abusive head trauma (AHT), Pediatric Brain Injury Research Network (PediBIRN) investigators derived and validated an AHT screening tool. The screening tool comes in the form of a directive, 4-variable, clinical decision rule (CDR). The "PediBIRN-4" CDR stratifies patients as "higher risk" vs. "lower risk" and recommends that every higher risk patient be thoroughly evaluated for abuse. Higher risk patients were those who presented for intensive care with any one or more of the CDR's four predictor variables. | Number | participants |
|
| Lower Risk | To reduce cases of missed or unrecognized abusive head trauma (AHT), Pediatric Brain Injury Research Network (PediBIRN) investigators derived and validated an AHT screening tool. The screening tool comes in the form of a directive, 4-variable, clinical decision rule (CDR). The "PediBIRN-4" CDR stratifies patients as "higher risk" vs. "lower risk." Lower risk patients were those who presented for intensive care with none of the CDR's four predictor variables. The CDR makes no recommendations regarding abuse evaluations of the patients it stratifies as lower risk. | Number | participants |
|
| OG001 | Control Sites | At the four matched control sites, physicians will engage in "AHT screening as usual." |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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"). | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 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). | 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. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial |
|
|
|
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| 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]. | From all eligible patients in each arm of the trial, this outcome estimates the proportion who were victims of AHT. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial |
|
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|
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| 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. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial |
|
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| 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. | 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. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial. |
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| 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. | 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. | Posted | Count of Participants | Participants | To be measured 32 months after the start of the clinical trial |
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| 0 |
| 183 |
| 0 |
| 183 |
| 0 |
| 183 |
| EG001 | Control Sites | At the four matched control sites, physicians will engage in "AHT screening as usual." | 0 | 237 | 0 | 237 | 0 | 237 |
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