Trial Outcomes & Findings for The CDR Implementation Trial (NCT NCT03162354)

NCT ID: NCT03162354

Last Updated: 2020-12-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 420 participants
• Primary outcome timeframe: To be measured 32 months after the start of the clinical trial
• Results posted on: 2020-12-16

Participant Flow

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.

All eligible patients were included in the analysis.

Unit of analysis: Pediatric intensive care units

Participant milestones

Measure	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.	Control Sites At the four matched control sites, physicians will engage in "AHT screening as usual."
Overall Study STARTED	183 4	237 4
Overall Study COMPLETED	183 4	237 4
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The CDR Implementation Trial

Baseline characteristics by cohort

Measure	Intervention Sites n=183 Participants 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.	Control Sites n=237 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."	Total n=420 Participants Total of all reporting groups
Age, Continuous	7.7 Months STANDARD_DEVIATION 7.2 • n=5 Participants	8.7 Months STANDARD_DEVIATION 8.8 • n=7 Participants	8.3 Months STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	87 Participants n=7 Participants	155 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants	150 Participants n=7 Participants	265 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	88 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	142 Participants n=5 Participants	127 Participants n=7 Participants	269 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants	37 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) White	99 Participants n=5 Participants	174 Participants n=7 Participants	273 Participants n=5 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	14 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	183 participants n=5 Participants	237 participants n=7 Participants	420 participants n=5 Participants
Higher Risk	158 participants n=5 Participants	175 participants n=7 Participants	333 participants n=5 Participants
Lower Risk	25 participants n=5 Participants	62 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention Sites n=158 Participants 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.	Control Sites n=175 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Number of Higher Risk Patients Evaluated Thoroughly for Abuse at Intervention vs. Control Sites	128 Participants	128 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention Sites n=25 Participants 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.	Control Sites n=62 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Number of Lower Risk Patients Evaluated Even Partially for Abuse at Intervention vs. Control Sites	17 Participants	37 Participants

PRIMARY outcome

Timeframe: 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.

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").

Outcome measures

Measure	Intervention Sites n=81 Participants 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.	Control Sites n=107 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
Estimated Rates (Percentages) of Missed AHT at Intervention vs. Control Sites	6 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention Sites n=183 Participants 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.	Control Sites n=237 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Number of Patients Evaluated at Least Partially for Abuse at Intervention vs. Control Sites	163 Participants	189 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention Sites n=163 Participants 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.	Control Sites n=189 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Number of Patients With Corroborating Findings of Abuse at Intervention vs. Control Sites (Aka Overall Diagnostic Yield)	75 Participants	93 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention Sites n=183 Participants 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.	Control Sites n=237 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites	38 Participants	75 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Intervention Sites n=38 Participants 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.	Control Sites n=75 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Number of Estimated Patients With Missed AHT at Intervention vs. Control Sites	6 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

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].

Outcome measures

Measure	Intervention Sites n=183 Participants 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.	Control Sites n=237 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
Estimated Prevalence of AHT at Intervention vs. Control Sites	81 Participants	107 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Intervention Sites n=132 Participants 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.	Control Sites n=158 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
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	128 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Intervention Sites n=172 Participants 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.	Control Sites n=183 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
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	38 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Intervention Sites n=74 Participants 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.	Control Sites n=81 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Change (From Prior PediBIRN Studies to the Current Clinical Trial) in the Estimated Rate (Percentage) of Missed AHT at Intervention Sites	11 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Intervention Sites n=188 Participants 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.	Control Sites At the four matched control sites, physicians will engage in "AHT screening as usual."
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention Sites n=74 Participants 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.	Control Sites n=61 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Estimated Rate (Percentage) of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies	11 Participants	7 Participants

POST_HOC outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention Sites n=172 Participants 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.	Control Sites n=165 Participants At the four matched control sites, physicians will engage in "AHT screening as usual."
The Number of Potential Cases of Missed AHT at Intervention vs. Control Sites in Prior PediBIRN Studies	68 Participants	48 Participants

Adverse Events

Intervention Sites

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Sites

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kent P. Hymel, MD; Professor of Pediatrics; Study PI

Penn State College of Medicine, Penn State Health Children's Hospital

Phone: 7036748989

Email: kphymel@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place